Trial Outcomes & Findings for A Study of t:Slim X2 With Control-IQ Technology (NCT NCT03844789)
NCT ID: NCT03844789
Last Updated: 2023-04-10
Results Overview
The primary outcome for the first phase is percent of time participants spent in blood sugar target range 70-180 mg/dL as measured by CGM in Closed Loop Control (CLC) group vs. Control Group. Larger percentages of time spent in this range is considered to be a desirable outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
101 participants
Primary outcome timeframe
From randomization to data collection completion at the end of 16 weeks
Results posted on
2023-04-10
Participant Flow
Between June 21, 2019, and August 30, 2019, a total of 101 patients (19 to 28 per trial site) were randomly assigned to the closed-loop group (78 patients) or the control group (23 patients).
Participant milestones
| Measure |
Closed Loop Control (CLC)
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be use t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM.
|
Control Group
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
|---|---|---|
|
Main Study
STARTED
|
78
|
23
|
|
Main Study
16 Week Main Study
|
78
|
22
|
|
Main Study
COMPLETED
|
78
|
22
|
|
Main Study
NOT COMPLETED
|
0
|
1
|
|
Extension Study
STARTED
|
78
|
22
|
|
Extension Study
COMPLETED
|
78
|
22
|
|
Extension Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of t:Slim X2 With Control-IQ Technology
Baseline characteristics by cohort
| Measure |
Closed Loop Control (CLC)
n=78 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Standard of Care
n=23 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Ages 6 to 9
|
21 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Age, Customized
Ages 10 to 13
|
57 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White, non-Hispanic
|
64 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
HIspanic or Latino
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African-American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Diabetes Duration
1 to 4 years
|
42 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Diabetes Duration
5 to 10 years
|
28 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Diabetes Duration
More than 10 years
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Insulin Modality
Insulin Pump
|
62 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Insulin Modality
Multiple Daily Injection (MDI)
|
16 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Prior Continuous Glucose Monitor Use
Never
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Prior Continuous Glucose Monitor Use
In past, but not current
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Prior Continuous Glucose Monitor Use
Current
|
72 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Body Mass Index (BMI) Z-score
|
0.4 Z-score
STANDARD_DEVIATION 1.0 • n=5 Participants
|
0.5 Z-score
STANDARD_DEVIATION 1.0 • n=7 Participants
|
0.45 Z-score
STANDARD_DEVIATION 1.0 • n=5 Participants
|
|
Parents Education
≤H.S. Diploma
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Parents Education
Associates Degree or Some College but no Degree
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Parents Education
Bachelor's Degree
|
32 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Parents Education
Master's Degree
|
34 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Parents Education
Doctoral or Prof Degree
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Annual Household Income
<$25,000
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Annual Household Income
$25,000 - <$35,000
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Annual Household Income
$35,000 - <$50,000
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Annual Household Income
$50,000 - <$75,000
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Annual Household Income
$75,000 - <$100,000
|
13 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Annual Household Income
$100,000 - <$200,000
|
27 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Annual Household Income
≥$200,000
|
26 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Annual Household Income
Missing Data
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Health Insurance
Private
|
70 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Health Insurance
CHP or other government sponsored/Medicaid
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Health Insurance
Military
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Health Insurance
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Health Insurance
None
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
HbA1c Local Lab at Screening
<8.0%
|
50 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
HbA1c Local Lab at Screening
8.0%<9.0%
|
18 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
HbA1c Local Lab at Screening
≥9.0%
|
10 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
HbA1c Central Lab at Randomization
<8.0%
|
50 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
HbA1c Central Lab at Randomization
8.0%<9.0%
|
20 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
HbA1c Central Lab at Randomization
≥9.0%
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Total Daily Insulin
|
0.89 Units of Insulin per kg per day
STANDARD_DEVIATION 0.24 • n=5 Participants
|
0.94 Units of Insulin per kg per day
STANDARD_DEVIATION 0.24 • n=7 Participants
|
0.92 Units of Insulin per kg per day
STANDARD_DEVIATION 0.24 • n=5 Participants
|
|
C-peptide (nmol/L)
<0.2 nmol/L
|
72 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
C-peptide (nmol/L)
≥0.2 nmol/L
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Diabetic Ketoacidosis (DKA) in Last 12 Months
No DKA events in the last 12 months
|
74 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Diabetic Ketoacidosis (DKA) in Last 12 Months
1 DKA event in the last 12 months
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Diabetic Ketoacidosis (DKA) in Last 12 Months
2 DKA events in the last 12 months
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Severe Hypoglycemia (SH) in Last 12 Months
|
78 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization to data collection completion at the end of 16 weeksPopulation: One participant in the control group was missing follow-up data.
The primary outcome for the first phase is percent of time participants spent in blood sugar target range 70-180 mg/dL as measured by CGM in Closed Loop Control (CLC) group vs. Control Group. Larger percentages of time spent in this range is considered to be a desirable outcome.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=78 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=22 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
Continuous Glucose Monitor (CGM)-Measured Percent Time in Range 70-180mg/dL Over 16 Week Trial Period
|
67 Percentage of Time
Standard Deviation 10
|
55 Percentage of Time
Standard Deviation 13
|
—
|
—
|
SECONDARY outcome
Timeframe: From randomization to data collection completion at the end of 16 weeksContinuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. Smaller percentages of CGM-measured time above 180 mg/dL is considered a positive outcome.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=78 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=22 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
CGM-Measured Percent of Time Above 180 mg/dL Over 16 Week Trial Period
|
31 Percentage of Time
Standard Deviation 10
|
43 Percentage of Time
Standard Deviation 14
|
—
|
—
|
SECONDARY outcome
Timeframe: From randomization to data collection completion at the end of 16 weeksContinuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM metrics were calculated by pooling all CGM readings in the 16-week period starting from the randomization visit up through the 16 week visit. If a participant dropped out before completing the 16-week visit, all available data through the last visit date was included for calculating CGM metrics. Minimum 168 hours of CGM data was required to calculate CGM metrics. Lower mean glucose numbers as measured by CGM in mg/dL is considered a positive outcome.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=78 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=22 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
CGM-Measured Mean Glucose Over 16 Week Trial Period
|
162 mg/dL
Standard Deviation 18
|
179 mg/dL
Standard Deviation 26
|
—
|
—
|
SECONDARY outcome
Timeframe: At data collection completion at the end of 16 weeksGlycated Hemoglobin A1C (HbA1c) is a physiological marker of the percentage of red blood cells that have glycated (bonded with a sugar). HbA1c is used to measure changes in average blood sugar over the past three months. 5-6% is normal, 7% and above is correlated with negative long-term health outcomes.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=78 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=22 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
Glycated Hemoglobin A1C (HbA1c) Percent at End Of 16 Week Trial Period
|
7.0 Percent of Hemoglobin that was Glycated
Standard Deviation 0.8
|
7.6 Percent of Hemoglobin that was Glycated
Standard Deviation 0.9
|
—
|
—
|
SECONDARY outcome
Timeframe: From randomization to data collection completion at the end of 16 weeksContinuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM measured blood sugar values below 70 mg/dL are considered to be somewhat dangerous due to the possibility of unconsciousness and death at low blood sugar values. Thus, less time spent below 70mg/dL is considered a positive outcome.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=78 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=22 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
CGM-measured Percent of Time Below 70 mg/dL Over 16 Week Trial Period
|
1.57 Percentage of Time
Interval 0.79 to 2.44
|
1.80 Percentage of Time
Interval 1.13 to 3.04
|
—
|
—
|
SECONDARY outcome
Timeframe: From randomization to data collection completion at the end of 16 weeksGM measured blood sugar values below 54 mg/dL have the potential to lead to unconsciousness or death. Thus, less time below 54 mg/dL is considered a better outcome.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=78 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=22 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
CGM-measured Median and Interquartile Range of Percent of Time Below 54 mg/dL Over 16 Week Trial Period
|
0.23 percentage of time
Interval 0.1 to 0.45
|
0.29 percentage of time
Interval 0.12 to 0.62
|
—
|
—
|
SECONDARY outcome
Timeframe: From randomization to data collection completion at the end of 16 weeksCGM measured blood sugar values above 250 mg/dL are considered to be undesirable. Thus, less time spent above 250mg/dL is considered a positive outcome.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=78 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=22 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
CGM-measured Percent of Time Above 250 mg/dL Over 16 Week Trial Period
|
7.8 Percentage of Time
Interval 5.1 to 14.3
|
18.4 Percentage of Time
Interval 9.4 to 24.6
|
—
|
—
|
SECONDARY outcome
Timeframe: From randomization to data collection completion at the end of 16 weeksContinuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM metrics were calculated by pooling all CGM readings in the 16-week trial period starting from randomization visit to week 16 visit. If a participant drops out before completing the 16-week visit, all available data through the last visit date will be included for calculating CGM metrics. Minimum 168 hours of CGM data were required to calculate CGM metrics. Coefficient of Variability (CV) is the ratio of the standard deviation to the mean of the blood sugar values of each participant as measured by CGM. The reported value is the mean and standard deviation of the participant outcomes multiplied by 100. This shows the extent of the mean variability of the blood sugar values in the population. Higher CV values (up to 100) indicate greater dispersion of CGM values, which would indicate more blood sugar variability, which is considered a negative outcome. Minimum value is 0.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=78 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=22 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
Continuous Glucose Monitor (CGM)-Measured Glucose Variability Measured With the Coefficient of Variation (CV) Over 16 Week Trial Period
|
38 Percentage
Standard Deviation 4
|
39 Percentage
Standard Deviation 4
|
—
|
—
|
SECONDARY outcome
Timeframe: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeksContinuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM metrics were calculated by pooling all CGM readings in the 12-week period starting from the 16 week visit at the end of the main study up through the 28th week visit. If a participant drops out before completing the 28-week visit, all available data through the last visit date will be included for calculating CGM metrics. Minimum 168 hours of CGM data will be required to calculate CGM metrics. Smaller percentages of CGM-measured percentages of time above 180 mg/dL is considered a positive outcome.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=78 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=22 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
CGM-measured Percent of Time Above 180 mg/dL Over 12 Week Trial Extension Period
|
33 Percentage of Time
Standard Deviation 11
|
34 Percentage of Time
Standard Deviation 10
|
—
|
—
|
SECONDARY outcome
Timeframe: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeksContinuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. Lower mean glucose numbers as measured by CGM in mg/dL is considered a positive outcome.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=78 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=22 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
CGM-measured Mean Glucose Over 12 Week Trial Extension Period
|
165 mg/dL
Standard Deviation 19
|
167 mg/dL
Standard Deviation 18
|
—
|
—
|
SECONDARY outcome
Timeframe: At completion of the extension study, end of week 28Hemoglobin A1C (HbA1c) is a physiological marker of the percentage of red blood cells that have glycated (bonded with a sugar). HbA1c is used to measure changes in average blood sugar over the past three months. 5-6% is normal, 7% and above is correlated with negative long-term health outcomes.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=76 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=21 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
Glycated Hemoglobin Percent (HbA1c) at Conclusion of 12 Week Trial Extension Period
|
7.2 Percent of Hemoglobin that was Glycated
Standard Deviation 0.9
|
7.3 Percent of Hemoglobin that was Glycated
Standard Deviation 0.7
|
—
|
—
|
SECONDARY outcome
Timeframe: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeksContinuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM measured blood sugar values below 70 mg/dL are considered to be undesirable. Thus, less time spent below 70mg/dL is considered a positive outcome.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=78 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=22 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
CGM-measured Percent of Time Below 70 mg/dL Over 12 Week Trial Extension Period
|
1.50 Percentage of Time
Interval 0.64 to 2.1
|
1.34 Percentage of Time
Interval 0.92 to 1.95
|
—
|
—
|
SECONDARY outcome
Timeframe: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeksContinuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM measured blood sugar values below 54 mg/dL have the potential to lead to unconsciousness or death. Thus, time below 54 mg/dL suggests that the person may have been close to danger.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=78 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=22 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
CGM-measured Percent of Time Below 54 mg/dL Over 12 Week Trial Extension Period
|
0.25 Percentage of Time
Interval 0.09 to 0.42
|
0.25 Percentage of Time
Interval 0.12 to 0.41
|
—
|
—
|
SECONDARY outcome
Timeframe: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeksContinuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM measured blood sugar values above 250 mg/dL are considered to be undesireable. Thus, less time spent above 250mg/dL is considered a positive outcome.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=78 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=22 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
CGM-measured Percent of Time Above 250 mg/dL Over 12 Week Trial Extension Period
|
9.0 percentage of time
Interval 6.7 to 15.4
|
10.1 percentage of time
Interval 6.3 to 15.8
|
—
|
—
|
SECONDARY outcome
Timeframe: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeksContinuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM metrics were calculated by pooling all CGM readings in the 12-week trial extension period starting from 16 week visit to week 28 visit. If a participant drops out before completing the 32-week visit, all available data through the last visit date will be included for calculating CGM metrics. Minimum 168 hours of CGM data were required to calculate CGM metrics. Coefficient of Variability (CV) is the ratio of the standard deviation to the mean of the blood sugar values of each participant as measured by CGM. The reported value is the mean and standard deviation of the participant outcomes multiplied by 100. This shows the extent of the mean variability of the blood sugar values in the study group. Higher CV values (up to 100) indicate greater dispersion of CGM values, which would indicate more blood sugar variability, which is considered a negative outcome. Minimum value is 0.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=78 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=22 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
Continuous Glucose Monitor (CGM)-Measured Glucose Variability Percentage Measured With the Coefficient of Variation (CV) Over 12 Week Trial Extension Period
|
38 Percentage
Standard Deviation 4
|
38 Percentage
Standard Deviation 4
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomization to data collection completion at the end of 16 weeksContinuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM-Measured percent of time in blood sugar range 70-140 mg/dL. Larger percentages of time spent in this range is considered to be a desirable outcome.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=78 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=22 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
CGM-Measured Percent of Time in Range 70-140 mg/dL Over 16 Weeks
|
44 Percentage of Time
Standard Deviation 10
|
35 Percentage of Time
Standard Deviation 11
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomization to data collection completion at the end of 16 weeksContinuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM metrics were calculated by pooling all CGM readings in the 16-week period starting from the randomization visit up through the 16 week visit. If a participant dropped out before completing the 16-week visit, all available data through the last visit date will be included for calculating CGM metrics. Minimum 168 hours of CGM data will be required to calculate CGM metrics. Standard Deviation represents how much glucose levels fluctuate over time from a given average.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=78 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=22 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
Glucose Variability Measured With the Standard Deviation (SD) Over 16 Weeks
|
61 mg/dL
Standard Deviation 11
|
70 mg/dL
Standard Deviation 13
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomization to data collection completion at the end of 16 weeksCGM measured blood sugar values below 60 mg/dL are considered to be undesirable. Thus, less time spent below 60mg/dL is considered a positive outcome
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=78 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=22 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
CGM-Measured Percent of Time Below 60 mg/dL Over 16 Weeks
|
0.67 Percentage of Time
Standard Deviation 0.62
|
0.75 Percentage of Time
Standard Deviation 0.55
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomization to data collection completion at the end of 16 weeksContinuous Blood Glucose Monitor (CGM) metrics were calculated by pooling all CGM readings in the 16-week period starting from the randomization visit up through the 16 week visit. If a participant dropped out before completing the 16-week visit, all available data through the last visit date was included for calculating CGM metrics. Minimum 168 hours of CGM data was required to calculate CGM metrics. The low blood glucose index (LBGI) is a Glucose-variability-based metric of the risk for hypoglycemia. LBGI increases with the frequency and extent of hypoglycemic excursions and has been used as a predictor of severe events. The minimum value possible is 0, indicating no risk of low blood sugar. The maximum possible value is 100, indicating maximum possible risk of low blood sugar.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=78 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=22 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
Low Blood Glucose Index (LBGI) Over 16 Weeks
|
0.55 Score on a Scale
Standard Deviation 0.33
|
0.64 Score on a Scale
Standard Deviation 0.30
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomization to data collection completion at the end of 16 weeksA Hypoglycemic event was defined as at least 15 consecutive minutes where the CGM was lower than 70mg/dL. Fewer hypoglycemia events are considered better.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=77 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=22 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
Hypoglycemia Events (Defined as at Least 15 Consecutive Minutes <70 mg\dL) Over 16 Weeks
|
4.0 Hypoglycemic Event
Standard Deviation 2.8
|
4.6 Hypoglycemic Event
Standard Deviation 2.5
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomization to data collection completion at the end of 16 weeksCGM measured blood sugar values above 300 mg/dL are considered to be undesirable. Thus, less time spent above 300 mg/dL is considered a positive outcome
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=78 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=22 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
CGM-Measured Percent of Time >300 mg/dL Over 16 Weeks
|
4.1 Percentage of Time
Standard Deviation 4.1
|
7.7 Percentage of Time
Standard Deviation 6.3
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomization to data collection completion at the end of 16 weeksContinuous Blood Glucose Monitor (CGM) metrics were calculated by pooling all CGM readings in the 16-week period starting from the randomization visit up through the 16 week visit (end of study). If a participant dropped out before completing the 16-week visit, all available data through the last visit date was included for calculating CGM metrics. Minimum 168 hours of CGM data was required to calculate CGM metrics. The High Blood Glucose Index (HBGI) is a Glucose-variability-based metric of the risk for hyperglycemia that can be calculated from CGM readings. HBGI increases with the frequency and extent of hyperglycemic excursions and has been used as a predictor of severe events. The minimum value possible is 0, indicating no risk of high blood sugar. The maximum possible value is 100, indicating maximum possible risk of high blood sugar.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=78 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=22 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
High Blood Glucose Index (HBGI) Over 16 Weeks
|
7.5 Score on a scale
Standard Deviation 3.1
|
10.8 Score on a scale
Standard Deviation 4.5
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomization to data collection completion at the end of 16 weeksThis is a comparison of a binary CGM outcome indicating how many participants and what percent of participants experienced an improvement of greater than 5% in the percentage of time they were in the safe blood sugar range of 70-180 mg/dL. More participants (a greater percentage of participants) improving by this much is considered positive.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=77 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=22 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
CGM-Measured Percent Time in Range 70-180 mg/dL Improvement From Baseline to 16 Weeks ≥5%
|
62 Participants
|
12 Participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomization to data collection completion at the end of 16 weeksThis is a comparison of a binary CGM outcome indicating how many participants and what percent of participants experienced an improvement of greater than 10% in the percentage of time they were in the ideal blood sugar range of 70-140 mg/dL. More participants (a greater percentage of participants) improving this much is considered positive
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=77 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=22 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
CGM-Measured Percent Time in Range 70-180 mg/dL Improvement From Baseline to 16 Weeks ≥10%
|
44 Participants
|
7 Participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomization to data collection completion at the end of 16 weeksHbA1c is a physiological marker that is used to measure changes in average blood sugar over the past three months. Numbers less than 7.0 are considered better for long-term health; thus, larger numbers or percentages of people with an HbA1c less than 7.0 is considered a positive outcome
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=77 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=22 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
Glycated Hemoglobin Percent (HbA1c) Less Than 7.0% at 16 Weeks
|
39 Participants
|
4 Participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomization to data collection completion at the end of 16 weeksHbA1c is a physiological marker that is used to measure changes in average blood sugar over the past three months. Numbers less than 7.5 are considered better for long-term health; thus, larger numbers or percentages of people with an HbA1c less than 7.5 is considered a positive outcome
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=77 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=22 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
Glycated Hemoglobin Percent (HbA1c) Less Than 7.5% at 16 Weeks
|
57 Participants
|
10 Participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomization to data collection completion at the end of 16 weeksHbA1c is a physiological marker that is used to measure changes in average blood sugar over the past three months. Improvements of 0.5% or greater are considered clinically significant improvements.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=77 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=22 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
Absolute Glycated Hemoglobin Percent HbA1c Improvement From Baseline to 16 Weeks Greater Than 0.5%
|
40 Participants
|
11 Participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomization to data collection completion at the end of 16 weeksHbA1c is a physiological marker that is used to measure changes in average blood sugar over the past three months. Improvements of 1.0% or greater are considered clinically significant improvements
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=78 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=22 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
Absolute Glycated Hemoglobin Percent (HbA1c) Improvement From Baseline to 16 Weeks Greater Than 1.0%
|
19 Participants
|
2 Participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomization to data collection completion at the end of 16 weeksHbA1c is a physiological marker that is used to measure changes in average blood sugar over the past three months. Improvements of 1.0% or greater are considered clinically significant improvements.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=77 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=22 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
Glycated Hemoglobin Percent (HbA1c) Relative Improvement From Baseline to 16 Weeks Greater Than 10%
|
28 Participants
|
4 Participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomization to data collection completion at the end of 16 weeksHbA1c is a physiological marker that is used to measure changes in average blood sugar over the past three months. Improvements of 1.0% or greater are considered clinically significant improvements, HbA1c values less than 7.0 are considered better for long-term health.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=77 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=22 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
Glycated Hemoglobin Percent HbA1c Reduction From Baseline to 16 Weeks Greater Than 1.0% or HbA1c Less Than 7.0%
|
47 Participants
|
6 Participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At data collection completion at the end of 16 weeksThe Hypoglycemia Fear Survey-II was developed to measure behaviors and worries related to fear of hypoglycemia in adults with type 1 diabetes and was adapted for children and parents. Items are rated on a 5-point Likert scale (0=never, 4=always), with higher scores indicating higher fear of hypoglycemia. Maximum possible score: 132. Minimum possible score: 0. All questionnaires were administered online and participants/parents could skip specific questionnaires or items within a questionnaire. At least 75% of the questions must have been competed to be included in analysis. The score used for analysis was based on the average among the questions that were answered and then scaled accordingly.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=78 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=22 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
n=78 Participants
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
n=22 Participants
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
Fear of Hypoglycemia Survey (HFS-II) at 16 Weeks
|
37 score on a scale
Standard Deviation 13
|
45 score on a scale
Standard Deviation 13
|
31 score on a scale
Standard Deviation 12
|
36 score on a scale
Standard Deviation 14
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At data collection completion at the end of 16 weeksThe scale comprises eight questions characterizing the participant's exposure to episodes of moderate and severe hypoglycemia. It also examines the glycemic threshold for, and symptomatic responses to hypoglycemia. A score of four or more on a scale of 0 to 7 implies impaired awareness of hypoglycemia. Parents and children took the questionnaire independently.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=76 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=22 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
n=57 Participants
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
n=14 Participants
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
Clarke Hypoglycemia Awareness Scores Questionnaire at 16 Weeks
|
1.2 score on a scale
Standard Deviation 1.1
|
1.6 score on a scale
Standard Deviation 1.1
|
1.3 score on a scale
Standard Deviation 1.1
|
1.2 score on a scale
Standard Deviation 1.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At data collection completion at the end of 16 weeksThe Problem Areas In Diabetes Survey is a measure of diabetes-related emotional distress and consists of a scale of 16 items for the Parent version and 11 items for the Child version. Patients and parents rate the degree to which each item is currently problematic for them on a 6-point Likert scale, from 1 (no problem) to 6 (serious problem). Parent version maximum score: 96, minimum score 16. Child version maximum score 66, minimum score 11.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=77 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=22 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
n=78 Participants
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
n=22 Participants
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
Problem Areas in Diabetes Survey (PAID) at 16 Weeks
|
36 units on a scale
Standard Deviation 12
|
45 units on a scale
Standard Deviation 17
|
34 units on a scale
Standard Deviation 16
|
37 units on a scale
Standard Deviation 17
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At data collection completion at the end of 16 weeksThe INSPIRE (Insulin Delivery Systems: Perceptions, Ideas, Reflections and Expectations) survey was developed to assess various aspects of a user's experience regarding automated insulin delivery for both patients and family members. The surveys include various topics important to patients with type 1 diabetes and their family members based upon \>200 hours of qualitative interviews and focus groups. Response options for all surveys include a 5-point Likert scale from strongly agree to strongly disagree, along with an N/A option. Total scores on the INSPIRE questionnaires were calculated by obtaining a mean score across items, then multiplying the mean score by 25 to scale total INSPIRE measure scores from 0 to 100, with higher scores indicating greater positive expectations for automated insulin delivery systems.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=78 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=76 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
Insulin Delivery Systems: Perceptions, Ideas, Reflections and Expections (INSPIRE) Survey Scores at 16 Weeks
|
87 score on a scale
Standard Deviation 12
|
75 score on a scale
Standard Deviation 16
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At data collection completion at the end of 16 weeksThis is a 33-item scale developed and validated for the measurement of diabetes-specific quality of life. Separate forms have been validated for child self-report (5-7 year old; 8-12 year old; and 12-18 year old) and parent report for these same age groups. Participants record the extent to which they (or their child) experienced each of 33 problems related to diabetes in the prior month using a 5-point Likert-type response scale (0= never a problem; 1 = almost never a problem 2 =sometimes a problem 3= often a problem 4 = almost always a problem). Items are reverse-scored and linearly transformed to a 0-100 scale (0=100, 1=7, 2=50, 3=25, 4=0) so that lower score demonstrate more diabetes symptoms and management problems, and hence lower diabetes-specific health-related quality of life. Higher scores indicate fewer symptoms or problems
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=78 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=22 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
n=78 Participants
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
n=22 Participants
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
Pediatric Quality of Life Inventory (PedsQL Diabetes Module) at 16 Weeks
|
77 score on a scale
Standard Deviation 10
|
72 score on a scale
Standard Deviation 12
|
76 score on a scale
Standard Deviation 13
|
76 score on a scale
Standard Deviation 16
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At data collection completion at the end of 16 weeksPittsburgh Sleep Quality Index (PSQI) is a 10-item questionnaire that measures the sleep quality and pattern of sleep in adults. Seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=73 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=20 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
Pittsburgh Sleep Quality Index (Parent Only) at 16 Weeks (Parent Only)
|
4.3 score on a scale
Standard Deviation 2.9
|
6.5 score on a scale
Standard Deviation 3.9
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At data collection completion at the end of 16 weeksSystem Usability Scores (SUS)-composite score from 0 to 100 with higher scores indicating better perceived usability
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=78 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=55 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
System Usability Scale (SUS) at 16 Weeks
|
86 score on a scale
Standard Deviation 15
|
79 score on a scale
Standard Deviation 15
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomization to data collection completion at the end of 16 weeksTotal Daily Insulin (Units/kg/day) over 16 weeks. Total daily insulin dose is calculated as the sum of all insulin doses delivered by the insulin delivery system divided by the weight of the participant in kilograms and the actual duration of the treatment period in days.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=78 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=21 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
Total Daily Insulin (Units/kg/Day) Over 16 Weeks
|
0.94 units of insulin per kg per day
Standard Deviation 0.25
|
0.98 units of insulin per kg per day
Standard Deviation 0.32
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 7 days leading up to the final study visit in week 16Insulin metrics were calculated at randomization and 16 weeks using Tandem pump data where available, otherwise using data reported on the CRF. Insulin metrics were calculated from the pump data using data in the 7 days prior to the visit. The basal:bolus ratio describes the amount of insulin used by participants to keep the blood sugar stable (basal insulin) as opposed to the amount of insulin used to metabolize consumed carbs (bolus insulin) within the total amount of insulin delivered per day.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=78 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=21 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
Basal: Bolus Insulin Ratio Over 16 Weeks
|
0.87 ratio
Standard Deviation 0.30
|
0.84 ratio
Standard Deviation 0.38
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At data collection completion at the end of 16 weeksParticipant Weight in kg measured at 16 weeks
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=78 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=21 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
Weight at 16 Weeks
|
46 Kg
Standard Deviation 14
|
45 Kg
Standard Deviation 20
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeksThe primary outcome for the extension phase is improving the percent of time in the blood sugar range 70-180 mg/dL over the 12 weeks of the extension phase of the study
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=78 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=22 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
CGM-Measured Percent of Time in Range 70-180mg/dL Over 12 Week Trial Extension Period
|
66 Percentage of Time
Standard Deviation 10
|
65 Percentage of Time
Standard Deviation 10
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeksCGM-Measured percent of time in blood sugar range 70-140 mg/dL over the 12 week extension study. Larger percentages of time spent in this range is considered to be a desireable outcome.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=78 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=22 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
CGM-Measured Percent of Time in Range 70-140 mg/dL Over 12 Week Trial Extension Period
|
42 Percentage of Time
Standard Deviation 11
|
42 Percentage of Time
Standard Deviation 8
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeksContinuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM metrics were calculated by pooling all CGM readings in the 16-week trial period starting from the randomization visit to week 16 visit. If a participant drops out before completing the 16-week visit, all available data through the last visit date will be included for calculating CGM metrics. Minimum 168 hours of CGM data were required to calculate CGM metrics. Coefficient of Variability (CV) is the ratio of the standard deviation to the mean of the blood sugar values of each participant as measured by CGM. The reported value is the mean and standard deviation of the participant outcomes multiplied by 100. This shows the extent of the mean variability of the blood sugar values in the population. Higher CV values (up to 100) indicate greater dispersion of CGM values, which would indicate more blood sugar variability, which is considered a negative outcome. Minimum value is 0.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=78 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=22 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
Glucose Variability of Blood Sugar as Measured by Continuous Glucose Monitor (CGM), Measured With the Standard Deviation (SD) Over 16 Weeks
|
62 mg/dL
Standard Deviation 11
|
64 mg/dL
Standard Deviation 12
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomization to data collection completion at the end of 16 weeksContinuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM metrics were calculated by pooling all CGM readings in the 16-week trial period starting from the randomization visit to week 16 visit. If a participant drops out before completing the 16-week visit, all available data through the last visit date will be included for calculating CGM metrics. Minimum 168 hours of CGM data were required to calculate CGM metrics. Coefficient of Variability (CV) is the ratio of the standard deviation to the mean of the blood sugar values of each participant as measured by CGM. The reported value is the mean and standard deviation of the participant outcomes multiplied by 100. This shows the extent of the mean variability of the blood sugar values in the population. Higher CV values (up to 100) indicate greater dispersion of CGM values, which would indicate more blood sugar variability, which is considered a negative outcome. Minimum value is 0.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=78 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=22 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
Continuous Blood Glucose Monitor (CGM)-Measured Percent of Time Less Than 60 mg/dL Over 16 Weeks
|
0.48 Percentage of Time
Interval 0.22 to 0.6
|
0.60 Percentage of Time
Interval 0.32 to 1.19
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeksContinuous Blood Glucose Monitor (CGM) metrics were calculated by pooling all CGM readings in the 12-week period starting from the end of the 16th week of the main trial up through the 28 week visit (end of study extension). If a participant dropped out before completing the 28-week visit, all available data through the last visit date was included for calculating CGM metrics. Minimum 168 hours of CGM data was required to calculate CGM metrics. The low blood glucose index (LBGI) is a Glucose-variability-based metric of the risk for hypoglycemia. LBGI increases with the frequency and extent of hypoglycemic excursions and has been used as a predictor of severe events. The minimum value possible is 0, indicating no risk of low blood sugar. The maximum possible value is 100, indicating maximum possible risk of low blood sugar.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=78 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=22 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
Continuous Blood Glucose Monitor (CGM)-Measured Low Blood Glucose Index (LBGI) Over 12 Week Trial Extension Period
|
0.48 units on a scale
Interval 0.26 to 0.63
|
0.48 units on a scale
Interval 0.34 to 0.58
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeksCGM metrics were calculated by pooling all CGM readings in the 12-week period starting from the 16th week of the main trial through the 12th week of the extension. If a participant drops out before completing the 12-week visit, all available data through the last visit date will be included for calculating CGM metrics. Minimum 168 hours of CGM data will be required to calculate CGM metrics. A hypoglycemic event is defined as 15 consecutive minutes with a sensor glucose value below 54 mg/dL. Fewer glycemic events per week is considered a better outcome.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=78 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=22 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
Number of Hypoglycemia Events (Defined as at Least 15 Consecutive Minutes Less Than 70 mg\dL as Measured by Continuous Glucose Meter) Over 12 Week Trial Extension Period
|
3.4 Hypoglycemic Event
Interval 1.4 to 5.2
|
2.9 Hypoglycemic Event
Interval 2.8 to 4.1
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeksCGM measured blood sugar values above 300 mg/dL are considered to be undesireable. Thus, less time spent above 300mg/dL is considered a positive outcome
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=78 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=22 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
CGM-Measured Percent of Time Above 300 mg/dL Over 12 Week Trial Extension Period
|
2.9 Percentage of Time
Interval 1.8 to 5.9
|
3.5 Percentage of Time
Interval 1.8 to 6.6
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeksContinuous Blood Glucose Monitor (CGM) metrics were calculated by pooling all CGM readings in the 12-week period starting from the end of the 16th week of the main trial up through the 28 week visit (end of study extension). If a participant dropped out before completing the 28-week visit, all available data through the last visit date was included for calculating CGM metrics. Minimum 168 hours of CGM data was required to calculate CGM metrics. The High Blood Glucose Index (HBGI) is a Glucose-variability-based metric of the risk for hyperglycemia that can be calculated from CGM readings. HBGI increases with the frequency and extent of hyperglycemic excursions and has been used as a predictor of severe events. The minimum value possible is 0, indicating no risk of high blood sugar. The maximum possible value is 100, indicating maximum possible risk of high blood sugar.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=78 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=22 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
High Blood Glucose Index (HBGI) Over 12 Weeks of Trial Extension Period
|
8.0 units on a scale
Standard Deviation 3.3
|
8.3 units on a scale
Standard Deviation 3.2
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At completion of the extension study, end of week 28HbA1c is a physiological marker that is used to measure changes in average blood sugar over the past three months. Numbers less than 7.0 are considered better for long-term health; thus, larger numbers or percentages of people with an HbA1c less than 7.0 is considered a positive outcome.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=76 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=21 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
Glycated Hemoglobin Percent (HbA1c) Less Than 7.0% at Conclusion of 12 Week Trial Extension Period
|
32 Participants
|
4 Participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At completion of the extension study, end of week 28HbA1c is a physiological marker that is used to measure changes in average blood sugar over the past three months. Numbers less than 7.5 are considered better for long-term health; thus, larger numbers or percentages of people with an HbA1c less than 7.5 is considered a positive outcome.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=76 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=21 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
Glycated Hemoglobin Percent (HbA1c) Less Than 7.5% at Conclusion of 12 Week Trial Extension Period
|
48 Participants
|
13 Participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At completion of the extension study, end of week 28The Hypoglycemia Fear Survey-II was developed to measure behaviors and worries related to fear of hypoglycemia in adults with type 1 diabetes and was adapted for children and parents. Items are rated on a 5-point Likert scale (0=never, 4=always), with higher scores indicating higher fear of hypoglycemia. Maximum possible score: 132. Minimum possible score: 0. All questionnaires were administered online and participants/parents could skip specific questionnaires or items within a questionnaire. At least 75% of the questions must have been competed to be included in analysis. The score used for analysis was based on the average among the questions that were answered and then scaled accordingly.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=78 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=22 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
n=78 Participants
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
n=22 Participants
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
Fear of Hypoglycemia Survey (HFS-II) at Conclusion of 12 Week Trial Extension Period
|
36 score on a scale
Standard Deviation 12
|
43 score on a scale
Standard Deviation 17
|
30 score on a scale
Standard Deviation 11
|
32 score on a scale
Standard Deviation 14
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At completion of the extension study, end of week 28The scale comprises eight questions characterizing the participant's exposure to episodes of moderate and severe hypoglycemia. It also examines the glycemic threshold for, and symptomatic responses to hypoglycemia. A score of four or more on a scale of 0 to 7 implies impaired awareness of hypoglycemia.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=78 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=21 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
n=57 Participants
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
n=14 Participants
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
Clarke Hypoglycemia Awareness Scores Questionnaire at Conclusion of 12 Week Trial Extension Period
|
1.1 score on a scale
Standard Deviation 1.1
|
1.5 score on a scale
Standard Deviation 1.2
|
1.5 score on a scale
Standard Deviation 1.2
|
1.7 score on a scale
Standard Deviation 1.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At completion of the extension study, end of week 28The Problem Areas In Diabetes Survey is a measure of diabetes-related emotional distress and consists of a scale of 16 items for the Parent version and 11 items for the Child version. Patients and parents rate the degree to which each item is currently problematic for them on a 6-point Likert scale, from 1 (no problem) to 6 (serious problem). Parent version maximum score: 96, minimum score 16. Child version maximum score 66, minimum score 11.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=78 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=22 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
n=78 Participants
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
n=22 Participants
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
Problem Areas in Diabetes Survey (PAID) at Conclusion of 12 Week Trial Extension Period
|
36 score on a scale
Standard Deviation 13
|
40 score on a scale
Standard Deviation 17
|
30 score on a scale
Standard Deviation 11
|
37 score on a scale
Standard Deviation 19
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At completion of the extension study, end of week 28The INSPIRE (Insulin Delivery Systems: Perceptions, Ideas, Reflections and Expectations) survey was developed to assess various aspects of a user's experience regarding automated insulin delivery for both patients and family members. The surveys include various topics important to patients with type 1 diabetes and their family members based upon \>200 hours of qualitative interviews and focus groups. Response options for all surveys include a 5-point Likert scale from strongly agree to strongly disagree, along with an N/A option. Total scores on the INSPIRE questionnaires were calculated by obtaining a mean score across items, then multiplying the mean score by 25 to scale total INSPIRE measure scores from 0 to 100, with higher scores indicating greater positive expectations for automated insulin delivery systems.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=78 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=22 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
n=77 Participants
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
n=22 Participants
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
Insulin Delivery Systems: Perceptions, Ideas, Reflections and Expectations (INSPIRE) Survey Scores at Conclusion of 12 Week Trial Extension Period
|
89 score on a scale
Standard Deviation 12
|
86 score on a scale
Standard Deviation 17
|
76 score on a scale
Standard Deviation 17
|
78 score on a scale
Standard Deviation 14
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At completion of the extension study, end of week 28This is a 33-item scale developed and validated for the measurement of diabetes-specific quality of life. Separate forms have been validated for child self-report (5-7 year old; 8-12 year old; and 12-18 year old) and parent report for these same age groups. Participants record the extent to which they (or their child) experienced each of 33 problems related to diabetes in the prior month using a 5-point Likert-type response scale (0= never a problem; 1 = almost never a problem 2 =sometimes a problem 3= often a problem 4 = almost always a problem). Items are reverse-scored and linearly transformed to a 0-100 scale (0=100, 1=7, 2=50, 3=25, 4=0) so that lower score demonstrate more diabetes symptoms and management problems, and hence lower diabetes-specific health-related quality of life. Higher scores indicate fewer symptoms or problems.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=78 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=22 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
n=78 Participants
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
n=22 Participants
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
Pediatric Quality of Life Inventory (PedsQL Diabetes Module) at Conclusion of 12 Week Trial Extension Period
|
77 score on a scale
Standard Deviation 11
|
77 score on a scale
Standard Deviation 15
|
78 score on a scale
Standard Deviation 13
|
77 score on a scale
Standard Deviation 18
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At completion of the extension study, end of week 28Pittsburgh Sleep Quality Index (PSQI) is a 10-item questionnaire that measures the sleep quality and pattern of sleep in adults. Seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=74 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=20 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
Pittsburgh Sleep Quality Index (Parent Only) at Conclusion of 12 Week Trial Extension Period
|
4.4 score on a scale
Standard Deviation 2.9
|
5.4 score on a scale
Standard Deviation 3.6
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At completion of the extension study, end of week 28System Usability Scores (SUS)-composite score from 0 to 100 with higher scores indicating better perceived usability.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=77 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=22 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
n=56 Participants
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
n=14 Participants
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
System Usability Scale (SUS) at Conclusion of 12 Week Trial Extension Period
|
86 score on a scale
Standard Deviation 21
|
84 score on a scale
Standard Deviation 22
|
81 score on a scale
Standard Deviation 18
|
83 score on a scale
Standard Deviation 10
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeksTotal Daily Insulin (Units/kg/day) over 12 weeks. Total daily insulin dose is calculated as the sum of all insulin doses delivered by the insulin delivery system divided by the weight of the participant in kilograms and the actual duration of the treatment period in days.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=76 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=22 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
Total Daily Insulin (TDI) (Units/kg/Day) Over 12 Week Trial Extension Period
|
0.93 units of insulin per kg per day
Standard Deviation 0.25
|
1.04 units of insulin per kg per day
Standard Deviation 0.34
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 7 days leading up to the final extension study visit in week 28Insulin metrics were calculated at 16 weeks and 28 weeks using Tandem pump data where available, otherwise using data reported on the CRF. Insulin metrics were calculated from the pump data using data in the 7 days prior to the visit. The basal:bolus ratio describes the amount of insulin used by participants to keep the blood sugar stable (basal insulin) as opposed to the amount of insulin used to metabolize consumed carbs (bolus insulin) within the total amount of insulin delivered per day.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=76 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=22 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
Basal: Bolus Insulin Ratio at Conclusion of 12 Week Trial Extension Period
|
0.84 ratio
Interval 0.71 to 1.1
|
1.0 ratio
Interval 0.83 to 1.47
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At completion of the extension study, end of week 28Body Mass Index (BMI) is a calculation of participant body weight in kilograms and height in centimeters. The z-score was calculated from values taken at the end of the 28 weeks of the study. Z-score of zero represents the US population mean for their age and sex group. Positive Z scores indicate higher body mass index values than the population mean, which is generally considered undesirable
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=76 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
|
Control Group
n=22 Participants
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
|
Closed-Loop Control (CLC) Group (Child Versions)
Questionnaires completed by participants assigned to CLC group.
|
Control (SAP) Group (Child Versions)
Questionnaires completed by participants assigned to Control group.
|
|---|---|---|---|---|
|
Body Mass Index (BMI) at Conclusion of 12 Week Trial Extension Period
|
.46 Z-score
Standard Deviation 0.97
|
0.68 Z-score
Standard Deviation 1.03
|
—
|
—
|
Adverse Events
Closed Loop Control up to 16 Weeks (Main Study)
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Standard of Care up to 16 Weeks (Main Study)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Continued Closed Loop Control Week 16 to Week 28 (Extension Study)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Standard of Care to Closed Loop Control Week 16 to Week 28 (Extension Study)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Closed Loop Control up to 16 Weeks (Main Study)
n=78 participants at risk
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements initiated a run-in phase of 2 to 4 weeks that was customized based on whether the participant is already a pump or CGM user. Participants who skipped or successfully completed the run-in were randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm used the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks.
|
Standard of Care up to 16 Weeks (Main Study)
n=23 participants at risk
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements initiated a run-in phase of 2 to 4 weeks that was customized based on whether the participant is already a pump or CGM user. Participants who skipped or successfully completed the run-in were randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks.
|
Continued Closed Loop Control Week 16 to Week 28 (Extension Study)
n=78 participants at risk
All participants were provided the option of continuing to use the t:slim X2 \& Dexcom G6 CGM technology with Control-IQ system in a 12 week Extension Phase.
|
Standard of Care to Closed Loop Control Week 16 to Week 28 (Extension Study)
n=22 participants at risk
All participants were provided the option of continuing to use the t:slim X2 \& Dexcom G6 CGM technology with Control-IQ system in a 12 week Extension Phase.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Hospitalization for Gastroenteritis Leading to Ketosis
|
1.3%
1/78 • Number of events 1 • 28 weeks
|
0.00%
0/23 • 28 weeks
|
0.00%
0/78 • 28 weeks
|
0.00%
0/22 • 28 weeks
|
Other adverse events
| Measure |
Closed Loop Control up to 16 Weeks (Main Study)
n=78 participants at risk
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements initiated a run-in phase of 2 to 4 weeks that was customized based on whether the participant is already a pump or CGM user. Participants who skipped or successfully completed the run-in were randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm used the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks.
|
Standard of Care up to 16 Weeks (Main Study)
n=23 participants at risk
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements initiated a run-in phase of 2 to 4 weeks that was customized based on whether the participant is already a pump or CGM user. Participants who skipped or successfully completed the run-in were randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks.
|
Continued Closed Loop Control Week 16 to Week 28 (Extension Study)
n=78 participants at risk
All participants were provided the option of continuing to use the t:slim X2 \& Dexcom G6 CGM technology with Control-IQ system in a 12 week Extension Phase.
|
Standard of Care to Closed Loop Control Week 16 to Week 28 (Extension Study)
n=22 participants at risk
All participants were provided the option of continuing to use the t:slim X2 \& Dexcom G6 CGM technology with Control-IQ system in a 12 week Extension Phase.
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Abscess at sensor site
|
0.00%
0/78 • 28 weeks
|
4.3%
1/23 • Number of events 2 • 28 weeks
|
0.00%
0/78 • 28 weeks
|
0.00%
0/22 • 28 weeks
|
|
Endocrine disorders
Hyperglycemia
|
2.6%
2/78 • Number of events 2 • 28 weeks
|
0.00%
0/23 • 28 weeks
|
7.7%
6/78 • Number of events 7 • 28 weeks
|
4.5%
1/22 • Number of events 2 • 28 weeks
|
|
Endocrine disorders
Ketosis
|
15.4%
12/78 • Number of events 12 • 28 weeks
|
4.3%
1/23 • Number of events 1 • 28 weeks
|
0.00%
0/78 • 28 weeks
|
4.5%
1/22 • Number of events 1 • 28 weeks
|
|
Endocrine disorders
Accidental over-delivery of insulin
|
1.3%
1/78 • Number of events 1 • 28 weeks
|
0.00%
0/23 • 28 weeks
|
0.00%
0/78 • 28 weeks
|
0.00%
0/22 • 28 weeks
|
|
Endocrine disorders
Hypoglycemia
|
1.3%
1/78 • Number of events 1 • 28 weeks
|
4.3%
1/23 • Number of events 1 • 28 weeks
|
0.00%
0/78 • 28 weeks
|
0.00%
0/22 • 28 weeks
|
Additional Information
Marc Breton
University of Virginia Center for Diabetes Technology
Phone: 434-982-6484
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place