Trial Outcomes & Findings for Safety of Artificial Pancreas Therapy in Preschoolers, Age 2-6 (NCT NCT04084171)
NCT ID: NCT04084171
Last Updated: 2023-03-22
Results Overview
Percentage of subjects with less than 6% time below 70mg/dL and less than 40% time above 180mg/dL.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
Results posted on
2023-03-22
Participant Flow
12 participants were enrolled across three clinical sites.
All participants enrolled completed the study.
Participant milestones
| Measure |
Artificial Pancreas Therapy
Subjects will use the Tandem t:slim X2 with Control-IQ Technology + Dexcom G6 to automatically modulate their insulin delivery and control their glycemia.
Tandem t:slim X2 with Control-IQ Technology + Dexcom G6: Subjects will use the Tandem t:slim X2 with Control- IQ Technology and Dexcom G6 CGM to control their glycemia. The Tandem t:slim X2 with Control-IQ device is an automated insulin delivery pump that automatically adjusts insulin delivery to predicted and prevailing glucose levels, as measured by a Dexcom G6 continuous glucose monitor \[CGM\].
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
Baseline
|
12
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety of Artificial Pancreas Therapy in Preschoolers, Age 2-6
Baseline characteristics by cohort
| Measure |
Artificial Pancreas Therapy
n=12 Participants
Subjects will use the Tandem t:slim X2 with Control-IQ Technology + Dexcom G6 to automatically modulate their insulin delivery and control their glycemia.
Tandem t:slim X2 with Control-IQ Technology + Dexcom G6: Subjects will use the Tandem t:slim X2 with Control- IQ Technology and Dexcom G6 CGM to control their glycemia. The Tandem t:slim X2 with Control-IQ device is an automated insulin delivery pump that automatically adjusts insulin delivery to predicted and prevailing glucose levels, as measured by a Dexcom G6 continuous glucose monitor \[CGM\].
|
|---|---|
|
Age, Continuous
|
4.7 years
STANDARD_DEVIATION 1.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
|
Diabetes duration
|
2.08 years
STANDARD_DEVIATION 0.89 • n=5 Participants
|
|
HbA1c (%)
|
7.3 percentage
STANDARD_DEVIATION 0.8 • n=5 Participants
|
|
Weight
|
19.3 kg
STANDARD_DEVIATION 3.1 • n=5 Participants
|
|
Total insulin dose
|
0.76 U/(kg*day)
STANDARD_DEVIATION 0.14 • n=5 Participants
|
|
Total daily insulin (units)
|
14.6 units
STANDARD_DEVIATION 3.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.Percentage of subjects with less than 6% time below 70mg/dL and less than 40% time above 180mg/dL.
Outcome measures
| Measure |
Artificial Pancreas Therapy
n=12 Participants
Subjects will use the Tandem t:slim X2 with Control-IQ Technology + Dexcom G6 to automatically modulate their insulin delivery and control their glycemia.
Tandem t:slim X2 with Control-IQ Technology + Dexcom G6: Subjects will use the Tandem t:slim X2 with Control-IQ Technology and Dexcom G6 CGM to control their glycemia. The Tandem t:slim X2 with Control-IQ device is an automated insulin delivery pump that automatically adjusts insulin delivery to predicted and prevailing glucose levels, as measured by a Dexcom G6 continuous glucose monitor \[CGM\].
|
|---|---|
|
Primary Outcome
Baseline
|
33 percentage of subjects
|
|
Primary Outcome
5 days of AP Therapy
|
83 percentage of subjects
|
SECONDARY outcome
Timeframe: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.Percent of time spent below 70 mg/dl.
Outcome measures
| Measure |
Artificial Pancreas Therapy
n=12 Participants
Subjects will use the Tandem t:slim X2 with Control-IQ Technology + Dexcom G6 to automatically modulate their insulin delivery and control their glycemia.
Tandem t:slim X2 with Control-IQ Technology + Dexcom G6: Subjects will use the Tandem t:slim X2 with Control-IQ Technology and Dexcom G6 CGM to control their glycemia. The Tandem t:slim X2 with Control-IQ device is an automated insulin delivery pump that automatically adjusts insulin delivery to predicted and prevailing glucose levels, as measured by a Dexcom G6 continuous glucose monitor \[CGM\].
|
|---|---|
|
Below 70 mg/dl.
Baseline
|
3.7 percentage of time
Interval 1.5 to 6.4
|
|
Below 70 mg/dl.
5 days of AP Therapy
|
3.2 percentage of time
Interval 1.5 to 4.6
|
SECONDARY outcome
Timeframe: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.Percent of time spent below 60mg/dl.
Outcome measures
| Measure |
Artificial Pancreas Therapy
n=12 Participants
Subjects will use the Tandem t:slim X2 with Control-IQ Technology + Dexcom G6 to automatically modulate their insulin delivery and control their glycemia.
Tandem t:slim X2 with Control-IQ Technology + Dexcom G6: Subjects will use the Tandem t:slim X2 with Control-IQ Technology and Dexcom G6 CGM to control their glycemia. The Tandem t:slim X2 with Control-IQ device is an automated insulin delivery pump that automatically adjusts insulin delivery to predicted and prevailing glucose levels, as measured by a Dexcom G6 continuous glucose monitor \[CGM\].
|
|---|---|
|
Below 60 mg/dl.
Baseline
|
1.6 percentage of time
Interval 0.3 to 2.8
|
|
Below 60 mg/dl.
5 days of AP Therapy
|
0.7 percentage of time
Interval 0.5 to 1.4
|
SECONDARY outcome
Timeframe: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.Percent of time spent below 54mg/dL.
Outcome measures
| Measure |
Artificial Pancreas Therapy
n=12 Participants
Subjects will use the Tandem t:slim X2 with Control-IQ Technology + Dexcom G6 to automatically modulate their insulin delivery and control their glycemia.
Tandem t:slim X2 with Control-IQ Technology + Dexcom G6: Subjects will use the Tandem t:slim X2 with Control-IQ Technology and Dexcom G6 CGM to control their glycemia. The Tandem t:slim X2 with Control-IQ device is an automated insulin delivery pump that automatically adjusts insulin delivery to predicted and prevailing glucose levels, as measured by a Dexcom G6 continuous glucose monitor \[CGM\].
|
|---|---|
|
Below 54 mg/dl.
Baseline
|
0.6 percentage of time
Interval 0.1 to 1.6
|
|
Below 54 mg/dl.
5 days of AP Therapy
|
0.3 percentage of time
Interval 0.2 to 0.7
|
SECONDARY outcome
Timeframe: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.Percent of time spent below 50mg/dL.
Outcome measures
| Measure |
Artificial Pancreas Therapy
n=12 Participants
Subjects will use the Tandem t:slim X2 with Control-IQ Technology + Dexcom G6 to automatically modulate their insulin delivery and control their glycemia.
Tandem t:slim X2 with Control-IQ Technology + Dexcom G6: Subjects will use the Tandem t:slim X2 with Control-IQ Technology and Dexcom G6 CGM to control their glycemia. The Tandem t:slim X2 with Control-IQ device is an automated insulin delivery pump that automatically adjusts insulin delivery to predicted and prevailing glucose levels, as measured by a Dexcom G6 continuous glucose monitor \[CGM\].
|
|---|---|
|
Below 50mg/dl.
Baseline
|
0.2 percentage of time
Interval 0.0 to 0.9
|
|
Below 50mg/dl.
5 days of AP Therapy
|
0.2 percentage of time
Interval 0.1 to 0.3
|
SECONDARY outcome
Timeframe: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.Percent of time spent above 180mg/dl.
Outcome measures
| Measure |
Artificial Pancreas Therapy
n=12 Participants
Subjects will use the Tandem t:slim X2 with Control-IQ Technology + Dexcom G6 to automatically modulate their insulin delivery and control their glycemia.
Tandem t:slim X2 with Control-IQ Technology + Dexcom G6: Subjects will use the Tandem t:slim X2 with Control-IQ Technology and Dexcom G6 CGM to control their glycemia. The Tandem t:slim X2 with Control-IQ device is an automated insulin delivery pump that automatically adjusts insulin delivery to predicted and prevailing glucose levels, as measured by a Dexcom G6 continuous glucose monitor \[CGM\].
|
|---|---|
|
Above 180 mg/dl.
Baseline
|
34.1 percentage of time
Standard Deviation 17.3
|
|
Above 180 mg/dl.
5 days of AP Therapy
|
25.7 percentage of time
Standard Deviation 12.1
|
SECONDARY outcome
Timeframe: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.Percent of time spent above 250mg/dl.
Outcome measures
| Measure |
Artificial Pancreas Therapy
n=12 Participants
Subjects will use the Tandem t:slim X2 with Control-IQ Technology + Dexcom G6 to automatically modulate their insulin delivery and control their glycemia.
Tandem t:slim X2 with Control-IQ Technology + Dexcom G6: Subjects will use the Tandem t:slim X2 with Control-IQ Technology and Dexcom G6 CGM to control their glycemia. The Tandem t:slim X2 with Control-IQ device is an automated insulin delivery pump that automatically adjusts insulin delivery to predicted and prevailing glucose levels, as measured by a Dexcom G6 continuous glucose monitor \[CGM\].
|
|---|---|
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Above 250mg/dl.
Baseline
|
9.7 percentage of time
Interval 6.1 to 19.5
|
|
Above 250mg/dl.
5 days of AP Therapy
|
4.2 percentage of time
Interval 2.3 to 9.0
|
SECONDARY outcome
Timeframe: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.Percent of time spent above 300 mg/dl.
Outcome measures
| Measure |
Artificial Pancreas Therapy
n=12 Participants
Subjects will use the Tandem t:slim X2 with Control-IQ Technology + Dexcom G6 to automatically modulate their insulin delivery and control their glycemia.
Tandem t:slim X2 with Control-IQ Technology + Dexcom G6: Subjects will use the Tandem t:slim X2 with Control-IQ Technology and Dexcom G6 CGM to control their glycemia. The Tandem t:slim X2 with Control-IQ device is an automated insulin delivery pump that automatically adjusts insulin delivery to predicted and prevailing glucose levels, as measured by a Dexcom G6 continuous glucose monitor \[CGM\].
|
|---|---|
|
Above 300 mg/dl.
Baseline
|
3.4 percentage of time
Interval 0.6 to 5.4
|
|
Above 300 mg/dl.
5 days of AP Therapy
|
0.6 percentage of time
Interval 0.1 to 1.6
|
SECONDARY outcome
Timeframe: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.Percent of time spent between 70 mg/dl and 140mg/dl.
Outcome measures
| Measure |
Artificial Pancreas Therapy
n=12 Participants
Subjects will use the Tandem t:slim X2 with Control-IQ Technology + Dexcom G6 to automatically modulate their insulin delivery and control their glycemia.
Tandem t:slim X2 with Control-IQ Technology + Dexcom G6: Subjects will use the Tandem t:slim X2 with Control-IQ Technology and Dexcom G6 CGM to control their glycemia. The Tandem t:slim X2 with Control-IQ device is an automated insulin delivery pump that automatically adjusts insulin delivery to predicted and prevailing glucose levels, as measured by a Dexcom G6 continuous glucose monitor \[CGM\].
|
|---|---|
|
Between 70-140mg/dl.
Baseline
|
41.8 percentage of time
Standard Deviation 15.9
|
|
Between 70-140mg/dl.
5 days of AP Therapy
|
51.5 percentage of time
Standard Deviation 12.8
|
SECONDARY outcome
Timeframe: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.Percent of time spent between 70 mg/dl and 180mg/dl.
Outcome measures
| Measure |
Artificial Pancreas Therapy
n=12 Participants
Subjects will use the Tandem t:slim X2 with Control-IQ Technology + Dexcom G6 to automatically modulate their insulin delivery and control their glycemia.
Tandem t:slim X2 with Control-IQ Technology + Dexcom G6: Subjects will use the Tandem t:slim X2 with Control-IQ Technology and Dexcom G6 CGM to control their glycemia. The Tandem t:slim X2 with Control-IQ device is an automated insulin delivery pump that automatically adjusts insulin delivery to predicted and prevailing glucose levels, as measured by a Dexcom G6 continuous glucose monitor \[CGM\].
|
|---|---|
|
Between 70-180mg/dl
Baseline
|
61.7 percentage of time
Standard Deviation 16.1
|
|
Between 70-180mg/dl
5 days of AP Therapy
|
71.3 percentage of time
Standard Deviation 12.5
|
SECONDARY outcome
Timeframe: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.Number of hypoglycemia events (below 70 mg/dL).
Outcome measures
| Measure |
Artificial Pancreas Therapy
n=12 Participants
Subjects will use the Tandem t:slim X2 with Control-IQ Technology + Dexcom G6 to automatically modulate their insulin delivery and control their glycemia.
Tandem t:slim X2 with Control-IQ Technology + Dexcom G6: Subjects will use the Tandem t:slim X2 with Control-IQ Technology and Dexcom G6 CGM to control their glycemia. The Tandem t:slim X2 with Control-IQ device is an automated insulin delivery pump that automatically adjusts insulin delivery to predicted and prevailing glucose levels, as measured by a Dexcom G6 continuous glucose monitor \[CGM\].
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|---|---|
|
Number of Hypoglycemia Below 70 mg/dL
Baseline
|
2.13 hypoglycemia event
Standard Deviation 1.36
|
|
Number of Hypoglycemia Below 70 mg/dL
5 days of AP Therapy
|
1.79 hypoglycemia event
Standard Deviation 0.79
|
SECONDARY outcome
Timeframe: The 5 day period of data collection included 48 hours of supervised hotel admission. The remaining 72 hours consisted of at-home Control IQ use under parental supervision and remote study staff monitoring.Average number of carbohydrate treatments per day. Participants were treated with \~16g fast-acting carbohydrates for CGM readings under 80mg/dL during the day and under 70mg/dL overnight (or at higher glycemic thresholds per parent discretion). A repeat treatment was considered if CGM value was\<80mg/dL after \~20min. Hypoglycemic treatments could occur at any time per study physician request
Outcome measures
| Measure |
Artificial Pancreas Therapy
n=12 Participants
Subjects will use the Tandem t:slim X2 with Control-IQ Technology + Dexcom G6 to automatically modulate their insulin delivery and control their glycemia.
Tandem t:slim X2 with Control-IQ Technology + Dexcom G6: Subjects will use the Tandem t:slim X2 with Control-IQ Technology and Dexcom G6 CGM to control their glycemia. The Tandem t:slim X2 with Control-IQ device is an automated insulin delivery pump that automatically adjusts insulin delivery to predicted and prevailing glucose levels, as measured by a Dexcom G6 continuous glucose monitor \[CGM\].
|
|---|---|
|
Average Number of Treatments.
|
0.8 treatments/day
Interval 0.3 to 1.4
|
SECONDARY outcome
Timeframe: The 5 day period of data collection included 48 hours of supervised hotel admission. The remaining 72 hours consisted of at-home Control IQ use under parental supervision and remote study staff monitoring.Average amount of carbohydrates (grams) used as a treatment. Participants were treated with \~16g fast-acting carbohydrates for CGM readings under 80mg/dL during the day and under 70mg/dL overnight (or at higher glycemic thresholds per parent discretion). A repeat treatment was considered if CGM value was\<80mg/dL after \~20min. Hypoglycemic treatments could occur at any time per study physician request
Outcome measures
| Measure |
Artificial Pancreas Therapy
n=12 Participants
Subjects will use the Tandem t:slim X2 with Control-IQ Technology + Dexcom G6 to automatically modulate their insulin delivery and control their glycemia.
Tandem t:slim X2 with Control-IQ Technology + Dexcom G6: Subjects will use the Tandem t:slim X2 with Control-IQ Technology and Dexcom G6 CGM to control their glycemia. The Tandem t:slim X2 with Control-IQ device is an automated insulin delivery pump that automatically adjusts insulin delivery to predicted and prevailing glucose levels, as measured by a Dexcom G6 continuous glucose monitor \[CGM\].
|
|---|---|
|
Average of Carbohydrate Treatments (g).
|
17.5 grams
Standard Deviation 17.6
|
SECONDARY outcome
Timeframe: The 5 day period of data collection included 48 hours of supervised hotel admission. The remaining 72 hours consisted of at-home Control IQ use under parental supervision and remote study staff monitoring.Percentage of the amount of time spent with the Control-IQ system running in closed loop mode.
Outcome measures
| Measure |
Artificial Pancreas Therapy
n=12 Participants
Subjects will use the Tandem t:slim X2 with Control-IQ Technology + Dexcom G6 to automatically modulate their insulin delivery and control their glycemia.
Tandem t:slim X2 with Control-IQ Technology + Dexcom G6: Subjects will use the Tandem t:slim X2 with Control-IQ Technology and Dexcom G6 CGM to control their glycemia. The Tandem t:slim X2 with Control-IQ device is an automated insulin delivery pump that automatically adjusts insulin delivery to predicted and prevailing glucose levels, as measured by a Dexcom G6 continuous glucose monitor \[CGM\].
|
|---|---|
|
Percent of Time Spent in Closed Loop
|
96.6 percentage of time
Interval 93.6 to 98.9
|
SECONDARY outcome
Timeframe: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.Percentage of subjects with more than 70% time in 70-180mg/dL range with less than 4% time below 70mg/dL.
Outcome measures
| Measure |
Artificial Pancreas Therapy
n=12 Participants
Subjects will use the Tandem t:slim X2 with Control-IQ Technology + Dexcom G6 to automatically modulate their insulin delivery and control their glycemia.
Tandem t:slim X2 with Control-IQ Technology + Dexcom G6: Subjects will use the Tandem t:slim X2 with Control-IQ Technology and Dexcom G6 CGM to control their glycemia. The Tandem t:slim X2 with Control-IQ device is an automated insulin delivery pump that automatically adjusts insulin delivery to predicted and prevailing glucose levels, as measured by a Dexcom G6 continuous glucose monitor \[CGM\].
|
|---|---|
|
CGM Consensus Goal
Baseline
|
8 percentage of participants
|
|
CGM Consensus Goal
5 days of AP Therapy
|
58 percentage of participants
|
Adverse Events
Artificial Pancreas Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Marc Breton, PhD
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