Trial Outcomes & Findings for Control-IQ Technology for High Insulin Users With Type 1 Diabetes (Higher-IQ) (NCT NCT05422053)
NCT ID: NCT05422053
Last Updated: 2025-04-03
Results Overview
Number of severe hypoglycemia events (with cognitive impairment such that assistance of another individual is needed for treatment) during the entire study period
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
34 participants
Primary outcome timeframe
3 months
Results posted on
2025-04-03
Participant Flow
Participant milestones
| Measure |
t:Slim X2 Insulin Pump With Control-IQ Technology
Adults with type 1 diabetes will use the t:slim X2 insulin pump with Control-IQ technology 1.5 for 3-months of outpatient use. Meal and exercise challenges will be performed.
t:slim X2 insulin pump with Control-IQ technology 1.5: t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 CGM.
|
|---|---|
|
Overall Study
STARTED
|
34
|
|
Overall Study
COMPLETED
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Control-IQ Technology for High Insulin Users With Type 1 Diabetes (Higher-IQ)
Baseline characteristics by cohort
| Measure |
t:Slim X2 Insulin Pump With Control-IQ Technology
n=34 Participants
Adults with type 1 diabetes will use the t:slim X2 insulin pump with Control-IQ technology 1.5 for 3-months of outpatient use. Meal and exercise challenges will be performed.
t:slim X2 insulin pump with Control-IQ technology 1.5: t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 CGM.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
39.9 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 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
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=5 Participants
|
|
Socio-economic factors (income)
Less than $25,000
|
3 participants
n=5 Participants
|
|
Socio-economic factors (income)
$25,000 to less than $35,000
|
0 participants
n=5 Participants
|
|
Socio-economic factors (income)
$35,000 to less than $50,000
|
3 participants
n=5 Participants
|
|
Socio-economic factors (income)
$50,000 to less than $75,000
|
1 participants
n=5 Participants
|
|
Socio-economic factors (income)
$75,000 to less than $100,000
|
8 participants
n=5 Participants
|
|
Socio-economic factors (income)
$100,000 to less than $200,000
|
11 participants
n=5 Participants
|
|
Socio-economic factors (income)
$200,000 or more
|
3 participants
n=5 Participants
|
|
Socio-economic factors (income)
Unknown
|
5 participants
n=5 Participants
|
|
Socio-economic factors (education)
Less than high school
|
1 participants
n=5 Participants
|
|
Socio-economic factors (education)
High school graduate / diploma / GED
|
4 participants
n=5 Participants
|
|
Socio-economic factors (education)
Some college but no degree
|
8 participants
n=5 Participants
|
|
Socio-economic factors (education)
Associate degree (AA)
|
3 participants
n=5 Participants
|
|
Socio-economic factors (education)
Bachelor's degree (BA, BS, AB)
|
13 participants
n=5 Participants
|
|
Socio-economic factors (education)
Master's degree (MA, MS, MSW, MBA, MPH)
|
5 participants
n=5 Participants
|
|
Socio-economic factors (education)
Professional degree (MD, DDS, DVM, LLB, JD)
|
0 participants
n=5 Participants
|
|
Socio-economic factors (education)
Doctorate degree (PhD, EdD)
|
0 participants
n=5 Participants
|
|
Socio-economic factors (education)
Unknown
|
0 participants
n=5 Participants
|
|
Socio-economic factors (education)
Does not wish to provide
|
0 participants
n=5 Participants
|
|
Duration of Diabetes
|
21.8 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
HbA1c at Control-IQ Start
|
7.7 percentage of glycated hemoglobin
STANDARD_DEVIATION 1.1 • n=5 Participants
|
|
BMI
|
37.6 kg/m^2
STANDARD_DEVIATION 5.2 • n=5 Participants
|
|
Total daily insulin
|
1.2 units/kg/day
STANDARD_DEVIATION 0.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsNumber of severe hypoglycemia events (with cognitive impairment such that assistance of another individual is needed for treatment) during the entire study period
Outcome measures
| Measure |
t:Slim X2 Insulin Pump With Control-IQ Technology
n=34 Participants
Adults with type 1 diabetes will use the t:slim X2 insulin pump with Control-IQ technology 1.5 for 3-months of outpatient use. Meal and exercise challenges will be performed.
t:slim X2 insulin pump with Control-IQ technology 1.5: t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 CGM.
|
|---|---|
|
Number of Severe Hypoglycemic Events
|
0 events
|
PRIMARY outcome
Timeframe: 3 monthsNumber of diabetic ketoacidosis events during the entire study period
Outcome measures
| Measure |
t:Slim X2 Insulin Pump With Control-IQ Technology
n=34 Participants
Adults with type 1 diabetes will use the t:slim X2 insulin pump with Control-IQ technology 1.5 for 3-months of outpatient use. Meal and exercise challenges will be performed.
t:slim X2 insulin pump with Control-IQ technology 1.5: t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 CGM.
|
|---|---|
|
Number of Diabetic Ketoacidosis Events
|
0 events
|
PRIMARY outcome
Timeframe: 3 monthsNumber of unanticipated adverse device effects during the entire study period
Outcome measures
| Measure |
t:Slim X2 Insulin Pump With Control-IQ Technology
n=34 Participants
Adults with type 1 diabetes will use the t:slim X2 insulin pump with Control-IQ technology 1.5 for 3-months of outpatient use. Meal and exercise challenges will be performed.
t:slim X2 insulin pump with Control-IQ technology 1.5: t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 CGM.
|
|---|---|
|
Unanticipated Adverse Device Effects
|
0 events
|
PRIMARY outcome
Timeframe: 3 monthsNumber of serious adverse events during the entire study period
Outcome measures
| Measure |
t:Slim X2 Insulin Pump With Control-IQ Technology
n=34 Participants
Adults with type 1 diabetes will use the t:slim X2 insulin pump with Control-IQ technology 1.5 for 3-months of outpatient use. Meal and exercise challenges will be performed.
t:slim X2 insulin pump with Control-IQ technology 1.5: t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 CGM.
|
|---|---|
|
Other Serious Adverse Events
|
1 events
|
SECONDARY outcome
Timeframe: 3 monthsPercent time CGM glucose \<54 mg/dL overall
Outcome measures
| Measure |
t:Slim X2 Insulin Pump With Control-IQ Technology
n=34 Participants
Adults with type 1 diabetes will use the t:slim X2 insulin pump with Control-IQ technology 1.5 for 3-months of outpatient use. Meal and exercise challenges will be performed.
t:slim X2 insulin pump with Control-IQ technology 1.5: t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 CGM.
|
|---|---|
|
CGM Time <54 mg/dL Overall
|
0.2 percentage of time
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: 3 monthsPercent time CGM glucose \<54 mg/dL daytime only (06:00 - 24:00)
Outcome measures
| Measure |
t:Slim X2 Insulin Pump With Control-IQ Technology
n=34 Participants
Adults with type 1 diabetes will use the t:slim X2 insulin pump with Control-IQ technology 1.5 for 3-months of outpatient use. Meal and exercise challenges will be performed.
t:slim X2 insulin pump with Control-IQ technology 1.5: t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 CGM.
|
|---|---|
|
CGM Time <54 mg/dL Daytime Only
|
0.2 percentage of time
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: 3 monthsPercent time CGM glucose \<54 mg/dL nighttime only (00:00 - 06:00)
Outcome measures
| Measure |
t:Slim X2 Insulin Pump With Control-IQ Technology
n=34 Participants
Adults with type 1 diabetes will use the t:slim X2 insulin pump with Control-IQ technology 1.5 for 3-months of outpatient use. Meal and exercise challenges will be performed.
t:slim X2 insulin pump with Control-IQ technology 1.5: t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 CGM.
|
|---|---|
|
CGM Time <54 mg/dL Nighttime Only
|
0.4 percentage of time
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: 3 monthsPercent time CGM glucose \<70 mg/dL overall
Outcome measures
| Measure |
t:Slim X2 Insulin Pump With Control-IQ Technology
n=34 Participants
Adults with type 1 diabetes will use the t:slim X2 insulin pump with Control-IQ technology 1.5 for 3-months of outpatient use. Meal and exercise challenges will be performed.
t:slim X2 insulin pump with Control-IQ technology 1.5: t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 CGM.
|
|---|---|
|
CGM Time <70 mg/dL Overall
|
1.0 percentage of time
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: 3 monthsPercent time CGM glucose \<70 mg/dL daytime only (06:00 - 24:00)
Outcome measures
| Measure |
t:Slim X2 Insulin Pump With Control-IQ Technology
n=34 Participants
Adults with type 1 diabetes will use the t:slim X2 insulin pump with Control-IQ technology 1.5 for 3-months of outpatient use. Meal and exercise challenges will be performed.
t:slim X2 insulin pump with Control-IQ technology 1.5: t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 CGM.
|
|---|---|
|
CGM Time <70 mg/dL Daytime Only
|
0.9 percentage of time
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: 3 monthsPercent time CGM glucose \<70 mg/dL nighttime only (00:00 - 06:00)
Outcome measures
| Measure |
t:Slim X2 Insulin Pump With Control-IQ Technology
n=34 Participants
Adults with type 1 diabetes will use the t:slim X2 insulin pump with Control-IQ technology 1.5 for 3-months of outpatient use. Meal and exercise challenges will be performed.
t:slim X2 insulin pump with Control-IQ technology 1.5: t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 CGM.
|
|---|---|
|
CGM Time <70 mg/dL Nighttime Only
|
1.4 percentage of time
Standard Deviation 1.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsChange in Hemoglobin A1c from baseline
Outcome measures
| Measure |
t:Slim X2 Insulin Pump With Control-IQ Technology
n=34 Participants
Adults with type 1 diabetes will use the t:slim X2 insulin pump with Control-IQ technology 1.5 for 3-months of outpatient use. Meal and exercise challenges will be performed.
t:slim X2 insulin pump with Control-IQ technology 1.5: t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 CGM.
|
|---|---|
|
Hemoglobin A1c
|
-0.82 percentage of glycated hemoglobin
Standard Deviation 0.73
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsPercent time CGM glucose in range 70-180 mg/dl overall
Outcome measures
| Measure |
t:Slim X2 Insulin Pump With Control-IQ Technology
n=34 Participants
Adults with type 1 diabetes will use the t:slim X2 insulin pump with Control-IQ technology 1.5 for 3-months of outpatient use. Meal and exercise challenges will be performed.
t:slim X2 insulin pump with Control-IQ technology 1.5: t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 CGM.
|
|---|---|
|
CGM Time in Range 70-180 mg/dL Overall
|
64.8 percentage of time
Standard Deviation 10.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsPercent time CGM glucose in range 70-180 mg/dl daytime only (06:00 - 24:00)
Outcome measures
| Measure |
t:Slim X2 Insulin Pump With Control-IQ Technology
n=34 Participants
Adults with type 1 diabetes will use the t:slim X2 insulin pump with Control-IQ technology 1.5 for 3-months of outpatient use. Meal and exercise challenges will be performed.
t:slim X2 insulin pump with Control-IQ technology 1.5: t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 CGM.
|
|---|---|
|
CGM Time in Range 70-180 mg/dL Daytime Only
|
63.5 percentage of time
Standard Deviation 10.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsPercent time CGM glucose in range 70-180 mg/dl nighttime only (00:00 - 06:00)
Outcome measures
| Measure |
t:Slim X2 Insulin Pump With Control-IQ Technology
n=34 Participants
Adults with type 1 diabetes will use the t:slim X2 insulin pump with Control-IQ technology 1.5 for 3-months of outpatient use. Meal and exercise challenges will be performed.
t:slim X2 insulin pump with Control-IQ technology 1.5: t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 CGM.
|
|---|---|
|
CGM Time in Range 70-180 mg/dL Nighttime Only
|
68.5 percentage of time
Standard Deviation 14.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsPercent time CGM glucose\> 180 mg/dL overall
Outcome measures
| Measure |
t:Slim X2 Insulin Pump With Control-IQ Technology
n=34 Participants
Adults with type 1 diabetes will use the t:slim X2 insulin pump with Control-IQ technology 1.5 for 3-months of outpatient use. Meal and exercise challenges will be performed.
t:slim X2 insulin pump with Control-IQ technology 1.5: t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 CGM.
|
|---|---|
|
CGM Time >180 mg/dL Overall
|
34.2 percentage of time
Standard Deviation 11.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsPercent time CGM glucose\> 180 mg/dL daytime only (06:00 - 24:00)
Outcome measures
| Measure |
t:Slim X2 Insulin Pump With Control-IQ Technology
n=34 Participants
Adults with type 1 diabetes will use the t:slim X2 insulin pump with Control-IQ technology 1.5 for 3-months of outpatient use. Meal and exercise challenges will be performed.
t:slim X2 insulin pump with Control-IQ technology 1.5: t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 CGM.
|
|---|---|
|
CGM Time >180 mg/dL Daytime Only
|
35.6 percentage of time
Standard Deviation 11.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsPercent time CGM glucose\> 180 mg/dL nighttime only (00:00 - 06:00)
Outcome measures
| Measure |
t:Slim X2 Insulin Pump With Control-IQ Technology
n=34 Participants
Adults with type 1 diabetes will use the t:slim X2 insulin pump with Control-IQ technology 1.5 for 3-months of outpatient use. Meal and exercise challenges will be performed.
t:slim X2 insulin pump with Control-IQ technology 1.5: t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 CGM.
|
|---|---|
|
CGM Time >180 mg/dL Nighttime Only
|
30.1 percentage of time
Standard Deviation 15.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsPercent time CGM glucose \>250 mg/dL overall
Outcome measures
| Measure |
t:Slim X2 Insulin Pump With Control-IQ Technology
n=34 Participants
Adults with type 1 diabetes will use the t:slim X2 insulin pump with Control-IQ technology 1.5 for 3-months of outpatient use. Meal and exercise challenges will be performed.
t:slim X2 insulin pump with Control-IQ technology 1.5: t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 CGM.
|
|---|---|
|
CGM Time >250 mg/dL Overall
|
10.5 percentage of time
Standard Deviation 6.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsPercent time CGM glucose \>250 mg/dL daytime only (06:00 - 24:00)
Outcome measures
| Measure |
t:Slim X2 Insulin Pump With Control-IQ Technology
n=34 Participants
Adults with type 1 diabetes will use the t:slim X2 insulin pump with Control-IQ technology 1.5 for 3-months of outpatient use. Meal and exercise challenges will be performed.
t:slim X2 insulin pump with Control-IQ technology 1.5: t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 CGM.
|
|---|---|
|
CGM Time >250 mg/dL Daytime Only
|
10.7 percentage of time
Standard Deviation 6.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsPercent time CGM glucose \>250 mg/dL nighttime only (00:00 - 06:00)
Outcome measures
| Measure |
t:Slim X2 Insulin Pump With Control-IQ Technology
n=34 Participants
Adults with type 1 diabetes will use the t:slim X2 insulin pump with Control-IQ technology 1.5 for 3-months of outpatient use. Meal and exercise challenges will be performed.
t:slim X2 insulin pump with Control-IQ technology 1.5: t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 CGM.
|
|---|---|
|
CGM Time >250 mg/dL Nighttime Only
|
9.6 percentage of time
Standard Deviation 10.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsPercent time CGM glucose in range 70-140 mg/dl overall
Outcome measures
| Measure |
t:Slim X2 Insulin Pump With Control-IQ Technology
n=34 Participants
Adults with type 1 diabetes will use the t:slim X2 insulin pump with Control-IQ technology 1.5 for 3-months of outpatient use. Meal and exercise challenges will be performed.
t:slim X2 insulin pump with Control-IQ technology 1.5: t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 CGM.
|
|---|---|
|
CGM Time in Range 70-140 mg/dL Overall
|
37.9 percentage of time
Standard Deviation 10.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsPercent time CGM glucose in range 70-140 mg/dl daytime only (06:00 - 24:00)
Outcome measures
| Measure |
t:Slim X2 Insulin Pump With Control-IQ Technology
n=34 Participants
Adults with type 1 diabetes will use the t:slim X2 insulin pump with Control-IQ technology 1.5 for 3-months of outpatient use. Meal and exercise challenges will be performed.
t:slim X2 insulin pump with Control-IQ technology 1.5: t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 CGM.
|
|---|---|
|
CGM Time in Range 70-140 mg/dL Daytime Only
|
37.0 percentage of time
Standard Deviation 10.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsPercent time CGM glucose in range 70-140 mg/dl nighttime only (00:00 - 06:00)
Outcome measures
| Measure |
t:Slim X2 Insulin Pump With Control-IQ Technology
n=34 Participants
Adults with type 1 diabetes will use the t:slim X2 insulin pump with Control-IQ technology 1.5 for 3-months of outpatient use. Meal and exercise challenges will be performed.
t:slim X2 insulin pump with Control-IQ technology 1.5: t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 CGM.
|
|---|---|
|
CGM Time in Range 70-140 mg/dL Nighttime Only
|
40.6 percentage of time
Standard Deviation 14.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsCGM-measured mean glucose (mg/dL) overall
Outcome measures
| Measure |
t:Slim X2 Insulin Pump With Control-IQ Technology
n=34 Participants
Adults with type 1 diabetes will use the t:slim X2 insulin pump with Control-IQ technology 1.5 for 3-months of outpatient use. Meal and exercise challenges will be performed.
t:slim X2 insulin pump with Control-IQ technology 1.5: t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 CGM.
|
|---|---|
|
CGM Mean Glucose mg/dL Overall
|
167.4 mg/dL
Standard Deviation 17.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsCGM-measured mean glucose (mg/dL) daytime only (06:00 - 24:00)
Outcome measures
| Measure |
t:Slim X2 Insulin Pump With Control-IQ Technology
n=34 Participants
Adults with type 1 diabetes will use the t:slim X2 insulin pump with Control-IQ technology 1.5 for 3-months of outpatient use. Meal and exercise challenges will be performed.
t:slim X2 insulin pump with Control-IQ technology 1.5: t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 CGM.
|
|---|---|
|
CGM Mean Glucose mg/dL Daytime Only
|
168.8 mg/dL
Standard Deviation 17.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsCGM-measured mean glucose (mg/dL) nighttime only (00:00 - 06:00)
Outcome measures
| Measure |
t:Slim X2 Insulin Pump With Control-IQ Technology
n=34 Participants
Adults with type 1 diabetes will use the t:slim X2 insulin pump with Control-IQ technology 1.5 for 3-months of outpatient use. Meal and exercise challenges will be performed.
t:slim X2 insulin pump with Control-IQ technology 1.5: t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 CGM.
|
|---|---|
|
CGM Mean Glucose mg/dL Nighttime Only
|
163.1 mg/dL
Standard Deviation 25.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsCGM measured glucose variability measured with the coefficient of variation overall
Outcome measures
| Measure |
t:Slim X2 Insulin Pump With Control-IQ Technology
n=34 Participants
Adults with type 1 diabetes will use the t:slim X2 insulin pump with Control-IQ technology 1.5 for 3-months of outpatient use. Meal and exercise challenges will be performed.
t:slim X2 insulin pump with Control-IQ technology 1.5: t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 CGM.
|
|---|---|
|
Coefficient of Variation Overall
|
34.7 percentage of coefficient of variation
Standard Deviation 5.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsCGM measured glucose variability measured with the coefficient of variation daytime only (06:00 - 24:00)
Outcome measures
| Measure |
t:Slim X2 Insulin Pump With Control-IQ Technology
n=34 Participants
Adults with type 1 diabetes will use the t:slim X2 insulin pump with Control-IQ technology 1.5 for 3-months of outpatient use. Meal and exercise challenges will be performed.
t:slim X2 insulin pump with Control-IQ technology 1.5: t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 CGM.
|
|---|---|
|
Coefficient of Variation Daytime Only
|
34.4 percentage of coefficient of variation
Standard Deviation 4.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsCGM measured glucose variability measured with the coefficient of variation nighttime only (00:00 - 06:00)
Outcome measures
| Measure |
t:Slim X2 Insulin Pump With Control-IQ Technology
n=34 Participants
Adults with type 1 diabetes will use the t:slim X2 insulin pump with Control-IQ technology 1.5 for 3-months of outpatient use. Meal and exercise challenges will be performed.
t:slim X2 insulin pump with Control-IQ technology 1.5: t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 CGM.
|
|---|---|
|
Coefficient of Variation Nighttime Only
|
33.7 percentage of coefficient of variation
Standard Deviation 6.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsCGM measured standard deviation of glucose (mg/dL) overall
Outcome measures
| Measure |
t:Slim X2 Insulin Pump With Control-IQ Technology
n=34 Participants
Adults with type 1 diabetes will use the t:slim X2 insulin pump with Control-IQ technology 1.5 for 3-months of outpatient use. Meal and exercise challenges will be performed.
t:slim X2 insulin pump with Control-IQ technology 1.5: t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 CGM.
|
|---|---|
|
Standard Deviation of Glucose, Overall
|
58.2 mg/dL
Standard Deviation 11.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsCGM measured standard deviation of glucose (mg/dL), daytime only (06:00 - 24:00)
Outcome measures
| Measure |
t:Slim X2 Insulin Pump With Control-IQ Technology
n=34 Participants
Adults with type 1 diabetes will use the t:slim X2 insulin pump with Control-IQ technology 1.5 for 3-months of outpatient use. Meal and exercise challenges will be performed.
t:slim X2 insulin pump with Control-IQ technology 1.5: t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 CGM.
|
|---|---|
|
Standard Deviation of Glucose, Daytime
|
58.4 mg/dL
Standard Deviation 11.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsCGM measured standard deviation of glucose (mg/dL), nighttime only (00:00 - 06:00)
Outcome measures
| Measure |
t:Slim X2 Insulin Pump With Control-IQ Technology
n=34 Participants
Adults with type 1 diabetes will use the t:slim X2 insulin pump with Control-IQ technology 1.5 for 3-months of outpatient use. Meal and exercise challenges will be performed.
t:slim X2 insulin pump with Control-IQ technology 1.5: t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 CGM.
|
|---|---|
|
Standard Deviation of Glucose, Nighttime Only
|
55.1 mg/dL
Standard Deviation 14.3
|
Adverse Events
t:Slim X2 Insulin Pump With Control-IQ Technology
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
t:Slim X2 Insulin Pump With Control-IQ Technology
n=34 participants at risk
Adults with type 1 diabetes will use the t:slim X2 insulin pump with Control-IQ technology 1.5 for 3-months of outpatient use. Meal and exercise challenges will be performed.
t:slim X2 insulin pump with Control-IQ technology 1.5: t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 CGM.
|
|---|---|
|
Cardiac disorders
New onset atrial fibrillation
|
2.9%
1/34 • Number of events 1 • 13 weeks
|
Other adverse events
| Measure |
t:Slim X2 Insulin Pump With Control-IQ Technology
n=34 participants at risk
Adults with type 1 diabetes will use the t:slim X2 insulin pump with Control-IQ technology 1.5 for 3-months of outpatient use. Meal and exercise challenges will be performed.
t:slim X2 insulin pump with Control-IQ technology 1.5: t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 CGM.
|
|---|---|
|
Ear and labyrinth disorders
Otitis media
|
2.9%
1/34 • Number of events 1 • 13 weeks
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
2.9%
1/34 • Number of events 1 • 13 weeks
|
|
Gastrointestinal disorders
Nausea
|
2.9%
1/34 • Number of events 1 • 13 weeks
|
|
Gastrointestinal disorders
Tooth fracture
|
2.9%
1/34 • Number of events 1 • 13 weeks
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
1/34 • Number of events 1 • 13 weeks
|
|
General disorders
Influenza like illness
|
2.9%
1/34 • Number of events 1 • 13 weeks
|
|
Infections and infestations
Bronchitis
|
2.9%
1/34 • Number of events 1 • 13 weeks
|
|
Infections and infestations
COVID-19
|
5.9%
2/34 • Number of events 2 • 13 weeks
|
|
Infections and infestations
Ear Infection
|
2.9%
1/34 • Number of events 1 • 13 weeks
|
|
Infections and infestations
Influenza
|
5.9%
2/34 • Number of events 2 • 13 weeks
|
|
Infections and infestations
Otitis Externa
|
2.9%
1/34 • Number of events 1 • 13 weeks
|
|
Infections and infestations
Pharyngitis streptococcal
|
2.9%
1/34 • Number of events 1 • 13 weeks
|
|
Infections and infestations
Tooth abscess
|
2.9%
1/34 • Number of events 1 • 13 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
20.6%
7/34 • Number of events 10 • 13 weeks
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
2.9%
1/34 • Number of events 1 • 13 weeks
|
|
Metabolism and nutrition disorders
Ketonemia
|
2.9%
1/34 • Number of events 1 • 13 weeks
|
|
Metabolism and nutrition disorders
Dyslipidemia
|
2.9%
1/34 • Number of events 1 • 13 weeks
|
|
Musculoskeletal and connective tissue disorders
Ligament sprain
|
2.9%
1/34 • Number of events 1 • 13 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.9%
1/34 • Number of events 1 • 13 weeks
|
|
Musculoskeletal and connective tissue disorders
Stiff person syndrome
|
2.9%
1/34 • Number of events 1 • 13 weeks
|
|
Nervous system disorders
Migraine
|
2.9%
1/34 • Number of events 1 • 13 weeks
|
|
Renal and urinary disorders
Chronic kidney disease
|
2.9%
1/34 • Number of events 1 • 13 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.9%
1/34 • Number of events 1 • 13 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.9%
1/34 • Number of events 1 • 13 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea syndrome
|
2.9%
1/34 • Number of events 1 • 13 weeks
|
|
Vascular disorders
Hypertension
|
2.9%
1/34 • Number of events 1 • 13 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place