Trial Outcomes & Findings for Control-IQ Technology in Individuals With Type 2 Diabetes (NCT NCT05111301)
NCT ID: NCT05111301
Last Updated: 2024-03-06
Results Overview
CGM-measured percentage below 54 mg/dl, compared to baseline
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
14 weeks
Results posted on
2024-03-06
Participant Flow
Study participants were recruited from 3 clinical centers in the United States. All eligible participants were included without regard to gender, race, or ethnicity. Each site was asked to contribute \~10 participants (5 basal only / 5 MDI) toward the overall recruitment goal.
Participant milestones
| Measure |
Basal Insulin Only (Group A)
* 2 to 4 week CGM run-in
* 2 to 4 week pump run-in
* 6 weeks Control-IQ technology use
Control-IQ technology 1.5: All subjects wearing the t-slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor.
Outcomes will be analyzed overall and subgroup analysis will be performed by Group, and by baseline A1c level.
|
Multiple Daily Injections (Group B)
* 2 to 4 week CGM run-in
* 2 to 4 week pump run-in
* 6 weeks Control-IQ technology use
Control-IQ technology 1.5: All subjects wearing the t-slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor.
Outcomes will be analyzed overall and subgroup analysis will be performed by Group, and by baseline A1c level.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
17
|
|
Overall Study
COMPLETED
|
13
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Control-IQ Technology in Individuals With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Basal Insulin Only (Group A)
n=13 Participants
* 2 to 4 week CGM run-in
* 2 to 4 week pump run-in
* 6 weeks Control-IQ technology use
Control-IQ technology 1.5: All subjects wearing the t-slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor.
Outcomes will be analyzed overall and subgroup analysis will be performed by Group, and by baseline A1c level.
|
Multiple Daily Injections (Group B)
n=17 Participants
* 2 to 4 week CGM run-in
* 2 to 4 week pump run-in
* 6 weeks Control-IQ technology use
Control-IQ technology 1.5: All subjects wearing the t-slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor.
Outcomes will be analyzed overall and subgroup analysis will be performed by Group, and by baseline A1c level.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 12 • n=99 Participants
|
54 years
STANDARD_DEVIATION 12 • n=107 Participants
|
54 years
STANDARD_DEVIATION 12 • n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Hemoglobin A1c
|
8.2 Percent of glycated hemoglobin
STANDARD_DEVIATION 0.9 • n=99 Participants
|
8.9 Percent of glycated hemoglobin
STANDARD_DEVIATION 1.3 • n=107 Participants
|
8.6 Percent of glycated hemoglobin
STANDARD_DEVIATION 1.2 • n=206 Participants
|
PRIMARY outcome
Timeframe: 14 weeksCGM-measured percentage below 54 mg/dl, compared to baseline
Outcome measures
| Measure |
Overall
n=30 Participants
* 2 to 4 week CGM run-in with insulin injections (baseline)
* 2 to 4 week open loop with insulin pump and Dexcom G6 sensor
* 6 weeks Control-IQ technology 1.5 use
Control-IQ technology 1.5: All subjects wearing the t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor.
|
Basal Insulin Only (Group A)
n=13 Participants
* 2 to 4 week CGM run-in with insulin injections (baseline)
* 2 to 4 week open loop with insulin pump and Dexcom G6 sensor
* 6 weeks Control-IQ technology 1.5 use
Control-IQ technology 1.5: All subjects wearing the t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor.
|
Multiple Daily Injections (Group B)
n=17 Participants
* 2 to 4 week CGM run-in with insulin injections (baseline)
* 2 to 4 week open loop with insulin pump and Dexcom G6 sensor
* 6 weeks Control-IQ technology 1.5 use
Control-IQ technology 1.5: All subjects wearing the t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor.
|
|---|---|---|---|
|
CGM Time Below 54 mg/dL
Baseline
|
0.00 percentage of time
Interval 0.0 to 0.11
|
0.00 percentage of time
Interval 0.0 to 0.11
|
0.00 percentage of time
Interval 0.0 to 0.0
|
|
CGM Time Below 54 mg/dL
Open-Loop
|
0.00 percentage of time
Interval 0.0 to 0.08
|
0.00 percentage of time
Interval 0.0 to 0.12
|
0.00 percentage of time
Interval 0.0 to 0.03
|
|
CGM Time Below 54 mg/dL
Control-IQ
|
0.02 percentage of time
Interval 0.0 to 0.07
|
0.02 percentage of time
Interval 0.01 to 0.08
|
0.02 percentage of time
Interval 0.0 to 0.05
|
PRIMARY outcome
Timeframe: 14 weeksCGM-measured percentage above 180 mg/dl, compared to baseline
Outcome measures
| Measure |
Overall
n=30 Participants
* 2 to 4 week CGM run-in with insulin injections (baseline)
* 2 to 4 week open loop with insulin pump and Dexcom G6 sensor
* 6 weeks Control-IQ technology 1.5 use
Control-IQ technology 1.5: All subjects wearing the t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor.
|
Basal Insulin Only (Group A)
n=13 Participants
* 2 to 4 week CGM run-in with insulin injections (baseline)
* 2 to 4 week open loop with insulin pump and Dexcom G6 sensor
* 6 weeks Control-IQ technology 1.5 use
Control-IQ technology 1.5: All subjects wearing the t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor.
|
Multiple Daily Injections (Group B)
n=17 Participants
* 2 to 4 week CGM run-in with insulin injections (baseline)
* 2 to 4 week open loop with insulin pump and Dexcom G6 sensor
* 6 weeks Control-IQ technology 1.5 use
Control-IQ technology 1.5: All subjects wearing the t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor.
|
|---|---|---|---|
|
CGM Time Above 180 mg/dL
Baseline
|
44 percentage of time
Standard Deviation 25
|
39 percentage of time
Standard Deviation 15
|
48 percentage of time
Standard Deviation 31
|
|
CGM Time Above 180 mg/dL
Open-Loop
|
37 percentage of time
Standard Deviation 20
|
34 percentage of time
Standard Deviation 22
|
39 percentage of time
Standard Deviation 19
|
|
CGM Time Above 180 mg/dL
Control-IQ
|
29 percentage of time
Standard Deviation 18
|
26 percentage of time
Standard Deviation 15
|
31 percentage of time
Standard Deviation 20
|
SECONDARY outcome
Timeframe: 14 weeksCGM-measured percentage in range 70-180 mg/dl, compared to baseline
Outcome measures
| Measure |
Overall
n=30 Participants
* 2 to 4 week CGM run-in with insulin injections (baseline)
* 2 to 4 week open loop with insulin pump and Dexcom G6 sensor
* 6 weeks Control-IQ technology 1.5 use
Control-IQ technology 1.5: All subjects wearing the t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor.
|
Basal Insulin Only (Group A)
n=13 Participants
* 2 to 4 week CGM run-in with insulin injections (baseline)
* 2 to 4 week open loop with insulin pump and Dexcom G6 sensor
* 6 weeks Control-IQ technology 1.5 use
Control-IQ technology 1.5: All subjects wearing the t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor.
|
Multiple Daily Injections (Group B)
n=17 Participants
* 2 to 4 week CGM run-in with insulin injections (baseline)
* 2 to 4 week open loop with insulin pump and Dexcom G6 sensor
* 6 weeks Control-IQ technology 1.5 use
Control-IQ technology 1.5: All subjects wearing the t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor.
|
|---|---|---|---|
|
CGM Time In Range 70-180 mg/dL
Baseline
|
56 percentage of time
Standard Deviation 25
|
61 percentage of time
Standard Deviation 15
|
52 percentage of time
Standard Deviation 31
|
|
CGM Time In Range 70-180 mg/dL
Open-Loop
|
63 percentage of time
Standard Deviation 20
|
66 percentage of time
Standard Deviation 22
|
61 percentage of time
Standard Deviation 18
|
|
CGM Time In Range 70-180 mg/dL
Control-IQ
|
71 percentage of time
Standard Deviation 18
|
74 percentage of time
Standard Deviation 15
|
68 percentage of time
Standard Deviation 20
|
SECONDARY outcome
Timeframe: 14 weeksCGM-measured percentage below 70 mg/dl, compared to baseline
Outcome measures
| Measure |
Overall
n=30 Participants
* 2 to 4 week CGM run-in with insulin injections (baseline)
* 2 to 4 week open loop with insulin pump and Dexcom G6 sensor
* 6 weeks Control-IQ technology 1.5 use
Control-IQ technology 1.5: All subjects wearing the t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor.
|
Basal Insulin Only (Group A)
n=13 Participants
* 2 to 4 week CGM run-in with insulin injections (baseline)
* 2 to 4 week open loop with insulin pump and Dexcom G6 sensor
* 6 weeks Control-IQ technology 1.5 use
Control-IQ technology 1.5: All subjects wearing the t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor.
|
Multiple Daily Injections (Group B)
n=17 Participants
* 2 to 4 week CGM run-in with insulin injections (baseline)
* 2 to 4 week open loop with insulin pump and Dexcom G6 sensor
* 6 weeks Control-IQ technology 1.5 use
Control-IQ technology 1.5: All subjects wearing the t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor.
|
|---|---|---|---|
|
CGM Time Below 70 mg/dL
Baseline
|
0.05 percentage of time
Interval 0.0 to 0.47
|
0.00 percentage of time
Interval 0.0 to 0.25
|
0.11 percentage of time
Interval 0.0 to 0.47
|
|
CGM Time Below 70 mg/dL
Open-Loop
|
0.10 percentage of time
Interval 0.0 to 0.51
|
0.19 percentage of time
Interval 0.0 to 0.35
|
0.03 percentage of time
Interval 0.0 to 0.6
|
|
CGM Time Below 70 mg/dL
Control-IQ
|
0.12 percentage of time
Interval 0.04 to 0.34
|
0.09 percentage of time
Interval 0.05 to 0.25
|
0.13 percentage of time
Interval 0.03 to 0.36
|
SECONDARY outcome
Timeframe: 14 weeksCGM-measured percentage above 250 mg/dl, compared to baseline
Outcome measures
| Measure |
Overall
n=30 Participants
* 2 to 4 week CGM run-in with insulin injections (baseline)
* 2 to 4 week open loop with insulin pump and Dexcom G6 sensor
* 6 weeks Control-IQ technology 1.5 use
Control-IQ technology 1.5: All subjects wearing the t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor.
|
Basal Insulin Only (Group A)
n=13 Participants
* 2 to 4 week CGM run-in with insulin injections (baseline)
* 2 to 4 week open loop with insulin pump and Dexcom G6 sensor
* 6 weeks Control-IQ technology 1.5 use
Control-IQ technology 1.5: All subjects wearing the t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor.
|
Multiple Daily Injections (Group B)
n=17 Participants
* 2 to 4 week CGM run-in with insulin injections (baseline)
* 2 to 4 week open loop with insulin pump and Dexcom G6 sensor
* 6 weeks Control-IQ technology 1.5 use
Control-IQ technology 1.5: All subjects wearing the t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor.
|
|---|---|---|---|
|
CGM Time Above 250 mg/dL
Baseline
|
8.5 percentage of time
Interval 1.7 to 21.1
|
12.9 percentage of time
Interval 1.7 to 14.7
|
6.8 percentage of time
Interval 2.4 to 29.6
|
|
CGM Time Above 250 mg/dL
Open-Loop
|
6.7 percentage of time
Interval 2.1 to 12.2
|
8.1 percentage of time
Interval 0.9 to 16.9
|
6.3 percentage of time
Interval 3.8 to 10.0
|
|
CGM Time Above 250 mg/dL
Control-IQ
|
2.9 percentage of time
Interval 1.1 to 12.8
|
1.9 percentage of time
Interval 0.8 to 7.5
|
2.9 percentage of time
Interval 1.3 to 13.1
|
SECONDARY outcome
Timeframe: 14 weeksCGM-measured percentage in range 70-140 mg/dl, compared to baseline
Outcome measures
| Measure |
Overall
n=30 Participants
* 2 to 4 week CGM run-in with insulin injections (baseline)
* 2 to 4 week open loop with insulin pump and Dexcom G6 sensor
* 6 weeks Control-IQ technology 1.5 use
Control-IQ technology 1.5: All subjects wearing the t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor.
|
Basal Insulin Only (Group A)
n=13 Participants
* 2 to 4 week CGM run-in with insulin injections (baseline)
* 2 to 4 week open loop with insulin pump and Dexcom G6 sensor
* 6 weeks Control-IQ technology 1.5 use
Control-IQ technology 1.5: All subjects wearing the t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor.
|
Multiple Daily Injections (Group B)
n=17 Participants
* 2 to 4 week CGM run-in with insulin injections (baseline)
* 2 to 4 week open loop with insulin pump and Dexcom G6 sensor
* 6 weeks Control-IQ technology 1.5 use
Control-IQ technology 1.5: All subjects wearing the t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor.
|
|---|---|---|---|
|
CGM Time In Range 70-140 mg/dL
Baseline
|
30 percentage of time
Standard Deviation 17
|
32 percentage of time
Standard Deviation 13
|
28 percentage of time
Standard Deviation 20
|
|
CGM Time In Range 70-140 mg/dL
Open-Loop
|
34 percentage of time
Standard Deviation 22
|
38 percentage of time
Standard Deviation 23
|
31 percentage of time
Standard Deviation 21
|
|
CGM Time In Range 70-140 mg/dL
Control-IQ
|
42 percentage of time
Standard Deviation 18
|
45 percentage of time
Standard Deviation 17
|
40 percentage of time
Standard Deviation 19
|
SECONDARY outcome
Timeframe: 14 weeksCGM measured mean glucose mg/dL, compared to baseline
Outcome measures
| Measure |
Overall
n=30 Participants
* 2 to 4 week CGM run-in with insulin injections (baseline)
* 2 to 4 week open loop with insulin pump and Dexcom G6 sensor
* 6 weeks Control-IQ technology 1.5 use
Control-IQ technology 1.5: All subjects wearing the t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor.
|
Basal Insulin Only (Group A)
n=13 Participants
* 2 to 4 week CGM run-in with insulin injections (baseline)
* 2 to 4 week open loop with insulin pump and Dexcom G6 sensor
* 6 weeks Control-IQ technology 1.5 use
Control-IQ technology 1.5: All subjects wearing the t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor.
|
Multiple Daily Injections (Group B)
n=17 Participants
* 2 to 4 week CGM run-in with insulin injections (baseline)
* 2 to 4 week open loop with insulin pump and Dexcom G6 sensor
* 6 weeks Control-IQ technology 1.5 use
Control-IQ technology 1.5: All subjects wearing the t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor.
|
|---|---|---|---|
|
CGM Mean Glucose mg/dL
Control-IQ
|
163 mg/dL
Standard Deviation 28
|
159 mg/dL
Standard Deviation 23
|
166 mg/dL
Standard Deviation 32
|
|
CGM Mean Glucose mg/dL
Baseline
|
184 mg/dL
Standard Deviation 42
|
174 mg/dL
Standard Deviation 22
|
192 mg/dL
Standard Deviation 52
|
|
CGM Mean Glucose mg/dL
Open-Loop
|
172 mg/dL
Standard Deviation 32
|
170 mg/dL
Standard Deviation 35
|
174 mg/dL
Standard Deviation 30
|
SECONDARY outcome
Timeframe: 14 weeksCGM measured glucose variability measured with the coefficient of variation (CV), compared to baseline
Outcome measures
| Measure |
Overall
n=30 Participants
* 2 to 4 week CGM run-in with insulin injections (baseline)
* 2 to 4 week open loop with insulin pump and Dexcom G6 sensor
* 6 weeks Control-IQ technology 1.5 use
Control-IQ technology 1.5: All subjects wearing the t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor.
|
Basal Insulin Only (Group A)
n=13 Participants
* 2 to 4 week CGM run-in with insulin injections (baseline)
* 2 to 4 week open loop with insulin pump and Dexcom G6 sensor
* 6 weeks Control-IQ technology 1.5 use
Control-IQ technology 1.5: All subjects wearing the t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor.
|
Multiple Daily Injections (Group B)
n=17 Participants
* 2 to 4 week CGM run-in with insulin injections (baseline)
* 2 to 4 week open loop with insulin pump and Dexcom G6 sensor
* 6 weeks Control-IQ technology 1.5 use
Control-IQ technology 1.5: All subjects wearing the t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor.
|
|---|---|---|---|
|
Coefficient of Variation (CV)
Baseline
|
28 percentage of coefficient of variation
Interval 24.0 to 31.0
|
29 percentage of coefficient of variation
Interval 27.0 to 31.0
|
25 percentage of coefficient of variation
Interval 23.0 to 32.0
|
|
Coefficient of Variation (CV)
Open-Loop
|
29 percentage of coefficient of variation
Interval 23.0 to 34.0
|
30 percentage of coefficient of variation
Interval 23.0 to 31.0
|
29 percentage of coefficient of variation
Interval 23.0 to 34.0
|
|
Coefficient of Variation (CV)
Control-IQ
|
28 percentage of coefficient of variation
Interval 24.0 to 31.0
|
27 percentage of coefficient of variation
Interval 24.0 to 30.0
|
30 percentage of coefficient of variation
Interval 24.0 to 31.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 weeksThe number of severe hypoglycemic events (needing assistance)
Outcome measures
| Measure |
Overall
n=30 Participants
* 2 to 4 week CGM run-in with insulin injections (baseline)
* 2 to 4 week open loop with insulin pump and Dexcom G6 sensor
* 6 weeks Control-IQ technology 1.5 use
Control-IQ technology 1.5: All subjects wearing the t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor.
|
Basal Insulin Only (Group A)
n=13 Participants
* 2 to 4 week CGM run-in with insulin injections (baseline)
* 2 to 4 week open loop with insulin pump and Dexcom G6 sensor
* 6 weeks Control-IQ technology 1.5 use
Control-IQ technology 1.5: All subjects wearing the t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor.
|
Multiple Daily Injections (Group B)
n=17 Participants
* 2 to 4 week CGM run-in with insulin injections (baseline)
* 2 to 4 week open loop with insulin pump and Dexcom G6 sensor
* 6 weeks Control-IQ technology 1.5 use
Control-IQ technology 1.5: All subjects wearing the t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor.
|
|---|---|---|---|
|
Severe Hypoglycemia (Needing Assistance)
|
0 events
|
0 events
|
0 events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 weeksThe number of DKA events
Outcome measures
| Measure |
Overall
n=30 Participants
* 2 to 4 week CGM run-in with insulin injections (baseline)
* 2 to 4 week open loop with insulin pump and Dexcom G6 sensor
* 6 weeks Control-IQ technology 1.5 use
Control-IQ technology 1.5: All subjects wearing the t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor.
|
Basal Insulin Only (Group A)
n=13 Participants
* 2 to 4 week CGM run-in with insulin injections (baseline)
* 2 to 4 week open loop with insulin pump and Dexcom G6 sensor
* 6 weeks Control-IQ technology 1.5 use
Control-IQ technology 1.5: All subjects wearing the t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor.
|
Multiple Daily Injections (Group B)
n=17 Participants
* 2 to 4 week CGM run-in with insulin injections (baseline)
* 2 to 4 week open loop with insulin pump and Dexcom G6 sensor
* 6 weeks Control-IQ technology 1.5 use
Control-IQ technology 1.5: All subjects wearing the t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor.
|
|---|---|---|---|
|
DKA
|
0 events
|
0 events
|
0 events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 weeksThe number of Hyperosmolar Hyperglycemic Syndrome events
Outcome measures
| Measure |
Overall
n=30 Participants
* 2 to 4 week CGM run-in with insulin injections (baseline)
* 2 to 4 week open loop with insulin pump and Dexcom G6 sensor
* 6 weeks Control-IQ technology 1.5 use
Control-IQ technology 1.5: All subjects wearing the t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor.
|
Basal Insulin Only (Group A)
n=13 Participants
* 2 to 4 week CGM run-in with insulin injections (baseline)
* 2 to 4 week open loop with insulin pump and Dexcom G6 sensor
* 6 weeks Control-IQ technology 1.5 use
Control-IQ technology 1.5: All subjects wearing the t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor.
|
Multiple Daily Injections (Group B)
n=17 Participants
* 2 to 4 week CGM run-in with insulin injections (baseline)
* 2 to 4 week open loop with insulin pump and Dexcom G6 sensor
* 6 weeks Control-IQ technology 1.5 use
Control-IQ technology 1.5: All subjects wearing the t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor.
|
|---|---|---|---|
|
Hyperosmolar Hyperglycemic Syndrome
|
0 events
|
0 events
|
0 events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 weeksThe number of Serious Adverse Events
Outcome measures
| Measure |
Overall
n=30 Participants
* 2 to 4 week CGM run-in with insulin injections (baseline)
* 2 to 4 week open loop with insulin pump and Dexcom G6 sensor
* 6 weeks Control-IQ technology 1.5 use
Control-IQ technology 1.5: All subjects wearing the t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor.
|
Basal Insulin Only (Group A)
n=13 Participants
* 2 to 4 week CGM run-in with insulin injections (baseline)
* 2 to 4 week open loop with insulin pump and Dexcom G6 sensor
* 6 weeks Control-IQ technology 1.5 use
Control-IQ technology 1.5: All subjects wearing the t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor.
|
Multiple Daily Injections (Group B)
n=17 Participants
* 2 to 4 week CGM run-in with insulin injections (baseline)
* 2 to 4 week open loop with insulin pump and Dexcom G6 sensor
* 6 weeks Control-IQ technology 1.5 use
Control-IQ technology 1.5: All subjects wearing the t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor.
|
|---|---|---|---|
|
All Serious Adverse Events
|
0 events
|
0 events
|
0 events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 weeksThe number of Unanticipated Adverse Device Effects
Outcome measures
| Measure |
Overall
n=30 Participants
* 2 to 4 week CGM run-in with insulin injections (baseline)
* 2 to 4 week open loop with insulin pump and Dexcom G6 sensor
* 6 weeks Control-IQ technology 1.5 use
Control-IQ technology 1.5: All subjects wearing the t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor.
|
Basal Insulin Only (Group A)
n=13 Participants
* 2 to 4 week CGM run-in with insulin injections (baseline)
* 2 to 4 week open loop with insulin pump and Dexcom G6 sensor
* 6 weeks Control-IQ technology 1.5 use
Control-IQ technology 1.5: All subjects wearing the t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor.
|
Multiple Daily Injections (Group B)
n=17 Participants
* 2 to 4 week CGM run-in with insulin injections (baseline)
* 2 to 4 week open loop with insulin pump and Dexcom G6 sensor
* 6 weeks Control-IQ technology 1.5 use
Control-IQ technology 1.5: All subjects wearing the t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor.
|
|---|---|---|---|
|
Unanticipated Adverse Device Effects
|
0 events
|
0 events
|
0 events
|
Adverse Events
Basal Insulin Only (Group A)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Multiple Daily Injections (Group B)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Basal Insulin Only (Group A)
n=13 participants at risk
* 2 to 4 week CGM run-in
* 2 to 4 week pump run-in
* 6 weeks Control-IQ technology use
Control-IQ technology 1.5: All subjects wearing the t-slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor.
Outcomes will be analyzed overall and subgroup analysis will be performed by Group, and by baseline A1c level.
|
Multiple Daily Injections (Group B)
n=17 participants at risk
* 2 to 4 week CGM run-in
* 2 to 4 week pump run-in
* 6 weeks Control-IQ technology use
Control-IQ technology 1.5: All subjects wearing the t-slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor.
Outcomes will be analyzed overall and subgroup analysis will be performed by Group, and by baseline A1c level.
|
|---|---|---|
|
Endocrine disorders
Hyperglycemia
|
0.00%
0/13 • 14 weeks
|
5.9%
1/17 • Number of events 1 • 14 weeks
|
|
Respiratory, thoracic and mediastinal disorders
COVID-19
|
0.00%
0/13 • 14 weeks
|
11.8%
2/17 • Number of events 2 • 14 weeks
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/13 • 14 weeks
|
5.9%
1/17 • Number of events 1 • 14 weeks
|
|
Skin and subcutaneous tissue disorders
Sunburn
|
7.7%
1/13 • Number of events 1 • 14 weeks
|
0.00%
0/17 • 14 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/13 • 14 weeks
|
5.9%
1/17 • Number of events 1 • 14 weeks
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/13 • 14 weeks
|
5.9%
1/17 • Number of events 1 • 14 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place