Trial Outcomes & Findings for Optimizing Closed-Loop Control of Type 1 Diabetes Mellitus in Adolescents (NCT NCT01890954)
NCT ID: NCT01890954
Last Updated: 2022-09-13
Results Overview
Percentage of time that blood glucose (BG) values (measured with both finger-stick and CGM) were near normoglycemia (70-180 mg/dL).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
17 participants
Primary outcome timeframe
8 hours
Results posted on
2022-09-13
Participant Flow
Participant milestones
| Measure |
Usual Care First, Then Closed Loop Control
8 hours observational (09:00-17:00) during usual care with a missed insulin bolus for 30g carbohydrates snack (09:00) and an under-bolus (75% meal insulin with full correction insulin) for an 80g lunch (13:00). 1 day of wash-out. 8 hours using Closed Loop Control with DiAs with a missed insulin bolus for 30g of carbohydrates snack (09:00) and an under-bolus (75% meal insulin with no correction insulin) for an 80g lunch (13:00).
|
Closed Loop Control First, Then Usual Care
8 hours observational (09:00-17:00) using Closed Loop Control with DiAs with a missed insulin bolus for 30g of carbohydrates snack (09:00) and an under-bolus (75% meal insulin with no correction insulin) for an 80g lunch (13:00). 1 day of wash-out. 8 hours observational (09:00-17:00) during usual care with a missed insulin bolus for 30g carbohydrates snack (09:00) and an under-bolus (75% meal insulin with full correction insulin) for an 80g lunch (13:00).
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Optimizing Closed-Loop Control of Type 1 Diabetes Mellitus in Adolescents
Baseline characteristics by cohort
| Measure |
Usual Care First, Then Closed Loop Control
n=8 Participants
8 hours observational (09:00-17:00) during usual care with a missed insulin bolus for 30g carbohydrates snack (09:00) and an under-bolus (75% meal insulin with full correction insulin) for an 80g lunch (13:00). 1 day of wash-out. 8 hours using Closed Loop Control with DiAs with a missed insulin bolus for 30g of carbohydrates snack (09:00) and an under-bolus (75% meal insulin with no correction insulin) for an 80g lunch (13:00).
|
Closed Loop Control First, Then Usual Care
n=8 Participants
8 hours observational (09:00-17:00) using Closed Loop Control with DiAs with a missed insulin bolus for 30g of carbohydrates snack (09:00) and an under-bolus (75% meal insulin with no correction insulin) for an 80g lunch (13:00). 1 day of wash-out. 8 hours observational during usual care with a missed insulin bolus for 30g carbohydrates snack (09:00) and an under-bolus (75% meal insulin with full correction insulin) for an 80g lunch (13:00).
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
15 years
STANDARD_DEVIATION 2 • n=5 Participants
|
15 years
STANDARD_DEVIATION 2 • n=7 Participants
|
15 years
STANDARD_DEVIATION 2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 hoursPercentage of time that blood glucose (BG) values (measured with both finger-stick and CGM) were near normoglycemia (70-180 mg/dL).
Outcome measures
| Measure |
Closed Loop Control With DiAs System
n=16 Participants
8 hours observational (09:00-17:00) during closed-loop control (DiAs) with a missed insulin bolus for 30g carbohydrates snack (09:00) and an under-bolus (75% meal insulin with full correction insulin) for an 80g lunch (13:00).
|
Usual Care Without DiAs System (CGM Only)
n=16 Participants
8 hours observational (09:00-17:00) during usual care with a missed insulin bolus for 30g carbohydrates snack (09:00) and an under-bolus (75% meal insulin with full correction insulin) for an 80g lunch (13:00).
|
|---|---|---|
|
Percent of Time Spent Near Normoglycemia
Overall (8 hours)
|
43.4 percentage time near normoglycemia
Standard Error 6.5
|
18.9 percentage time near normoglycemia
Standard Error 7
|
|
Percent of Time Spent Near Normoglycemia
Post-snack (4 hours)
|
45.1 percentage time near normoglycemia
Standard Error 8.7
|
21.3 percentage time near normoglycemia
Standard Error 7.7
|
|
Percent of Time Spent Near Normoglycemia
Post-lunch (4 hours)
|
42.3 percentage time near normoglycemia
Standard Error 9.2
|
16.9 percentage time near normoglycemia
Standard Error 7.4
|
Adverse Events
Closed Loop Control With DiAs System
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care Without DiAs System (CGM Only)
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place