Trial Outcomes & Findings for Safety and Efficacy of Initializing the Control-IQ Artificial Pancreas System Using Total Daily Insulin (NCT NCT03804983)
NCT ID: NCT03804983
Last Updated: 2024-08-01
Results Overview
The primary outcome for this study is the percent of time spent between 70mg/dL and 180mg/dL as computed by the number of CGM values falling in this interval divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
5 days post camp (home) compared to 5 days before camp (baseline)
Results posted on
2024-08-01
Participant Flow
Of 22 enrolled participants, 20 were randomized to treatment. One participant was dropped after meeting stopping criteria.
1 participant dropped prior to randomization for personal reasons (travel issues); 1 participant dropped prior to randomization as they didn't attend screening appointment.
Participant milestones
| Measure |
Hybrid Closed Loop (HCL)
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ with Hybrid Closed Loop (HCL) or the Control-IQ with MyTDI. Participants randomized to Control-IQ, participants will continue using their home insulin parameters during the ski admission and then 5 additional days at home.
Hybrid Closed Loop (HCL): Participants will use Control-IQ with Hybrid Closed Loop (HCL) with their own insulin parameters during the entire two-week study, including the 72-hour ski admission and the at-home study collection times. Parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
Control-IQ With MyTDI
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ or the Control-IQ with MyTDI. Participants randomized to Control-IQ with MyTDI, participants will be adjusted as noted below during the ski admission and will then continue these parameters for 5 additional days at home:
* A single basal rate equal to total daily insulin (TDI)/48 will be implemented across the whole day
* A single correction factor (CF) of 1650/TDI will be implemented across the whole day
* Carbohydrate ratios (CR) will be set at:
* 00:00-04:00 CR=450/TDI
* 04:00-11:00 CR=360/TDI
* 11:00-00:00 CR=450/TDI TDI will be set at the internal Control-IQ estimation total daily dose; if not available, total daily dose over the last 5 days will be used.
Control-IQ with MyTDI: Participants will use their own insulin parameters during the first 5 days of the study. After randomization at the ski admission, the participants insulin parameters will be modified using the MyTDI calculations. Additionally, parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Hybrid Closed Loop (HCL)
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ with Hybrid Closed Loop (HCL) or the Control-IQ with MyTDI. Participants randomized to Control-IQ, participants will continue using their home insulin parameters during the ski admission and then 5 additional days at home.
Hybrid Closed Loop (HCL): Participants will use Control-IQ with Hybrid Closed Loop (HCL) with their own insulin parameters during the entire two-week study, including the 72-hour ski admission and the at-home study collection times. Parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
Control-IQ With MyTDI
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ or the Control-IQ with MyTDI. Participants randomized to Control-IQ with MyTDI, participants will be adjusted as noted below during the ski admission and will then continue these parameters for 5 additional days at home:
* A single basal rate equal to total daily insulin (TDI)/48 will be implemented across the whole day
* A single correction factor (CF) of 1650/TDI will be implemented across the whole day
* Carbohydrate ratios (CR) will be set at:
* 00:00-04:00 CR=450/TDI
* 04:00-11:00 CR=360/TDI
* 11:00-00:00 CR=450/TDI TDI will be set at the internal Control-IQ estimation total daily dose; if not available, total daily dose over the last 5 days will be used.
Control-IQ with MyTDI: Participants will use their own insulin parameters during the first 5 days of the study. After randomization at the ski admission, the participants insulin parameters will be modified using the MyTDI calculations. Additionally, parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Family Obligation
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy of Initializing the Control-IQ Artificial Pancreas System Using Total Daily Insulin
Baseline characteristics by cohort
| Measure |
Hybrid Closed Loop (HCL)
n=10 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ with Hybrid Closed Loop (HCL) or the Control-IQ with MyTDI. Participants randomized to Control-IQ, participants will continue using their home insulin parameters during the ski admission and then 5 additional days at home.
Hybrid Closed Loop (HCL): Participants will use Control-IQ with Hybrid Closed Loop (HCL) with their own insulin parameters during the entire two-week study, including the 72-hour ski admission and the at-home study collection times. Parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
Control-IQ With MyTDI
n=10 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ or the Control-IQ with MyTDI. Participants randomized to Control-IQ with MyTDI, participants will be adjusted as noted below during the ski admission and will then continue these parameters for 5 additional days at home:
* A single basal rate equal to total daily insulin (TDI)/48 will be implemented across the whole day
* A single correction factor (CF) of 1650/TDI will be implemented across the whole day
* Carbohydrate ratios (CR) will be set at:
* 00:00-04:00 CR=450/TDI
* 04:00-11:00 CR=360/TDI
* 11:00-00:00 CR=450/TDI TDI will be set at the internal Control-IQ estimation total daily dose; if not available, total daily dose over the last 5 days will be used.
Control-IQ with MyTDI: Participants will use their own insulin parameters during the first 5 days of the study. After randomization at the ski admission, the participants insulin parameters will be modified using the MyTDI calculations. Additionally, parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 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
|
14.3 years
STANDARD_DEVIATION 1.7 • n=5 Participants
|
14.7 years
STANDARD_DEVIATION 1.6 • n=7 Participants
|
14.5 years
STANDARD_DEVIATION 1.65 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 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
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 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
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 days post camp (home) compared to 5 days before camp (baseline)The primary outcome for this study is the percent of time spent between 70mg/dL and 180mg/dL as computed by the number of CGM values falling in this interval divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
Outcome measures
| Measure |
Hybrid Closed Loop (HCL)
n=9 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ with Hybrid Closed Loop (HCL) or the Control-IQ with MyTDI. Participants randomized to Control-IQ, participants will continue using their home insulin parameters during the ski admission and then 5 additional days at home.
Hybrid Closed Loop (HCL): Participants will use Control-IQ with Hybrid Closed Loop (HCL) with their own insulin parameters during the entire two-week study, including the 72-hour ski admission and the at-home study collection times. Parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
Control-IQ With MyTDI
n=9 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ or the Control-IQ with MyTDI. Participants randomized to Control-IQ with MyTDI, participants will be adjusted as noted below during the ski admission and will then continue these parameters for 5 additional days at home:
* A single basal rate equal to total daily insulin (TDI)/48 will be implemented across the whole day
* A single correction factor (CF) of 1650/TDI will be implemented across the whole day
* Carbohydrate ratios (CR) will be set at:
* 00:00-04:00 CR=450/TDI
* 04:00-11:00 CR=360/TDI
* 11:00-00:00 CR=450/TDI TDI will be set at the internal Control-IQ estimation total daily dose; if not available, total daily dose over the last 5 days will be used.
Control-IQ with MyTDI: Participants will use their own insulin parameters during the first 5 days of the study. After randomization at the ski admission, the participants insulin parameters will be modified using the MyTDI calculations. Additionally, parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
|---|---|---|
|
Percent Time in Range at Home Pre/Post Intervention at Home
Baseline
|
77.8 percentage of time spent in range
Standard Deviation 6.2
|
70.7 percentage of time spent in range
Standard Deviation 12.4
|
|
Percent Time in Range at Home Pre/Post Intervention at Home
Home
|
68.9 percentage of time spent in range
Standard Deviation 8.9
|
70.1 percentage of time spent in range
Standard Deviation 14.4
|
SECONDARY outcome
Timeframe: 5 days post camp (home) compared to 5 days before camp (baseline)Average of available CGM values within time frame
Outcome measures
| Measure |
Hybrid Closed Loop (HCL)
n=9 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ with Hybrid Closed Loop (HCL) or the Control-IQ with MyTDI. Participants randomized to Control-IQ, participants will continue using their home insulin parameters during the ski admission and then 5 additional days at home.
Hybrid Closed Loop (HCL): Participants will use Control-IQ with Hybrid Closed Loop (HCL) with their own insulin parameters during the entire two-week study, including the 72-hour ski admission and the at-home study collection times. Parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
Control-IQ With MyTDI
n=9 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ or the Control-IQ with MyTDI. Participants randomized to Control-IQ with MyTDI, participants will be adjusted as noted below during the ski admission and will then continue these parameters for 5 additional days at home:
* A single basal rate equal to total daily insulin (TDI)/48 will be implemented across the whole day
* A single correction factor (CF) of 1650/TDI will be implemented across the whole day
* Carbohydrate ratios (CR) will be set at:
* 00:00-04:00 CR=450/TDI
* 04:00-11:00 CR=360/TDI
* 11:00-00:00 CR=450/TDI TDI will be set at the internal Control-IQ estimation total daily dose; if not available, total daily dose over the last 5 days will be used.
Control-IQ with MyTDI: Participants will use their own insulin parameters during the first 5 days of the study. After randomization at the ski admission, the participants insulin parameters will be modified using the MyTDI calculations. Additionally, parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
|---|---|---|
|
Average CGM at Home
Baseline
|
142.4 mg/dL
Standard Deviation 13.6
|
152.2 mg/dL
Standard Deviation 19.2
|
|
Average CGM at Home
Week 2-Home Portion
|
156.5 mg/dL
Standard Deviation 14.9
|
152.9 mg/dL
Standard Deviation 21.2
|
SECONDARY outcome
Timeframe: 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline)average of CGM values within time frame
Outcome measures
| Measure |
Hybrid Closed Loop (HCL)
n=9 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ with Hybrid Closed Loop (HCL) or the Control-IQ with MyTDI. Participants randomized to Control-IQ, participants will continue using their home insulin parameters during the ski admission and then 5 additional days at home.
Hybrid Closed Loop (HCL): Participants will use Control-IQ with Hybrid Closed Loop (HCL) with their own insulin parameters during the entire two-week study, including the 72-hour ski admission and the at-home study collection times. Parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
Control-IQ With MyTDI
n=9 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ or the Control-IQ with MyTDI. Participants randomized to Control-IQ with MyTDI, participants will be adjusted as noted below during the ski admission and will then continue these parameters for 5 additional days at home:
* A single basal rate equal to total daily insulin (TDI)/48 will be implemented across the whole day
* A single correction factor (CF) of 1650/TDI will be implemented across the whole day
* Carbohydrate ratios (CR) will be set at:
* 00:00-04:00 CR=450/TDI
* 04:00-11:00 CR=360/TDI
* 11:00-00:00 CR=450/TDI TDI will be set at the internal Control-IQ estimation total daily dose; if not available, total daily dose over the last 5 days will be used.
Control-IQ with MyTDI: Participants will use their own insulin parameters during the first 5 days of the study. After randomization at the ski admission, the participants insulin parameters will be modified using the MyTDI calculations. Additionally, parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
|---|---|---|
|
Average CGM at Camp
Baseline
|
142.4 mg/dL
Standard Deviation 13.6
|
152.2 mg/dL
Standard Deviation 19.2
|
|
Average CGM at Camp
Camp
|
144.3 mg/dL
Standard Deviation 24.6
|
141.3 mg/dL
Standard Deviation 13.1
|
SECONDARY outcome
Timeframe: 5 days post camp (home) compared to 5 days before camp (baseline)the percentage of CGM values falling below 50mg/dL, calculated as the number of CGM values \<50mg/dL within the time frame divided by the total number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Outcome measures
| Measure |
Hybrid Closed Loop (HCL)
n=9 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ with Hybrid Closed Loop (HCL) or the Control-IQ with MyTDI. Participants randomized to Control-IQ, participants will continue using their home insulin parameters during the ski admission and then 5 additional days at home.
Hybrid Closed Loop (HCL): Participants will use Control-IQ with Hybrid Closed Loop (HCL) with their own insulin parameters during the entire two-week study, including the 72-hour ski admission and the at-home study collection times. Parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
Control-IQ With MyTDI
n=9 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ or the Control-IQ with MyTDI. Participants randomized to Control-IQ with MyTDI, participants will be adjusted as noted below during the ski admission and will then continue these parameters for 5 additional days at home:
* A single basal rate equal to total daily insulin (TDI)/48 will be implemented across the whole day
* A single correction factor (CF) of 1650/TDI will be implemented across the whole day
* Carbohydrate ratios (CR) will be set at:
* 00:00-04:00 CR=450/TDI
* 04:00-11:00 CR=360/TDI
* 11:00-00:00 CR=450/TDI TDI will be set at the internal Control-IQ estimation total daily dose; if not available, total daily dose over the last 5 days will be used.
Control-IQ with MyTDI: Participants will use their own insulin parameters during the first 5 days of the study. After randomization at the ski admission, the participants insulin parameters will be modified using the MyTDI calculations. Additionally, parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
|---|---|---|
|
Percentage of CGM Values Below 50mg/dL at Home
Baseline
|
0.0 percentage
Interval 0.0 to 0.3
|
0.0 percentage
Interval 0.0 to 0.1
|
|
Percentage of CGM Values Below 50mg/dL at Home
Home
|
0.0 percentage
Interval 0.0 to 0.1
|
0.6 percentage
Interval 0.0 to 0.8
|
SECONDARY outcome
Timeframe: 2 days during camp admission (Camp) compared to 5 days prior to camp (Baseline)the percentage of CGM values falling below 50mg/dL, computed as the number of CGM values \<50mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Outcome measures
| Measure |
Hybrid Closed Loop (HCL)
n=9 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ with Hybrid Closed Loop (HCL) or the Control-IQ with MyTDI. Participants randomized to Control-IQ, participants will continue using their home insulin parameters during the ski admission and then 5 additional days at home.
Hybrid Closed Loop (HCL): Participants will use Control-IQ with Hybrid Closed Loop (HCL) with their own insulin parameters during the entire two-week study, including the 72-hour ski admission and the at-home study collection times. Parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
Control-IQ With MyTDI
n=9 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ or the Control-IQ with MyTDI. Participants randomized to Control-IQ with MyTDI, participants will be adjusted as noted below during the ski admission and will then continue these parameters for 5 additional days at home:
* A single basal rate equal to total daily insulin (TDI)/48 will be implemented across the whole day
* A single correction factor (CF) of 1650/TDI will be implemented across the whole day
* Carbohydrate ratios (CR) will be set at:
* 00:00-04:00 CR=450/TDI
* 04:00-11:00 CR=360/TDI
* 11:00-00:00 CR=450/TDI TDI will be set at the internal Control-IQ estimation total daily dose; if not available, total daily dose over the last 5 days will be used.
Control-IQ with MyTDI: Participants will use their own insulin parameters during the first 5 days of the study. After randomization at the ski admission, the participants insulin parameters will be modified using the MyTDI calculations. Additionally, parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
|---|---|---|
|
Percentage of CGM Values Below 50mg/dL at Camp
Baseline
|
0.0 percentage
Standard Deviation 0.0
|
0.0 percentage
Standard Deviation 0.0
|
|
Percentage of CGM Values Below 50mg/dL at Camp
Camp
|
0.3 percentage
Standard Deviation 0.7
|
0.16 percentage
Standard Deviation 0.36
|
SECONDARY outcome
Timeframe: 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline)the percentage of CGM values falling below 54mg/dL. computed as the number of CGM values \<54mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Outcome measures
| Measure |
Hybrid Closed Loop (HCL)
n=9 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ with Hybrid Closed Loop (HCL) or the Control-IQ with MyTDI. Participants randomized to Control-IQ, participants will continue using their home insulin parameters during the ski admission and then 5 additional days at home.
Hybrid Closed Loop (HCL): Participants will use Control-IQ with Hybrid Closed Loop (HCL) with their own insulin parameters during the entire two-week study, including the 72-hour ski admission and the at-home study collection times. Parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
Control-IQ With MyTDI
n=9 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ or the Control-IQ with MyTDI. Participants randomized to Control-IQ with MyTDI, participants will be adjusted as noted below during the ski admission and will then continue these parameters for 5 additional days at home:
* A single basal rate equal to total daily insulin (TDI)/48 will be implemented across the whole day
* A single correction factor (CF) of 1650/TDI will be implemented across the whole day
* Carbohydrate ratios (CR) will be set at:
* 00:00-04:00 CR=450/TDI
* 04:00-11:00 CR=360/TDI
* 11:00-00:00 CR=450/TDI TDI will be set at the internal Control-IQ estimation total daily dose; if not available, total daily dose over the last 5 days will be used.
Control-IQ with MyTDI: Participants will use their own insulin parameters during the first 5 days of the study. After randomization at the ski admission, the participants insulin parameters will be modified using the MyTDI calculations. Additionally, parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
|---|---|---|
|
Percentage of CGM Values Below 54mg/dL at Camp
Baseline
|
0.1 percentage
Interval 0.0 to 0.6
|
0.1 percentage
Interval 0.0 to 0.3
|
|
Percentage of CGM Values Below 54mg/dL at Camp
Camp
|
0.0 percentage
Interval 0.0 to 0.0
|
0.0 percentage
Interval 0.0 to 0.7
|
SECONDARY outcome
Timeframe: 5 days post camp (home) compared to 5 days before camp (baseline)the percentage of CGM values falling below 60mg/dL. computed as the number of CGM values \<60mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Outcome measures
| Measure |
Hybrid Closed Loop (HCL)
n=9 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ with Hybrid Closed Loop (HCL) or the Control-IQ with MyTDI. Participants randomized to Control-IQ, participants will continue using their home insulin parameters during the ski admission and then 5 additional days at home.
Hybrid Closed Loop (HCL): Participants will use Control-IQ with Hybrid Closed Loop (HCL) with their own insulin parameters during the entire two-week study, including the 72-hour ski admission and the at-home study collection times. Parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
Control-IQ With MyTDI
n=9 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ or the Control-IQ with MyTDI. Participants randomized to Control-IQ with MyTDI, participants will be adjusted as noted below during the ski admission and will then continue these parameters for 5 additional days at home:
* A single basal rate equal to total daily insulin (TDI)/48 will be implemented across the whole day
* A single correction factor (CF) of 1650/TDI will be implemented across the whole day
* Carbohydrate ratios (CR) will be set at:
* 00:00-04:00 CR=450/TDI
* 04:00-11:00 CR=360/TDI
* 11:00-00:00 CR=450/TDI TDI will be set at the internal Control-IQ estimation total daily dose; if not available, total daily dose over the last 5 days will be used.
Control-IQ with MyTDI: Participants will use their own insulin parameters during the first 5 days of the study. After randomization at the ski admission, the participants insulin parameters will be modified using the MyTDI calculations. Additionally, parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
|---|---|---|
|
Percentage of CGM Values Below 60mg/dL at Home
Baseline
|
0.7 percentage
Interval 0.2 to 1.1
|
0.7 percentage
Interval 0.0 to 0.8
|
|
Percentage of CGM Values Below 60mg/dL at Home
Home
|
0.5 percentage
Interval 0.0 to 0.6
|
1.3 percentage
Interval 0.1 to 1.8
|
SECONDARY outcome
Timeframe: 2 days during camp admission (Camp) compared to 5 days prior to camp (Baseline)the percentage of CGM values falling below 60mg/dL. computed as the number of CGM values \<60mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Outcome measures
| Measure |
Hybrid Closed Loop (HCL)
n=9 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ with Hybrid Closed Loop (HCL) or the Control-IQ with MyTDI. Participants randomized to Control-IQ, participants will continue using their home insulin parameters during the ski admission and then 5 additional days at home.
Hybrid Closed Loop (HCL): Participants will use Control-IQ with Hybrid Closed Loop (HCL) with their own insulin parameters during the entire two-week study, including the 72-hour ski admission and the at-home study collection times. Parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
Control-IQ With MyTDI
n=9 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ or the Control-IQ with MyTDI. Participants randomized to Control-IQ with MyTDI, participants will be adjusted as noted below during the ski admission and will then continue these parameters for 5 additional days at home:
* A single basal rate equal to total daily insulin (TDI)/48 will be implemented across the whole day
* A single correction factor (CF) of 1650/TDI will be implemented across the whole day
* Carbohydrate ratios (CR) will be set at:
* 00:00-04:00 CR=450/TDI
* 04:00-11:00 CR=360/TDI
* 11:00-00:00 CR=450/TDI TDI will be set at the internal Control-IQ estimation total daily dose; if not available, total daily dose over the last 5 days will be used.
Control-IQ with MyTDI: Participants will use their own insulin parameters during the first 5 days of the study. After randomization at the ski admission, the participants insulin parameters will be modified using the MyTDI calculations. Additionally, parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
|---|---|---|
|
Percentage of CGM Values Below 60mg/dL at Camp
Baseline
|
0.7 percentage
Interval 0.2 to 1.1
|
0.7 percentage
Interval 0.0 to 0.8
|
|
Percentage of CGM Values Below 60mg/dL at Camp
Camp
|
0.5 percentage
Interval 0.0 to 0.5
|
0.9 percentage
Interval 0.0 to 2.3
|
SECONDARY outcome
Timeframe: 5 days post camp (home) compared to 5 days before camp (baseline)the percentage of CGM values falling below 70mg/dL, computed as the number of CGM values \<70mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Outcome measures
| Measure |
Hybrid Closed Loop (HCL)
n=9 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ with Hybrid Closed Loop (HCL) or the Control-IQ with MyTDI. Participants randomized to Control-IQ, participants will continue using their home insulin parameters during the ski admission and then 5 additional days at home.
Hybrid Closed Loop (HCL): Participants will use Control-IQ with Hybrid Closed Loop (HCL) with their own insulin parameters during the entire two-week study, including the 72-hour ski admission and the at-home study collection times. Parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
Control-IQ With MyTDI
n=9 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ or the Control-IQ with MyTDI. Participants randomized to Control-IQ with MyTDI, participants will be adjusted as noted below during the ski admission and will then continue these parameters for 5 additional days at home:
* A single basal rate equal to total daily insulin (TDI)/48 will be implemented across the whole day
* A single correction factor (CF) of 1650/TDI will be implemented across the whole day
* Carbohydrate ratios (CR) will be set at:
* 00:00-04:00 CR=450/TDI
* 04:00-11:00 CR=360/TDI
* 11:00-00:00 CR=450/TDI TDI will be set at the internal Control-IQ estimation total daily dose; if not available, total daily dose over the last 5 days will be used.
Control-IQ with MyTDI: Participants will use their own insulin parameters during the first 5 days of the study. After randomization at the ski admission, the participants insulin parameters will be modified using the MyTDI calculations. Additionally, parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
|---|---|---|
|
Percentage of CGM Values Below 70mg/dL at Home
Baseline
|
1.9 percentage
Interval 0.6 to 5.3
|
2.1 percentage
Interval 0.7 to 3.2
|
|
Percentage of CGM Values Below 70mg/dL at Home
Home
|
0.9 percentage
Interval 0.3 to 1.9
|
2.4 percentage
Interval 0.7 to 3.7
|
SECONDARY outcome
Timeframe: 2 days during camp admission (Camp) compared to 5 days prior to camp (Baseline)the percentage of CGM values falling below 70mg/dL, computed as the number of CGM values \<70mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Outcome measures
| Measure |
Hybrid Closed Loop (HCL)
n=9 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ with Hybrid Closed Loop (HCL) or the Control-IQ with MyTDI. Participants randomized to Control-IQ, participants will continue using their home insulin parameters during the ski admission and then 5 additional days at home.
Hybrid Closed Loop (HCL): Participants will use Control-IQ with Hybrid Closed Loop (HCL) with their own insulin parameters during the entire two-week study, including the 72-hour ski admission and the at-home study collection times. Parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
Control-IQ With MyTDI
n=9 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ or the Control-IQ with MyTDI. Participants randomized to Control-IQ with MyTDI, participants will be adjusted as noted below during the ski admission and will then continue these parameters for 5 additional days at home:
* A single basal rate equal to total daily insulin (TDI)/48 will be implemented across the whole day
* A single correction factor (CF) of 1650/TDI will be implemented across the whole day
* Carbohydrate ratios (CR) will be set at:
* 00:00-04:00 CR=450/TDI
* 04:00-11:00 CR=360/TDI
* 11:00-00:00 CR=450/TDI TDI will be set at the internal Control-IQ estimation total daily dose; if not available, total daily dose over the last 5 days will be used.
Control-IQ with MyTDI: Participants will use their own insulin parameters during the first 5 days of the study. After randomization at the ski admission, the participants insulin parameters will be modified using the MyTDI calculations. Additionally, parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
|---|---|---|
|
Percentage of CGM Values Below 70mg/dL at Camp
Baseline
|
1.9 percentage
Interval 0.6 to 5.3
|
2.1 percentage
Interval 0.7 to 3.2
|
|
Percentage of CGM Values Below 70mg/dL at Camp
Camp
|
1.4 percentage
Interval 0.0 to 2.4
|
3.8 percentage
Interval 0.5 to 4.7
|
SECONDARY outcome
Timeframe: 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline)the percentage of CGM values falling between 70mg/dL and 180mg/dL, computed as the number of CGM values \<=180mg/dL and \>70mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Outcome measures
| Measure |
Hybrid Closed Loop (HCL)
n=9 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ with Hybrid Closed Loop (HCL) or the Control-IQ with MyTDI. Participants randomized to Control-IQ, participants will continue using their home insulin parameters during the ski admission and then 5 additional days at home.
Hybrid Closed Loop (HCL): Participants will use Control-IQ with Hybrid Closed Loop (HCL) with their own insulin parameters during the entire two-week study, including the 72-hour ski admission and the at-home study collection times. Parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
Control-IQ With MyTDI
n=9 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ or the Control-IQ with MyTDI. Participants randomized to Control-IQ with MyTDI, participants will be adjusted as noted below during the ski admission and will then continue these parameters for 5 additional days at home:
* A single basal rate equal to total daily insulin (TDI)/48 will be implemented across the whole day
* A single correction factor (CF) of 1650/TDI will be implemented across the whole day
* Carbohydrate ratios (CR) will be set at:
* 00:00-04:00 CR=450/TDI
* 04:00-11:00 CR=360/TDI
* 11:00-00:00 CR=450/TDI TDI will be set at the internal Control-IQ estimation total daily dose; if not available, total daily dose over the last 5 days will be used.
Control-IQ with MyTDI: Participants will use their own insulin parameters during the first 5 days of the study. After randomization at the ski admission, the participants insulin parameters will be modified using the MyTDI calculations. Additionally, parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
|---|---|---|
|
Percentage of CGM Values Between 70mg/dL and 180mg/dL at Camp
Baseline
|
77.8 percentage
Standard Deviation 6.2
|
70.7 percentage
Standard Deviation 12.4
|
|
Percentage of CGM Values Between 70mg/dL and 180mg/dL at Camp
Camp Portion
|
78.4 percentage
Standard Deviation 12.8
|
76.5 percentage
Standard Deviation 8.0
|
SECONDARY outcome
Timeframe: 5 days post camp (home) compared to 5 days before camp (baseline)the percentage of CGM values falling above 180mg/dL, computed as the number of CGM values \>180mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Outcome measures
| Measure |
Hybrid Closed Loop (HCL)
n=9 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ with Hybrid Closed Loop (HCL) or the Control-IQ with MyTDI. Participants randomized to Control-IQ, participants will continue using their home insulin parameters during the ski admission and then 5 additional days at home.
Hybrid Closed Loop (HCL): Participants will use Control-IQ with Hybrid Closed Loop (HCL) with their own insulin parameters during the entire two-week study, including the 72-hour ski admission and the at-home study collection times. Parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
Control-IQ With MyTDI
n=9 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ or the Control-IQ with MyTDI. Participants randomized to Control-IQ with MyTDI, participants will be adjusted as noted below during the ski admission and will then continue these parameters for 5 additional days at home:
* A single basal rate equal to total daily insulin (TDI)/48 will be implemented across the whole day
* A single correction factor (CF) of 1650/TDI will be implemented across the whole day
* Carbohydrate ratios (CR) will be set at:
* 00:00-04:00 CR=450/TDI
* 04:00-11:00 CR=360/TDI
* 11:00-00:00 CR=450/TDI TDI will be set at the internal Control-IQ estimation total daily dose; if not available, total daily dose over the last 5 days will be used.
Control-IQ with MyTDI: Participants will use their own insulin parameters during the first 5 days of the study. After randomization at the ski admission, the participants insulin parameters will be modified using the MyTDI calculations. Additionally, parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
|---|---|---|
|
Percentage of CGM Values Above 180mg/dL at Home
Baseline
|
18.9 percentage
Standard Deviation 17.7
|
26.9 percentage
Standard Deviation 12.7
|
|
Percentage of CGM Values Above 180mg/dL at Home
Home
|
29.1 percentage
Standard Deviation 10.3
|
27.2 percentage
Standard Deviation 14.4
|
SECONDARY outcome
Timeframe: 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline)the percentage of CGM values falling above 180mg/dL, computed as the number of CGM values \>180mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Outcome measures
| Measure |
Hybrid Closed Loop (HCL)
n=9 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ with Hybrid Closed Loop (HCL) or the Control-IQ with MyTDI. Participants randomized to Control-IQ, participants will continue using their home insulin parameters during the ski admission and then 5 additional days at home.
Hybrid Closed Loop (HCL): Participants will use Control-IQ with Hybrid Closed Loop (HCL) with their own insulin parameters during the entire two-week study, including the 72-hour ski admission and the at-home study collection times. Parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
Control-IQ With MyTDI
n=9 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ or the Control-IQ with MyTDI. Participants randomized to Control-IQ with MyTDI, participants will be adjusted as noted below during the ski admission and will then continue these parameters for 5 additional days at home:
* A single basal rate equal to total daily insulin (TDI)/48 will be implemented across the whole day
* A single correction factor (CF) of 1650/TDI will be implemented across the whole day
* Carbohydrate ratios (CR) will be set at:
* 00:00-04:00 CR=450/TDI
* 04:00-11:00 CR=360/TDI
* 11:00-00:00 CR=450/TDI TDI will be set at the internal Control-IQ estimation total daily dose; if not available, total daily dose over the last 5 days will be used.
Control-IQ with MyTDI: Participants will use their own insulin parameters during the first 5 days of the study. After randomization at the ski admission, the participants insulin parameters will be modified using the MyTDI calculations. Additionally, parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
|---|---|---|
|
Percentage of CGM Values Above 180mg/dL at Camp
Baseline
|
18.9 percentage
Standard Deviation 7.7
|
26.9 percentage
Standard Deviation 12.7
|
|
Percentage of CGM Values Above 180mg/dL at Camp
Camp
|
20.1 percentage
Standard Deviation 13.4
|
20.1 percentage
Standard Deviation 7.3
|
SECONDARY outcome
Timeframe: 5 days post camp (home) compared to 5 days before camp (baseline)the percentage of CGM values falling above 250mg/dL, computed as the number of CGM values \>250mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Outcome measures
| Measure |
Hybrid Closed Loop (HCL)
n=9 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ with Hybrid Closed Loop (HCL) or the Control-IQ with MyTDI. Participants randomized to Control-IQ, participants will continue using their home insulin parameters during the ski admission and then 5 additional days at home.
Hybrid Closed Loop (HCL): Participants will use Control-IQ with Hybrid Closed Loop (HCL) with their own insulin parameters during the entire two-week study, including the 72-hour ski admission and the at-home study collection times. Parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
Control-IQ With MyTDI
n=9 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ or the Control-IQ with MyTDI. Participants randomized to Control-IQ with MyTDI, participants will be adjusted as noted below during the ski admission and will then continue these parameters for 5 additional days at home:
* A single basal rate equal to total daily insulin (TDI)/48 will be implemented across the whole day
* A single correction factor (CF) of 1650/TDI will be implemented across the whole day
* Carbohydrate ratios (CR) will be set at:
* 00:00-04:00 CR=450/TDI
* 04:00-11:00 CR=360/TDI
* 11:00-00:00 CR=450/TDI TDI will be set at the internal Control-IQ estimation total daily dose; if not available, total daily dose over the last 5 days will be used.
Control-IQ with MyTDI: Participants will use their own insulin parameters during the first 5 days of the study. After randomization at the ski admission, the participants insulin parameters will be modified using the MyTDI calculations. Additionally, parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
|---|---|---|
|
Percentage of CGM Values Above 250mg/dL at Home
Baseline
|
3.4 percentage
Interval 2.7 to 4.2
|
6.5 percentage
Interval 1.7 to 9.3
|
|
Percentage of CGM Values Above 250mg/dL at Home
Home
|
5.8 percentage
Interval 4.2 to 7.3
|
3.8 percentage
Interval 1.8 to 9.3
|
SECONDARY outcome
Timeframe: 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline)the percentage of CGM values falling above 250mg/dL, computed as the number of CGM values \>250mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Outcome measures
| Measure |
Hybrid Closed Loop (HCL)
n=9 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ with Hybrid Closed Loop (HCL) or the Control-IQ with MyTDI. Participants randomized to Control-IQ, participants will continue using their home insulin parameters during the ski admission and then 5 additional days at home.
Hybrid Closed Loop (HCL): Participants will use Control-IQ with Hybrid Closed Loop (HCL) with their own insulin parameters during the entire two-week study, including the 72-hour ski admission and the at-home study collection times. Parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
Control-IQ With MyTDI
n=9 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ or the Control-IQ with MyTDI. Participants randomized to Control-IQ with MyTDI, participants will be adjusted as noted below during the ski admission and will then continue these parameters for 5 additional days at home:
* A single basal rate equal to total daily insulin (TDI)/48 will be implemented across the whole day
* A single correction factor (CF) of 1650/TDI will be implemented across the whole day
* Carbohydrate ratios (CR) will be set at:
* 00:00-04:00 CR=450/TDI
* 04:00-11:00 CR=360/TDI
* 11:00-00:00 CR=450/TDI TDI will be set at the internal Control-IQ estimation total daily dose; if not available, total daily dose over the last 5 days will be used.
Control-IQ with MyTDI: Participants will use their own insulin parameters during the first 5 days of the study. After randomization at the ski admission, the participants insulin parameters will be modified using the MyTDI calculations. Additionally, parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
|---|---|---|
|
Percentage of CGM Values Above 250mg/dL at Camp
Baseline
|
16 percentage
Standard Deviation 13.6
|
10 percentage
Standard Deviation 11.4
|
|
Percentage of CGM Values Above 250mg/dL at Camp
Camp
|
14.88 percentage
Standard Deviation 12.36
|
8.04 percentage
Standard Deviation 10.14
|
SECONDARY outcome
Timeframe: 5 days post camp (home) compared to 5 days before camp (baseline)the percentage of CGM values falling above 300mg/dL, computed as the number of CGM values \>300mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Outcome measures
| Measure |
Hybrid Closed Loop (HCL)
n=9 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ with Hybrid Closed Loop (HCL) or the Control-IQ with MyTDI. Participants randomized to Control-IQ, participants will continue using their home insulin parameters during the ski admission and then 5 additional days at home.
Hybrid Closed Loop (HCL): Participants will use Control-IQ with Hybrid Closed Loop (HCL) with their own insulin parameters during the entire two-week study, including the 72-hour ski admission and the at-home study collection times. Parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
Control-IQ With MyTDI
n=9 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ or the Control-IQ with MyTDI. Participants randomized to Control-IQ with MyTDI, participants will be adjusted as noted below during the ski admission and will then continue these parameters for 5 additional days at home:
* A single basal rate equal to total daily insulin (TDI)/48 will be implemented across the whole day
* A single correction factor (CF) of 1650/TDI will be implemented across the whole day
* Carbohydrate ratios (CR) will be set at:
* 00:00-04:00 CR=450/TDI
* 04:00-11:00 CR=360/TDI
* 11:00-00:00 CR=450/TDI TDI will be set at the internal Control-IQ estimation total daily dose; if not available, total daily dose over the last 5 days will be used.
Control-IQ with MyTDI: Participants will use their own insulin parameters during the first 5 days of the study. After randomization at the ski admission, the participants insulin parameters will be modified using the MyTDI calculations. Additionally, parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
|---|---|---|
|
Percentage of CGM Values Above 300mg/dL at Home
Baseline
|
0.3 percentage
Interval 0.0 to 0.8
|
0.3 percentage
Interval 0.0 to 2.2
|
|
Percentage of CGM Values Above 300mg/dL at Home
Home
|
0.7 percentage
Interval 0.2 to 3.2
|
0.9 percentage
Interval 0.0 to 2.7
|
SECONDARY outcome
Timeframe: 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline)the percentage of CGM values falling above 300mg/dL, computed as the number of CGM values \>300mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Outcome measures
| Measure |
Hybrid Closed Loop (HCL)
n=9 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ with Hybrid Closed Loop (HCL) or the Control-IQ with MyTDI. Participants randomized to Control-IQ, participants will continue using their home insulin parameters during the ski admission and then 5 additional days at home.
Hybrid Closed Loop (HCL): Participants will use Control-IQ with Hybrid Closed Loop (HCL) with their own insulin parameters during the entire two-week study, including the 72-hour ski admission and the at-home study collection times. Parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
Control-IQ With MyTDI
n=9 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ or the Control-IQ with MyTDI. Participants randomized to Control-IQ with MyTDI, participants will be adjusted as noted below during the ski admission and will then continue these parameters for 5 additional days at home:
* A single basal rate equal to total daily insulin (TDI)/48 will be implemented across the whole day
* A single correction factor (CF) of 1650/TDI will be implemented across the whole day
* Carbohydrate ratios (CR) will be set at:
* 00:00-04:00 CR=450/TDI
* 04:00-11:00 CR=360/TDI
* 11:00-00:00 CR=450/TDI TDI will be set at the internal Control-IQ estimation total daily dose; if not available, total daily dose over the last 5 days will be used.
Control-IQ with MyTDI: Participants will use their own insulin parameters during the first 5 days of the study. After randomization at the ski admission, the participants insulin parameters will be modified using the MyTDI calculations. Additionally, parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
|---|---|---|
|
Percentage of CGM Values Above 300mg/dL at Camp
Baseline
|
0.3 percentage
Interval 0.0 to 0.8
|
0.3 percentage
Interval 0.0 to 2.2
|
|
Percentage of CGM Values Above 300mg/dL at Camp
Camp
|
0.0 percentage
Interval 0.0 to 1.0
|
0.0 percentage
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 5 days post camp (home) compared to 5 days before camp (baseline)sum of the recorded insulin injection over the time frame in units
Outcome measures
| Measure |
Hybrid Closed Loop (HCL)
n=9 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ with Hybrid Closed Loop (HCL) or the Control-IQ with MyTDI. Participants randomized to Control-IQ, participants will continue using their home insulin parameters during the ski admission and then 5 additional days at home.
Hybrid Closed Loop (HCL): Participants will use Control-IQ with Hybrid Closed Loop (HCL) with their own insulin parameters during the entire two-week study, including the 72-hour ski admission and the at-home study collection times. Parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
Control-IQ With MyTDI
n=9 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ or the Control-IQ with MyTDI. Participants randomized to Control-IQ with MyTDI, participants will be adjusted as noted below during the ski admission and will then continue these parameters for 5 additional days at home:
* A single basal rate equal to total daily insulin (TDI)/48 will be implemented across the whole day
* A single correction factor (CF) of 1650/TDI will be implemented across the whole day
* Carbohydrate ratios (CR) will be set at:
* 00:00-04:00 CR=450/TDI
* 04:00-11:00 CR=360/TDI
* 11:00-00:00 CR=450/TDI TDI will be set at the internal Control-IQ estimation total daily dose; if not available, total daily dose over the last 5 days will be used.
Control-IQ with MyTDI: Participants will use their own insulin parameters during the first 5 days of the study. After randomization at the ski admission, the participants insulin parameters will be modified using the MyTDI calculations. Additionally, parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
|---|---|---|
|
Change in Total Daily Insulin at Home
Baseline
|
39.0 Units
Standard Deviation 7.3
|
48.7 Units
Standard Deviation 18.4
|
|
Change in Total Daily Insulin at Home
Home
|
48.2 Units
Standard Deviation 11.2
|
54.9 Units
Standard Deviation 29.0
|
SECONDARY outcome
Timeframe: 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline)sum of the recorded insulin injection over the time frame in units
Outcome measures
| Measure |
Hybrid Closed Loop (HCL)
n=9 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ with Hybrid Closed Loop (HCL) or the Control-IQ with MyTDI. Participants randomized to Control-IQ, participants will continue using their home insulin parameters during the ski admission and then 5 additional days at home.
Hybrid Closed Loop (HCL): Participants will use Control-IQ with Hybrid Closed Loop (HCL) with their own insulin parameters during the entire two-week study, including the 72-hour ski admission and the at-home study collection times. Parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
Control-IQ With MyTDI
n=9 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ or the Control-IQ with MyTDI. Participants randomized to Control-IQ with MyTDI, participants will be adjusted as noted below during the ski admission and will then continue these parameters for 5 additional days at home:
* A single basal rate equal to total daily insulin (TDI)/48 will be implemented across the whole day
* A single correction factor (CF) of 1650/TDI will be implemented across the whole day
* Carbohydrate ratios (CR) will be set at:
* 00:00-04:00 CR=450/TDI
* 04:00-11:00 CR=360/TDI
* 11:00-00:00 CR=450/TDI TDI will be set at the internal Control-IQ estimation total daily dose; if not available, total daily dose over the last 5 days will be used.
Control-IQ with MyTDI: Participants will use their own insulin parameters during the first 5 days of the study. After randomization at the ski admission, the participants insulin parameters will be modified using the MyTDI calculations. Additionally, parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
|---|---|---|
|
Change in Total Daily Insulin at Camp
Camp
|
38.8 Units
Standard Deviation 11.3
|
50.9 Units
Standard Deviation 27.5
|
|
Change in Total Daily Insulin at Camp
Baseline
|
39.0 Units
Standard Deviation 7.3
|
48.7 Units
Standard Deviation 18.4
|
SECONDARY outcome
Timeframe: 5 days post camp (home) compared to 5 days before camp (baseline)sum of the meal sized recorded over the time frame
Outcome measures
| Measure |
Hybrid Closed Loop (HCL)
n=9 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ with Hybrid Closed Loop (HCL) or the Control-IQ with MyTDI. Participants randomized to Control-IQ, participants will continue using their home insulin parameters during the ski admission and then 5 additional days at home.
Hybrid Closed Loop (HCL): Participants will use Control-IQ with Hybrid Closed Loop (HCL) with their own insulin parameters during the entire two-week study, including the 72-hour ski admission and the at-home study collection times. Parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
Control-IQ With MyTDI
n=9 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ or the Control-IQ with MyTDI. Participants randomized to Control-IQ with MyTDI, participants will be adjusted as noted below during the ski admission and will then continue these parameters for 5 additional days at home:
* A single basal rate equal to total daily insulin (TDI)/48 will be implemented across the whole day
* A single correction factor (CF) of 1650/TDI will be implemented across the whole day
* Carbohydrate ratios (CR) will be set at:
* 00:00-04:00 CR=450/TDI
* 04:00-11:00 CR=360/TDI
* 11:00-00:00 CR=450/TDI TDI will be set at the internal Control-IQ estimation total daily dose; if not available, total daily dose over the last 5 days will be used.
Control-IQ with MyTDI: Participants will use their own insulin parameters during the first 5 days of the study. After randomization at the ski admission, the participants insulin parameters will be modified using the MyTDI calculations. Additionally, parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
|---|---|---|
|
Change in Total Meal Carbohydrates at Home
Baseline
|
226.3 Grams
Standard Deviation 38.6
|
204.1 Grams
Standard Deviation 100.4
|
|
Change in Total Meal Carbohydrates at Home
Home
|
276.5 Grams
Standard Deviation 94.5
|
192.6 Grams
Standard Deviation 115.4
|
SECONDARY outcome
Timeframe: 2 days during camp admission (Camp) compared to 5 days prior to camp (Baseline)sum of the meal sized recorded over the time frame
Outcome measures
| Measure |
Hybrid Closed Loop (HCL)
n=9 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ with Hybrid Closed Loop (HCL) or the Control-IQ with MyTDI. Participants randomized to Control-IQ, participants will continue using their home insulin parameters during the ski admission and then 5 additional days at home.
Hybrid Closed Loop (HCL): Participants will use Control-IQ with Hybrid Closed Loop (HCL) with their own insulin parameters during the entire two-week study, including the 72-hour ski admission and the at-home study collection times. Parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
Control-IQ With MyTDI
n=9 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ or the Control-IQ with MyTDI. Participants randomized to Control-IQ with MyTDI, participants will be adjusted as noted below during the ski admission and will then continue these parameters for 5 additional days at home:
* A single basal rate equal to total daily insulin (TDI)/48 will be implemented across the whole day
* A single correction factor (CF) of 1650/TDI will be implemented across the whole day
* Carbohydrate ratios (CR) will be set at:
* 00:00-04:00 CR=450/TDI
* 04:00-11:00 CR=360/TDI
* 11:00-00:00 CR=450/TDI TDI will be set at the internal Control-IQ estimation total daily dose; if not available, total daily dose over the last 5 days will be used.
Control-IQ with MyTDI: Participants will use their own insulin parameters during the first 5 days of the study. After randomization at the ski admission, the participants insulin parameters will be modified using the MyTDI calculations. Additionally, parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
|---|---|---|
|
Change in Total Meal Carbohydrates at Camp
Baseline
|
226.3 Grams
Standard Deviation 38.6
|
204.1 Grams
Standard Deviation 100.4
|
|
Change in Total Meal Carbohydrates at Camp
Camp
|
280.0 Grams
Standard Deviation 43.0
|
254.6 Grams
Standard Deviation 143.5
|
SECONDARY outcome
Timeframe: 2 days during camp admission (Camp) compared to 5 days prior to camp (Baseline)Sum of hypoglycemic events within the time frame. An event is defined by a group of consecutive CGM values below 70 mg/dL)
Outcome measures
| Measure |
Hybrid Closed Loop (HCL)
n=9 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ with Hybrid Closed Loop (HCL) or the Control-IQ with MyTDI. Participants randomized to Control-IQ, participants will continue using their home insulin parameters during the ski admission and then 5 additional days at home.
Hybrid Closed Loop (HCL): Participants will use Control-IQ with Hybrid Closed Loop (HCL) with their own insulin parameters during the entire two-week study, including the 72-hour ski admission and the at-home study collection times. Parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
Control-IQ With MyTDI
n=9 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ or the Control-IQ with MyTDI. Participants randomized to Control-IQ with MyTDI, participants will be adjusted as noted below during the ski admission and will then continue these parameters for 5 additional days at home:
* A single basal rate equal to total daily insulin (TDI)/48 will be implemented across the whole day
* A single correction factor (CF) of 1650/TDI will be implemented across the whole day
* Carbohydrate ratios (CR) will be set at:
* 00:00-04:00 CR=450/TDI
* 04:00-11:00 CR=360/TDI
* 11:00-00:00 CR=450/TDI TDI will be set at the internal Control-IQ estimation total daily dose; if not available, total daily dose over the last 5 days will be used.
Control-IQ with MyTDI: Participants will use their own insulin parameters during the first 5 days of the study. After randomization at the ski admission, the participants insulin parameters will be modified using the MyTDI calculations. Additionally, parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
|---|---|---|
|
Change in Number of Hypoglycemic Events at Camp
Baseline
|
1 events per day
Interval 0.4 to 2.0
|
0.5 events per day
Interval 0.4 to 1.4
|
|
Change in Number of Hypoglycemic Events at Camp
Camp
|
1 events per day
Interval 0.0 to 1.0
|
1 events per day
Interval 0.5 to 2.5
|
SECONDARY outcome
Timeframe: 2 days during camp admission (Camp)Sum of the number of CHO treatments recorded over the time frame
Outcome measures
| Measure |
Hybrid Closed Loop (HCL)
n=9 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ with Hybrid Closed Loop (HCL) or the Control-IQ with MyTDI. Participants randomized to Control-IQ, participants will continue using their home insulin parameters during the ski admission and then 5 additional days at home.
Hybrid Closed Loop (HCL): Participants will use Control-IQ with Hybrid Closed Loop (HCL) with their own insulin parameters during the entire two-week study, including the 72-hour ski admission and the at-home study collection times. Parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
Control-IQ With MyTDI
n=9 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ or the Control-IQ with MyTDI. Participants randomized to Control-IQ with MyTDI, participants will be adjusted as noted below during the ski admission and will then continue these parameters for 5 additional days at home:
* A single basal rate equal to total daily insulin (TDI)/48 will be implemented across the whole day
* A single correction factor (CF) of 1650/TDI will be implemented across the whole day
* Carbohydrate ratios (CR) will be set at:
* 00:00-04:00 CR=450/TDI
* 04:00-11:00 CR=360/TDI
* 11:00-00:00 CR=450/TDI TDI will be set at the internal Control-IQ estimation total daily dose; if not available, total daily dose over the last 5 days will be used.
Control-IQ with MyTDI: Participants will use their own insulin parameters during the first 5 days of the study. After randomization at the ski admission, the participants insulin parameters will be modified using the MyTDI calculations. Additionally, parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
|---|---|---|
|
Number of Hypoglycemia Treatment at Camp
|
1.5 events per day
Interval 1.0 to 2.5
|
2.5 events per day
Interval 0.0 to 3.0
|
SECONDARY outcome
Timeframe: 2 days during camp admission (Camp)Sum of the amount of carbohydrates used for treatments recorded over the time frame
Outcome measures
| Measure |
Hybrid Closed Loop (HCL)
n=9 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ with Hybrid Closed Loop (HCL) or the Control-IQ with MyTDI. Participants randomized to Control-IQ, participants will continue using their home insulin parameters during the ski admission and then 5 additional days at home.
Hybrid Closed Loop (HCL): Participants will use Control-IQ with Hybrid Closed Loop (HCL) with their own insulin parameters during the entire two-week study, including the 72-hour ski admission and the at-home study collection times. Parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
Control-IQ With MyTDI
n=9 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ or the Control-IQ with MyTDI. Participants randomized to Control-IQ with MyTDI, participants will be adjusted as noted below during the ski admission and will then continue these parameters for 5 additional days at home:
* A single basal rate equal to total daily insulin (TDI)/48 will be implemented across the whole day
* A single correction factor (CF) of 1650/TDI will be implemented across the whole day
* Carbohydrate ratios (CR) will be set at:
* 00:00-04:00 CR=450/TDI
* 04:00-11:00 CR=360/TDI
* 11:00-00:00 CR=450/TDI TDI will be set at the internal Control-IQ estimation total daily dose; if not available, total daily dose over the last 5 days will be used.
Control-IQ with MyTDI: Participants will use their own insulin parameters during the first 5 days of the study. After randomization at the ski admission, the participants insulin parameters will be modified using the MyTDI calculations. Additionally, parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
|---|---|---|
|
Total Amount of Carbohydrates Corresponding to Hypoglycemia Treatment at Camp
|
35.9 grams per day
Standard Deviation 37
|
43.6 grams per day
Standard Deviation 35.2
|
SECONDARY outcome
Timeframe: 5 days post camp (home) compared to 5 days before camp (baseline)change in number of hypoglycemia between baseline and home
Outcome measures
| Measure |
Hybrid Closed Loop (HCL)
n=9 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ with Hybrid Closed Loop (HCL) or the Control-IQ with MyTDI. Participants randomized to Control-IQ, participants will continue using their home insulin parameters during the ski admission and then 5 additional days at home.
Hybrid Closed Loop (HCL): Participants will use Control-IQ with Hybrid Closed Loop (HCL) with their own insulin parameters during the entire two-week study, including the 72-hour ski admission and the at-home study collection times. Parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
Control-IQ With MyTDI
n=9 Participants
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ or the Control-IQ with MyTDI. Participants randomized to Control-IQ with MyTDI, participants will be adjusted as noted below during the ski admission and will then continue these parameters for 5 additional days at home:
* A single basal rate equal to total daily insulin (TDI)/48 will be implemented across the whole day
* A single correction factor (CF) of 1650/TDI will be implemented across the whole day
* Carbohydrate ratios (CR) will be set at:
* 00:00-04:00 CR=450/TDI
* 04:00-11:00 CR=360/TDI
* 11:00-00:00 CR=450/TDI TDI will be set at the internal Control-IQ estimation total daily dose; if not available, total daily dose over the last 5 days will be used.
Control-IQ with MyTDI: Participants will use their own insulin parameters during the first 5 days of the study. After randomization at the ski admission, the participants insulin parameters will be modified using the MyTDI calculations. Additionally, parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
|---|---|---|
|
Change in Hypoglycemia Events at Home
Baseline
|
1 events per day
Interval 0.4 to 2.0
|
0.6 events per day
Interval 0.4 to 1.4
|
|
Change in Hypoglycemia Events at Home
Home
|
0.3 events per day
Interval 0.2 to 0.8
|
0.7 events per day
Interval 0.2 to 1.3
|
Adverse Events
Hybrid Closed Loop (HCL)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control-IQ With MyTDI
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Hybrid Closed Loop (HCL)
n=10 participants at risk
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ with Hybrid Closed Loop (HCL) or the Control-IQ with MyTDI. Participants randomized to Control-IQ, participants will continue using their home insulin parameters during the ski admission and then 5 additional days at home.
Hybrid Closed Loop (HCL): Participants will use Control-IQ with Hybrid Closed Loop (HCL) with their own insulin parameters during the entire two-week study, including the 72-hour ski admission and the at-home study collection times. Parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
Control-IQ With MyTDI
n=10 participants at risk
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ or the Control-IQ with MyTDI. Participants randomized to Control-IQ with MyTDI, participants will be adjusted as noted below during the ski admission and will then continue these parameters for 5 additional days at home:
* A single basal rate equal to total daily insulin (TDI)/48 will be implemented across the whole day
* A single correction factor (CF) of 1650/TDI will be implemented across the whole day
* Carbohydrate ratios (CR) will be set at:
* 00:00-04:00 CR=450/TDI
* 04:00-11:00 CR=360/TDI
* 11:00-00:00 CR=450/TDI TDI will be set at the internal Control-IQ estimation total daily dose; if not available, total daily dose over the last 5 days will be used.
Control-IQ with MyTDI: Participants will use their own insulin parameters during the first 5 days of the study. After randomization at the ski admission, the participants insulin parameters will be modified using the MyTDI calculations. Additionally, parameters will be reduced 20% during the ski admission to adjust for the increased activity.
|
|---|---|---|
|
Endocrine disorders
Hyperglycemia or ketosis events without meeting criteria for Diabetes Ketoacidosis
|
0.00%
0/10 • 13 days
Any untoward medical occurrence in a study participant, irrespective of the relationship between the adverse event and the device(s) under investigation
|
10.0%
1/10 • Number of events 1 • 13 days
Any untoward medical occurrence in a study participant, irrespective of the relationship between the adverse event and the device(s) under investigation
|
|
Nervous system disorders
Concussion
|
0.00%
0/10 • 13 days
Any untoward medical occurrence in a study participant, irrespective of the relationship between the adverse event and the device(s) under investigation
|
10.0%
1/10 • Number of events 1 • 13 days
Any untoward medical occurrence in a study participant, irrespective of the relationship between the adverse event and the device(s) under investigation
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory illness
|
0.00%
0/10 • 13 days
Any untoward medical occurrence in a study participant, irrespective of the relationship between the adverse event and the device(s) under investigation
|
10.0%
1/10 • Number of events 1 • 13 days
Any untoward medical occurrence in a study participant, irrespective of the relationship between the adverse event and the device(s) under investigation
|
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