An interventional study of TTR controller (Medtronic) in Diabetes Mellitus, Type 1 Diabetes and Metabolic and Nutritional Disorders, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 15 Years to 30 Years. Per ClinicalTrials.gov, last updated 2017-09-29.
Sponsored by Stanford University · Not applicable, Interventional, and Treatment
The purpose of this study is to evaluate a treat-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes.
The purpose of this study is to demonstrate the safety and efficacy of a closed-loop "treat-to-range" (TTR) system in an inpatient clinical research center setting. The TTR system only effects insulin delivery when the glucose is projected to be above or below specified target ranges. These initial studies will assess the safety of this algorithm (mathematical equation) under the extreme conditions of a missed meal insulin bolus and meal over-insulinization. This is a "hybrid" system, which allows the research team to deliver insulin boluses manually with the TTR controller only becoming active when blood glucose levels are projected to be out of the specified range.
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This study's enrollment of 22 is below the median of 80 across 8,491 interventional studies indexed under Diabetes Mellitus.
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Exclusion Criteria:
The intervention will consist of using the TTR controller (Medtronic) for post-prandial glucose control following high and low glycemic meals
Device: TTR controller (Medtronic)
Subjects will arrive in the morning and the TTR controller (Medtronic) will be initialized, and then they will give their usual premeal insulin bolus for breakfast. At lunch, they will either have a low glycemic index meal or a high glycemic index meal and the meal bolus will be omitted. The device will be turned off before dinner, they will have their usual insulin bolus for dinner, eat dinner, and then be discharged to home. On another admission, they will receive an insulin dose before lunch which will be 120% of their usual insulin bolus.
Safety and Feasibility of TTR Closed-loop Control System as Measure by the Count of Successful Hospital Admissions
A successful hospital admission was defined as requiring no more than 2 TTR closed-loop control system adjustments of algorithm tuning parameters after initial set up, and not meeting any stopping criteria. The system was considered feasible if 75% of hospital admissions were successful.
Time frame: Day of hospital admission (12 hours)
| Milestone | TTR Controller |
|---|---|
| Started | 22 |
| Completed | 22 |
| Not completed | 0 |
A successful hospital admission was defined as requiring no more than 2 TTR closed-loop control system adjustments of algorithm tuning parameters after initial set up, and not meeting any stopping criteria. The system was considered feasible if 75% of hospital admissions were successful.
| Admissions | Cohort A1 - Missed Bolus Meal | Cohort A2 - Missed Bolus Meal | Cohort B - Overbolus Meal |
|---|---|---|---|
| Successful Admission | 7 | 4 | 7 |
| Unsuccessful Admission | 2 | 3 | 2 |
Collected over Day of hospital admission (12 hours). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TTR Controller | — | 0/22 (0%) | 6/22 (27.3%) |
| Event | TTR Controller |
|---|---|
| HypoglycemiaMetabolism and nutrition disorders | 6/22 |
| Hypoglycemia <50 mg/dLMetabolism and nutrition disorders | 2/22 |
| Significant Post-Prandial HyperglycemiaMetabolism and nutrition disorders | 1/22 |
Subjects with Type 1 Diabetes
| Age, Categorical(Participants) | TTR Controller |
|---|---|
| <=18 years | 6 |
| Between 18 and 65 years | 16 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | TTR Controller |
|---|---|
| Female | 13 |
| Male | 9 |
Plan to share: No
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