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This research study designed to look at how well adolescents' and young adults' blood sugars can be controlled with a "closed loop artificial pancreas" using a continuous glucose sensor, an insulin pump, and a computer program that automatically determines how much insulin to give based on the glucose level. The investigators will also study the effect of wearing a small heating patch, the InsuPatch, at the site of insulin infusion, on the ability of the closed loop system to control the blood sugar levels and to reduce the rise in glucose levels after meals.
This is an open-label, single-center, randomized crossover study evaluating the performance of a closed-loop (CL) insulin delivery system using a subcutaneous glucose sensor and an external insulin pump comparing the peak post-prandial glucose levels and the post-prandial glucose AUC during either CL control alone or CL control with the InsuPatch in an inpatient hospital research unit (HRU) setting. The closed loop visit consists of approximately 67 hours over 4 days and 3 nights.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ePID closed loop system using Insupatch | Experimental | Insupatch activated at mealtimes |
|
| ePID closed loop system without InsuPatch | Active Comparator | InsuPatch will not be activated at mealtimes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ePID closed loop system | Device | Insulin pump controlled by closed loop unit and algorithm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Post-Prandial Glucose Excursions | Peak post-prandial plasma glucose excursions after breakfast, lunch, and dinner on days #2 and #3. One day with InsuPatch activated and one day without InsuPatch activated | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Total Area Under Curve of the meal-related glucose excursion over target | 48 hours | |
| Nadir glucose levels following the meals | 48 hours | |
| Mean 24 hour glucose levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stuart Weinzimer, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University School of Medicine | New Haven | Connecticut | 06520 | United States |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| InsuPatch | Device | device which applies local heating at 40 degrees Celsius to the vicinity of the subcutaneous insulin infusion insertion site |
|
| 48 hours |
| Mean daytime and nighttime glucose levels | 48 hours |
| Peak post-prandial insulin levels following meals | 48 hours |
| Area Under Curve meal-related insulin excursion following meals | 48 hours |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |