Effect of the InsuPatch on Automated Closed-loop Glucose Control in Type 1 Diabetes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of the Insupatch on Automated Closed-loop Glucose Control in Type 1 Diabetes

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Device: ePID closed loop system
* Device: InsuPatch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 12-40 years clinical diagnosis of type 1 diabetes duration of type 1 diabetes ≥ 1 year HbA1c ≤ 9 % Treated with pump therapy for at least 3 months Body weight > 40 kg Exclusion Criteria: Insulin resistant (defined as requiring > 1.5 units/kg/day at time of study enrollment Presence of any medical or psychiatric disorder that may interfere with subject safety or study conduct Use of any medications (besides insulin) known to blood glucose levels, including oral or other systemic glucocorticoid therapy. Inhaled, intranasal, or rectal corticosteroid use is allowed along as not given within 4 weeks of admission. Use of topical glucocorticoids is allowable as long as affected skin area does not overlap with study device sites. Subjects using herbal supplements will be excluded, due to the unknown effects of these supplements on glucose control History of poor wound healing, heat sensitivity, or diminished skin integrity. History of hypoglycemic seizure within last 3 months Anemic (low hematocrit), or evidence of renal insufficiency (elevated serum creatinine) Female subjects who are pregnant, lactating, or unwilling to be tested for pregnancy Subjects unable to give consent / permission / assent

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ePID closed loop system using Insupatch<br>Insupatch activated at mealtimes | Device: ePID closed loop system<br>* Insulin pump controlled by closed loop unit and algorithm<br>Device: InsuPatch<br>* device which applies local heating at 40 degrees Celsius to the vicinity of the subcutaneous insulin infusion insertion site<br>|
| Active Comparator: ePID closed loop system without InsuPatch<br>InsuPatch will not be activated at mealtimes | Device: ePID closed loop system<br>* Insulin pump controlled by closed loop unit and algorithm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 |