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

Early Phase 1CompletedNCT01787318

Yale University10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 1 Diabetes

Interventions

ePID closed loop systemDEVICE

Insulin pump controlled by closed loop unit and algorithm

InsuPatchDEVICE

device which applies local heating at 40 degrees Celsius to the vicinity of the subcutaneous insulin infusion insertion site

Eligibility

Sex: ALLMin age: 12 YearsMax age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. age 12-40 years 2. clinical diagnosis of type 1 diabetes 3. duration of type 1 diabetes ≥ 1 year 4. HbA1c ≤ 9 % 5. Treated with pump therapy for at least 3 months 6. Body weight \> 40 kg Exclusion Criteria: 1. Insulin resistant (defined as requiring \> 1.5 units/kg/day at time of study enrollment 2. Presence of any medical or psychiatric disorder that may interfere with subject safety or study conduct 3. 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 4. History of poor wound healing, heat sensitivity, or diminished skin integrity. 5. History of hypoglycemic seizure within last 3 months 6. Anemic (low hematocrit), or evidence of renal insufficiency (elevated serum creatinine) 7. Female subjects who are pregnant, lactating, or unwilling to be tested for pregnancy 8. Subjects unable to give consent / permission / assent

Locations (1)

Yale University School of Medicine

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

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

Time frame: 48 hours

Secondary Outcomes

Total Area Under Curve of the meal-related glucose excursion over target

Time frame: 48 hours

Nadir glucose levels following the meals

Time frame: 48 hours

Mean 24 hour glucose levels

Time frame: 48 hours

Mean daytime and nighttime glucose levels

Time frame: 48 hours

Peak post-prandial insulin levels following meals

Time frame: 48 hours

Area Under Curve meal-related insulin excursion following meals

Time frame: 48 hours

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.