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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Device: ePID closed loop system; Device: InsuPatch

Detailed Description

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
• Enrollment (Actual): 10
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Stuart Weinzimer, MD, Yale University

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: January 16, 2013
• First Submitted That Met QC Criteria: February 5, 2013
• First Posted (Estimate): February 8, 2013

Study Record Updates

• Last Update Posted (Estimate): April 14, 2016
• Last Update Submitted That Met QC Criteria: April 13, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: HIC # 1208010682