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

Type 1 Diabetes Clinical Trial

— IPCL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01787318
• Other study ID #: HIC # 1208010682
• Status: Completed
• Phase: Phase 0
• First received: January 16, 2013
• Last updated: April 13, 2016
• Start date: January 2013
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Device:
• ePID closed loop system
Insulin pump controlled by closed loop unit and algorithm
• InsuPatch
device which applies local heating at 40 degrees Celsius to the vicinity of the subcutaneous insulin infusion insertion site

Locations

Country	Name	City	State
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Total Area Under Curve of the meal-related glucose excursion over target		48 hours	No
Secondary	Nadir glucose levels following the meals		48 hours	No
Secondary	Mean 24 hour glucose levels		48 hours	No
Secondary	Mean daytime and nighttime glucose levels		48 hours	No
Secondary	Peak post-prandial insulin levels following meals		48 hours	Yes
Secondary	Area Under Curve meal-related insulin excursion following meals		48 hours	No