Back to resultsEffect of the InsuPatch on Automated Closed-loop Glucose Control in Type 1 Diabetes (IPCL)
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
ePID closed loop system
InsuPatch
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes
Eligibility Criteria
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
Sites / Locations
- Yale University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ePID closed loop system using Insupatch
ePID closed loop system without InsuPatch
Arm Description
Insupatch activated at mealtimes
InsuPatch will not be activated at mealtimes
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Total Area Under Curve of the meal-related glucose excursion over target
Nadir glucose levels following the meals
Mean 24 hour glucose levels
Mean daytime and nighttime glucose levels
Peak post-prandial insulin levels following meals
Area Under Curve meal-related insulin excursion following meals
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01787318
Brief Title
Effect of the InsuPatch on Automated Closed-loop Glucose Control in Type 1 Diabetes
Acronym
IPCL
Official Title
Effect of the Insupatch on Automated Closed-loop Glucose Control in Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ePID closed loop system using Insupatch
Arm Type
Experimental
Arm Description
Insupatch activated at mealtimes
Arm Title
ePID closed loop system without InsuPatch
Arm Type
Active Comparator
Arm Description
InsuPatch will not be activated at mealtimes
Intervention Type
Device
Intervention Name(s)
ePID closed loop system
Intervention Description
Insulin pump controlled by closed loop unit and algorithm
Intervention Type
Device
Intervention Name(s)
InsuPatch
Intervention Description
device which applies local heating at 40 degrees Celsius to the vicinity of the subcutaneous insulin infusion insertion site
Primary Outcome Measure Information:
Title
Peak Post-Prandial Glucose Excursions
Description
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 Outcome Measure Information:
Title
Total Area Under Curve of the meal-related glucose excursion over target
Time Frame
48 hours
Title
Nadir glucose levels following the meals
Time Frame
48 hours
Title
Mean 24 hour glucose levels
Time Frame
48 hours
Title
Mean daytime and nighttime glucose levels
Time Frame
48 hours
Title
Peak post-prandial insulin levels following meals
Time Frame
48 hours
Title
Area Under Curve meal-related insulin excursion following meals
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart Weinzimer, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of the InsuPatch on Automated Closed-loop Glucose Control in Type 1 Diabetes
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