Evaluating Meal Performance and Effect of Moderate Intensity Exercise in Patients With Type 1 Diabetes With the Insulet Automated Glucose Control System: IDE 2
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Insulet Corporation
- Enrollment
- 24
- Locations
- 3
- Primary Endpoint
- Percentage of time in hypoglycemic range (defined as < 70 mg/dL)
Study Overview
Brief Summary
To assess the safety and performance of the Insulet AP (artificial pancreas) system, using the Omnipod® insulin management system, Dexcom G4 Share® AP System and personalized model predictive control algorithm in adults with type 1 diabetes consuming high fat meals and undertaking moderate intensity exercise.
Detailed Description
The two-part study schedule consists of a 7±1 day outpatient, open-loop phase, followed by one 54-hour, hybrid closed-loop phases conducted in a supervised CRC or hotel/rental house setting.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age at time of consent 18.0 to 65.0 years
- •Diagnosed with type 1 diabetes for at least one year. Diagnosis is based on investigator's clinical judgment.
- •Total daily dose (TDD) of insulin ≥0.3 units/kg/day and A1C >6% at screening
- •Currently using an insulin pump with U-100 rapid-acting insulin analogs and on pump therapy for at least 6 months prior to study start
- •Willing to use the study CGM device for the duration of the study
- •Willing to use the Omnipod® Insulin Management System during the study
- •Willing to perform all fingerstick BG testing with the study-approved glucose meter at the frequency specified in the study protocol
- •Willing to abide by meal recommendations for breakfast, lunch and dinner during the study
- •Willing to participate in moderate intensity exercise for up to 45 minutes if taking part in Option B
- •Willing to refrain from use of acetaminophen and supplemental vitamin C (>2000 mg/daily) for the entire duration of participation in the study
- •Willing and able to sign the Informed Consent Form (ICF)
Exclusion Criteria
- •A1C >10% at the screening visit
- •One or more episodes of severe hypoglycemia requiring emergency room (ER) visit or hospitalization within the past 6 months
- •Hypoglycemic unawareness as determined by a score of ≥4 "R" responses on the Clarke Questionnaire
- •One or more episodes of diabetic ketoacidosis requiring ER visit or hospitalization within the past 6 months
- •Used non-insulin anti-diabetic medication within last 30 days
- •Pregnant or lactating, or is a woman of childbearing potential and not on acceptable form of birth control (acceptable includes abstinence, condoms, oral/injectable contraceptives, IUD or implant)
- •Dermatological conditions at the proposed sensor wear sites that in the investigator's opinion could preclude ability to wear the Pod and/or the Dexcom sensor
- •Current or known history of cardiovascular disease, arrhythmia, myocardial infarction (MI) or stroke. An electrocardiogram (ECG) must be obtained within 6 months.
- •Currently undergoing systemic treatment with steroids or immunosuppressive medication
- •Current illness that would interfere with participation in the study
- •Currently participating in another clinical study using an investigational drug or device
- •Recent (within the preceding 30 days) participation in a clinical study using an investigational drug.
Arms & Interventions
Meal Performance and/or Exercise
This study is a two-part, multi-center, observational clinical trial being conducted in a Clinical Research Center (CRC) setting using the Insulet AP (artificial pancreas) system.
Subjects may participate in hybrid closed-loop session Option A - Meal Performance and/or Option B - Exercise, but are not required to participate in both. If participating in both, Option A and Option B must be conducted in separate sessions.
Intervention: Insulet AP (artificial pancreas) System (Device)
Outcomes
Primary Outcomes
Percentage of time in hypoglycemic range (defined as < 70 mg/dL)
Time Frame: 54 hours
Percentage of time in hyperglycemic range(defined as ≥ 250 mg/dL)
Time Frame: 54 hours
Secondary Outcomes
- Percentage of time < 50 mg/dL(54 hours)
- Mean glucose(54 hours)
- Percentage of time < 60 mg/dL(54 hours)
- Effect of changing setpoints(54 hour)
- Percentage of time between 70-180 mg/dL(54 hours)
- Meal challenge-12 hour PPG dinner(54 hours)
- Percentage of time between 70-140 mg/dL(54 hours)
- Meal challenge-4 hour PPG breakfast(54 hours)
- Exercise challenge-immediate and delayed glucose response(54 hour)
- Percentage of time > 180 mg/dL(54 hours)
- Percentage of time ≥ 300 mg/dL(54 hours)
- Standard deviation(54 hours)
- Coefficient of variation(54 hours)
- Meal challenge-4 hour PPG lunch(54 hour)