Clinical trial NCT03064906: Insulet Artificial Pancreas Evaluating Meal Performance and Moderate Exercise (IDE2)
Official title: Evaluating Meal Performance and Effect of Moderate Intensity Exercise in Patients With Type 1 Diabetes With the Insulet Automated Glucose Control System: IDE 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: T1D, Omnipod
Lead sponsor: Insulet Corporation
Sponsor class: INDUSTRY
First posted: 2017-02-27
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The two-part study schedule consists of a 7±1 day outpatient, open-loop phase, followed by one 54-hour (Option A - Meal Performance and/or Option B - Exercise), hybrid closed-loop phases conducted in a supervised CRC or hotel/rental house setting. Subjects may participate in hybrid closed-loop session Option A and/or Option B.
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: Inclusion Criteria:

1. Age at time of consent 18.0 to 65.0 years
2. Diagnosed with type 1 diabetes for at least one year. Diagnosis is based on investigator's clinical judgment.
3. Total daily dose (TDD) of insulin ≥0.3 units/kg/day and A1C \>6% at screening
4. 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
5. Willing to use the study CGM device for the duration of the study
6. Willing to use the Omnipod® Insulin Management System during the study
7. Willing to perform all fingerstick BG testing with the study-approved glucose meter at the frequency specified in the study protocol
8. Willing to abide by meal recommendations for breakfast, lunch and dinner during the study
9. Willing to participate in moderate intensity exercise for up to 45 minutes if taking part in Option B
10. Willing to refrain from use of acetaminophen and supplemental vitamin C (\>2000 mg/daily) for the entire duration of participation in the study
11. Willing and able to sign the Informed Consent Form (ICF)

Exclusion Criteria:

1. A1C \>10% at the screening visit
2. One or more episodes of severe hypoglycemia requiring emergency room (ER) visit or hospitalization within the past 6 months
3. Hypoglycemic unawareness as determined by a score of ≥4 "R" responses on the Clarke Questionnaire
4. One or more episodes of diabetic ketoacidosis requiring ER visit or hospitalization within the past 6 months
5. Used non-insulin anti-diabetic medication within last 30 days
6. 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)
7. 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
8. Current or known history of cardiovascular disease, arrhythmia, myocardial infarction (MI) or stroke. An electrocardiogram (ECG) must be obtained within 6 months.
9. Currently undergoing systemic treatment with steroids or immunosuppressive medication
10. Current illness that would interfere with participation in the study
11. Currently participating in another clinical study using an investigational drug or device
12. Recent (within the preceding 30 days) participation in a clinical study using an investigational drug.

Primary outcomes:
measure: Percentage of time in hypoglycemic range (defined as < 70 mg/dL)
timeFrame: 54 hours
measure: Percentage of time in hyperglycemic range(defined as ≥ 250 mg/dL)
timeFrame: 54 hours
Secondary outcomes:
measure: Mean glucose
timeFrame: 54 hours
measure: Percentage of time < 50 mg/dL
timeFrame: 54 hours
measure: Percentage of time < 60 mg/dL
timeFrame: 54 hours
measure: Percentage of time > 180 mg/dL
timeFrame: 54 hours
measure: Percentage of time ≥ 300 mg/dL
timeFrame: 54 hours
measure: Percentage of time between 70-180 mg/dL
timeFrame: 54 hours
measure: Percentage of time between 70-140 mg/dL
timeFrame: 54 hours
measure: Standard deviation
timeFrame: 54 hours
measure: Coefficient of variation
timeFrame: 54 hours
measure: Meal challenge-12 hour PPG dinner
timeFrame: 54 hours
measure: Meal challenge-4 hour PPG breakfast
timeFrame: 54 hours
measure: Meal challenge-4 hour PPG lunch
timeFrame: 54 hour
measure: Exercise challenge-immediate and delayed glucose response
timeFrame: 54 hour
measure: Effect of changing setpoints
timeFrame: 54 hour
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research
state: California
city: Denver
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: Stanford University
name: Bruce Buckingham, MD
role: PRINCIPAL_INVESTIGATOR
References: