Insulet Artificial Pancreas Evaluating Meal Performance and Moderate Exercise (IDE2) (IDE2)

Evaluating Meal Performance and Effect of Moderate Intensity Exercise in Patients With Type 1 Diabetes With the Insulet Automated Glucose Control System: IDE 2

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Device: Insulet AP (artificial pancreas) System

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94305
      • Stanford University
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research
  • Colorado
    • Denver, Colorado, United States, 80045
      • University of Colorado Denver

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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.

Device: Insulet AP (artificial pancreas) System; Insulet AP (artificial pancreas) system, using the Omnipod® insulin management system, Dexcom G4 Share® AP System and personalized model predictive control algorithm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of time in hypoglycemic range (defined as < 70 mg/dL)	54 hours
Percentage of time in hyperglycemic range(defined as ≥ 250 mg/dL)	54 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean glucose		54 hours
Percentage of time < 50 mg/dL		54 hours
Percentage of time < 60 mg/dL		54 hours
Percentage of time > 180 mg/dL		54 hours
Percentage of time ≥ 300 mg/dL		54 hours
Percentage of time between 70-180 mg/dL		54 hours
Percentage of time between 70-140 mg/dL		54 hours
Standard deviation		54 hours
Coefficient of variation		54 hours
Meal challenge-12 hour PPG dinner	The post-prandial glucose response including time to peak glucose, peak glucose concentration, and peak glucose excursion and the 12-hour post-prandial period following dinner.	54 hours
Meal challenge-4 hour PPG breakfast	The post-prandial glucose response including time to peak glucose, peak glucose concentration, and peak glucose excursion for the 4-hour post-prandial period following breakfast.	54 hours
Meal challenge-4 hour PPG lunch	The post-prandial glucose response including time to peak glucose, peak glucose concentration, and peak glucose excursion for the 4-hour post-prandial period following lunch.	54 hour
Exercise challenge-immediate and delayed glucose response	The immediate (2 hours) and delayed (24 hours) glucose response to moderate intensity exercise.	54 hour
Effect of changing setpoints	Effect of changing setpoints to overall performance.	54 hour

Collaborators and Investigators

• Sponsor: Insulet Corporation

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2017
• Primary Completion (Actual): April 7, 2017
• Study Completion (Actual): April 7, 2017

Study Registration Dates

• First Submitted: February 22, 2017
• First Submitted That Met QC Criteria: February 24, 2017
• First Posted (Actual): February 27, 2017

Study Record Updates

• Last Update Posted (Actual): June 12, 2018
• Last Update Submitted That Met QC Criteria: June 8, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: T1D, Omnipod
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Gastrointestinal Agents; Pancrelipase
• Other Study ID Numbers: IDE2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes