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

NCT03064906 | Completed FDA Device

• 1 other identifier: IDE2
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

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.

Conditions

Type 1 Diabetes Mellitus

Keywords

T1D, Omnipod

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• 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

Study Arms (1)

Meal Performance and/or Exercise

OTHER

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

Interventions

Insulet AP (artificial pancreas) System DEVICE

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

Meal Performance and/or Exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Insulet Corporation: lead

Study Sites (3)

Stanford University

Palo Alto, California, 94305, United States

Location

Diablo Clinical Research

Walnut Creek, California, 94598, United States

Location

University of Colorado Denver

Denver, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Pancreas, Artificial; Drug Delivery Systems

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Artificial Organs; Surgical Equipment; Equipment and Supplies; Drug Therapy; Therapeutics

Study Officials

• Bruce Buckingham, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: February 27, 2017
• Study Start: March 18, 2017
• Primary Completion: April 7, 2017
• Study Completion: April 7, 2017
• Last Updated: June 12, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)