Insulet Artificial Pancreas Free-Living IDE3

NCT03216460 | Completed FDA Device

• 1 other identifier: IDE3
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

Brief Summary

Subjects will undergo a 7±1 day outpatient, standard therapy phase during which sensor and insulin data will be collected. Subjects or their caregivers will manage their diabetes at home per their usual routine using the study CGM and remain on current MDI or pump therapy. This will be followed by a 5-day/4-night or from approximately 48 to 72 hours for children ages 2.0-5.9 years, hybrid closed-loop phase conducted in a supervised hotel/rental house setting.

Conditions

Type1 Diabetes Mellitus

Keywords

T1D, Omnipod

Outcome Measures

Primary Outcomes (2)

• Percentage of time in hypoglycemic range (defined as < 70 mg/dL)

  96 hours

• Percentage of time in hyperglycemic range (defined as ≥ 250 mg/dL)

  96 hours

Secondary Outcomes (10)

• Mean Glucose

  96 hours

• Percentage of time < 50 mg/dL

  96 hours

• Percentage of time < 54 mg/dL

  96 hours

• Percentage of time < 60 mg/dL

  96 hours

• Percentage of time > 180 mg/dL

  96 hours

Study Arms (1)

Supervised Free-Living

OTHER

Subjects will undergo a 7±1 day outpatient, standard therapy phase during which sensor and insulin data will be collected. Subjects or their caregivers will manage their diabetes at home per their usual routine using the study CGM and remain on current MDI or pump therapy. This will be followed by a 5-day/4-night or from approximately 48 to 72 hours for children ages 2.0-5.9 years, hybrid closed-loop phase conducted in a supervised hotel/rental house setting, where subjects will participate in specific setpoint challenges, meal challenges, and exercise

Device: Insulet automated glucose control system

Interventions

Insulet automated glucose control system DEVICE

Insulet AP (artificial pancreas) system, using the Omnipod® insulin management system, Dexcom G4Share® AP System and personalized model predictive control algorithm.

Supervised Free-Living

Eligibility Criteria

• Age: 2 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age at time of consent 2.0-85 years
• Individuals aged ≥6.0 must be diagnosed with type 1 diabetes for at least one year. Preschool children aged 2.0-5.9 years must be diagnosed with type 1 diabetes for at least 6 months. Diagnosis is based on investigator's clinical judgment.
• A1C \<10% at screening
• Currently using U-100 rapid-acting insulin analogs with insulin pump or receiving multiple daily injections suitable for conversion to pump therapy for at least 3 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 or per investigator discretion
• Willing to participate in setpoint and meal challenges
• Willing to use carbohydrate counting for determination of meal boluses
• Willing to participate in moderate intensity exercise for at least 30 minutes per day
• 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) and/or has a parent/guardian willing and able to sign the ICF. Assent will be obtained from pediatric and adolescent subjects per State requirements.

You may not qualify if:

• One or more episodes of severe hypoglycemia requiring emergency room (ER) visit or hospitalization within the past 6 months
• One or more episodes of diabetic ketoacidosis requiring ER visit or hospitalization within the past 6 months
• Planning to start a non-insulin anti-diabetic medication during the study. If on non-insulin medication, dose must be stable in the previous 30 days.
• Using a basal insulin with a usual duration of insulin action \> 36 hours
• 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/pump 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 coronary artery disease that is not stable with medical management, including unstable angina, or angina that prevents moderate exercise despite medical management, or a history of myocardial infarction, percutaneous coronary intervention, or coronary artery bypass grafting within the previous 12 months. Abnormal electrocardiogram consistent with increased risk of arrhythmia, ischemia, or prolonged QT interval (\> 440 ms). Electrocardiogram is only required for subjects \>50 years old or with diabetes duration \>20 years.
• Stroke
• Known history of seizure disorder
• Known history of adrenal insufficiency
• Current renal or hepatic disease
• Untreated or unstable hypothyroidism or celiac disease (per investigator's judgment)
• Currently undergoing cancer treatment
• Currently undergoing systemic treatment with steroids or immunosuppressive medication
• Known history of any chronic infections that would interfere with participation in the study or place study personnel at undue risk due to blood-borne contaminants

Sponsors & Collaborators

• Insulet Corporation: lead

Study Sites (3)

Stanford University

Palo Alto, California, 94305, United States

Location

University of Colorado Denver

Denver, Colorado, 80045, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

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: This study is a single-arm, multi-center, observational clinical study.

Study Record Dates

• First Submitted: July 1, 2017
• First Posted: July 13, 2017
• Study Start: February 4, 2019
• Primary Completion: May 28, 2019
• Study Completion: May 28, 2019
• Last Updated: August 2, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)