Insulet Artificial Pancreas Early Feasibility Study

NCT02897557 | Completed FDA Device

• 1 other identifier: AP-IDE #1 and 1a
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose is to perform an early investigation on the safety and performance of an Automated Glucose Control (AGC) algorithm using the OmniPod® Insulin Management System and gather clinical data that will be used to make improvements or modifications to the algorithm for subsequent studies in adults, adolescents and children with type 1 diabetes.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (2)

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

  36 hours

• Percentage of time in severe hyperglycemic range (defined as >/=250 mg/dL)

  36 hours

Secondary Outcomes (8)

• Mean glucose

  36 hours

• Percentage of time < 50 mg/dL

  36 hours

• Percentage of time < 60 mg/dL

  36 hours

• Percentage of time > 180 mg/dL

  36 hours

• Percentage of time >/= 300 mg/dL

  36 hours

Study Arms (1)

Single Cohort in CRC

EXPERIMENTAL

This study is a single-arm, multi-center, observational clinical trial being conducted in a Clinical Research Center (CRC) setting.

Device: Insulet Artificial Pancreas (AP) System

Interventions

Insulet Artificial Pancreas (AP) System DEVICE

Single Cohort in CRC

Eligibility Criteria

• Age: 6 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must meet all of the following criteria to be included in the study:
• Age - For the adult cohort: age 18 to 65 years; adolescent cohort: age 12.0 to 17.9 years; pediatric cohort: age 6.0 to 11.9 years
• Diagnosed with type 1 diabetes for at least 1 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 for at least 6 months prior to start of study
• Willing to use the study CGM device for one week prior to study start and for the duration of the study
• Willing to use the OmniPod® Insulin Management System during the study
• Willing to perform all SMBG 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 refrain from use of acetaminophen, pseudoephedrine, 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 or guardian willing and able to sign the ICF. Subjects aged ≥ 8 years will be asked to sign an assent form.

You may not qualify if:

• Subjects who meet any of the following criteria will be excluded from the study:
• 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 or more "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 on the abdomen
• Known history of myocardial infarction (MI) or stroke within the past 6 months
• 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

Sponsors & Collaborators

• Insulet Corporation: lead

Study Sites (4)

Stanford University

Palo Alto, California, 94305, United States

Location

William Sansum Diabetes Center

Santa Barbara, California, 93105, 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

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)

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: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2016
• First Posted: September 13, 2016
• Study Start: September 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: March 1, 2017
• Last Updated: April 9, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)