An Outpatient Study of Automated Blood Glucose Control With an Insulin-Only Bionic Pancreas

Bruce A. Buckingham1 site in 1 country16 target enrollmentAugust 2015

ConditionsDiabetes Mellitus, Type 1

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetes Mellitus, Type 1
Sponsor: Bruce A. Buckingham
Enrollment: 16
Locations: 1
Primary Endpoint: Mean glucose
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is an open-label, non-randomized, pilot study to determine the safety and feasibility of the insulin-only bionic pancreas.

Detailed Description

A total of 16 subjects, ages 18-45, will be enrolled in this crossover study. The study will consist of three 7-day study arms in the following order, one usual care arm, one bionic pancreas insulin only arm with a static glucose target, and one bionic pancreas insulin only arm with at dynamic glucose target.

Registry

clinicaltrials.gov

Start Date

August 2015

End Date

July 2016

Last Updated

7 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Bruce A. Buckingham

Responsible Party

Sponsor Investigator

Principal Investigator

Bruce A. Buckingham

Professor of Pediatrics (Endocrinology), MD

Stanford University

Eligibility Criteria

Inclusion Criteria

•Type 1 diabetes for at least 1 year
•insulin pump for ≥ 6 months
•Prescription medication regimen stable for \> 1 month
•Subject comprehends written English
•Female patients who are sexually active must be on acceptable method of contraception e.g. oral contraceptive pill, diaphragm, IUD (Intrauterine Device)
•Female patients must have a negative urine pregnancy test
•Informed Consent Form signed by the subject
•Lives and works within a 60 minute drive-time radius of Stanford University
•Willing to remain within a 60 minute drive-time radius of Stanford University during all 3 of the 7-day study arms (21 days)
•Have someone over 18 years of age who lives with them,

Exclusion Criteria

•Current alcohol abuse (intake averaging \> 3 drinks daily in last 30 days), use of marijuana within 1 month of enrollment, or other substance abuse (use within the last 6 months of controlled substances other than marijuana without a prescription)
•Subject has a history of diagnosed medical eating disorder
•Subject has a history of visual impairment which would not allow subject to participate
•Subject has an active skin condition that would affect sensor placement
•Subject has adhesive allergies
•Subjects requiring an intermediate or long-acting insulin (such as NPH, Neutral Protamine Hagedorn, detemir or glargine)
•Subjects requiring other anti-diabetic medications other than insulin (oral or injectable)
•Current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study
•Unwilling or unable to refrain from drinking more than 2 drinks in an hour or more than 4 drinks in a day or use of marijuana during the trial
•Subject has active Graves' disease