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A Multicenter Study of Outpatient Automated Blood Glucose Control With a Bihormonal Bionic Pancreas

NCT02092220 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2017-11-22

Study results available
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Summary

This study will test the hypothesis that a wearable bionic pancreas system that automatically delivers insulin and glucagon can provide superior regulation of glycemia versus usual care for adults with type 1 diabetes.

Please note that all participants must work or attend school at one of the following campuses: Massachusetts General Hospital in Boston, MA; University of Massachusetts Medical Center in Worcester, MA; University of North Carolina in Chapel Hill, NC; Stanford University in Palo Alto, CA.

Conditions

  • Diabetes Mellitus Type 1

Interventions

DEVICE

Bionic Pancreas

DEVICE

Insulin pump with or without CGM

Sponsors & Collaborators

  • Boston University

    collaborator OTHER

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Steven J Russell, MD, PhD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2015-07-31
Completion
2016-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02092220 on ClinicalTrials.gov