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Outpatient Automated Blood Glucose Control With a Bi-hormonal Bionic Endocrine Pancreas

NCT01762059 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2017-07-21

Study results available
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Summary

This study will test the hypothesis that a wearable automated bionic pancreas system that automatically delivers both insulin and glucagon can improved glycemic control vs. usual in the outpatient environment.

Conditions

Interventions

DEVICE

Bi-homonal Bionic Pancreas

A computer algorithm will automatically deliver insulin lispro and glucagon based on the signal from a minimally invasive continuous glucose monitor.

OTHER

Usual care

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
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-10-31
Completion
2014-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01762059 on ClinicalTrials.gov