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Post Bariatric Closed Loop Glucagon Trial

NCT02966275 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2018-12-13

Study results available
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Summary

This study is to test our automated hypoglycemia prevention and treatment device (glucagon-only bionic pancreas) in subjects that have undergone post-bariatric surgery that are experiencing symptoms of hypoglycemia.

Conditions

Interventions

DEVICE

Glucagon-only bionic pancreas - glucagon

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

DEVICE

Glucagon-only bionic pancreas - placebo

A computer algorithm will automatically deliver placebo based on the signal from a minimally invasive continuous glucose monitor.

Sponsors & Collaborators

  • Joslin Diabetes Center

    collaborator OTHER

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2017-12-31
Completion
2017-12-31
FDA Device
Yes

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 NCT02966275 on ClinicalTrials.gov