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Closed-Loop Glucagon Pump for Treatment of Post-Bariatric Hypoglycemia

NCT03255629 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2022-09-06

Study results available
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Summary

To assess the efficacy of a closed loop glucagon system to prevent and treat hypoglycemia occurring in patients with Post-Bariatric Hypoglycemia (PBH) in response to meals and exercise.

Conditions

  • Post-bariatric Hypoglycemia

Interventions

DRUG

glucagon

novel, stable non-aqueous glucagon formulation provided by Xeris Pharmaceuticals

DEVICE

Closed loop glucagon pump

a novel closed-loop glucagon system (CLG) incorporating a novel, stable non-aqueous glucagon formulation together with an infusion pump system (Omnipod) guided by real-time continuous glucose monitoring (Dexcom) that is triggered by a hypoglycemia alert algorithm.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Xeris Pharmaceuticals

    collaborator INDUSTRY

  • Harvard University

    collaborator OTHER

  • Joslin Diabetes Center

    lead OTHER

Principal Investigators

  • Mary E Patti, MD · Joslin Diabetes Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-19
Primary Completion
2018-08-22
Completion
2018-08-22
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT03255629 on ClinicalTrials.gov