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The Bihormonal iLet Bionic Pancreas Feasibility Study

NCT03840278 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2019-12-16

Study results available
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Summary

Our objective is to evaluate the function of the bihormonal configuration of the ILet bionic pancreas delivering dasiglucagon when compared to the insulin-only configuration of the ILet bionic pancreas in a home-use study in adults with type 1 diabetes.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DEVICE

Bihormonal iLet Bionic Pancreas

Bihormonal iLet Bionic Pancreas using insulin and dasiglucagon

DEVICE

Insulin-only Bionic Pancreas

Insulin-only iLet Bionic Pancreas using just insulin

DRUG

Dasiglucagon

Experimental stable glucagon for use in the iLet Bionic Pancreas

Sponsors & Collaborators

  • Beta Bionics, Inc.

    collaborator INDUSTRY

  • Zealand Pharma

    collaborator INDUSTRY

  • 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
2019-05-15
Primary Completion
2019-07-03
Completion
2019-07-03
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03840278 on ClinicalTrials.gov