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The Set-Point Study: Evaluating Effects of Changing Glucose Target on Bionic Pancreas Performance

NCT02509065 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-11-20

Study results available
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Summary

The current study is designed to determine the effect on mean glucose, hypoglycemia, glucagon usage, and insulin usage of adjusting upward the glucose target of the bi-hormonal bionic pancreas, and determine whether there is a target at which adequate glycemic control is achieved by an insulin-only bionic pancreas with minimal hypoglycemia.

Conditions

Interventions

DEVICE

Bionic Pancreas

Participant wears the bionic pancreas, including an insulin and/or glucagon pump depending on which arm they are in. The 100 mg/dl arm for type 1 diabetes patients will deliver insulin and glucagon. The 100 mg/dl arm for type 2 diabetes patients will deliver just insulin. The 115 mg/dl arm will deliver insulin and glucagon. The 120 mg/dl arm will deliver just insulin. The 145 mg/dl arm will deliver just insulin. The 130 mg/dl and 110 mg/dl arms will deliver insulin and placebo, or insulin and glucagon, and will be double blinded.

OTHER

Usual Care

Participant cares for their diabetes according to their usual practice, with blinded CGM monitoring. No medication will be administered by the study in this intervention.

Sponsors & Collaborators

  • 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
2015-08-31
Primary Completion
2017-12-31
Completion
2017-12-31

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 NCT02509065 on ClinicalTrials.gov