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The Set-Point Study for Type 2 Diabetes: Evaluating the Use of an Insulin Only Bionic Pancreas System in Type 2 Diabetes

NCT03552523 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2019-09-10

Study results available
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Summary

Our goal is to conduct an outpatient study testing the bionic pancreas in the insulin-only configuration at a set-point of 100 mg/dl in 10 adult (≥ 18 years of age) subjects with type 2 diabetes in a random-order crossover study versus usual care with daily injections or an insulin pump.

Conditions

Interventions

DEVICE

Bionic Pancreas

During this arm the subject will ONLY use our bionic pancreas device with an insulin only configuration using a rapid-acting insulin analog. Subjects will wear a continuous glucose monitoring device (the Dexcom G5) as part of the bionic pancreas, and use the study provided glucose meter.

OTHER

Usual Care

Subject will wear a continuous glucose monitoring device (the Dexcom G5) and use the study provided glucose meter.. Subject will not change their prescribed home insulin therapy regimen during this arm whether that be an insulin pump or multiple daily injections.

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
2017-07-28
Primary Completion
2018-03-29
Completion
2018-03-29
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 NCT03552523 on ClinicalTrials.gov