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The Monitoring Study

NCT02969863 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2018-07-30

Study results available
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Summary

To conduct an outpatient study testing two configurations of the bionic pancreas (bi-hormonal and insulin-only) with and without remote monitoring of hypoglycemia in 25 adult (≥ 18 years of age) subjects with type 1 diabetes in a random-order crossover study versus usual care with an insulin pump with and without remote monitoring of hypoglycemia.

Conditions

  • Type1diabetes

Interventions

DEVICE

Bihormonal Bionic Pancreas

Participants will wear a Bionic Pancreas that uses glucagon and insulin (bihormonal) to automate their glucose control based on continuous glucose monitor readings.

DEVICE

Insulin Only Bionic Pancreas

Participants will wear a Bionic Pancreas that uses just insulin (insulin-only) to automate their glucose control based on continuous glucose monitor readings.

OTHER

Monitored for Hypoglycemia

During half of the study arms (one each bihormonal bionic pancreas, insulin-only bionic pancreas and usual care) the subjects will be remotely monitored for device connectivity and hypoglycemia, and will be notified by study staff any time their continuous glucose monitor reads less than 50 mg/dl for 15 mintues.

OTHER

Not Monitored for Hypoglycemia

During half of the study arms (one each bihormonal bionic pancreas, insulin-only bionic pancreas and usual care) the subjects will be remotely monitored for device connectivity only, not hypoglycemia.

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
2017-04-01
Primary Completion
2017-06-01
Completion
2017-12-28
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT02969863 on ClinicalTrials.gov