The Monitoring Study

NACompletedINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

April 1, 2017

Primary Completion Date

June 1, 2017

Study Completion Date

December 28, 2017

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.

Trial Locations (1)

02114

MGH Diabetes Research Center, Boston

All Listed Sponsors
lead

Massachusetts General Hospital

OTHER

NCT02969863 - The Monitoring Study | Biotech Hunter | Biotech Hunter