NCT02969863

The Monitoring Study

The Monitoring Study: Evaluating the Effect of Remote Monitoring For Hypoglycemia on Bionic Pancreas Safety and Efficacy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The rationale for this study is to measure the safety of eliminating the glycemic monitoring that the investigators have done in all of the previous outpatient studies under both insulin only and bihormonal bionic pancreas control. The investigators are planning to transition the outpatient studies to an integrated bionic pancreas, the iLet, in the near future. The intended use of this device does not include remote monitoring, which would not be feasible on a commercial scale. Therefore, in this trial the investigators will test the effects on hypoglycemia of eliminating blood glucose related monitoring. In addition, the investigators will perform a pilot trial testing the effects of the bionic pancreas on food intake, exercise, weight and body composition. The primary purpose of this pilot is to assess the feasibility of performing these measurements in the context of a larger trial and to collect data that can be used to power sub-studies of pivotal trials looking at these outcomes. Finally, the investigators will test the accuracy of two new CGM devices to see if they have sufficient accuracy to provide glucose data to the bionic pancreas. If so, this would provide new options for users who may have difficulties with the only currently validated CGM for this purpose, the Dexcom G4 AP / G5 platform.

Conditions

• Type1diabetes

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-04-01
• Primary completion: 2017-06-01
• Completion: 2017-12-28
• First posted: 2016-11-21
• Last updated: 2018-07-30
• Results posted: 2018-07-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study