The Monitoring Study

Type1diabetes Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type1diabetes

• NCT number: NCT02969863
• Study type: Interventional
• Source: Massachusetts General Hospital
• Status: Completed
• Phase: N/A
• Start date: April 1, 2017
• Completion date: December 28, 2017