NCT04227626

Inpatient Closed Loop Glucose Control With the Gen 2 GlucoSTAT

A Feasibility Study of Automated Glucose Control With the Gen2 GlucoSTAT Bionic Pancreas in Volunteers With Type 1 and Type 2 Diabetes

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to perform a first-in-humans trial of a fully integrated, automated, closed-loop blood glucose control system designed for inpatient use. The GlucoSTAT was designed for use by patients with diabetes while they are in the hospital, and others who may develop high blood sugar as a result of their medical problems.

Detailed description

Our envisioned end product is an in-patient automated closed-loop control system for PG regulation in the ICU as well as on the general hospital wards. In order to qualify the system for the broad spectrum of challenges it will face in the inpatient setting, this study will test the ability of the new integrated configuration of the system (the GlucoSTAT) to control PG in subjects with extremes of insulin sensitivity. The first goal of this study is to test the safety and efficacy of the control system in insulin sensitive subjects with type 1 diabetes. The second goal of this study is to test the safety and efficacy of the control system in subjects with type 2 diabetes and substantial insulin resistance (TDD \> 0.75 u/kg/day, with up to 3 subjects with a TDD \> 2 u/kg/day).

Conditions

• Type 1 Diabetes
• Type 2 Diabetes Treated With Insulin

Interventions

Type	Name	Description
DEVICE	GlucoSTAT	Closed-loop blood glucose control using intravenous insulin and dextrose

Timeline

• Start date: 2021-04-01
• Primary completion: 2021-04-01
• Completion: 2021-04-01
• First posted: 2020-01-13
• Last updated: 2020-10-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study