NCT01819844

Inpatient Closed-loop Glucose Control

Subcutaneous Continuous Glucose Monitoring and Intravenous Dosing of Insulin and Dextrose for Automated Glycemic Control in the Inpatient Setting

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test an experimental medical device designed to automatically control blood sugar. This device 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

The goal of this first-in-man trial is to test the safety and efficacy of the automated, closed-loop control system in insulin sensitive subjects with type 1 diabetes, insulin sensitive subjects with type 2 diabetes (TTD \> 1u/kg/day), and subjects with type 2 diabetes and substantial insulin resistance (\<2 u/kg/day). The results of this study will help to design future studies, exploring the use of the closed-loop system for BG control in hospitalized patients, including those with diabetes or hyperglycemia of critical illness.

Conditions

• Diabetes Mellitus
• Hyperglycemia

Interventions

Type	Name	Description
DEVICE	Closed-loop blood glucose control	The InPatient Closed Loop Device is made up of the three components; the Abbott FreeStyle Navigator subcutaneous continuous glucose monitor, the Symbiq insulin-dextrose infusion system, and the control algorithm. In this feasibility trial we will study 6 insulin-sensitive subjects with type 1 diabetes and 6 subjects with type 2 diabetes and a high insulin requirement (3 with total daily dose from 1-1.9 u/kg and 3 with total daily dose \> 2 u/kg).

Timeline

• Start date: 2013-03-01
• Primary completion: 2014-06-01
• Completion: 2014-12-01
• First posted: 2013-03-28
• Last updated: 2017-12-12
• Results posted: 2017-07-21

Locations

1 site across 1 country: United States