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USS Virginia Closed-Loop for Overnight Control in Type 1 Diabetes

Diabetes Mellitus Clinical Trial

Official title:
Unified Safety System (USS) Virginia Closed-Loop Versus Sensor Augmented Pump Therapy for Overnight Control in Type 1 Diabetes

Clinical Trial Summary

The purpose of this study is to use the USS Virginia Closed-Loop system for overnight insulin delivery in adults with Type 1 Diabetes (T1DM) in an outpatient setting to evaluate the system's ability to significantly improve blood glucose levels. This protocol will test the feasibility of "bedside" closed-loop control - an approach comprised of standard sensor-augmented pump therapy during the day using off-the-shelf devices and overnight closed-loop control using experimental devices in an outpatient setting. The rationale for this study is as follows: we anticipate that closed-loop control may ultimately be adopted by patients with T1DM in a selective manner. Patient may choose to start using these systems for overnight control only, e.g. to alleviate the well documented fear of hypoglycemia while asleep. To test this paradigm of "bedside" closed-loop control, subjects will be studied with continuous glucose monitoring (CGM)-augmented usual pump therapy during the day followed by overnight use of USS Virginia Closed Loop Control.

Clinical Trial Description

The subject will participate in both the Experimental and the Control Admissions. The order of the two admissions will be randomized. During the Control Admission at home, the subject will use the study insulin pump along with a continuous glucose monitor receiver. During the Experimental Admission, the subject will be the research house/hotel where the subject will be in control of the DiAs. Participation in this study will require 5 study visits over 11-14 weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02131766
Study type Interventional
Source University of Virginia
Contact
Status Completed
Phase N/A
Start date June 2014
Completion date March 2015
View Details
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