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USS Virginia Closed-Loop Versus SAP Therapy for Hypoglycemia Reduction in T1D

Type 1 Diabetes Mellitus Clinical Trial

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

Clinical Trial Summary

This is a randomized, controlled trial of Unified Safety System (USS) Virginia closed-loop versus sensor-augmented pump (SAP) therapy for hypoglycemia prevention in subjects with type 1 diabetes and hypoglycemia unawareness and/or risk for hypoglycemia.

Clinical Trial Description

The purpose of this study is to evaluate the effectiveness of the control system in reducing hypoglycemia by comparing, in a randomized study, 24 hour control with USS Virginia versus sensor augmented pump (SAP) therapy in subjects with type 1 diabetes and hypoglycemia unawareness and/or risk for hypoglycemia. We will also evaluate the effectiveness of the control system to improve hypoglycemia counterregulation, hypoglycemia awareness, and overall glycemic control. To achieve this goal, we will conduct pre- and post-intervention inpatient assessments of hypoglycemia counterregulation and symptom awareness. Subjects randomized to USS Virginia will participate in two training visits at a monitored outpatient setting for the step-wise deployment of the cell phone based Artificial Pancreas (AP) System at home. The first training visit includes training on the study pump and AP System followed by 1 week use of AP System at home in Pump mode. The second training visit includes additional training on USS Virginia+AP System and confirmation of independent use by the subject followed by 4 week use of the AP System at home in Closed Loop mode. Subjects randomized to sensor-augmented pump therapy will complete 5 weeks of CGM with the home pump. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02302963
Study type Interventional
Source University of Virginia
Contact
Status Completed
Phase N/A
Start date June 2015
Completion date January 2017
View Details
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