NCT02302963

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 12 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	AP System (DiAs or inControl) with USS Virginia	Subject will participate in two 24-hour study insulin pump and AP System training sessions. At the conclusion of each training session, subject will wear the equipment at home for a total of 5 weeks.
DEVICE	Sensor-Augmented Pump Therapy (placebo)	Subject will participate in 5 weeks use of CGM and personal insulin pump at home.

Timeline

• Start date: 2015-06-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2014-11-27
• Last updated: 2022-10-07
• Results posted: 2022-10-07

Locations

2 sites across 1 country: United States