CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 85 enrolled
Drug / intervention
AP System (DiAs or inControl) with USS Virginia +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02302963
NCT02302963N/ACompleted
CompareCT.gov

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

University of Virginia·interventional·Posted Nov 27, 2014·Updated Oct 7, 2022

In Brief

A clinical study evaluating AP System (DiAs or inControl) with USS Virginia and Sensor-Augmented Pump Therapy (placebo) for Type 1 Diabetes Mellitus. Completed, enrolled 85 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes Mellitus
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Stanford University, TypeZero Technologies, LLC

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 27, 2014
Enrollment StartJun 1, 2015
Primary CompletionJan 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 11.6 years ago

Interventions

AP System (DiAs or inControl) with USS Virginiadevice

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.

Sensor-Augmented Pump Therapy (placebo)device

Subject will participate in 5 weeks use of CGM and personal insulin pump at home.