MedTrace Logo

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

NCT02302963 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2022-10-07

Study results available
· View outcomes & findings →

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.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

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.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Stanford University

    collaborator OTHER

  • TypeZero Technologies, LLC

    collaborator INDUSTRY

  • University of Virginia

    lead OTHER

Principal Investigators

  • Stacey M. Anderson, MD · UVA Center for Diabetes Technology

  • Bruce Buckingham, MD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02302963 on ClinicalTrials.gov