CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
Diabetes Assistant (DiAs)device
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/NCT01714505
NCT01714505N/ACompleted
CompareCT.gov

Early Feasibility Study 2 of Outpatient Control-to-Range - Testing System Efficacy

University of Virginia·interventional·Posted Oct 26, 2012·Updated Sep 9, 2014

In Brief

A clinical study evaluating Diabetes Assistant (DiAs) for Diabetes Mellitus, Type 1. Completed, enrolled 20 participants across 2 sites.

Detailed Summary

An unblinded, randomized, cross-over design with each patient participating in two 40-hour outpatient admissions: (a) Experimental involving automated Control-to-Range (CTR) and (b) Control using Continuous Glucose Monitor (CGM)- augmented insulin pump treatment outside of a hospital based clinical research center. The principal goal is to validate a smart phone-based control-to-range (CTR) system for ambulatory use and to estimate the effect of CTR vs. sensor-augmented pump therapy, thereby providing justification for further larger home-based trials of CTR.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 1
CountriesUnited States
CollaboratorsJuvenile Diabetes Research Foundation, Sansum Diabetes Research Institute, University of Padova, University Hospital, Montpellier

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 26, 2012
Enrollment StartOct 1, 2012
Primary CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 13.7 years ago

Interventions

Diabetes Assistant (DiAs)device

A medical platform that uses a smart-phone to connect to a continuous glucose sensor to insulin pump and run closed-loop control. The cell phone runs the Control to Range and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range (80-180 mg/dL during the day) and help avoid hypoglycemia during the night.