CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 22 enrolled
Drug / intervention
heart rate Control to Range System (hrCTR) using DiAs Platform +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/NCT01945060
NCT01945060N/ACompleted
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Closed Loop Control in Adolescents Using Heart Rate as Exercise Indicator

Marc Breton·interventional·Posted Sep 18, 2013·Updated Aug 21, 2023

In Brief

A clinical study evaluating heart rate Control to Range System (hrCTR) using DiAs Platform and DiAs Control-to-Range System not informed for heart rate for Type 1 Diabetes Mellitus. Completed, enrolled 22 participants across 2 sites.

Detailed Summary

The purpose of this study is to see if the Artificial Pancreas (AP) Platform can successfully control blood sugar in people with type 1 diabetes mellitus on insulin pump therapy in a hospital setting. Investigators will also be studying to see if the heart rate informed Control To Range (hrCTR) can improve the performance of the system during and immediately after exercise.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes Mellitus
CountriesUnited States
CollaboratorsVirginia Commonwealth University, DexCom, Inc., Tandem Diabetes Care, Inc.

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 18, 2013
Enrollment StartSep 1, 2013
Primary CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 12.8 years ago

Interventions

heart rate Control to Range System (hrCTR) using DiAs Platformdevice

Diabetes Assistant (DiAs) Medical Platform System * A smart-phone medical platform (DiAs); * Continuous Glucose Monitor; * Insulin pump; * Bluetooth connection; * Remote Monitoring Server.

DiAs Control-to-Range System not informed for heart rateother

Not informing system of heart rate during exercise.