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Closed Loop Control in Adolescents Using Heart Rate as Exercise Indicator

NCT01945060 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2023-08-21

Study results available
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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.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DEVICE

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

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

OTHER

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

Not informing system of heart rate during exercise.

Sponsors & Collaborators

  • Virginia Commonwealth University

    collaborator OTHER

  • DexCom, Inc.

    collaborator INDUSTRY

  • Tandem Diabetes Care, Inc.

    collaborator INDUSTRY

  • Marc Breton

    lead OTHER

Principal Investigators

  • Gary Francis, MD, PhD · Virginia Commonwealth University

  • Marc Breton, PhD · University of Virginia

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • United States

Study Locations

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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 NCT01945060 on ClinicalTrials.gov