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Safety and Efficacy of Initializing the Control-IQ Artificial Pancreas System Using Total Daily Insulin

NCT03804983 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2024-08-01

Study results available
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Summary

The purpose of this proposed study is to assess the use of a new feature of the Control-IQ system, MyTDI.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DEVICE

Hybrid Closed Loop (HCL)

Participants will use Control-IQ with Hybrid Closed Loop (HCL) with their own insulin parameters during the entire two-week study, including the 72-hour ski admission and the at-home study collection times. Parameters will be reduced 20% during the ski admission to adjust for the increased activity.

DEVICE

Control-IQ with MyTDI

Participants will use their own insulin parameters during the first 5 days of the study. After randomization at the ski admission, the participants insulin parameters will be modified using the MyTDI calculations. Additionally, parameters will be reduced 20% during the ski admission to adjust for the increased activity.

Sponsors & Collaborators

  • Tandem Diabetes Care, Inc.

    collaborator INDUSTRY

  • DexCom, Inc.

    collaborator INDUSTRY

  • University of Virginia

    lead OTHER

Principal Investigators

  • Marc D. Breton, PhD · University of Virginia

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-01-15
Primary Completion
2019-02-16
Completion
2019-02-16
FDA Device
Yes

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 NCT03804983 on ClinicalTrials.gov