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Artificial Pancreas and Remote Monitoring During a T1DM Youth Ski Camp

NCT03369067 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-10-01

Study results available
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Summary

An early feasibility study that will test the efficacy of the Tandem t:slim X2 with Control-IQ and Dexcom Continuous Glucose System G6 in a winter/ski camp environment.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DEVICE

Tandem t:slim X2 with Control-IQ Technology + Dexcom G6

Subjects will use the Tandem t:slim X2 with Control-IQ Technology and Dexcom G6 CGM to control their glycemia. The Tandem t:slim X2 with Control-IQ device is an automated insulin delivery pump that automatically adjusts insulin delivery to predicted and prevailing glucose levels, as measured by a Dexcom G6 continuous glucose monitor \[CGM\].

DEVICE

Dexcom CGM G5

The Dexcom G5 CGM is a subcutaneous glucose sensor that provides an estimate of the prevailing blood glucose concentration approximately every 5 minutes.The Dexcom G5 sensor alerts the user if the prevailing glucose concentration is higher or lower than predetermined thresholds, or if it is changing too fast. In addition, the Share/Follow functionality of the Dexcom G5 allows up to 5 people ("followers") to receive in real-time information about the current blood glucose concentration and rate of change. The Dexcom G5 system will be used by participants and clinical study staff to monitor glucose levels 24h/day during the camp, ensure participants safety, and compute glycemic control outcomes

DEVICE

Continuous Subcutaneous Insulin Infusion

Subjects will use a subcutaneous pump to deliver insulin and control their glycemia.

Sponsors & Collaborators

  • Tandem Diabetes Care, Inc.

    collaborator INDUSTRY

  • DexCom, Inc.

    collaborator INDUSTRY

  • University of Virginia

    lead OTHER

Principal Investigators

  • Marc Breton, PhD · University of Virginia Center for Diabetes Technology

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-12-18
Primary Completion
2018-04-15
Completion
2018-04-15
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 NCT03369067 on ClinicalTrials.gov