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A Study of t:Slim X2 With Control-IQ Technology

NCT03844789 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2023-04-10

Study results available
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Summary

The purpose of this study is to learn whether an investigational automated insulin delivery system ("study system") for children with type 1 diabetes can safely improve blood glucose (sometimes called blood sugar) control. The system uses continuous glucose monitoring (CGM), an insulin pump, and a software algorithm to automatically give insulin and control blood glucose. This is called a "closed-loop control" system.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DEVICE

t:slim X2 with Control-IQ Technology & Dexcom G6 CGM

Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM

DEVICE

Control Group

Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.

Sponsors & Collaborators

  • Tandem Diabetes Care, Inc.

    collaborator INDUSTRY

  • DexCom, Inc.

    collaborator INDUSTRY

  • Jaeb Center for Health Research

    collaborator OTHER

  • University of Virginia

    lead OTHER

Principal Investigators

  • Melissa J Schoelwer, MD · University of Virginia

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-06-06
Primary Completion
2019-12-20
Completion
2020-03-20
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 NCT03844789 on ClinicalTrials.gov