Feasibility and Effectiveness of Real-time, Remote Continuous Glucose Monitoring in Adolescents With Poorly Controlled Type 1 Diabetes

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT04540536
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
13 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Continuous Glucose Monitoring — OTHER
    Participants will be provided with a Dexcom G6 continuous glucose monitor for the duration of the study.
  • Secure texting — OTHER
    A secure platform (TigerConnect) will be used for three-way communication between parents, participants, and clinical personnel

Study Details

Adolescents with Type 1 Diabetes (age 13-18 years, T1D duration \>6 months managed on insulin) and poor glycemic control will wear a blinded CGM to obtain baseline data. After assuring adherence to CGM wear, participants will receive a non-blinded CGM and will share their blood glucose levels with the study team. Clinical personnel will remotely monitor patients in real-time for 3 months and communicate regularly over secure text messaging with participants and their parents. Following active remote monitoring, the participants will wear a non-blinded CGM for 3 months. Primary outcome assessment will be the change in HbA1c after 3 months of real-time remote continuous glucose monitoring.

Key Dates

Start date
Nov 1, 2021
Status verified
Feb 2026
Primary completion
Dec 1, 2024
Completion
Dec 1, 2024

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Primary Outcome Measure

Change in Hemoglobin A1c From Baseline to 3 Months [ Time Frame: 3 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Childrens Medical CenterDallasTexas75390-
UT Southwestern Medical CenterDallasTexas75390-

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