MedTrace Logo

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

NCT04540536 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-03-03

Study results available
· View outcomes & findings →

Summary

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.

Conditions

  • Diabetes Mellitus, Type 1
  • Noncompliance, Patient

Interventions

OTHER

Continuous Glucose Monitoring

Participants will be provided with a Dexcom G6 continuous glucose monitor for the duration of the study.

OTHER

Secure texting

A secure platform (TigerConnect) will be used for three-way communication between parents, participants, and clinical personnel

Sponsors & Collaborators

  • DexCom, Inc.

    collaborator INDUSTRY

  • University of Texas Southwestern Medical Center

    lead OTHER

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2024-12-01
Completion
2024-12-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT04540536 on ClinicalTrials.gov