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
- Diabetes Mellitus, Type 1
- Noncompliance, Patient
Eligibility Criteria
- Sex
- ALL
- Age
- 13 Years - 18 Years
- Healthy Volunteers
- Not accepted
Interventions
- Continuous Glucose Monitoring — OTHERParticipants will be provided with a Dexcom G6 continuous glucose monitor for the duration of the study.
- Secure texting — OTHERA 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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Childrens Medical Center | Dallas | Texas | 75390 | - |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | - |
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