NCT04540536

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 13 Years – 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2021-11-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2020-09-07
• Last updated: 2026-03-03
• Results posted: 2026-03-03

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study