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

NCT ID: NCT04540536

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2024-12-01

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Interventions

Continuous Glucose Monitoring

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

Intervention Type: OTHER

Secure texting

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age between 13-18
• Diagnosis of type 1 diabetes for at least six months.
• Both sexes and all ethnicities included.
• Subject and at least one parent able to communicate in English.
• Poorly controlled T1D as evidenced by a >30% annual risk of developing DKA in the following year OR Hemoglobin A1c ≥ 12%
• Treated with subcutaneous insulin, either with a basal/bolus insulin regimen or a continuous subcutaneous insulin infusion (CSII) device.
• Willing to wear CGM and utilize the share function to clinician and guardian, with measuring blood glucose checks as required by the CGM.
• Owning a smartphone compatible with Dexcom G6 software to allow the use of share/follow features with internet access capabilities
• Willing to participate in secure text messaging with study personnel.
• Female participants must have a negative pregnancy test.

Exclusion Criteria

• Type 2 diabetes, secondary diabetes or CF related diabetes.
• Other severe chronic disease (e.g., cancer) which in the judgment of the investigator is likely to significantly affect glycemic control.
• Patients cannot be taking systemic corticosteroids at enrollment because of adverse effects on glycemic control, but we will not disqualify subjects who require such therapy during the study. Inhaled or topical corticosteroids are permissible.
• Patients with uncontrolled hypothyroidism (TSH >20) or uncontrolled hyperthyroidism will be excluded from the study. Patients with out of range values may be retested after medication dose adjustment.
• Developmental delay or behavioral disorder in the patient of sufficient severity, in the judgment of the investigator, to interfere with study activities. Severe uncontrolled depression defined as PHQ-9A >15 at time of enrollment is an exclusion criterion.
• Medical or psychiatric disorder in a parent of sufficient severity, in the judgment of the investigator, to interfere with study activities.
• Pregnancy, planned pregnancy or breast feeding
• CGM adhesive allergy
• Skin condition that makes CGM placement contraindicated.
• Sickle cell disease or hemoglobinopathy
• Red blood cell transfusion within 3 months prior to study enrollment

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DexCom, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Abha Choudhary

Assistant Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Childrens Medical Center

Dallas, Texas, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

Other Identifiers

STU-2020-0699

Identifier Type: -

Identifier Source: org_study_id