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

NCT04540536 | Completed Results FDA Device

• 1 other identifier: STU-2020-0699
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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

Keywords

Type 1 Diabetes; Continuous Glucose Monitors; Telemedicine; Remote Monitoring; Secure Texting; Poorly controlled diabetes

Outcome Measures

Primary Outcomes (1)

• Change in Hemoglobin A1c From Baseline to 3 Months

  Change in hemoglobin A1c from baseline to 3 months (three-month follow-up visit after remote continuous glucose monitoring and secure text messaging)

  3 months

Secondary Outcomes (1)

• Change in Depression Score After Clinical Remote CGM Monitoring and Secure Text Messaging.

  3 months

Other Outcomes (17)

• Change in Quality of Life Score After Clinical Remote CGM Monitoring and Secure Text Messaging.

  3 months

• Change in Self Efficacy Score After Clinical Remote CGM Monitoring and Secure Text Messaging.

  3 months

• Change in Parent-child Collaboration Score After Clinical Remote CGM Monitoring and Secure Text Messaging.

  3 months

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

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• DexCom, Inc.: collaborator

Study Sites (2)

Childrens Medical Center

Dallas, Texas, 75390, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Patient Compliance

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Limitations and Caveats

This was a pilot study so overall number of participant enrolled and ultimately assigned to the study arm was small.

Results Point of Contact

• Title: Abha Choudhary
• Organization: UTexasSouthwestern

abha.choudhary@utsouthwestern.edu

2144565959

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: July 17, 2020
• First Posted: September 7, 2020
• Study Start: November 1, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 3, 2026
• Results First Posted: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)