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Feasibility and Effectiveness of Real-time, Remote Continuous Glucose Monitoring in Adolescents With Poorly Controlled Type 1 Diabetes 20 Adolescent Remote

Completed
Clinical Trial NCT04540536 was an interventional study for Diabetes Mellitus, Type 1, Noncompliance, Patient that is now completed. The study started on November 1, 2021, with plans to enroll 20 participants. Led by University of Texas Southwestern Medical Center, the expected completion date was December 1, 2024. The latest data from ClinicalTrials.gov was last updated on March 3, 2026.
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 ove...Show More
Official Title

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

Conditions
Diabetes Mellitus, Type 1Noncompliance, Patient
Other Study IDs
  • STU-2020-0699
NCT ID Number
NCT04540536
Start Date (Actual)
2021-11-01
Last Update Posted
2026-03-03
Completion Date (Estimated)
2024-12-01
Enrollment (Estimated)
20
Study Type
Interventional
PHASE
N/A
Status
Completed
Keywords
Type 1 Diabetes
Continuous Glucose Monitors
Telemedicine
Remote Monitoring
Secure Texting
Poorly controlled diabetes
Primary Purpose
Supportive Care
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
N/A
Continuous Glucose Monitoring
Participants will be provided with a Dexcom G6 continuous glucose monitor for the duration of the study.
Secure Texting
A secure platform (TigerConnect) will be used for three-way communication between parents, participants, and clinical personnel
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Change in Depression Score After Clinical Remote CGM Monitoring and Secure Text Messaging.
Depression screening will be assessed by Patient Health Questionnaire (PHQ-9A), a depression questionnaire consisting of 9 items answered on a scale from "0" (not at all) to "3" (nearly every day). Total depression severity score ranges of 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.
3 months
Eligibility Criteria

Eligible Ages
Child, Adult
Minimum Age
13 Years
Eligible Sexes
All
  • 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.

  • 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
University of Texas Southwestern Medical Center logoUniversity of Texas Southwestern Medical Center284 active studies to explore
DexCom, Inc. logoDexCom, Inc.
Study Responsible Party
Abha Choudhary, Principal Investigator, Assistant Professor of Pediatrics, University of Texas Southwestern Medical Center
No contact data.
2 Study Locations in 1 Countries

Texas

Childrens Medical Center, Dallas, Texas, 75390, United States
UT Southwestern Medical Center, Dallas, Texas, 75390, United States