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Completed

NCT Number: NCT04540536

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Behavior Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Health Behavior Immune System Diseases Metabolic Diseases Noncompliance, Patient Nutritional and Metabolic Diseases Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Childrens Medical Center, Dallas, Texas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Change in Hemoglobin A1c From Baseline to 3 Months

    Time frame: 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)

Secondary outcomes

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

    Time frame: 3 months

    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.

Other outcomes

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

    Time frame: 3 months

    Quality of life screening assessed by the Pediatric Quality Life Inventory for teens 13-18, PedsQL4.08, a 23-item questionnaire with a 5-point Likert scale from 0 (never) to 4 (almost always). Items are reversed and then added. The higher the score, the better the quality of life.

    Scale - minimum score:0, Maximum score us 92

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

    Time frame: 3 months

    Self-efficacy assessed by The Self-Efficacy for Diabetes Self-Management Measure (SEDM), a 10-item self-report scale that covers the major aspects of diabetes self-management including monitoring blood glucose levels, dosing insulin, food choices, and exercise, and performance of diabetes-related tasks when feeling overwhelmed or frustrated. Total score range for the SEDM is 1-10, with a higher score indicating higher self-efficacy.

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

    Time frame: 3 months

    Parent-child collaboration in diabetes care assessed using the Collaborative Parent Involvement Scale, a 12-item questionnaire with a five-point Likert scale, from almost never to always, and is targeted for adolescents. The scale aims to assess parental use of problem solving, teachable moments, diabetes, help with autonomy, and supervision of diabetes care when the adolescent is not around. Higher scores indicate better parent-adolescent collaboration Minimum score is zero and maximum is 60

  4. Change in Depression Score 3 Months After Clinical Remote Continuous Glucose Monitoring Monitoring and Immediately After a Period of Self-monitoring of CGM Data

    Time frame: 6 months

    Depression screening 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.

    Minimum is 0 and maximum is 27

  5. Change in Quality of Life Score 3 Months After Clinical Remote Continuous Glucose Monitoring Monitoring and Immediately After a Period of Self-monitoring of CGM Data

    Time frame: 6 months

    Quality of life screening assessed by the Pediatric Quality Life Inventory for teens 13-18, PedsQL4.08, a 23-item questionnaire with a 5-point Likert scale from 0 (never) to 4 (almost always). Items are reversed and then added. The higher the score, the better the quality of life.

    Minimum:0, maximum: 115

  6. Change in Self Efficacy Score 3 Months After Clinical Remote Continuous Glucose Monitoring Monitoring and Immediately After a Period of Self-monitoring of CGM Data

    Time frame: 6 months

    Self-efficacy assessed by The Self-Efficacy for Diabetes Self-Management Measure (SEDM), a 10-item self-report scale that covers the major aspects of diabetes self-management including monitoring blood glucose levels, dosing insulin, food choices, and exercise, and performance of diabetes-related tasks when feeling overwhelmed or frustrated. Total score range for the SEDM is 1-10, with a higher score indicating higher self-efficacy.

    Minimum: 0 to maximum: 100

  7. Change in Parent-child Collaboration Score 3 Months After Clinical Remote Continuous Glucose Monitoring Monitoring and Immediately After a Period of Self-monitoring of CGM Data

    Time frame: 6 months

    Parent-child collaboration in diabetes care assessed using the Collaborative Parent Involvement Scale, a 12-item questionnaire with a five-point Likert scale, from almost never to always, and is targeted for adolescents. The scale aims to assess parental use of problem solving, teachable moments, diabetes, help with autonomy, and supervision of diabetes care when the adolescent is not around. Higher scores indicate better parent-adolescent collaboration.

    Min: 0 and max : 60

  8. CGM Time in Range Percentage Change Will be Compared Between Baseline and End of Clinical Remote Monitoring of CGM at 3 Months

    Time frame: baseline, end of clinical remote monitoring of CGM (3 months)

    CGM time in range percentage change will be compared between baseline, and end of clinical remote monitoring of CGM at 3 months. This is obtained from the CGM data

  9. CGM Time in Range Percentage Change Will be Compared Between Baseline and End of Self-monitoring of CGM at 6 Months

    Time frame: baseline, end of self monitoring CGM (6 months)

    CGM time in range percentage change will be compared between baseline, and end of self-monitoring CGM at 6 months.This is obtained from the CGM data

  10. CGM Time in Range Percentage Change Will be Compared Between Clinical Remote Monitoring (3 Months) and Self-monitoring of CGM (6 Months)

    Time frame: clinical remote monitoring of CGM (3 months), self monitoring of CGM (6 months)

    CGM time in range percentage change will be compared between clinical remote monitoring of CGM at 3 months and self-monitoring of CG, at 6 months. This is obtained from the CGM data.

  11. Percent Change of Time in Hyperglycemia From Baseline to Clinical Remote Monitoring of CGM at 3 Months

    Time frame: baseline, clinical remote monitoring of CGM (3 months)

    Percent change is calculated as the relative difference between time in hyperglycemia at clinical remote monitoring of CGM at 3 months and baseline. Time in hyperglycemia is defined as the percentage of glucose readings above the prespecified threshold (e.g., >180 mg/dL) during continuous glucose monitoring. A negative value indicates a reduction in time spent in hyperglycemia.

  12. Percent Change of Time in Hyperglycemia From Clinical Remote Monitoring of CGM at 3 Months to Self-monitoring CGM at 6 Months

    Time frame: clinical remote monitoring of CGM (3 months), self-monitoring of CGM (6 months)

    Percent change is calculated as the relative difference between time in hyperglycemia at self-monitoring of CGM (6 months) and clinical remote monitoring of CGM (3 months). Time in hyperglycemia is defined as the percentage of glucose readings above the prespecified threshold (e.g., >180 mg/dL) during continuous glucose monitoring. A negative value indicates a reduction in time spent in hyperglycemia.

  13. Percent Change of Time in Hyperglycemia From Baseline to Self-monitoring of CGM at 6 Months

    Time frame: baseline, self monitoring of CGM (6 months)

    Percent change is calculated as the relative difference between time in hyperglycemia at self-monitoring of CGM at 6 months and baseline. Time in hyperglycemia is defined as the percentage of glucose readings above the prespecified threshold (e.g., >180 mg/dL) during continuous glucose monitoring. A negative value indicates a reduction in time spent in hyperglycemia.

  14. Percent Change of Time Participants Wore the CGM From Baseline to Clinical Remote Monitoring of CGM at 3 Months

    Time frame: Baseline, clinical remote monitoring of CGM (at 3 months)

    This measure describes the relative change in the percentage of time participants wore the continuous glucose monitor (CGM)between baseline and clinical remote monitoring of CGM at 3 months. Wear time was calculated based on the amount of time the device recorded valid glucose readings compared with the total possible monitoring time. Change in CGM wear time was calculated as [the difference in wear-time percentage between clinical remote monitoring period- percent valid wear time at baseline] / percent of valid wear time at baseline x 100. A positive value indicates increased wear time at Timepoint 2 compared with Timepoint 1; a negative value indicates decreased wear time.

  15. Percent Change of Time Participants Wore the CGM From Baseline to Clinical Remote Monitoring of CGM at 6 Months

    Time frame: baseline, self monitoring of CGM (6 months)

    This measure describes the relative change in the percentage of time participants wore the continuous glucose monitor (CGM)between baseline and self-monitoring of CGM at 6 months. Wear time was calculated based on the amount of time the device recorded valid glucose readings compared with the total possible monitoring time. Change in CGM wear time was calculated as [the difference in wear-time percentage between self- monitoring period- percent valid wear time at baseline] / percent of valid wear time at baseline x 100. A positive value indicates increased wear time at Timepoint 2 compared with Timepoint 1; a negative value indicates decreased wear time.

  16. Percent Change of Time Participants Wore the CGM Clinical Remote Monitoring of CGM at 3 Months to Self-monitoring CGM at 6 Months

    Time frame: clinical remote monitoring of CGM (3 months), self-monitoring of CGM (6 months)

    This measure describes the relative change in the percentage of time participants wore the continuous glucose monitor (CGM) between Clinical Remote Monitoring of CGM at 3 Months to Self-monitoring CGM at 6 Months. Wear time was calculated based on the amount of time the device recorded valid glucose readings compared with the total possible monitoring time. Change in CGM wear time was calculated as [the difference in wear-time percentage between self- monitoring period- percent valid wear time at Clinical Remote Monitoring of CGM] / percent of valid wear time at Clinical Remote Monitoring of CGM x 100. A positive value indicates increased wear time at Timepoint 2 compared with Timepoint 1; a negative value indicates decreased wear time.

  17. Mean Time (Hours) Taken for a Text to be Read by a Participant or a Guardian.

    Time frame: 3 months

    Mean time (in hours) taken for a text to be read by a participant or a guardian.

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • DexCom, Inc.

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Sep 7, 2020
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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