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

February 27, 2026 updated by: Abha Choudhary, University of Texas Southwestern Medical Center
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

13 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
3 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
3 months
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 months
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
3 months
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
6 months
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 months
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
6 months
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
6 months
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
baseline, end of clinical remote monitoring of CGM (3 months)
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
baseline, end of self monitoring CGM (6 months)
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.
clinical remote monitoring of CGM (3 months), self monitoring of CGM (6 months)
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.
baseline, clinical remote monitoring of CGM (3 months)
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.
clinical remote monitoring of CGM (3 months), self-monitoring of CGM (6 months)
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.
baseline, self monitoring of CGM (6 months)
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.
Baseline, clinical remote monitoring of CGM (at 3 months)
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.
baseline, self monitoring of CGM (6 months)
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.
clinical remote monitoring of CGM (3 months), self-monitoring of CGM (6 months)
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Texas Southwestern Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
DexCom, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 17, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 7, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STU-2020-0699

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Drug Interventions

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Sponsor/Collaborators

Locations

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