CGM Academy for Youth With Type 1 Diabetes

February 4, 2026 updated by: Barber, Rebecca, Children's Hospital Los Angeles

Randomized Control Trial Evaluating the Impact of CGM Academy Education Curriculum Versus Standard Care on Glycemic Outcomes for Youth With Type 1 Diabetes

The goal of this randomized clinical trial is to compare the effects of a virtual education curriculum in blood glucose variation of youth with type 1 diabetes wearing continuous glucose monitoring (CGM) device. The main questions the study aims to answer are:

  • Do participants undertaking the proposed curriculum present improved glucose variation than participants of standard education?
  • Explore relationships between participant's glycemic outcomes with diabetes distress, diabetes family responsibilities, and number of hours of diabetes education.

Participants in the intervention group will:

  • receive an interactive workbook with problem-based learning scenarios and video links about CGM and glucose management strategies.
  • participate in four in-depth online group sessions with diabetes care and education specialists
  • complete questionnaires three times: at the time of study enrollment, week 4 and 6 months.

Participants in the comparison group will:

  • receive standard education provided to all patients at CHLA
  • complete questionnaires three times: at the time of study enrollment, week 4 and 6 months.

Study Overview

Status

Status

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

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.

Detailed Description

Youth with type 1 diabetes (T1D) are at increased risk for kidney failure, vision loss, heart disease, and premature mortality due to challenges with glycemic excursions. Continuous glucose monitoring (CGM) systems represent an important advance in diabetes technology with significant advantages over self-monitored blood glucose and the potential to optimize glycemic management. Despite these advances, youth with T1D, including patients at Children's Hospital Los Angeles (CHLA), fail to achieve recommended glycemic targets, highlighting the opportunity for testing innovative diabetes education programs aimed at increased technology uptake such as the CGM Academy intervention.

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 (Estimated)

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.
90

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90027
        • Recruiting
        • Children's Hospital Los Angeles
        • Contact:
        • Principal Investigator:
          • Rebecca Barber, PhD, RN

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

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Current age of 8-18 years, age group eligible for CGM therapy with Dexcom G6 and G7
  • T1D duration ≥6 months, as insulin adjustments during honeymoon stage differs from establishedT1D
  • Able to speak, read, and write English or Spanish
  • Smartphone compatible with Dexcom G6 and G7application
  • Ability to participate in virtual visits

Exclusion Criteria:

• Known history of medical adhesive allergies

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Experimental: CGM Academy
  • receive an interactive workbook with problem-based learning scenarios and video links about CGM and glucose management strategies.
  • participate in four in-depth online group sessions with diabetes care and education specialists
  • complete questionnaires three times: at the time of study enrollment, week 4 and 6 months.
Behavioral: CGM Academy
Educational materials as well as online sessions with diabetes educators.
No Intervention: Standard Diabetes Education
  • receive standard education provided to all patients at CHLA
  • complete questionnaires three times: at the time of study enrollment, week 4 and 6 months.

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
Mean change in Hemoglobin A1c from baseline to 6 months
Time Frame: Baseline to 6 months
Change in Hemoglobin A1c
Baseline to 6 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
Mean change in HbA1c (%) from baseline to 6 months.
Time Frame: Baseline to 6 months
Change in Hemoglobin A1c
Baseline to 6 months
Mean change in CGM metrics measured by CGM readings
Time Frame: Week 4 & 6 months
% Glucose Time in Range (70-180 mg/dL), % Glucose Time Below Range (<70mg/dL), % Glucose Time Above Range (>180mg/dL).
Week 4 & 6 months
Average number of diabetes educator hours used per study participant at week 4 & 6 months.
Time Frame: Week 4 and 6 months
Number of hours spent in diabetes education
Week 4 and 6 months
Change in perceived diabetes distress at baseline, week 4 & 6 months
Time Frame: Baseline, Week 4 & 6 months
The Problem Areas in Diabetes survey (PAID) is an 18-item survey to assess the perceived burden associated with diabetes. Youth and caregivers are given statements about diabetes-related issues and report on a 5-point Likert scale (0 = not a problem, 1 = minor problem, 2 = moderate problem, 3 = somewhat serious problem, 4 = serious problem) the degree to which the statements are a problem for them. Increasing scores denote increased burden perceived.
Baseline, Week 4 & 6 months
Change in perceived diabetes family responsibility at baseline, week 4 & 6 months.
Time Frame: Baseline, week 4 & 6 months
The Diabetes Family Responsibility Questionnaire (DFRQ) is a 14-item validated survey assessing parental and child involvement in various diabetes management tasks. Youth and caregivers report on a 3-point scale (1=child, 2=equal, 3=parent) who is responsible for a given diabetes task. Higher scores indicate more parental involvement in diabetes management.
Baseline, week 4 & 6 months
Perceived benefits of Continuous Glucose Monitor (CGM) use
Time Frame: week 4 & 6 months
Adolescent Benefits and Burdens of CGM Survey - BenCGM & BurCGM. Participants answer each question on a scale of Strong Disagree, Disagree, Neutral, Agree, Strongly Agree.
week 4 & 6 months
Perceived burden of Continuous Glucose Monitor (CGM) use
Time Frame: week 4 & 6 months
Adolescent Benefits and Burdens of CGM Survey - BenCGM & BurCGM. Participants answer each question on a scale of Strong Disagree, Disagree, Neutral, Agree, Strongly Agree.
week 4 & 6 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.
Children's Hospital Los Angeles

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rebecca Barber, PhD, RN, Children's Hospital Los Angeles

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.
May 1, 2025

Primary Completion (Estimated)

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.
September 30, 2026

Study Completion (Estimated)

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 30, 2026

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).
May 22, 2023

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.
May 8, 2024

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.
May 10, 2024

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.
February 6, 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 4, 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.
July 1, 2025

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.
  • CHLA-23-00298

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

No

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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