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NCT Number: NCT06516640

Type 2 Continuous Glucose Monitoring Academy

The goal of this clinical trial is to evaluate the Impact of Continuous Glucose Monitoring Academy Education Curriculum Versus Standard Care on Glycemic Outcomes for Youth With Type 2 Diabetes (T2D):

* The first aim is to determine how feasible it is to adapt the Continuous Glucose Monitoring Academy curriculum to teach youth with T2D glucose management strategies. * The second aim is to evaluate the effects of the Continuous Glucose Monitoring Academy metrics. * The third aim is to explore the relationships between these metrics with diabetes distress, diabetes family responsibilities, and process metrics.

Participants will join for a total of four weeks of education, followed by a six-month clinical review. They will have access to an online workbook and videos, and will participate in virtual sessions with a diabetes educator who will cover glucose management strategies in-depth. Participants will wear their preferred Continuous Glucose Monitoring system (Dexcom or FreeStyle Libre) provided via insurance and inserted at the baseline visit.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

8 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location status: Recruiting

Location contact

Natalia Garban

CONTACT

[email protected]

Rebecca Barber, PhD, RN

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Current age of 8-21 years;
  • T2D diagnosis;
  • Able to speak, read, and write English or Spanish

Exclusion criteria

a. Known history of medical adhesive allergies;

Treatment and study plan

Continuous Glucose Monitoring Academy

Behavioral

Educational materials as well as online sessions with diabetes educators.

standard education

Behavioral

Standard of care receives general education about diabetes.

Other names: Standard of Care

Primary outcomes

  1. Mean change in Time in Range (TIR) from baseline to 6 months

    Time frame: Baseline to 6 months

    Change in % glucose TIR (70-180 mg/dL)

Secondary outcomes

  1. Mean change in Hemoglobin A1c (HbA1c) from baseline to 6 months

    Time frame: Baseline to 6 months

    Change in Hemoglobin A1c

  2. Mean change in CGM metrics measured by CGM readings

    Time frame: Week 4 & 6 months

    % Glucose Time Below Range (<70mg/dL), % Glucose Time Above Range (>180mg/dL), % Glucose Variability (coefficient of variation, CV)

  3. Change in perceived diabetes distress at baseline, week 4 & 6 months

    Time frame: Baseline, Week 4 & 6 months

    The Type 2 Diabetes Distress Assessment System (T2-DDAS) measures how much overall emotional distress is due to diabetes. Respondents are given statements about diabetes-related issues and indicate 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. Increasing scores denote increased burden perceived.

  4. 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.

  5. 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

  6. Mean change in perceived benefits of Continuous Glucose (CGM) Monitor use

    Time frame: Week 4 & 6 months

    Name of questionnaire: Adolescent Benefits and Burdens of CGM Survey - BenCGM & BurCGM. Participants answer each question on a scale of Strong Disagree, Disagree, Neutral, Agree, Strongly Agree.

  7. Mean change in perceived burden of Continuous Glucose Monitor (CGM) use

    Time frame: Week 4 & 6 months

    Name of questionnaire: Adolescent Benefits and Burdens of CGM Survey - BenCGM & BurCGM. Participants answer each question on a scale of Strong Disagree, Disagree, Neutral, Agree, Strongly Agree.

Study contacts

Contact information is provided by the study sponsor or research team.

Natalia Garban

CONTACT

[email protected]

3233611359

Rebecca Barber

CONTACT

[email protected]

3233611359

Sponsors and collaborators

Lead sponsor

Children's Hospital Los Angeles

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

Randomized Control Trial Evaluating the Impact of Continuous Glucose Monitoring Academy Education Curriculum Versus Standard Care on Glycemic Outcomes for Youth With Type 2 Diabetes

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 24, 2024
Registry last updated
Feb 6, 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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