Type 2 Continuous Glucose Monitoring Academy

NCT06516640 | Recruiting

• 2 other identifiers: CHLA-24-00199P50MD017344
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes

Keywords

Continuous Glucose Monitoring; Glycemic Control; Diabetes Education; Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

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

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

  Baseline to 6 months

Secondary Outcomes (7)

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

  Baseline to 6 months

• Mean change in CGM metrics measured by CGM readings

  Week 4 & 6 months

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

  Baseline, Week 4 & 6 months

• Change in perceived diabetes family responsibility at baseline, week 4 & 6 months

  Baseline, week 4 & 6 months

• Average number of diabetes educator hours used per study participant at week 4 & 6 months.

  Week 4 and 6 months

Study Arms (2)

Control

PLACEBO COMPARATOR

Receives standard of care, regular education in the clinic.

Behavioral: Standard Education

Continuous Glucose Monitoring Academy

EXPERIMENTAL

Receive an interactive workbook with problem-based learning scenarios and video links about Continuous Glucose Monitoring and glucose management strategies (CGM Academy Program). 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: Continuous Glucose Monitoring Academy; Behavioral: Standard Education

Interventions

Continuous Glucose Monitoring Academy BEHAVIORAL

Educational materials as well as online sessions with diabetes educators.

Continuous Glucose Monitoring Academy

Standard Education BEHAVIORAL

Standard of care receives general education about diabetes.

Also known as: Standard of Care

Continuous Glucose Monitoring Academy; Control

Eligibility Criteria

• Age: 8 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• a. Known history of medical adhesive allergies;

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Rebecca Barber, PhD, RN

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natalia Garban

CONTACT

3233611359; ngarban@chla.usc.edu

Rebecca Barber

CONTACT

3233611359; rbarber@chla.usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse Scientist

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: July 24, 2024
• Study Start: June 23, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 6, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)