CGM Academy for Youth With Type 1 Diabetes

NCT ID: NCT06408207

Last Updated: 2025-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Type1 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Simple randomization
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Everyone will know their assigned intervention.

Study Groups

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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.

Group Type EXPERIMENTAL

CGM Academy

Intervention Type BEHAVIORAL

Educational materials as well as online sessions with diabetes educators.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CGM Academy

Educational materials as well as online sessions with diabetes educators.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Barber, Rebecca

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rebecca Barber, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Los Angeles

Locations

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Children's Hospital Los Angeles

Los Angeles, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Rebecca Barber, PhD, RN

Role: CONTACT

(323) 361-1359 ext. 11359

Natalia Garban

Role: CONTACT

Facility Contacts

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Natalia Garban

Role: primary

Other Identifiers

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CHLA-23-00298

Identifier Type: -

Identifier Source: org_study_id

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