CGM Academy for Youth With Type 1 Diabetes

Children's Hospital Los Angeles

Status: Enrolling

Conditions: Type1 Diabetes

Treatments: Behavioral: CGM Academy

Study type: Interventional

Funder types: Other

Identifiers

NCT06408207

CHLA-23-00298

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

90 participants in 2 patient groups

CGM Academy

Experimental group

Description:

* 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.

Treatment:

Behavioral: CGM Academy

Standard Diabetes Education

No Intervention group

Description:

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