Clinical trial NCT06408207: CGM Academy for Youth With Type 1 Diabetes
Official title: Randomized Control Trial Evaluating the Impact of CGM Academy Education Curriculum Versus Standard Care on Glycemic Outcomes for Youth With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type1 Diabetes
Keywords: Continuous Glucose Monitoring
Glycemic Control
Diabetes Education
Type1 Diabetes
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
First posted: 2024-05-10
Enrollment: 90
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Simple randomization
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean change in Hemoglobin A1c from baseline to 6 months
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Mean change in HbA1c (%) from baseline to 6 months.
timeFrame: Baseline to 6 months
measure: Mean change in CGM metrics measured by CGM readings
timeFrame: Week 4 & 6 months
measure: Change in perceived diabetes distress at baseline, week 4 & 6 months
timeFrame: Baseline, Week 4 & 6 months
measure: Change in perceived diabetes family responsibility at baseline, week 4 & 6 months.
timeFrame: Baseline, week 4 & 6 months
measure: Average number of diabetes educator hours used per study participant at week 4 & 6 months.
timeFrame: Week 4 and 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
Study officials:
affiliation: Children's Hospital Los Angeles
name: Rebecca Barber, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: