CGM Academy for Youth With Type 1 Diabetes

Type1 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06408207
• Other study ID #: CHLA-23-00298
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2024
• Source: Children's Hospital Los Angeles
• Contact: Rebecca Barber, PhD, RN
• Phone: (323) 361-1359
• Email: rbarber[@]chla.usc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type1 Diabetes

Intervention

Behavioral:
• CGM Academy
Educational materials as well as online sessions with diabetes educators.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Los Angeles

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in Hemoglobin A1c from baseline to 6 months	Change in Hemoglobin A1c	Baseline to 6 months
Secondary	Mean change in HbA1c (%) from baseline to 6 months.	Change in Hemoglobin A1c	Baseline to 6 months
Secondary	Mean change in CGM metrics measured by CGM readings	% Glucose Time in Range (70-180 mg/dL), % Glucose Time Below Range (<70mg/dL), % Glucose Time Above Range (>180mg/dL).	Week 4 & 6 months
Secondary	Change in perceived diabetes distress at baseline, week 4 & 6 months	The Problem Areas in Diabetes survey (PAID) is an 18-item survey to assess the perceived burden associated with diabetes. Youth and caregivers are given statements about diabetes-related issues and report 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 for them. Increasing scores denote increased burden perceived.	Baseline, Week 4 & 6 months
Secondary	Change in perceived diabetes family responsibility at 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.	Baseline, week 4 & 6 months
Secondary	Average number of diabetes educator hours used per study participant at week 4 & 6 months.	Number of hours spent in diabetes education	Week 4 and 6 months