CGM Academy for Youth With Type 1 Diabetes
ConditionType1 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-18
SponsorChildren's Hospital Los Angeles
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
CGM Academy
BehavioralEducational materials as well as online sessions with diabetes educators.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: CGM AcademyExperimental treatment 1 intervention
Group B: Standard Diabetes EducationNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Mean change in Hemoglobin A1c from baseline to 6 months
Change in Hemoglobin A1c
Time frame
Baseline to 6 monthsSecondary outcomes
1
Mean change in HbA1c (%) from baseline to 6 months.
Change in Hemoglobin A1c
Time frame
Baseline to 6 months2
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).
Time frame
Week 4 & 6 months3
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.
Time frame
Baseline, Week 4 & 6 months4
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.
Time frame
Baseline, week 4 & 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov