Health TrialsbyHealthPanel

Type 2 Continuous Glucose Monitoring Academy

ConditionType 2 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-21
SponsorChildren's Hospital Los Angeles

About this trial

The goal of this clinical trial is to evaluate the Impact of Continuous Glucose Monitoring Academy Education Curriculum Versus Standard Care on Glycemic Outcomes for Youth With Type 2 Diabetes (T2D):

* The first aim is to determine how feasible it is to adapt the Continuous Glucose Monitoring Academy curriculum to teach youth with T2D glucose management strategies. * The second aim is to evaluate the effects of the Continuous Glucose Monitoring Academy metrics. * The third aim is to explore the relationships between these metrics with diabetes distress, diabetes family responsibilities, and process metrics.

Participants will join for a total of four weeks of education, followed by a six-month clinical review. They will have access to an online workbook and videos, and will participate in virtual sessions with a diabetes educator who will cover glucose management strategies in-depth. Participants will wear their preferred Continuous Glucose Monitoring system (Dexcom or FreeStyle Libre) provided via insurance and inserted at the baseline visit.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Current age of 8-21 years;

T2D diagnosis;

Able to speak, read, and write English or Spanish

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Continuous Glucose Monitoring Academy

    Behavioral

    Educational materials as well as online sessions with diabetes educators.

  • Standard Education

    Behavioral

    Standard of care receives general education about diabetes.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: ControlPlacebo comparator 1 intervention
Group B: Continuous Glucose Monitoring AcademyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Mean change in Time in Range (TIR) from baseline to 6 months

Change in % glucose TIR (70-180 mg/dL)

Time frame
Baseline to 6 months

Secondary outcomes

1

Mean change in Hemoglobin A1c (HbA1c) from baseline to 6 months

Change in Hemoglobin A1c

Time frame
Baseline to 6 months
2

Mean change in CGM metrics measured by CGM readings

% Glucose Time Below Range (\<70mg/dL), % Glucose Time Above Range (\>180mg/dL), % Glucose Variability (coefficient of variation, CV)

Time frame
Week 4 & 6 months
3

Change in perceived diabetes distress at baseline, week 4 & 6 months

The Type 2 Diabetes Distress Assessment System (T2-DDAS) measures how much overall emotional distress is due to diabetes. Respondents are given statements about diabetes-related issues and indicate 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. Increasing scores denote increased burden perceived.

Time frame
Baseline, Week 4 & 6 months
4

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 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Hospital Los Angeles

Lead sponsor

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Source ClinicalTrials.gov
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