Structured Education Program and Glycemic Control in Adolescents With Type 1 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age11-14
SponsorDasman Diabetes Institute
About this trial
Type 1 diabetes is becoming more common in Kuwaiti and Arab adolescents. Many young people with this condition struggle to keep their blood glucose levels under control, which can lead to diabetes-related complications and affect their quality of life.
The goal of this clinical trial is to evaluate the effectiveness of a structured educational program on glycemic control among Arab adolescents with type 1 diabetes aged 11 to 14 years.
Participants will be randomly assigned to one of two groups. The intervention group will receive the structured education program, and the control group will continue with standard care.
All participants will undergo assessments that include:
* collecting demographic and diabetes management data * measuring weight and height * measuring HbA1c levels and lipid profile * filling out questionnaires on quality of life, carbohydrate and insulin dosing knowledge, physical activity * collecting dietary intake * providing AGP report
Participants in the intervention group will additionally be required to:
* attend the program for 4 consecutive days, one day for parents and three days for children * fill out 3-day food diary records during the program * attend a refresher course after 6 months
Participants in the control group will have the opportunity to participate in the program after approximately six months.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Arab adolescents
Males and females aged 11 to 14 years.
Have been diagnosed with type 1 diabetes for at least 6 months.
Wearing a continuous glucose monitor (CGM).
Disqualifiers
Presence of learning disabilities or any known psychological issues.
Attendance at any diabetes education or carbohydrate counting programs within the six months preceding the study.
Trial design
Design model
Parallel
Treatments tested in this trial
Structured education program
BehavioralA structured group educational program culturally adapted from a UK model for adolescents with type 1 diabetes. The program aims to empower adolescents by providing knowledge and tools needed for effective diabetes management. It is delivered by dietitians, diabetes educators, and a pediatric endocrinologist in small groups. The curriculum targets both caregivers and adolescents: the first day is for parents and covers diabetes basics, management of hypoglycemia and hyperglycemia, insulin dosing, sick day management, and exercise considerations. The following three days focus on adolescents and include interactive sessions on the role of food in diabetes management, the effect of different nutrients on blood glucose levels, carbohydrate sources, reading food labels, advanced carbohydrate counting, and insulin dose adjustment.
Treatment groups
128 Participants
are divided into 2 treatment groupsGroup A: Control armNo intervention 0 interventions
Group B: Intervention armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in HbA1c Levels
Change in HbA1c Levels from baseline to 6 months
Time frame
Baseline and 6 months2
Change in %Time In Range (%TIR)
Change in %TIR from baseline to 6 months
Time frame
Baseline and 6 monthsSecondary outcomes
1
Change in Carbohydrate Counting and Insulin Adjustment Knowledge Scores
Change in Carbohydrate Counting and Insulin Adjustment Knowledge Scores from baseline to 6 months
Time frame
Baseline and 6 months2
Change in Diabetes-Specific Quality of Life Scores
Change in Diabetes-Specific Quality of Life Scores from baseline to 6 months, will be assessed using the validated Arabic version of the Pediatric Quality of Life Inventory 3.0 Diabetes Module (PedsQL DM).
Time frame
Baseline and 6 months3
Change in Hypoglycemia Frequency
This will be assessed by: a) the percentage of time blood glucose levels are below the target range (%TBR), and b) parent-reported episodes requiring treatment such as glucagon administration.
Time frame
Baseline and 6 months4
Change in Diabetes-Related Hospitalizations
Frequency of hospital admissions for diabetic ketoacidosis or hypoglycemia, reported by parents, within a month prior the assessment visit.
Time frame
Baseline and 6 monthsSponsors and contacts
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Source ClinicalTrials.gov