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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:
Participants in the intervention group will additionally be required to:
Participants in the control group will have the opportunity to participate in the program after approximately six months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control arm | No Intervention | Participants will receive usual care at their treating hospitals. | |
| Intervention arm | Experimental | Participants will attend a structured education program over 4 days and a refresher course after 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Structured education program | Behavioral | A 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c Levels | Change in HbA1c Levels from baseline to 6 months | Baseline and 6 months |
| Change in %Time In Range (%TIR) | Change in %TIR from baseline to 6 months | Baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Carbohydrate Counting and Insulin Adjustment Knowledge Scores | Change in Carbohydrate Counting and Insulin Adjustment Knowledge Scores from baseline to 6 months | Baseline and 6 months |
| Change in Diabetes-Specific Quality of Life Scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Badreya Al-Lahou, PhD | Contact | +965 22242999 | 2660 | badreya.allahou@dasmaninstitute.org |
| Name | Affiliation | Role |
|---|---|---|
| Ebaa Al Ozairi, MD | Dasman Diabetes Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dasman Diabetes Institute | Recruiting | Kuwait City | Sharq | 15462 | Kuwait |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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The investigators and data analysts will be masked to group assignments.
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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).
| Baseline and 6 months |
| 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. | Baseline and 6 months |
| Change in Diabetes-Related Hospitalizations | Frequency of hospital admissions for diabetic ketoacidosis or hypoglycemia, reported by parents, within a month prior the assessment visit. | Baseline and 6 months |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |