An interventional study of Structured education program in Type 1 Diabetes (T1D) and Type 1 Diabetes Mellitus (T1DM), sponsored by Dasman Diabetes Institute. Recruiting at 1 site in Kuwait. Open to participants aged 11 Years to 14 Years. Per ClinicalTrials.gov, last updated 2025-05-22.
Sponsored by Dasman Diabetes Institute · Not applicable, Interventional, and Treatment
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.
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
This study's planned enrollment of 128 is above the median of 40 across 2,820 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Dasman Diabetes Institute is the lead sponsor of 31 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants will receive usual care at their treating hospitals.
Participants will attend a structured education program over 4 days and a refresher course after 6 months.
Behavioral: Structured education program
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.
Change in HbA1c Levels
Change in HbA1c Levels from baseline to 6 months
Time frame: Baseline and 6 months
Change in %Time In Range (%TIR)
Change in %TIR from baseline to 6 months
Time frame: Baseline and 6 months
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 months
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 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.
Time frame: 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.
Time frame: Baseline and 6 months
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for May 2025; primary completion for May 2028, 36 months later.
Of 844 non-industry interventional studies with no phase under Diabetes Mellitus, Type 1, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's planned 36 months is above that.
Counting every sponsor, half of 949 studies reached it within 18 months; a quarter within 9 and three quarters within 35.
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Dasman Diabetes Institute