Structured Education Program and Glycemic Control in Adolescents With Type 1 Diabetes

Not Applicable

Recruiting

• Conditions: Type 1 Diabetes (T1D); Type 1 Diabetes Mellitus (T1DM)

• Registration Number: NCT06984133
• Lead Sponsor: Dasman Diabetes Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-14
• Study First Submitted QC: 2025-05-14
• Last Update Submitted: 2025-05-14
• Study Start: 2025-05-18
• Study First Posted: 2025-05-22
• Last Update Posted: 2025-05-22
• Primary Completion: 2028-05-18
• Study Completion: 2028-05-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

• 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).
• Individuals and their parents must be able to join the entire duration of the study.
• Individuals and their parents must voluntarily provide consent and assent.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in HbA1c Levels	Baseline and 6 months	Change in HbA1c Levels from baseline to 6 months
Change in %Time In Range (%TIR)	Baseline and 6 months	Change in %TIR from baseline to 6 months

Secondary Outcome Measures

Name	Time	Method
Change in Carbohydrate Counting and Insulin Adjustment Knowledge Scores	Baseline and 6 months	Change in Carbohydrate Counting and Insulin Adjustment Knowledge Scores from baseline to 6 months
Change in Diabetes-Specific Quality of Life Scores	Baseline and 6 months	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).
Change in Hypoglycemia Frequency	Baseline and 6 months	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.
Change in Diabetes-Related Hospitalizations	Baseline and 6 months	Frequency of hospital admissions for diabetic ketoacidosis or hypoglycemia, reported by parents, within a month prior the assessment visit.

Trial Locations

Locations (1)

Dasman Diabetes Institute; 🇰🇼 Kuwait City, Sharq, Kuwait