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

Dasman Diabetes Institute

Status: Enrolling

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

Treatments: Behavioral: Structured education program

Study type: Interventional

Funder types: Other

Identifiers

NCT06984133

RA HM-2025-02

Details and patient eligibility

About

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.

Enrollment: 128 estimated patients

Sex: All

Ages: 11 to 14 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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128 participants in 2 patient groups

Control arm

No Intervention group

Description:

Participants will receive usual care at their treating hospitals.

Intervention arm

Experimental group

Description:

Participants will attend a structured education program over 4 days and a refresher course after 6 months.

Treatment:

Behavioral: Structured education program