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

NCT06984133 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2025-05-22

No results posted yet for this study

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.

Conditions

  • Type 1 Diabetes (T1D)
  • Type 1 Diabetes Mellitus (T1DM)

Interventions

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.

Sponsors & Collaborators

  • Dasman Diabetes Institute

    lead OTHER

Principal Investigators

  • Ebaa Al Ozairi, MD · Dasman Diabetes Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-18
Primary Completion
2028-05-18
Completion
2028-05-18

Countries

  • Kuwait

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06984133 on ClinicalTrials.gov