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

NCT06984133 | Recruiting

• 1 other identifier: RA HM-2025-02
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Kuwait; Glycemic control; Type 1 diabetes; Carbohydrate counting; Arab adolescents; Structured education; Adolescents; Diabetes education program; HbA1c

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Change in Carbohydrate Counting and Insulin Adjustment Knowledge Scores

  Baseline and 6 months

• Change in Diabetes-Specific Quality of Life Scores

  Baseline and 6 months

• Change in Hypoglycemia Frequency

  Baseline and 6 months

• Change in Diabetes-Related Hospitalizations

  Baseline and 6 months

Study Arms (2)

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.

Behavioral: Structured education program

Interventions

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.

Intervention arm

Eligibility Criteria

• Age: 11 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dasman Diabetes Institute: lead

Study Sites (1)

Dasman Diabetes Institute

Kuwait City, Sharq, 15462, Kuwait

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Ebaa Al Ozairi, MD

  Dasman Diabetes Institute

  STUDY DIRECTOR

Central Study Contacts

Badreya Al-Lahou, PhD

CONTACT

+965 22242999; badreya.allahou@dasmaninstitute.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigators and data analysts will be masked to group assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 22, 2025
• Study Start: May 18, 2025
• Primary Completion (Estimated): May 18, 2028
• Study Completion (Estimated): May 18, 2028
• Last Updated: May 22, 2025

Record last verified: 2025-05

Locations

KU (1)