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NCT Number: NCT06984133

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

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.

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Key information

Conditions

Type 1 Diabetes (T1D) Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Type 1 Diabetes Mellitus (T1DM)

Age range

11 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dasman Diabetes Institute

Kuwait City, Sharq, 15462, Kuwait

Location status: Recruiting

Location contact

Badreya Al-Lahou, PhD

CONTACT

[email protected]

+965 22242999 ext. 2660

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in HbA1c Levels

    Time frame: Baseline and 6 months

    Change in HbA1c Levels from baseline to 6 months

  2. Change in %Time In Range (%TIR)

    Time frame: Baseline and 6 months

    Change in %TIR from baseline to 6 months

Secondary outcomes

  1. Change in Carbohydrate Counting and Insulin Adjustment Knowledge Scores

    Time frame: Baseline and 6 months

    Change in Carbohydrate Counting and Insulin Adjustment Knowledge Scores from baseline to 6 months

  2. Change in Diabetes-Specific Quality of Life Scores

    Time frame: 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).

  3. Change in Hypoglycemia Frequency

    Time frame: 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.

  4. Change in Diabetes-Related Hospitalizations

    Time frame: Baseline and 6 months

    Frequency of hospital admissions for diabetic ketoacidosis or hypoglycemia, reported by parents, within a month prior the assessment visit.

Study contacts

Contact information is provided by the study sponsor or research team.

Badreya Al-Lahou, PhD

CONTACT

[email protected]

+965 22242999 ext. 2660

Sponsors and collaborators

Lead sponsor

Dasman Diabetes Institute

Other

Registry information

Official study title

Evaluating the Effectiveness of a Structured Educational Program on Glycemic Control in Adolescents With Type 1 Diabetes: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 22, 2025
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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