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

NCT ID: NCT06984133

Last Updated: 2025-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-18

Study Completion Date

2028-05-18

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
The investigators and data analysts will be masked to group assignments.

Study Groups

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Control arm

Participants will receive usual care at their treating hospitals.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention arm

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

Group Type EXPERIMENTAL

Structured education program

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

11 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dasman Diabetes Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ebaa Al Ozairi, MD

Role: STUDY_DIRECTOR

Dasman Diabetes Institute

Locations

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Dasman Diabetes Institute

Kuwait City, Sharq, Kuwait

Site Status RECRUITING

Countries

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Kuwait

Central Contacts

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Badreya Al-Lahou, PhD

Role: CONTACT

+965 22242999 ext. 2660

Facility Contacts

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Badreya Al-Lahou, PhD

Role: primary

+965 22242999 ext. 2660

Other Identifiers

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RA HM-2025-02

Identifier Type: -

Identifier Source: org_study_id

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