Clinical trial NCT06984133: Structured Education Program and Glycemic Control in Adolescents With Type 1 Diabetes
Official title: Evaluating the Effectiveness of a Structured Educational Program on Glycemic Control in Adolescents With Type 1 Diabetes: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Dasman Diabetes Institute
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 128
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in HbA1c Levels
timeFrame: Baseline and 6 months
measure: Change in %Time In Range (%TIR)
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Change in Carbohydrate Counting and Insulin Adjustment Knowledge Scores
timeFrame: Baseline and 6 months
measure: Change in Diabetes-Specific Quality of Life Scores
timeFrame: Baseline and 6 months
measure: Change in Hypoglycemia Frequency
timeFrame: Baseline and 6 months
measure: Change in Diabetes-Related Hospitalizations
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Kuwait City
country: Kuwait
facility: Dasman Diabetes Institute
state: Sharq
Study officials:
affiliation: Dasman Diabetes Institute
name: Ebaa Al Ozairi, MD
role: STUDY_DIRECTOR
References: