Structured Education Program and Glycemic Control in Adolescents With Type 1 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Structured education program.
- Who it may be relevant to
- Registry conditions: Type 1 Diabetes (T1D), Type 1 Diabetes Mellitus (T1DM). Basic parameters: 11 years — 14 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Kuwait
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluating the Effectiveness of a Structured Educational Program on Glycemic Control in Adolescents With Type 1 Diabetes: A Randomized Controlled Trial
Overview
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.
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 dosin
Primary outcome measures
- Change in HbA1c Levels [Time frame: Baseline and 6 months]
- Change in %Time In Range (%TIR) [Time frame: Baseline and 6 months]
Secondary outcome measures (4)
- Change in Carbohydrate Counting and Insulin Adjustment Knowledge Scores [Time frame: Baseline and 6 months]
- Change in Diabetes-Specific Quality of Life Scores [Time frame: Baseline and 6 months]
- Change in Hypoglycemia Frequency [Time frame: Baseline and 6 months]
- Change in Diabetes-Related Hospitalizations [Time frame: Baseline and 6 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Kuwait · 1 center
- Dasman Diabetes Institute — Kuwait City
Identifiers
NCT: NCT06984133 · RA HM-2025-02