Structured Education Program and Glycemic Control in Adolescents With Type 1 Diabetes
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Structured education program.
- Кому может быть актуально
- Состояния в реестре: Type 1 Diabetes (T1D), Type 1 Diabetes Mellitus (T1DM). Базовые параметры: 11 лет — 14 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Кувейт
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Evaluating the Effectiveness of a Structured Educational Program on Glycemic Control in Adolescents With Type 1 Diabetes: A Randomized Controlled Trial
Обзор
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.
Вмешательства
- Поведенческое 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
Первичные конечные точки
- Change in HbA1c Levels [Срок оценки: Baseline and 6 months]
- Change in %Time In Range (%TIR) [Срок оценки: Baseline and 6 months]
Вторичные конечные точки (4)
- Change in Carbohydrate Counting and Insulin Adjustment Knowledge Scores [Срок оценки: Baseline and 6 months]
- Change in Diabetes-Specific Quality of Life Scores [Срок оценки: Baseline and 6 months]
- Change in Hypoglycemia Frequency [Срок оценки: Baseline and 6 months]
- Change in Diabetes-Related Hospitalizations [Срок оценки: Baseline and 6 months]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Кувейт · 1 центр
- Dasman Diabetes Institute — Kuwait City
Идентификаторы
NCT: NCT06984133 · RA HM-2025-02