Carb Counting vs. Simplified Qualitative Meal-Size Estimation

Официальное название

Carb Counting vs. Simplified Qualitative Meal-Size Estimation- A Randomized Control Trial

Обзор

The goal of this study is to compare qualitative meal-size estimation to accurate carb counting in adolescents with Type One Diabetes using all available AID (Automated Insulin Delivery) systems. We will compare glucose control parameters and patient related outcome measures between the groups. 120 children and adolescents with type 1 Diabetes who begin using AID system will be randomly assigned to one of two groups: simplified qualitative meal size estimation or accurate carb counting. The study will last 6 months, with an additional optional follow up points at 12 and 24 months. In the first visit all patients will receive nutrition guidance from the dietitian. In the accurate carb counting group, participants will use precise carb counting to manage their meals. In the simplified qualitative meal-size estimation group, participants will use a simplified meal announcement based on three presets for each meal, small, medium, or large, which will be personalized based on the dietitian's assessment. During the study, the dietitian will evaluate the insulin-to-carb ratio and meal estimation at least once in the first two weeks. Follow-up visits will be scheduled at 4-6 weeks, 3, and 6 months after the study's initiation. At each visit participants will upload their data from their AID systems. Evaluation of their diabetes control will be made and an assessment regarding the carbohydrates calculation method. Digital questionnaires assessing diabetes distress, disordered eating behaviors, dietary regimen, and eating patterns will be provided at the beginning of the study and after 6 months, with an additional optional follow-up points that will be held at 12 and 24 months after the study's initiation.

Вмешательства

• Поведенческое accurate carb counting
  Participants will use precise carb counting to manage their meals
• Поведенческое Simplified qualitative meal size estimation
  participants will use a simplified meal announcement based on three presets for each meal, small, medium, or large, which will be personalized based on the dietitian's assessment.

Первичные конечные точки

• Percentage of time in target range (70-18mg/dl) [Срок оценки: Screening, after 4-6 weeks, after 3 months and after 6 months]
• Hemoglobin A1C [Срок оценки: Screening, after 4-6 weeks, after 3 months and after 6 months]
• Percentage Continuous glucose monitoting usage [Срок оценки: Screening, after 4-6 weeks, after 3 months and after 6 months]
• Number of Episodes of severe hypoglycemia [Срок оценки: Screening, after 4-6 weeks, after 3 months and after 6 months]
• Number of episodes of Diabetic Ketoacidosis [Срок оценки: Screening, after 4-6 weeks, after 3 months and after 6 months]

Вторичные конечные точки (11)

• Total daily insulin dose [Срок оценки: at screening, after 4-6 weeks, after 3 months and after 6 months.]
• basal insulin dose [Срок оценки: at screening, after 4-6 weeks, after 3 months and after 6 months.]
• Number of manual boluses per day [Срок оценки: at screening, after 4-6 weeks, after 3 months and after 6 months.]
• Number of announced meals per day [Срок оценки: at screening, after 4-6 weeks, after 3 months and after 6 months.]
• Daily carbohydrates input [Срок оценки: at screening, after 4-6 weeks, after 3 months and after 6 months.]
• Percentage of automated insulin delivery use [Срок оценки: at screening, after 4-6 weeks, after 3 months and after 6 months.]
• Number of automated insulin delivery exits per week [Срок оценки: at screening, after 4-6 weeks, after 3 months and after 6 months.]
• Percentage of automated boluses [Срок оценки: at screening, after 4-6 weeks, after 3 months and after 6 months.]
• Score of Diabetes distress according to questionnaire [Срок оценки: At screening and after 6 months]
• Score of Disordered eating behaviors according to quesiotnnaire [Срок оценки: At screening and after 6 months]
• Score of Dietary regimen according to questionnaire [Срок оценки: At screening and after 6 months]

Критерии участия

Критерии включения

• T1D- diagnosed
• Age 6-18 years
• Treated with insulin (multiple daily injections or pump) and intending to initiate treatment with AID systems

Критерии исключения

• Non-T1D
• Unstable medical conditions (other than diabetes) that may impact weight or diabetes management (as severe psychiatric disorders, various syndromes)
• Use of medications that may impact weight or diabetes management (as use of steroids for an extended period of time. use of GLP-1)
• Inability to understand the information, material and questionnaires of 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

Открытое

Основная цель

Другое

Центры проведения

Израиль · 1 центр

• Schneider Children's Medical Center — Petah Tikva

Идентификаторы

NCT: NCT06687434 · RMC-0411-24ctil

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗