Carb Counting vs. Simplified Qualitative Meal-Size Estimation

Condition(s) studied

Investigational drug(s) / intervention(s)

accurate carb counting: Participants will use precise carb counting to manage their meals

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.

Study summary

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.

Eligibility

Primary outcome measure(s)

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

Trial sites (1)

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