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

What this Trial Is About

Researchers are comparing two ways of estimating meal sizes in children and adolescents aged 6 to 18 years with Type 1 Diabetes who are starting to use Automated Insulin Delivery (AID) systems. The study aims to evaluate glucose control and patient-related outcomes between those using accurate carbohydrate counting and those using a simplified qualitative meal-size estimation. The trial is a randomized control study involving 120 participants and will last six months with optional follow-ups at 12 and 24 months. Participants will be randomly assigned to one of two groups. One group will use precise carbohydrate counting to manage their meals, while the other will use a simplified meal announcement method based on personalized small, medium, or large presets assessed by a dietitian. All participants will receive nutrition guidance during their first visit, and the dietitian will review insulin-to-carb ratios and meal estimations during the first two weeks. Follow-up visits are scheduled at 4-6 weeks, 3 months, and 6 months from the study start. Throughout the study, participants will upload data from their AID systems at each visit for evaluation of their diabetes control and carbohydrate calculation methods. Digital questionnaires about diabetes distress, disordered eating, dietary regimen, and eating patterns will be completed at the start and after six months, with optional assessments at 12 and 24 months. The main outcomes measured include time spent in the target glucose range, HbA1c levels, continuous glucose monitoring use, and episodes of severe hypoglycemia or diabetic ketoacidosis, along with various secondary measures related to insulin dosing and diabetes management behaviors.

Carb Counting vs. Simplified Qualitative Meal-Size Estimation