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NCT06687434

Carb Counting vs. Simplified Qualitative Meal-Size Estimation

Recruiting · Not Applicable · Rabin Medical Center · registry updated 2025-05-20

Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.

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....

Inclusion

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

Exclusion

  • 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 -

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