RecruitingNot ApplicableNCT06687434

Carb Counting vs. Simplified Qualitative Meal-Size Estimation

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


Sponsor

Rabin Medical Center

Enrollment

120 participants

Start Date

Dec 15, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 6 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two methods of estimating meal size for insulin dosing in children and teens with Type 1 diabetes who are starting an automated insulin delivery (AID) system: traditional carbohydrate counting versus a simplified meal-size estimation method. **You may be eligible if...** - Your child has been diagnosed with Type 1 diabetes - They are between 6 and 18 years old - They use insulin (multiple daily injections or a pump) and are starting an automated insulin delivery (AID) system **You may NOT be eligible if...** - Your child does not have Type 1 diabetes - They have unstable medical conditions (other than diabetes) that could affect weight or diabetes management - They take medications that affect blood sugar or weight (such as steroids or GLP-1 medications) - They cannot understand or complete the study materials and questionnaires Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALaccurate carb counting

Participants will use precise carb counting to manage their meals

BEHAVIORALSimplified 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.


Locations(1)

Schneider Children's Medical Center

Petah Tikva, Israel

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NCT06687434


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