Carb Counting vs. Simplified Qualitative Meal-Size Estimation

Clalit Health Services

Status: Enrolling

Conditions: Type 1 Diabetes Mellitus

Treatments: Behavioral: Simplified qualitative meal size estimation; Behavioral: accurate carb counting

Study type: Interventional

Funder types: Other

Identifiers

NCT06687434

RMC-0411-24ctil

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Accurate carb counting

Experimental group

Description:

Participants will use precise carb counting to manage their meals

Treatment:

Behavioral: accurate carb counting

Simplified qualitative meal-size estimation

Experimental group

Description:

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 assessment.

Treatment:

Behavioral: Simplified qualitative meal size estimation