Carb Counting vs. Simplified Qualitative Meal-Size Estimation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: accurate carb counting, Simplified qualitative meal size estimation.
- Who it may be relevant to
- Registry conditions: Type 1 Diabetes Mellitus. Basic parameters: 6 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Carb Counting vs. Simplified Qualitative Meal-Size Estimation- A Randomized Control Trial
Overview
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.
Interventions
- Behavioral accurate carb counting
Participants will use precise carb counting to manage their meals - Behavioral 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.
Primary outcome measures
- Percentage of time in target range (70-18mg/dl) [Time frame: Screening, after 4-6 weeks, after 3 months and after 6 months]
- Hemoglobin A1C [Time frame: Screening, after 4-6 weeks, after 3 months and after 6 months]
- Percentage Continuous glucose monitoting usage [Time frame: Screening, after 4-6 weeks, after 3 months and after 6 months]
- Number of Episodes of severe hypoglycemia [Time frame: Screening, after 4-6 weeks, after 3 months and after 6 months]
- Number of episodes of Diabetic Ketoacidosis [Time frame: Screening, after 4-6 weeks, after 3 months and after 6 months]
Secondary outcome measures (11)
- Total daily insulin dose [Time frame: at screening, after 4-6 weeks, after 3 months and after 6 months.]
- basal insulin dose [Time frame: at screening, after 4-6 weeks, after 3 months and after 6 months.]
- Number of manual boluses per day [Time frame: at screening, after 4-6 weeks, after 3 months and after 6 months.]
- Number of announced meals per day [Time frame: at screening, after 4-6 weeks, after 3 months and after 6 months.]
- Daily carbohydrates input [Time frame: at screening, after 4-6 weeks, after 3 months and after 6 months.]
- Percentage of automated insulin delivery use [Time frame: at screening, after 4-6 weeks, after 3 months and after 6 months.]
- Number of automated insulin delivery exits per week [Time frame: at screening, after 4-6 weeks, after 3 months and after 6 months.]
- Percentage of automated boluses [Time frame: at screening, after 4-6 weeks, after 3 months and after 6 months.]
- Score of Diabetes distress according to questionnaire [Time frame: At screening and after 6 months]
- Score of Disordered eating behaviors according to quesiotnnaire [Time frame: At screening and after 6 months]
- Score of Dietary regimen according to questionnaire [Time frame: At screening and after 6 months]
Eligibility criteria
Inclusion criteria
- T1D- diagnosed
- Age 6-18 years
- Treated with insulin (multiple daily injections or pump) and intending to initiate treatment with AID systems
Exclusion criteria
- Non-T1D
- 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 -
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Israel · 1 center
- Schneider Children's Medical Center — Petah Tikva
Identifiers
NCT: NCT06687434 · RMC-0411-24ctil