NCT06687434 Carb Counting vs. Simplified Qualitative Meal-Size Estimation
| NCT ID | NCT06687434 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rabin Medical Center |
| Condition | Type 1 Diabetes Mellitus |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-12-15 |
| Primary Completion | 2027-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2024-12-15 with a primary completion date of 2027-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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 -
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06687434 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 18 Years, studying Type 1 Diabetes Mellitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06687434 currently recruiting?
Yes, NCT06687434 is actively recruiting participants. Contact the research team at talo@clalit.org.il for enrollment information.
Where is the NCT06687434 trial being conducted?
This trial is being conducted at Petah Tikva, Israel.
Who is sponsoring the NCT06687434 clinical trial?
NCT06687434 is sponsored by Rabin Medical Center. The trial plans to enroll 120 participants.
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