Comparing carb counting to meal-size estimation for managing Type 1 Diabetes in adolescents
Official title: Carb Counting vs. Simplified Qualitative Meal-Size Estimation- A Randomized Control Trial
Run by Rabin Medical Center · NCT06687434 · Data updated 2026-11-12
This study is testing whether counting carbs or estimating meal sizes helps teenagers with Type 1 Diabetes manage their blood sugar better while using automated insulin delivery systems.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Years to 18 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Rabin Medical Center Academic / other |
| Locations | 1 site (Petah Tikva) |
| Status | Recruiting |
| Started | December 15, 2024 |
| Main results expected | November 1, 2027 |
| Study ends | December 15, 2027 |
| Registry record updated | May 20, 2025 |
| Trial ID | NCT06687434 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adolescents aged 6-18 years diagnosed with Type 1 Diabetes who are starting treatment with an Automated Insulin Delivery system.
✕Probably not a fit
Patients with unstable medical conditions or those not diagnosed with Type 1 Diabetes may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the effectiveness of two different meal management strategies for adolescents with Type 1 Diabetes using Automated Insulin Delivery (AID) systems. Participants will be randomly assigned to either an accurate carb counting group or a simplified qualitative meal-size estimation group, with both groups receiving nutrition guidance from a dietitian. The study will assess glucose control parameters and patient-related outcomes over a 6-month period, with optional follow-up assessments at 12 and 24 months. The goal is to determine which method provides better management of diabetes in this population.
Why it matters
Potential benefit: If successful, this study could improve diabetes management strategies for adolescents, leading to better glucose control and overall health outcomes.
How similar studies have gone: While there have been studies on carb counting and diabetes management, this specific comparison of qualitative meal-size estimation versus accurate carb counting in adolescents is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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 -
Where it's running
-
Schneider Children's Medical Center
Petah Tikva, Israel Recruiting
Study contacts
- Study coordinator: Tal Oron, DR.
- Email: talo@clalit.org.il
- Phone: 972-544-290-296
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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VV-14300: a gene therapy approach for adults with type 1 diabetes not well controlled on an automated insulin system
This trial tests VV-14300 in adults with type 1 diabetes who aren’t reaching their blood sugar goals despite using an automated insulin delivery system.
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New gene therapies VV-14299 and VV-14300 for adults with Type 1 Diabetes failing automated insulin delivery
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.