Comparing carb counting to meal-size estimation for managing Type 1 Diabetes in adolescents
Carb Counting vs. Simplified Qualitative Meal-Size Estimation- A Randomized Control Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 6 Years to 18 Years |
| Sex | All |
| Sponsor | Rabin Medical Center Academic / other |
| Locations | 1 site (Petah Tikva) |
| Trial ID | NCT06687434 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with unstable medical conditions or those not diagnosed with Type 1 Diabetes may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Petah Tikva
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.