Carb Counting vs. Simplified Qualitative Meal-Size Estimation

Launched by RABIN MEDICAL CENTER · Nov 12, 2024

Keywords

ClinConnect Summary

This clinical trial is designed to compare two different methods for managing meals in adolescents with Type 1 Diabetes Mellitus who are starting to use Automated Insulin Delivery (AID) systems. The study will look at whether using precise carbohydrate counting or a simpler method of estimating meal sizes (small, medium, or large) leads to better blood sugar control. About 120 children and teens, aged 6 to 18, who have been diagnosed with Type 1 Diabetes and are starting AID systems, will be randomly placed into one of the two groups. The study will last for six months, with optional follow-ups at 12 and 24 months.

Participants can expect to receive nutrition guidance from a dietitian during their first visit, and they will be monitored regularly for their diabetes management and how they feel about their eating habits. Throughout the study, participants will track their data from the AID systems and complete surveys about their experiences. To be eligible for the trial, participants must have Type 1 Diabetes, be between 6 and 18 years old, and be using insulin for their diabetes management. Some individuals may not qualify if they have other serious health conditions or are taking certain medications. This trial aims to help improve diabetes care and meal management for young people with Type 1 Diabetes.

Gender

ALL

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 -