Carb Counting vs. Simplified Qualitative Meal-Size Estimation

Carb Counting vs. Simplified Qualitative Meal-Size Estimation- A Randomized Control Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Behavioral: accurate carb counting; Behavioral: Simplified qualitative meal size estimation

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tal Oron, DR.; Phone Number: 972-544-290-296; Email: talo@clalit.org.il
• Study Contact Backup: Name: Michal Gilon Keren, Phd; Phone Number: 972-524-311292; Email: michalgk@clalit.org.il

Study Locations

• Israel
  • Petah tikva, Israel, 4920235
    • Recruiting
    • Schneider Children's Medical Center
    • Contact: Alona Hamou, Msc; Phone Number: 972-545-950277; Email: alonah@clalit.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Accurate carb counting; Participants will use precise carb counting to manage their meals	Behavioral: accurate carb counting; Participants will use precise carb counting to manage their meals
Experimental: 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 assessment.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of time in target range (70-18mg/dl)	Screening, after 4-6 weeks, after 3 months and after 6 months
Hemoglobin A1C	Screening, after 4-6 weeks, after 3 months and after 6 months
Percentage Continuous glucose monitoting usage	Screening, after 4-6 weeks, after 3 months and after 6 months
Number of Episodes of severe hypoglycemia	Screening, after 4-6 weeks, after 3 months and after 6 months
Number of episodes of Diabetic Ketoacidosis	Screening, after 4-6 weeks, after 3 months and after 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Total daily insulin dose	at screening, after 4-6 weeks, after 3 months and after 6 months.
basal insulin dose	at screening, after 4-6 weeks, after 3 months and after 6 months.
Number of manual boluses per day	at screening, after 4-6 weeks, after 3 months and after 6 months.
Number of announced meals per day	at screening, after 4-6 weeks, after 3 months and after 6 months.
Daily carbohydrates input	at screening, after 4-6 weeks, after 3 months and after 6 months.
Percentage of automated insulin delivery use	at screening, after 4-6 weeks, after 3 months and after 6 months.
Number of automated insulin delivery exits per week	at screening, after 4-6 weeks, after 3 months and after 6 months.
Percentage of automated boluses	at screening, after 4-6 weeks, after 3 months and after 6 months.
Score of Diabetes distress according to questionnaire	At screening and after 6 months
Score of Disordered eating behaviors according to quesiotnnaire	At screening and after 6 months
Score of Dietary regimen according to questionnaire	At screening and after 6 months

Collaborators and Investigators

• Sponsor: Rabin Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 15, 2027

Study Registration Dates

• First Submitted: October 21, 2024
• First Submitted That Met QC Criteria: November 12, 2024
• First Posted (Actual): November 13, 2024

Study Record Updates

• Last Update Posted (Estimated): May 20, 2025
• Last Update Submitted That Met QC Criteria: May 15, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Automated insulin delivery system; carb counting
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: RMC-0411-24ctil

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No