Carb Counting vs. Simplified Qualitative Meal-Size Estimation
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 21, 2024
CompletedFirst Posted
Study publicly available on registry
November 13, 2024
CompletedStudy Start
First participant enrolled
December 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 15, 2027
May 20, 2025
October 1, 2024
2.9 years
October 21, 2024
May 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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 Outcomes (11)
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.
- +6 more secondary outcomes
Study Arms (2)
Accurate carb counting
EXPERIMENTALParticipants will use precise carb counting to manage their meals
Simplified qualitative meal-size estimation
EXPERIMENTALParticipants 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.
Interventions
Participants will use precise carb counting to manage their meals
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.
Eligibility Criteria
You may qualify if:
- T1D- diagnosed
- Age 6-18 years
- Treated with insulin (multiple daily injections or pump) and intending to initiate treatment with AID systems
You may not qualify if:
- Non-T1D
- Unstable medical conditions (other than diabetes) that may impact weight or diabetes management (as severe psychiatric disorders, various syndromes)
- Use of medications that may impact weight or diabetes management (as use of steroids for an extended period of time. use of GLP-1)
- Inability to understand the information, material and questionnaires of the study -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Schneider Children's Medical Center
Petah Tikva, 4920235, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2024
First Posted
November 13, 2024
Study Start
December 15, 2024
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
December 15, 2027
Last Updated
May 20, 2025
Record last verified: 2024-10