Clinical trial NCT06687434: Carb Counting vs. Simplified Qualitative Meal-Size Estimation
Official title: Carb Counting vs. Simplified Qualitative Meal-Size Estimation- A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: Automated insulin delivery system
carb counting
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2024-11-13
Enrollment: 120
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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 -

Primary outcomes:
measure: Percentage of time in target range (70-18mg/dl)
timeFrame: Screening, after 4-6 weeks, after 3 months and after 6 months
measure: Hemoglobin A1C
timeFrame: Screening, after 4-6 weeks, after 3 months and after 6 months
measure: Percentage Continuous glucose monitoting usage
timeFrame: Screening, after 4-6 weeks, after 3 months and after 6 months
measure: Number of Episodes of severe hypoglycemia
timeFrame: Screening, after 4-6 weeks, after 3 months and after 6 months
measure: Number of episodes of Diabetic Ketoacidosis
timeFrame: Screening, after 4-6 weeks, after 3 months and after 6 months
Secondary outcomes:
measure: Total daily insulin dose
timeFrame: at screening, after 4-6 weeks, after 3 months and after 6 months.
measure: basal insulin dose
timeFrame: at screening, after 4-6 weeks, after 3 months and after 6 months.
measure: Number of manual boluses per day
timeFrame: at screening, after 4-6 weeks, after 3 months and after 6 months.
measure: Number of announced meals per day
timeFrame: at screening, after 4-6 weeks, after 3 months and after 6 months.
measure: Daily carbohydrates input
timeFrame: at screening, after 4-6 weeks, after 3 months and after 6 months.
measure: Percentage of automated insulin delivery use
timeFrame: at screening, after 4-6 weeks, after 3 months and after 6 months.
measure: Number of automated insulin delivery exits per week
timeFrame: at screening, after 4-6 weeks, after 3 months and after 6 months.
measure: Percentage of automated boluses
timeFrame: at screening, after 4-6 weeks, after 3 months and after 6 months.
measure: Score of Diabetes distress according to questionnaire
timeFrame: At screening and after 6 months
measure: Score of Disordered eating behaviors according to quesiotnnaire
timeFrame: At screening and after 6 months
measure: Score of Dietary regimen according to questionnaire
timeFrame: At screening and after 6 months
Other outcomes:
Locations:
city: Petah tikva
country: Israel
facility: Schneider Children's Medical Center
Study officials:
References: