Type 1 Diabetes MellitusNCT06687434
Carb Counting vs. Simplified Qualitative Meal-Size Estimation
A study testing accurate carb counting and Simplified qualitative meal size estimation in people with Type 1 Diabetes Mellitus, run by Rabin Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- accurate carb counting and Simplified qualitative meal size estimation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Dec 2024to 15 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- T1D- diagnosed
- Age 6-18 years
- Treated with insulin (multiple daily injections or pump) and intending to initiate treatment with AID systems
Who cannot join
- 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 -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Schneider Children's Medical Center
Petah Tikva, 4920235
Alona Hamou, Msc, 972-545-950277, alonah@clalit.org.il
About this study
Official title: 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.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- accurate carb counting, Simplified qualitative meal size estimation
- Keywords
- Automated insulin delivery system, carb counting
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
accurate carb countingBehavioural
Participants will use precise carb counting to manage their meals
Simplified qualitative meal size estimationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Accurate carb counting | Experimental | Participants will use precise carb counting to manage their meals Receives: Behavioral: accurate carb counting |
| Simplified qualitative meal-size estimation | Experimental | 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. Receives: Behavioral: Simplified qualitative meal size estimation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time in target range (70-18mg/dl)
Measured: Screening, after 4-6 weeks, after 3 months and after 6 months
Hemoglobin A1C
Measured: Screening, after 4-6 weeks, after 3 months and after 6 months
Percentage Continuous glucose monitoting usage
Measured: Screening, after 4-6 weeks, after 3 months and after 6 months
Number of Episodes of severe hypoglycemia
Measured: Screening, after 4-6 weeks, after 3 months and after 6 months
Number of episodes of Diabetic Ketoacidosis
Measured: Screening, after 4-6 weeks, after 3 months and after 6 months
Secondary outcomes (11)
Total daily insulin dose
Measured: at screening, after 4-6 weeks, after 3 months and after 6 months.
basal insulin dose
Measured: at screening, after 4-6 weeks, after 3 months and after 6 months.
Number of manual boluses per day
Measured: at screening, after 4-6 weeks, after 3 months and after 6 months.
Number of announced meals per day
Measured: at screening, after 4-6 weeks, after 3 months and after 6 months.
Daily carbohydrates input
Measured: at screening, after 4-6 weeks, after 3 months and after 6 months.
Percentage of automated insulin delivery use
Measured: at screening, after 4-6 weeks, after 3 months and after 6 months.
Number of automated insulin delivery exits per week
Measured: at screening, after 4-6 weeks, after 3 months and after 6 months.
Percentage of automated boluses
Measured: at screening, after 4-6 weeks, after 3 months and after 6 months.
Score of Diabetes distress according to questionnaire
Measured: At screening and after 6 months
Score of Disordered eating behaviors according to quesiotnnaire
Measured: At screening and after 6 months
Score of Dietary regimen according to questionnaire
Measured: At screening and after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start15 Dec 2024
- Primary completion1 Nov 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06687434
- Sponsor's protocol ID
- RMC-0411-24ctil
- Status last verified
- Oct 2024
- First submitted
- 21 Oct 2024
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carb Counting vs. Simplified Qualitative Meal-Size Estimation- A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06687434
- Acronym / sponsor ID
- RMC-0411-24ctil
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Automated insulin delivery system, carb counting
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 13 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Accurate carb counting | Experimental | Behavioral: accurate carb countingParticipants will use precise carb counting to manage their meals |
| Simplified qualitative meal-size estimation | Experimental | Behavioral: Simplified qualitative meal size estimationParticipants 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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- T1D- diagnosed
- Age 6-18 years
- Treated with insulin (multiple daily injections or pump) and intending to initiate treatment with AID systems
Key exclusion criteria (4 listed)
- 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 -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| accurate carb countingParticipants will use precise carb counting to manage their meals | Behavioural | Accurate carb counting |
| Simplified qualitative meal size estimationparticipants 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. | Behavioural | Simplified qualitative meal-size estimation |
Primary outcome
Percentage of time in target range (70-18mg/dl)
Time frame: Screening, after 4-6 weeks, after 3 months and after 6 months
Hemoglobin A1C
Time frame: Screening, after 4-6 weeks, after 3 months and after 6 months
Percentage Continuous glucose monitoting usage
Time frame: Screening, after 4-6 weeks, after 3 months and after 6 months
Number of Episodes of severe hypoglycemia
Time frame: Screening, after 4-6 weeks, after 3 months and after 6 months
Number of episodes of Diabetic Ketoacidosis
Time frame: Screening, after 4-6 weeks, after 3 months and after 6 months
11 secondary outcomes
Total daily insulin dose
Time frame: at screening, after 4-6 weeks, after 3 months and after 6 months.
basal insulin dose
Time frame: at screening, after 4-6 weeks, after 3 months and after 6 months.
Number of manual boluses per day
Time frame: at screening, after 4-6 weeks, after 3 months and after 6 months.
Number of announced meals per day
Time frame: at screening, after 4-6 weeks, after 3 months and after 6 months.
Daily carbohydrates input
Time frame: at screening, after 4-6 weeks, after 3 months and after 6 months.
Percentage of automated insulin delivery use
Time frame: at screening, after 4-6 weeks, after 3 months and after 6 months.
Number of automated insulin delivery exits per week
Time frame: at screening, after 4-6 weeks, after 3 months and after 6 months.
Percentage of automated boluses
Time frame: at screening, after 4-6 weeks, after 3 months and after 6 months.
Score of Diabetes distress according to questionnaire
Time frame: At screening and after 6 months
Score of Disordered eating behaviors according to quesiotnnaire
Time frame: At screening and after 6 months
Score of Dietary regimen according to questionnaire
Time frame: At screening and after 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing accurate carb counting and Simplified qualitative meal size estimation in people with Type 1 Diabetes Mellitus, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tal Oron, DR. (972-544-290-296, talo@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of time in target range (70-18mg/dl) (time frame: Screening, after 4-6 weeks, after 3 months and after 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.