Diabetes MellitusNCT04132128
SUCCEED - Soroka Utility for Counting Carbs Easily and Effectively for Diabetes
A study testing carbohydrate counting in people with Diabetes Mellitus and Carbohydrates, run by Soroka University Medical Center.
Trial summary
Counting Carbohydrates (CC) is the preferable method used to calculate the amount of insulin needed for a meal. This method is employed by patients with type 1 diabetes melitus (T1DM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Carbohydrates, Insulin Sensitivity
- What is being tested?
- carbohydrate counting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- No sites listed yet
- Study dates
- 25 Nov 2015to 5 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men or woman with a clinical diagnosis of DM TYPE 1
- Age- >18
- Insulin treatment: pump or injection in basal- bolus system
Who cannot join
- No insulin treatment
- 8.5%> HbA1C.
- Pregnancy or Breastfeeding.
- Critical illness such as ens stage cancer or CHF
- Recurrent hospitalizations.
About this study
Counting Carbohydrates (CC) is the preferable method used to calculate the amount of insulin needed for a meal. This method is employed by patients with type 1 diabetes melitus (T1DM). the patients receive the general arithmetic calculation of how much insulin to inject for 15 grams/1 portion of carbohydrate (carb to insulin ratio (C:I) and insulin sensitivity (IS). However, Diabetes Educators are often confronted with difficulties guiding their T1DM patient when using this method and find patients get confused calculating the amount of carbs needed. The investigators sought to create a simple tool that would help our patients implement the CC method easily and properly.
Read the detailed description
Objectives: To develop an easily understood CC tool accessible to all T1D patients.
Primary outcome - HbA1c at 3 and 6 months after intervention. Second primary - patients satisfaction with the tool.
Methods: The investigators created a tool which includes two tables with the patients' individual doses calculated by the clinics professional team, displaying his IS and C:I. The first table's values drive from the IS, showing how many insulin units should be given to correct blood sugar levels according to the measured result before the meal, and second drives from the patient's own C:I, which shows how many insulin units should be given according to the chosen food items. Blood glucose target is also decided on an individual basis. Together, with the patient, the investigators create a list containing only food items in one's personal diet with attached values. Protein dishes and fatty items such as oil or an egg appear with the value of zero insulin if that is the correct figure for the particular patient. After filling out the two tables, the investigators apply them in 8 steps 1-measure blood sugar, 2-find the right insulin correction dose according to the 1st table, 3-plan the meal, 4-find the insulin dose for the food items chosen, 5-combine the insulin dose of step 2+4, 6-injection insulin by pen or insulin pump, 7-consume the meal. 8-measure blood sugar 2 hours after meal to make sure the right dose was applied. At all visits the lists are discussed and missing food items are added. Using this tool enables to introduce CC to most patients.The tool has been applied in different languages: Hebrew, Arabic, Russian, English and Amharic and was used by patients whose individual learning skills varied over a very wide spectrum.
Patients were randomized into two groups. Group 1-received the new tool. Group 2-learned carb counting on customary basis. All participants met 6 times with a registered dietician diabetes educator to practice carb counting.
Data collected at recruitments and at the end of the study: HbA1c, daily insulin dosage, lipids profiles and questioners (PAID of WHO).
Subgroup analyses were done according to gender, diabetes years and education.
- Conditions
- Diabetes Mellitus, Carbohydrates, Insulin Sensitivity, HbA1C
- Being tested
- carbohydrate counting
- Medical subject headings
- Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carbohydrate countingOther
taught how to count carbohydrates in their diet with their personal tool
| Study group | Role | What they receive |
|---|---|---|
| study | Experimental | 6 meetings with a dietician diabetes educator assimilating simple CC tool Receives: Other: carbohydrate counting |
| control | Other | meeting with dietician as needed with regular education of CC Receives: Other: carbohydrate counting |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
HbA1C for measuring glucose control
Measured: 6 months after intervention
Secondary outcomes (2)
patients satisfaction
patient questionnaire on satisfaction on quality of life. The scale is from 0 (no problem) to 4 (very problematic)
Measured: 6 months after intervention
HbA1C for measuring glucose control
HbA1C for measuring glucose control
Measured: 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start25 Nov 2015
- Primary completion28 Feb 2018
- Study completion5 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- described in above section
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Idit Liberty MD, Soroka University Medical Center
- Investigators
- Shula Witko, Study director, Diabetes Clinic Dietitian, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04132128
- Sponsor's protocol ID
- SOR- 0320-15 CTIL
- Status last verified
- May 2023
- First submitted
- 7 Aug 2019
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Shula Vitko, Dietitian of Diabetes clinic
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SUCCEED - Soroka Utility for Counting Carbs Easily and Effectively for Diabetes
- ClinicalTrials.gov ID
- NCT04132128
- Acronym / sponsor ID
- SOR- 0320-15 CTIL
- Conditions
- Diabetes Mellitus, Carbohydrates, Insulin Sensitivity, HbA1C
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- 25 Nov 2015 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 5 Aug 2019 (actual)
- First posted
- 18 Oct 2019 (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.
Counting Carbohydrates (CC) is the preferable method used to calculate the amount of insulin needed for a meal. This method is employed by patients with type 1 diabetes melitus (T1DM). the patients receive the general arithmetic calculation of how much insulin to inject for 15 grams/1 portion of carbohydrate (carb to insulin ratio (C:I) and insulin sensitivity (IS). However, Diabetes Educators are often confronted with difficulties guiding their T1DM patient when using this method and find patients get confused calculating the amount of carbs needed. The investigators sought to create a simple tool that would help our patients implement the CC method easily and properly.
Detailed description
Objectives: To develop an easily understood CC tool accessible to all T1D patients.
Primary outcome - HbA1c at 3 and 6 months after intervention. Second primary - patients satisfaction with the tool.
Methods: The investigators created a tool which includes two tables with the patients' individual doses calculated by the clinics professional team, displaying his IS and C:I. The first table's values drive from the IS, showing how many insulin units should be given to correct blood sugar levels according to the measured result before the meal, and second drives from the patient's own C:I, which shows how many insulin units should be given according to the chosen food items. Blood glucose target is also decided on an individual basis. Together, with the patient, the investigators create a list containing only food items in one's personal diet with attached values. Protein dishes and fatty items such as oil or an egg appear with the value of zero insulin if that is the correct figure for the particular patient. After filling out the two tables, the investigators apply them in 8 steps 1-measure blood sugar, 2-find the right insulin correction dose according to the 1st table, 3-plan the meal, 4-find the insulin dose for the food items chosen, 5-combine the insulin dose of step 2+4, 6-injection insulin by pen or insulin pump, 7-consume the meal. 8-measure blood sugar 2 hours after meal to make sure the right dose was applied. At all visits the lists are discussed and missing food items are added. Using this tool enables to introduce CC to most patients.The tool has been applied in different languages: Hebrew, Arabic, Russian, English and Amharic and was used by patients whose individual learning skills varied over a very wide spectrum.
Patients were randomized into two groups. Group 1-received the new tool. Group 2-learned carb counting on customary basis. All participants met 6 times with a registered dietician diabetes educator to practice carb counting.
Data collected at recruitments and at the end of the study: HbA1c, daily insulin dosage, lipids profiles and questioners (PAID of WHO).
Subgroup analyses were done according to gender, diabetes years and education.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- described in above section
| Arm | Type | Receives |
|---|---|---|
| study | Experimental | Other: carbohydrate counting6 meetings with a dietician diabetes educator assimilating simple CC tool |
| control | Other | Other: carbohydrate countingmeeting with dietician as needed with regular education of CC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- men or woman with a clinical diagnosis of DM TYPE 1
- Age- >18
- Insulin treatment: pump or injection in basal- bolus system
Key exclusion criteria (5 listed)
- No insulin treatment
- 8.5%> HbA1C.
- Pregnancy or Breastfeeding.
- Critical illness such as ens stage cancer or CHF
- Recurrent hospitalizations.
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 |
|---|---|---|
| carbohydrate countingtaught how to count carbohydrates in their diet with their personal tool | Other | control, study |
Primary outcome
HbA1c
Time frame: 6 months after intervention
HbA1C for measuring glucose control
2 secondary outcomes
patients satisfaction
Time frame: 6 months after intervention
HbA1C for measuring glucose control
Time frame: 3 months after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Individual participant dataSharing planned: Yes. Shula Vitko, Dietitian of Diabetes clinic
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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. This study is not recruiting at the moment.
Shula Witko study director
Diabetes Clinic Dietitian, Soroka University Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing carbohydrate counting in people with Diabetes Mellitus and Carbohydrates, run by Soroka University Medical Center.
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 5 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: finished, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: 6 months after intervention). 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 11 May 2023.