Clinical trial NCT04132128: SUCCEED - Soroka Utility for Counting Carbs Easily and Effectively for Diabetes
Official title: SUCCEED - Soroka Utility for Counting Carbs Easily and Effectively for Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Carbohydrates
Insulin Sensitivity
HbA1C
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2019-10-18
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: described in above section
Primary purpose: SUPPORTIVE_CARE

Brief 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). 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.

Eligibility criteria: Inclusion Criteria:

* men or woman with a clinical diagnosis of DM TYPE 1
* Age- \>18
* Insulin treatment: pump or injection in basal- bolus system

Exclusion Criteria:

* No insulin treatment
* 8.5%\> HbA1C.
* Pregnancy or Breastfeeding.
* Critical illness such as ens stage cancer or CHF
* Recurrent hospitalizations.

Primary outcomes:
measure: HbA1c
timeFrame: 6 months after intervention
Secondary outcomes:
measure: patients satisfaction
timeFrame: 6 months after intervention
measure: HbA1C for measuring glucose control
timeFrame: 3 months after intervention
Other outcomes:
Locations:
Study officials:
affiliation: Diabetes Clinic Dietitian, Soroka University Medical Center
name: Shula Witko
role: STUDY_DIRECTOR
References: