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Completed

NCT Number: NCT04132128

SUCCEED - Soroka Utility for Counting Carbs Easily and Effectively for Diabetes

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

carbohydrate counting

Other

taught how to count carbohydrates in their diet with their personal tool

Primary outcomes

  1. HbA1c

    Time frame: 6 months after intervention

    HbA1C for measuring glucose control

Secondary outcomes

  1. patients satisfaction

    Time frame: 6 months after intervention

    patient questionnaire on satisfaction on quality of life. The scale is from 0 (no problem) to 4 (very problematic)

  2. HbA1C for measuring glucose control

    Time frame: 3 months after intervention

    HbA1C for measuring glucose control

Sponsors and collaborators

Lead sponsor

Soroka University Medical Center

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Oct 18, 2019
Registry last updated
May 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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