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

Primary Purpose

Diabetes Mellitus, Carbohydrates, Insulin Sensitivity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
carbohydrate counting
Sponsored by
Soroka University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    study

    control

    Arm Description

    6 meetings with a dietician diabetes educator assimilating simple CC tool

    meeting with dietician as needed with regular education of CC

    Outcomes

    Primary Outcome Measures

    HbA1c
    HbA1C for measuring glucose control

    Secondary Outcome Measures

    patients satisfaction
    patient questionnaire on satisfaction on quality of life. The scale is from 0 (no problem) to 4 (very problematic)
    HbA1C for measuring glucose control
    HbA1C for measuring glucose control

    Full Information

    First Posted
    August 7, 2019
    Last Updated
    May 9, 2023
    Sponsor
    Soroka University Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04132128
    Brief Title
    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

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    November 25, 2015 (Actual)
    Primary Completion Date
    February 28, 2018 (Actual)
    Study Completion Date
    August 5, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Soroka University Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Carbohydrates, Insulin Sensitivity, HbA1C

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    described in above section
    Masking
    None (Open Label)
    Masking Description
    no masking - open label
    Allocation
    Randomized
    Enrollment
    107 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    study
    Arm Type
    Experimental
    Arm Description
    6 meetings with a dietician diabetes educator assimilating simple CC tool
    Arm Title
    control
    Arm Type
    Other
    Arm Description
    meeting with dietician as needed with regular education of CC
    Intervention Type
    Other
    Intervention Name(s)
    carbohydrate counting
    Intervention Description
    taught how to count carbohydrates in their diet with their personal tool
    Primary Outcome Measure Information:
    Title
    HbA1c
    Description
    HbA1C for measuring glucose control
    Time Frame
    6 months after intervention
    Secondary Outcome Measure Information:
    Title
    patients satisfaction
    Description
    patient questionnaire on satisfaction on quality of life. The scale is from 0 (no problem) to 4 (very problematic)
    Time Frame
    6 months after intervention
    Title
    HbA1C for measuring glucose control
    Description
    HbA1C for measuring glucose control
    Time Frame
    3 months after intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Shula Witko
    Organizational Affiliation
    Diabetes Clinic Dietitian, Soroka University Medical Center
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Shula Vitko, Dietitian of Diabetes clinic

    Learn more about this trial

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

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