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
About this trial
This is an interventional supportive care trial for Diabetes Mellitus
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.
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
NCT ID
NCT04132128
First Posted
August 7, 2019
Last Updated
May 9, 2023
Sponsor
Soroka University Medical Center
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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