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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Insulin Sensitivity; Carbohydrates; HbA1C
• Intervention / Treatment: Other: carbohydrate counting

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 Type: Interventional
• Enrollment (Actual): 107
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: study; 6 meetings with a dietician diabetes educator assimilating simple CC tool	Other: carbohydrate counting; taught how to count carbohydrates in their diet with their personal tool
Other: control; meeting with dietician as needed with regular education of CC	Other: carbohydrate counting; taught how to count carbohydrates in their diet with their personal tool

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	HbA1C for measuring glucose control	6 months after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1C for measuring glucose control	HbA1C for measuring glucose control	3 months after intervention
patients satisfaction	patient questionnaire on satisfaction on quality of life. The scale is from 0 (no problem) to 4 (very problematic)	6 months after intervention

Collaborators and Investigators

• Sponsor: Soroka University Medical Center
• Investigators: Study Director: Shula Witko, Diabetes Clinic Dietitian, Soroka University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2015
• Primary Completion (Actual): February 28, 2018
• Study Completion (Actual): August 5, 2019

Study Registration Dates

• First Submitted: August 7, 2019
• First Submitted That Met QC Criteria: October 17, 2019
• First Posted (Actual): October 18, 2019

Study Record Updates

• Last Update Posted (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Diabetes Mellitus; Insulin Resistance
• Other Study ID Numbers: SOR- 0320-15 CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Shula Vitko, Dietitian of Diabetes clinic
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL