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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04132128
Enrollment
107
Registered
2019-10-18
Start date
2015-11-25
Completion date
2019-08-05
Last updated
2023-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carbohydrates, Diabetes Mellitus, HbA1C, Insulin Sensitivity

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.

Interventions

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

Sponsors

Soroka University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Masking description

no masking - open label

Intervention model description

described in above section

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
HbA1c6 months after interventionHbA1C for measuring glucose control

Secondary

MeasureTime frameDescription
patients satisfaction6 months after interventionpatient questionnaire on satisfaction on quality of life. The scale is from 0 (no problem) to 4 (very problematic)
HbA1C for measuring glucose control3 months after interventionHbA1C for measuring glucose control

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026