Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04132128 |
Other study ID # |
SOR- 0320-15 CTIL |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
November 25, 2015 |
Est. completion date |
August 5, 2019 |
Study information
Verified date |
May 2023 |
Source |
Soroka University Medical Center |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.