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ELKa system is an advanced toolset which helps performing calculation of carbohydrate (CHO) and fat/protein (FP) exchanges. It consists of ELKa software including database of various meals and nutrients and ELKaPlus digital kitchen scale transmitting weight of products in a real-time to a computer via universal serial bus (USB) port. After choosing the name of particular product from the list, the program gives precise information about the amount of CHO and FP exchanges in serving.
The aim of the study is to investigate the benefit of using ELKa toolset in comparison with standard method of CHO and FP counting on metabolic control in type 1 diabetic children.
A randomized, controlled, parallel, open-label 26-week clinical trial will be conducted in 106 pediatric patients with type 1 diabetes mellitus (DM). Patients will be randomly assigned into two groups: the group A (n=53) using ELKa system for food exchange counting and the group B (n= 53) using standard method.
The glycated hemoglobin levels will be measured in both groups at the beginning, after 3 and 6 months of observation. The group A also will be asked about the frequency of using the toolset. We will also assess secondary endpoints (mentioned below).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control (B) | No Intervention | Patients performing CHO and FP exchanges calculation with standard method. | |
| ELKa (A) | Experimental | Patients counting CHO and FP exchanges with ELKa toolset. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ELKa | Device | ELKa should be used for every meal preparation. After choosing the name of particular product from the list, the program will give precise information about the amount of CHO and FP exchanges in serving. No standard calculation of exchanges need to be performed. |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c (glycated hemoglobin) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c (glycated hemoglobin) | 3 months | |
| ELKa usage frequency | Self-reported in questionnaire | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment satisfaction | Questionnaire regarded treatment satisfaction and wish to continuation. | 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Agnieszka Szypowska, Professor | Medical University of Warsaw | Study Chair |
| Agnieszka Kowalska, MD | Medical University of Warsaw | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Warsaw | Warsaw | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28232949 | Derived | Kowalska A, Piechowiak K, Ramotowska A, Szypowska A. Impact of ELKa, the Electronic Device for Prandial Insulin Dose Calculation, on Metabolic Control in Children and Adolescents with Type 1 Diabetes Mellitus: A Randomized Controlled Trial. J Diabetes Res. 2017;2017:1708148. doi: 10.1155/2017/1708148. Epub 2017 Jan 23. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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|
| ELKa usage frequency |
Self-reported in questionnaire |
| 6 months |
| Post- prandial glycemia | Mean post-prandial glycemia counted after the meal consumed between 1- 6 pm during subsequently 7- 10 days | 3 months |
| Post- prandial glycemia | Mean post-prandial glycemia counted after the meal consumed between 1- 6 pm during subsequently 7- 10 days | 6 months |
| mean diurnal glucose level | 3 months |
| mean diurnal glucose level | 6 months |
| Mean daily insulin dose [Insulin/kg/24h] | 3 months |
| Mean daily insulin dose [Insulin/kg/24h] | 6 months |
| BMI- standard deviation (BMI- sds) | 3 months |
| BMI- standard deviation (BMI- sds) | 6 months |
| Hypoglycemia episodes and severe hypoglycemia events | Hypoglycemia defined as glycemia below 70 mg/dl and, separately, glycemia below 50 mg/dl. Self-reported. | 3 months |
| Hypoglycemia episodes and severe hypoglycemia events | Hypoglycemia defined as glycemia below 70 mg/dl and, separately, glycemia below 50 mg/dl. Self-reported. | 6 months |
| Mean Amplitude of Glycemic Excursions (MAGE) | Measured in subgroup of patients with continuous glucose monitoring system (CGMS) | 3 months |
| Mean Amplitude of Glycemic Excursions (MAGE) | Measured in subgroup of patients with CGMS | 6 months |
| Glucose Area Under the Curve (AUC) | Measured in subgroup of patients with CGMS | 3 months |
| Glucose Area Under the Curve (AUC) | Measured in subgroup of patients with CGMS | 6 months |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |