Type 1 Diabetes Mellitus
Conditions
Keywords
diabetes, diet control toolset, food exchanges, CHO, FP
Brief summary
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.
Detailed description
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).
Interventions
DEVICEELKa
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.
Sponsors
Medical University of Warsaw
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* Age under 18 y * Confirmed DM type 1 * DM for \> 1 year * HbA1c ≤ 10% * Computer meeting ELKa system minimum requirements * Kitchen arrangement providing enough space for computer with ELKa system * Written informed consent
Exclusion criteria
* DM other than type 1 * Duration of diabetes \< 1 year * Conventional insulin therapy * Nutritional disorders * Celiac disease recognized in less than 4 months before inclusion * Preceding experience with software * Expected 21 or more consecutive days pausing in system usage * Any medical condition, which, in the opinion of the investigator, would interfere with the evaluation of the subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c (glycated hemoglobin) | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c (glycated hemoglobin) | 3 months | — |
| ELKa usage frequency | 3 months | Self-reported in questionnaire |
| Post- prandial glycemia | 3 months | Mean post-prandial glycemia counted after the meal consumed between 1- 6 pm during subsequently 7- 10 days |
| mean diurnal glucose level | 3 months | — |
| BMI- standard deviation (BMI- sds) | 3 months | — |
| Hypoglycemia episodes and severe hypoglycemia events | 3 months | Hypoglycemia defined as glycemia below 70 mg/dl and, separately, glycemia below 50 mg/dl. Self-reported. |
| Mean Amplitude of Glycemic Excursions (MAGE) | 3 months | Measured in subgroup of patients with continuous glucose monitoring system (CGMS) |
| Glucose Area Under the Curve (AUC) | 3 months | Measured in subgroup of patients with CGMS |
| Mean daily insulin dose [Insulin/kg/24h] | 3 months | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Treatment satisfaction | 6 months | Questionnaire regarded treatment satisfaction and wish to continuation. |
Countries
Poland
Outcome results
None listed