Impact of ELKa, the Toolset for Food Exchanges Calculation on Metabolic Control in Pediatric Diabetic Patients.
Impact of ELKa, the Toolset for Prandial Insulin Dose Calculation on Metabolic Control in Children and Adolescent With Diabetes Type 1.
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.
Panoramica dello studio
Descrizione dettagliata
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).
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Warsaw, Polonia
- Medical University of Warsaw
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Nessun intervento: control (B)
Patients performing CHO and FP exchanges calculation with standard method.
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Sperimentale: ELKa (A)
Patients counting CHO and FP exchanges with ELKa toolset.
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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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
HbA1c (glycated hemoglobin)
Lasso di tempo: 6 months
|
6 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
HbA1c (glycated hemoglobin)
Lasso di tempo: 3 months
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3 months
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|
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ELKa usage frequency
Lasso di tempo: 3 months
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Self-reported in questionnaire
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3 months
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ELKa usage frequency
Lasso di tempo: 6 months
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Self-reported in questionnaire
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6 months
|
|
Post- prandial glycemia
Lasso di tempo: 3 months
|
Mean post-prandial glycemia counted after the meal consumed between 1- 6 pm during subsequently 7- 10 days
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3 months
|
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Post- prandial glycemia
Lasso di tempo: 6 months
|
Mean post-prandial glycemia counted after the meal consumed between 1- 6 pm during subsequently 7- 10 days
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6 months
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mean diurnal glucose level
Lasso di tempo: 3 months
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3 months
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mean diurnal glucose level
Lasso di tempo: 6 months
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6 months
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|
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Mean daily insulin dose [Insulin/kg/24h]
Lasso di tempo: 3 months
|
3 months
|
|
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Mean daily insulin dose [Insulin/kg/24h]
Lasso di tempo: 6 months
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6 months
|
|
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BMI- standard deviation (BMI- sds)
Lasso di tempo: 3 months
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3 months
|
|
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BMI- standard deviation (BMI- sds)
Lasso di tempo: 6 months
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6 months
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Hypoglycemia episodes and severe hypoglycemia events
Lasso di tempo: 3 months
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Hypoglycemia defined as glycemia below 70 mg/dl and, separately, glycemia below 50 mg/dl.
Self-reported.
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3 months
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Hypoglycemia episodes and severe hypoglycemia events
Lasso di tempo: 6 months
|
Hypoglycemia defined as glycemia below 70 mg/dl and, separately, glycemia below 50 mg/dl.
Self-reported.
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6 months
|
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Mean Amplitude of Glycemic Excursions (MAGE)
Lasso di tempo: 3 months
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Measured in subgroup of patients with continuous glucose monitoring system (CGMS)
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3 months
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Mean Amplitude of Glycemic Excursions (MAGE)
Lasso di tempo: 6 months
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Measured in subgroup of patients with CGMS
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6 months
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Glucose Area Under the Curve (AUC)
Lasso di tempo: 3 months
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Measured in subgroup of patients with CGMS
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3 months
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Glucose Area Under the Curve (AUC)
Lasso di tempo: 6 months
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Measured in subgroup of patients with CGMS
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6 months
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Treatment satisfaction
Lasso di tempo: 6 months
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Questionnaire regarded treatment satisfaction and wish to continuation.
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6 months
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Collaboratori e investigatori
Sponsor
Investigatori
- Cattedra di studio: Agnieszka Szypowska, Professor, Medical University of Warsaw
- Direttore dello studio: Agnieszka Kowalska, MD, Medical University of Warsaw
Pubblicazioni e link utili
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Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- ELKA-01
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