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Register:	ClinicalTrials.gov
Last refreshed on:	30 March 2015
Main ID:	NCT02194517
Date of registration:	16/07/2014
Prospective Registration:	No
Primary sponsor:	Medical University of Warsaw
Public title:	Impact of ELKa, the Toolset for Food Exchanges Calculation on Metabolic Control in Pediatric Diabetic Patients.
Scientific title:	Impact of ELKa, the Toolset for Prandial Insulin Dose Calculation on Metabolic Control in Children and Adolescent With Diabetes Type 1.
Date of first enrolment:	April 2013
Target sample size:	106
Recruitment status:	Completed
URL:	http://clinicaltrials.gov/show/NCT02194517
Study type:	Interventional
Study design:	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Phase:	N/A

Countries of recruitment
Poland

Contacts

Name:	Agnieszka Kowalska, MD
Address:
Telephone:
Email:
Affiliation:	Medical University of Warsaw

Name:	Agnieszka Szypowska, Professor
Address:
Telephone:
Email:
Affiliation:	Medical University of Warsaw

Key inclusion & exclusion criteria

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

Age minimum: N/A
Age maximum: 18 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Type 1 Diabetes Mellitus

Intervention(s)

Device: ELKa

Primary Outcome(s)

HbA1c (glycated hemoglobin) [Time Frame: 6 months]

Secondary Outcome(s)

BMI- standard deviation (BMI- sds) [Time Frame: 3 months]

HbA1c (glycated hemoglobin) [Time Frame: 3 months]

Mean daily insulin dose [Insulin/kg/24h] [Time Frame: 6 months]

Post- prandial glycemia [Time Frame: 6 months]

Mean Amplitude of Glycemic Excursions (MAGE) [Time Frame: 6 months]

Glucose Area Under the Curve (AUC) [Time Frame: 6 months]

mean diurnal glucose level [Time Frame: 3 months]

mean diurnal glucose level [Time Frame: 6 months]

ELKa usage frequency [Time Frame: 6 months]

Mean Amplitude of Glycemic Excursions (MAGE) [Time Frame: 3 months]

ELKa usage frequency [Time Frame: 3 months]

BMI- standard deviation (BMI- sds) [Time Frame: 6 months]

Hypoglycemia episodes and severe hypoglycemia events [Time Frame: 6 months]

Glucose Area Under the Curve (AUC) [Time Frame: 3 months]

Hypoglycemia episodes and severe hypoglycemia events [Time Frame: 3 months]

Mean daily insulin dose [Insulin/kg/24h] [Time Frame: 3 months]

Post- prandial glycemia [Time Frame: 3 months]

Secondary ID(s)

ELKA-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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