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
Joint Authors
Ramatowska, Anna
Szypowska, Agnieszka
Piechowiak, Katarzyna
Kowalska, Agnieszka
Source
Issue
Vol. 2017, Issue 2017 (31 Dec. 2017), pp.1-9, 9 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2017-01-23
Country of Publication
Egypt
No. of Pages
9
Main Subjects
Abstract EN
Background.
The ELKa system is composed of computer software, with a database of nutrients, and a dedicated USB kitchen scale.
It was designed to automatize the everyday calculations of food exchanges and prandial insulin doses.
Aim.
To investigate the influence of the ELKa on metabolic control in children with type 1 diabetes mellitus (T1DM).
Methods.
A randomized, parallel, open-label clinical trial involved 106 patients aged <18 years with T1DM, Hb A 1C ≤ 10 % , undergoing intensive insulin therapy, allocated to the intervention group, who used the ELKa ( n = 53 ), or the control group ( n = 53 ), who used conventional calculation methods.
Results.
After the 26-week follow-up, the intention-to-treat analysis showed no differences to all endpoints.
In per protocol analysis, 22/53 (41.5%) patients reporting ELKa usage for >50% of meals achieved lower Hb A 1C levels ( P = 0.002 ), lower basal insulin amounts ( P = 0.049 ), and lower intrasubject standard deviation of blood glucose levels ( P = 0.023 ) in comparison with the control.
Moreover, in the intervention group, significant reduction of Hb A 1C level, by 0.55% point ( P = 0.002 ), was noted.
No intergroup differences were found in the hypoglycemic episodes, BMI-SDS, bolus insulin dosage, and total daily insulin dosage.
Conclusions.
The ELKa system improves metabolic control in children with T1DM under regular usage.
The trial is registered at ClinicalTrials.gov, number NCT02194517.
American Psychological Association (APA)
Kowalska, Agnieszka& Piechowiak, Katarzyna& Ramatowska, Anna& Szypowska, Agnieszka. 2017. 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. Journal of Diabetes Research،Vol. 2017, no. 2017, pp.1-9.
https://search.emarefa.net/detail/BIM-1173847
Modern Language Association (MLA)
Kowalska, Agnieszka…[et al.]. 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. Journal of Diabetes Research No. 2017 (2017), pp.1-9.
https://search.emarefa.net/detail/BIM-1173847
American Medical Association (AMA)
Kowalska, Agnieszka& Piechowiak, Katarzyna& Ramatowska, Anna& Szypowska, Agnieszka. 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. Journal of Diabetes Research. 2017. Vol. 2017, no. 2017, pp.1-9.
https://search.emarefa.net/detail/BIM-1173847
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1173847