Clinical Study

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

Table 1

Baseline characteristics of the study population.

ELKa ()Control () value

Men ( (%))20 (37.7%)22 (41.5%)0.843
Age at inclusion [years]9.8 (4.3)12.1 (3.7)0.006
Living in town > 20,000 habitants ( (%))36 (67.9%)29 (54.7%)0.231
Diabetes duration [years]4.52 (2.7)5.4 (3.5)0.266
[%]7.6 (1)7.4 (1)0.283
Treatment with CSII ( (%))53 (100%)53 (100%)1
TDD [IU/kg/24 h]0.79 (0.15)0.81 (0.2)0.479
Basal [IU/kg/24 h]0.23 (0.1)0.3 (0.1)0.429
BMI-SDS0.8 (0.8)0.6 (1)0.351
[/24 h]7.5 (1.8)7.4 (1.7)0.826
Family members involved in CHO/FP exchanges []2.2 (0.8)2 (1)0.104
Caregiver’s [years]38.6 (7)39.5 (6)0.467
Caregivers who completed at least upper secondary education ( (%))47 (88.7%)47 (88.7%)1
Caregivers using computer for >1/ ( (%))49 (92.4%)42 (79.2%)0.092
Caregivers having difficulties with computer ( (%))2 (3.8%)5 (9.4%)0.437

Values are mean (SD) unless stated otherwise in round brackets. Units are shown in square brackets. CSII: Continuous Subcutaneous Insulin Infusion; TDD: total daily dose of insulin; BMI–SDS: Body Mass Index-Standard Deviation Score; SMBG: self-monitoring of blood glucose; CHO: carbohydrates; FP: fat/protein.
-reported at the baseline.