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-SDS
0.8 (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.