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 3
Summary results of the per protocol analysis.
Group
value
ELKa
Control
Mean (SD)
Mean (SD)
[%]
13 w
23
7.1 (1.1)
50
7.6 (1.1)
0.149
26 w
22
6.9 (0.8)
52
7.6 (0.8)
0.002
Insulin
Basal insulin [IU/kg/24 h]
13 w
18
0.24 (0.1)
43
0.31 (0.11)
0.005
26 w
18
0.26 (0.1)
44
0.32 (0.1)
0.049
TDBD [IU/kg/24 h]
13 w
18
0.51 (0.15)
43
0.5 (0.14)
0.702
26 w
18
0.52 (0.11)
44
0.5 (0.14)
0.617
TDD [IU/kg/24 h]
13 w
18
0.75 (0.17)
43
0.81 (0.19)
0.298
26 w
18
0.78 (0.11)
44
0.82 (0.18)
0.42
Basal as % of TDD
13 w
18
0.33 (0.12)
43
0.39 (0.12)
0.034
26 w
18
0.34 (0.12)
44
0.4 (0.11)
0.057
Mean glucose level [mg/dL]
13 w
18
156 (29.7)
37
176 (33)
0.041
26 w
18
156 (26.5)
35
162 (30.8)
0.456
13 w
18
158 (35)
37
173 (35.7)
0.141
26 w
18
155 (31)
35
161 (32.9)
0.514
13 w
18
152 (26.5)
36
180 (39)
0.009
26 w
18
159 (26.7)
35
167 (31.9)
0.369
SD of mean glucose level
13 w
18
73.6 (18.8)
37
84.4 (14.6)
0.023
26 w
18
69.2 (14.6)
35
81.1 (20.6)
0.017
13 w
18
72.8 (23.1)
37
82.4 (16.1)
0.078
26 w
18
69.4 (17.3)
35
82 (22)
0.019
13 w
18
65.4 (20.8)
36
81.5 (24.9)
0.022
26 w
18
65.7 (16.5)
35
76.3 (23.3)
0.028
Per protocol analysis concerns patients who received allocated intervention and declared ELKa system usage for more than 50% of meals. , number of patients included in analysis; w, weeks; TDBD, total daily dose of bolus insulin; TDD, total daily dose of insulin. Units are listed in square brackets in the first column. downloaded from insulin pumps. downloaded from blood glucose meters, measured over 24 h. downloaded from blood glucose meters, measured between 07:00 AM and 09.59 PM. downloaded from blood glucose meters, measured between 10:00 PM and 06:59 AM.
