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 2
Summary results of the intention-to-treat analysis.
Group
value
ELKa
Control
Mean (SD)
Mean (SD)
[%]
Baseline
53
7.6 (1)
53
7.4 (1)
0.283
13 w
46
7.2 (1.1)
51
7.6 (1.1)
0.085
26 w
52
7.4 (1.2)
53
7.6 (0.8)
0.156
Insulin
Basal insulin [IU/kg/24 h]
Baseline
47
0.29 (0.14)
53
0.29 (0.11)
0.823
13 w
39
0.28 (0.14)
44
0.31 (0.11)
0.03
26 w
41
0.27 (0.11)
45
0.32 (0.1)
0.06
TDBD [IU/kg/24 h]
Baseline
47
0.5 (0.14)
53
0.52 (0.18)
0.521
13 w
39
0.53 (0.15)
44
0.5 (0.14)
0.326
26 w
41
0.53 (0.13)
45
0.5 (0.14)
0.445
TDD [IU/kg/24 h]
Baseline
47
0.79 (0.15)
53
0.81 (0.21)
0.479
13 w
39
0.81 (0.19)
44
0.81 (0.19)
0.978
26 w
41
0.8 (0.13)
45
0.82 (0.18)
0.318
Basal as % of TDD
Baseline
47
0.37 (0.14)
53
0.37 (0.12)
0.94
13 w
39
0.35 (0.13)
44
0.39 (0.12)
0.027
26 w
41
0.35 (0.13)
45
0.4 (0.11)
0.067
Mean glucose level [mg/dL]
Baseline
36
163 (36.3)
38
170 (36.5)
0.439
13 w
34
166 (41.7)
37
176 (33)
0.137
26 w
39
164 (34.9)
35
162 (30.8)
0.821
Baseline
36
160 (35.2)
38
171 (43.1)
0.249
13 w
34
169 (46.9)
37
173 (35.7)
0.369
26 w
39
163 (39)
35
161 (32.9)
0.797
Baseline
36
170 (58.1)
37
171 (36.5)
0.254
13 w
34
158 (34.3)
36
180 (39)
0.016
26 w
39
166 (35.8)
35
167 (31.9)
0.929
SD of mean glucose level
Baseline
36
81 (26.2)
38
79.3 (25.8)
0.927
13 w
34
80.2 (25.3)
37
84.4 (14.6)
0.14
26 w
39
78.9 (23.3)
35
81.1 (20.6)
0.327
Baseline
36
79 (25.7)
38
79.8 (26.3)
0.897
13 w
34
79.6 (27.7)
37
82.4 (16.1)
0.597
26 w
39
77.8 (25.3)
35
82 (22)
0.223
Baseline
36
74.5 (35.8)
37
74.7 (28.5)
0.587
13 w
34
74.4 (26.1)
36
81.5 (24.9)
0.239
26 w
39
75.8 (24.7)
35
76.3 (23.3)
0.525
Intention-to-treat analysis concerns all available cases. , 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.
