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 4
Intragroup change in levels.
Group
Number of pairs
[%], mean (SD)
Change
95% CI
value
Baseline
13 w
26 w
Intention-to-treat approach
ELKa
46
7.59 (1.05)
7.24 (1.07)
(−0.64 to −0.06)
0.011
ELKa
52
7.58 (1.03)
7.45 (1.19)
(−0.38 to 0.12)
0.305
Control
51
7.43 (0.99)
7.6 (1.08)
+0.1
(−0.11 to 0.44)
0.321
Control
53
7.4 (0.99)
7.57 (0.75)
+0.17
(−0.08 to 0.43)
0.178
Per protocol approach
ELKa
23
7.55 (1.2)
7.1 (1.05)
(−0.91 to 0.01)
0.054
ELKa
22
7.48 (1.09)
6.93 (0.84)
(−0.87 to −0.23)
0.002
Control
50
7.41 (0.99)
7.6 (1.09)
+0.15
(−0.08 to 0.47)
0.229
Control
52
7.38 (0.99)
7.58 (0.76)
+0.2
(−0.05 to 0.46)
0.117
Change in mean values within each group over 3 and 6 months. Intention-to-treat analysis concerns all available cases. Per protocol analysis concerns patients who received allocated intervention and declared ELKa system usage for more than 50% of meals.
