Journal of Diabetes Research / 2017 / Article / Tab 4

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 4

Intragroup change in levels.

GroupNumber of pairs [%], mean (SD)Change95% CI value
Baseline13 w26 w

Intention-to-treat approach
ELKa467.59 (1.05)7.24 (1.07)(−0.64 to −0.06)0.011
ELKa527.58 (1.03)7.45 (1.19)(−0.38 to 0.12)0.305
Control517.43 (0.99)7.6 (1.08)+0.1(−0.11 to 0.44)0.321
Control537.4 (0.99)7.57 (0.75)+0.17(−0.08 to 0.43)0.178
Per protocol approach
ELKa237.55 (1.2)7.1 (1.05)(−0.91 to 0.01)0.054
ELKa227.48 (1.09)6.93 (0.84)(−0.87 to −0.23)0.002
Control507.41 (0.99)7.6 (1.09)+0.15(−0.08 to 0.47)0.229
Control527.38 (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.

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