Journal of Diabetes Research / 2017 / Article / Tab 3

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 3

Summary results of the per protocol analysis.

Group value
ELKaControl
Mean (SD)Mean (SD)

[%]
 13 w237.1 (1.1)507.6 (1.1)0.149
 26 w226.9 (0.8)527.6 (0.8)0.002
Insulin
 Basal insulin [IU/kg/24 h]
  13 w180.24 (0.1)430.31 (0.11)0.005
  26 w180.26 (0.1)440.32 (0.1)0.049
 TDBD [IU/kg/24 h]
  13 w180.51 (0.15)430.5 (0.14)0.702
  26 w180.52 (0.11)440.5 (0.14)0.617
 TDD [IU/kg/24 h]
  13 w180.75 (0.17)430.81 (0.19)0.298
  26 w180.78 (0.11)440.82 (0.18)0.42
 Basal as % of TDD
  13 w180.33 (0.12)430.39 (0.12)0.034
  26 w180.34 (0.12)440.4 (0.11)0.057
Mean glucose level [mg/dL]
  13 w18156 (29.7)37176 (33)0.041
  26 w18156 (26.5)35162 (30.8)0.456
  13 w18158 (35)37173 (35.7)0.141
  26 w18155 (31)35161 (32.9)0.514
  13 w18152 (26.5)36180 (39)0.009
  26 w18159 (26.7)35167 (31.9)0.369
SD of mean glucose level
  13 w1873.6 (18.8)3784.4 (14.6)0.023
  26 w1869.2 (14.6)3581.1 (20.6)0.017
  13 w1872.8 (23.1)3782.4 (16.1)0.078
  26 w1869.4 (17.3)3582 (22)0.019
  13 w1865.4 (20.8)3681.5 (24.9)0.022
  26 w1865.7 (16.5)3576.3 (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.

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