Journal of Diabetes Research / 2017 / Article / Tab 2

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 2

Summary results of the intention-to-treat analysis.

Group value
ELKa Control
Mean (SD)Mean (SD)

[%]
 Baseline537.6 (1)537.4 (1)0.283
 13 w467.2 (1.1)517.6 (1.1)0.085
 26 w527.4 (1.2)537.6 (0.8)0.156
Insulin
 Basal insulin [IU/kg/24 h]
  Baseline470.29 (0.14)530.29 (0.11)0.823
  13 w390.28 (0.14)440.31 (0.11)0.03
  26 w410.27 (0.11)450.32 (0.1)0.06
 TDBD [IU/kg/24 h]
  Baseline470.5 (0.14)530.52 (0.18)0.521
  13 w390.53 (0.15)440.5 (0.14)0.326
  26 w410.53 (0.13)450.5 (0.14)0.445
 TDD [IU/kg/24 h]
  Baseline470.79 (0.15)530.81 (0.21)0.479
  13 w390.81 (0.19)440.81 (0.19)0.978
  26 w410.8 (0.13)450.82 (0.18)0.318
 Basal as % of TDD
  Baseline470.37 (0.14)530.37 (0.12)0.94
  13 w390.35 (0.13)440.39 (0.12)0.027
  26 w410.35 (0.13)450.4 (0.11)0.067
Mean glucose level [mg/dL]
  Baseline36163 (36.3)38170 (36.5)0.439
  13 w34166 (41.7)37176 (33)0.137
  26 w39164 (34.9)35162 (30.8)0.821
  Baseline36160 (35.2)38171 (43.1)0.249
  13 w34169 (46.9)37173 (35.7)0.369
  26 w39163 (39)35161 (32.9)0.797
  Baseline36170 (58.1)37171 (36.5)0.254
  13 w34158 (34.3)36180 (39)0.016
  26 w39166 (35.8)35167 (31.9)0.929
SD of mean glucose level
  Baseline3681 (26.2)3879.3 (25.8)0.927
  13 w3480.2 (25.3)3784.4 (14.6)0.14
  26 w3978.9 (23.3)3581.1 (20.6)0.327
  Baseline3679 (25.7)3879.8 (26.3)0.897
  13 w3479.6 (27.7)3782.4 (16.1)0.597
  26 w3977.8 (25.3)3582 (22)0.223
  Baseline3674.5 (35.8)3774.7 (28.5)0.587
  13 w3474.4 (26.1)3681.5 (24.9)0.239
  26 w3975.8 (24.7)3576.3 (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.

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