Table 3

Exploratory comparisons—ITT

Variable (N = 19)Closed loopŦControlŦPaired difference¥P valueΦ
Glucose control
 Time within 70–180 mg/dL (%)72.87 (67.83, 79.94)58.72 (51.28, 67.60)12.24 (7.92, 22.9)0.001
 Mean CGM readings (mg/dL)*147.72 ± 15.84161.28 ± 25.10−13.6 ± 19.90.008
 Fasting glucose level (mg/dL)*138.44 ± 18.15156.49 ± 32.02−18.04 ± 19.90.006
Glucose variability
 SD (mg/dL)*33.87 ± 5.7635.74 ± 7.32−1.86 ± 6.620.235
 % Coefficient variable*0.23 ± 0.030.24 ± 0.0500.455
Hypoglycemia
 Total events <70 mg/dL0.16 (0.10, 0.26)0.21 (0.14, 0.32)0 (−0.13, 0.06)0.376
 Total events <60 mg/dL0.06 (0.03, 0.14)0.14 (0.04, 0.19)−0.05 (−0.09, 0)0.016
 Area below 70 mg/dL (mg/dL×min)110.16 (58.82, 231.96)216.21 (84.46, 502.01)−106.2 (−372.08, 60.5)0.036
 Area below 65 mg/dL (mg/dL×min)56.62 (28.40, 160.72)125.50 (44.73, 311.51)−76.00 (−237.24, 28.55)0.044
 LBGI0.66 (0.45, 0.95)0.88 (0.64, 1.64)−0.2 (−1.1, 0.09)0.044
Hyperglycemia
 Time >140 mg/dL (%)50.65 (42.55, 60.82)56.89 (50.60, 65.48)−9.79 (−17.8, 1.57)0.013
 Time >180 mg/dL (%)22.29 (15.86, 30.81)36.63 (27.64, 42.67)−7.80 (−23.39, −4.98)0.002
 Area above 140 mg/dL (mg/dL×min)11,468.82 (7,097.15, 14,744.16)15,568.33 (13,052.78, 23,406.39)−5,423.63(−10,655.14, −2,218.73)0.003
 Area above 180 mg/dL (mg/dL×min)4,226.85 (2,407.29, 6,299.40)6,883.98 (5,603.48, 13,010.86)−3,628.56 (−7,296.24, −510.16)0.003
  High blood glucose index5.21 (3.42, 6.49)6.82 (5.76, 10.45)−2.5 (−5, −0.7)0.002
Overnight insulin delivery (units)
 Total night dose9.02 (6.96, 18.74)10.19 (8.00, 18.82)−0.5 (−1.4, 0.03)0.044
 Delivered basal amount during the night4.91 (3.96, 8.75)5.57 (4.49, 9.74)−0.68 (−1.06, −0.52)<0.001
 Delivered bolus amount during the night4.41 (2.99, 8.95)5.11 (3.02, 6.74)0.24 (−0.89, 0.95)0.968
  • ŦMedian values with the IQR in parentheses.

  • ¥Closed loop minus control. A positive value indicates the value was higher on the closed loop compared with control.

  • ΦComparisons between closed-loop and control nights were performed using the paired nonparametric Wilcoxon signed rank test, unless stated otherwise.

  • *Average values with the SD.

  • ‡Kovatchev LBGI to measure glucose variability (16).

  • ¶Kovatchev high blood glucose index to measure glucose variability (16).