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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 ± 15.84 161.28 ± 25.10 −13.6 ± 19.9 0.008 
 Fasting glucose level (mg/dL)* 138.44 ± 18.15 156.49 ± 32.02 −18.04 ± 19.9 0.006 
Glucose variability     
 SD (mg/dL)* 33.87 ± 5.76 35.74 ± 7.32 −1.86 ± 6.62 0.235 
 % Coefficient variable* 0.23 ± 0.03 0.24 ± 0.05 0.455 
Hypoglycemia     
 Total events <70 mg/dL 0.16 (0.10, 0.26) 0.21 (0.14, 0.32) 0 (−0.13, 0.06) 0.376 
 Total events <60 mg/dL 0.06 (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 
 LBGI 0.66 (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 index 5.21 (3.42, 6.49) 6.82 (5.76, 10.45) −2.5 (−5, −0.7) 0.002 
Overnight insulin delivery (units)     
 Total night dose 9.02 (6.96, 18.74) 10.19 (8.00, 18.82) −0.5 (−1.4, 0.03) 0.044 
 Delivered basal amount during the night 4.91 (3.96, 8.75) 5.57 (4.49, 9.74) −0.68 (−1.06, −0.52) <0.001 
 Delivered bolus amount during the night 4.41 (2.99, 8.95) 5.11 (3.02, 6.74) 0.24 (−0.89, 0.95) 0.968 
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 ± 15.84 161.28 ± 25.10 −13.6 ± 19.9 0.008 
 Fasting glucose level (mg/dL)* 138.44 ± 18.15 156.49 ± 32.02 −18.04 ± 19.9 0.006 
Glucose variability     
 SD (mg/dL)* 33.87 ± 5.76 35.74 ± 7.32 −1.86 ± 6.62 0.235 
 % Coefficient variable* 0.23 ± 0.03 0.24 ± 0.05 0.455 
Hypoglycemia     
 Total events <70 mg/dL 0.16 (0.10, 0.26) 0.21 (0.14, 0.32) 0 (−0.13, 0.06) 0.376 
 Total events <60 mg/dL 0.06 (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 
 LBGI 0.66 (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 index 5.21 (3.42, 6.49) 6.82 (5.76, 10.45) −2.5 (−5, −0.7) 0.002 
Overnight insulin delivery (units)     
 Total night dose 9.02 (6.96, 18.74) 10.19 (8.00, 18.82) −0.5 (−1.4, 0.03) 0.044 
 Delivered basal amount during the night 4.91 (3.96, 8.75) 5.57 (4.49, 9.74) −0.68 (−1.06, −0.52) <0.001 
 Delivered bolus amount during the night 4.41 (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).

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