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Table 2

Primary end points analysis—ITT and per protocol

Closed loopŦControlŦPaired difference¥P
Variable ITT (N = 19)     
 Primary     
  Time glucose level spent below 70 mg/dL (%) 2.53 (1.33, 3.78) 5.16 (2.03, 7.32) −1.86 (−4.85, −0.33) 0.020 
 Secondary     
  Time within 70–140 mg/dL (%) 47.41 (35.13, 55.86) 36.36 (30.76, 40.90) 13.48 (1.33, 20.55) 0.003 
  Time glucose level spent below 50 mg/dL (%) 0.25 (0.01, 1.07) 0.64 (0.12, 1.35) −0.26 (−0.87, 0.06) 0.124 
  Time glucose level spent above 240 mg/dL (%) 5.01 (2.63, 7.77) 8.82 (5.94, 19.23) −3.69 (−10.67, −0.89) 0.001 
Variable per protocol (N = 18)     
 Primary     
  Time glucose level spent below 70 mg/dL (%) 2.09 (0.90, 2.67) 4.72 (1.97, 7.43) −1.77 (−5.05, 0) 0.014 
 Secondary     
  Time within 70–140 mg/dL (%) 49.14 (36.48, 57.42) 36.21 (29.99, 41.30) 15.19 (3.04, 21.36) 0.002 
  Time glucose level spent below 50 mg/dL (%) 0.07 (0.00, 0.34) 0.51 (0.11, 1.12) −0.24 (−0.86, 0.13) 0.044 
  Time glucose level spent above 240 mg/dL (%) 3.83 (2.52, 5.07) 8.71 (5.52, 18.07) −5.32 (−8.45, −2.98) 0.001 
Closed loopŦControlŦPaired difference¥P
Variable ITT (N = 19)     
 Primary     
  Time glucose level spent below 70 mg/dL (%) 2.53 (1.33, 3.78) 5.16 (2.03, 7.32) −1.86 (−4.85, −0.33) 0.020 
 Secondary     
  Time within 70–140 mg/dL (%) 47.41 (35.13, 55.86) 36.36 (30.76, 40.90) 13.48 (1.33, 20.55) 0.003 
  Time glucose level spent below 50 mg/dL (%) 0.25 (0.01, 1.07) 0.64 (0.12, 1.35) −0.26 (−0.87, 0.06) 0.124 
  Time glucose level spent above 240 mg/dL (%) 5.01 (2.63, 7.77) 8.82 (5.94, 19.23) −3.69 (−10.67, −0.89) 0.001 
Variable per protocol (N = 18)     
 Primary     
  Time glucose level spent below 70 mg/dL (%) 2.09 (0.90, 2.67) 4.72 (1.97, 7.43) −1.77 (−5.05, 0) 0.014 
 Secondary     
  Time within 70–140 mg/dL (%) 49.14 (36.48, 57.42) 36.21 (29.99, 41.30) 15.19 (3.04, 21.36) 0.002 
  Time glucose level spent below 50 mg/dL (%) 0.07 (0.00, 0.34) 0.51 (0.11, 1.12) −0.24 (−0.86, 0.13) 0.044 
  Time glucose level spent above 240 mg/dL (%) 3.83 (2.52, 5.07) 8.71 (5.52, 18.07) −5.32 (−8.45, −2.98) 0.001 

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.

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