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
  • 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.