Table 3

Main and secondary outcomes during daytime (0800–2000), morning (0800–1200), and afternoon (1200–2000)

Intention-to-treat analysis
24-h AP (D/N-AP)E/N-APControl period (SAP)Paired differences (with CI)* E/N-AP – D/N-AP SAP – D/N-AP SAP – E/N-APP value
(n = 20)(n = 20)(n = 20)(n = 20)
Daytime (0800–2000)      
 Mean glucose, mmol/L 9.0 ± 0.5 9.2 ± 1.2 9.1 ± 1.0 0.3 (−0.2, 0.7) 0.38 
0.1 (−0.4, 0.6) 0.83 
−0.1 (−0.6, 0.3) 0.73 
 SD of glucose, mmol/L 3.2 ± 0.6 3.4 ± 0.7 3.3 ± 0.6 0.3 (0.1, 0.5) 0.003 
0.2 (−0.0, 0.4) 0.15 
−0.2 (−0.3, 0.1) 0.25 
 Time spent at glucose concentration, %      
  4.4–7.8 mmol/L 35.6 ± 6.5 34.1 ± 9.3 33.4 ± 8.8 −1.4 (−5.8, 3.0) 0.72 
−2.2 (−6.6, 2.3) 0.46 
−0.75 (−5.2, 3.7) 0.91 
  3.9–10 mmol/L 64.9 ± 8.1 61.2 ± 11.7 60.7 ± 10.3 −3.7 (−8.4, 1.0) 0.15 
−4.2 (−8.9, 0.6) 0.09 
−0.5 (−5.2, 4.3) 1.00 
  >10 mmol/L 32.8 ± 7.8 35.9 ± 12.1 35.8 ± 11.4 3.1 (−2.1, 8.2) 0.32 
3.0 (−2.1, 8.2) 0.34 
−0.1 (−5.2, 5.1) 1.00 
  <3.9 mmol/L 2.3 ± 1.3 2.9 ± 1.9 3.4 ± 2.2 0.6 (−0.3, 1.6) 0.25 
1.2 (0.2, 2.1) 0.01 
0.5 (−0.4, 1.4) 0.39 
  <2.8 mmol/L 0.2 (0.1, 0.3) 0.1 (0.0, 0.3) 0.4 (0.2, 0.6)  0.79 
0.27 
0.64 
 No. of hypoglycemic events per week      
  <3.9 mmol/L 3.3 ± 1.8 3.4 ± 1.9 3.9 ± 2.3 0.1 (−0.9, 1.2) 0.94 
0.6 (−0.4, 1.7) 0.34 
0.5 (−0.6, 1.5) 0.54 
  <2.8 mmol/L 0.9 (0.4, 1.1) 0.5 (0.3, 1.2) 0.9 (0.6, 1.7)  0.99 
0.35 
0.27 
 Blood glucose indices      
  Low 0.6 ± 0.3 0.7 ± 0.4 0.8 ± 0.4 0.1 (−0.1, 0.3) 0.31 
0.2 (0.0, 0.4) 0.02 
0.1 (−0.1, 0.3) 0.37 
  High 7.2 (6.1, 8.8) 7.5 (5.9, 10.1) 7.4 (6.7, 8.8)  0.51 
0.71 
0.95 
 Insulin need, IU/day 19.3 (16.1, 31.8) 18.5 (15.5, 24.9) 22.9 (18.2, 27.5)  0.74 
0.71 
0.28 
 Time in closed-loop over daytime, % 73.9 ± 14.3 10.4 ± 6.1 – – – 
Morning (0800–1200)      
 Mean glucose, mmol/L 8.5 ± 0.8 8.7 ± 1.0 9.1 ± 1.3 0.2 (−0.3, 0.7) 0.60 
0.6 (0.1, 1.1) 0.03 
0.4 (−0.2, 0.9) 0.22 
 SD of glucose, mmol/L 2.7 ± 0.5 3.1 ± 0.5 2.9 ± 0.5 0.3 (0.1, 0.6) 0.02 
0.2 (−0.1, 0.4) 0.30 
−0.2 (−0.4, 0.1) 0.36 
 Time spent at glucose concentration, %      
  4.4–7.8 mmol/L 42.4 ± 12.4 40.6 ± 12.9 34.5 ± 12.5 −1.8 (−8.0, 4.5) 0.77 
−7.9 (−14.1,-1.6) 0.01 
−6.1 (−12.3, 0.1) 0.06 
  3.9–10 mmol/L 72.3 ± 10.6 68.6 ± 9.6 62.7 ± 15.4 −3.7 (−10.3, 2.9) 0.36 
−9.6 (−16.2, −3.0) 0.003 
−5.9 (−12.5, 0.7) 0.09 
  >10 mmol/L 25.6 ± 10.7 29.1 ± 10.2 35.1 ± 16.4 3.5 (−3.4, 10.3) 0.44 
9.5 (2.6, 16.3) 0.005 
6.0 (−0.9, 12.8) 0.10 
  <3.9 mmol/L 1.5 (0.3, 3.0) 1.4 (0.8, 3.2) 1.7 (0.9, 3.1)  0.88 
0.88 
1.00 
  <2.8 mmol/L 0.0 (0.0, 0.3) 0.0 (0.0, 0.1) 0.0 (0.0, 0.3)  0.78 
0.88 
1.00 
 No. of hypoglycemic events per week      
  <3.9 mmol/L 0.9 ± 0.8 1.0 ± 0.8) 1.0 ± 0.7 0.1 (−0.4, 0.5) 0.93 
0.0 (−0.4, 0.5) 0.98 
−0.0 (−0.5, 0.4) 0.99 
  <2.8 mmol/L 0.1 (0.0, 0.5) 0.0 (0.0, 0.3) 0.1 (0.0, 0.3)  0.72 
0.60 
0.98 
 Blood glucose indices      
  Low 0.6 ± 0.4 0.6 ± 0.5) 0.6 ± 0.4 0.1 (−0.1, 0.3) 0.74 
0.0 (−0.2, 0.2) 0.94 
−0.0 (−0.2, 0.2) 0.91 
  High 5.4 (3.9, 6.2) 6.8 (4.4, 8.2) 7.0 (5.8, 8.9)  0.51 
0.19 
0.80 
 Insulin need, IU/morning 6.0 ± 2.4 5.2 ± 2.5 6.9 ± 3.5 −0.8 (−2.1, 0.5) 0.32 
0.9 (−0.4, 2.3) 0.23 
1.7 (0.4, 3.1) 0.009 
 Time in closed-loop over morning, % 70.7 ± 15.0 8.2 ± 8.1 – – – 
Afternoon (1200–2000)      
 Mean glucose, mmol/L 9.2 ± 0.7 9.5 ± 1.4 9.1 ± 1.0 0.3 (−0.3, 0.8) 0.40 
−0.1 (−0.7, 0.4) 0.88 
−0.4 (−1.0, 0.1) 0.19 
 SD of glucose, mmol/L 3.3 ± 0.6 3.5 ± 0.8 3.4 ± 0.6  0.07 
0.25 
0.80 
 Time spent at glucose concentration, %      
  4.4–7.8 mmol/L 32.2 ± 7.0 31.0 ± 9.1 32.8 ± 9.0 −1.3 (−6.3, 3.8) 0.81 
0.6 (−4.4, 5.6) 0.95 
1.9 (−3.1, 6.9) 0.64 
  3.9–10 mmol/L 61.2 ± 9.7 57.5 ± 13.7 59.6 ± 10.1 −3.8 (−8.9, 1.4) 0.19 
−1.6 (−6.8, 3.6) 0.73 
2.1 (−3.0, 7.3) 0.57 
  >10 mmol/L 36.3 ± 9.4 39.3 ± 14.1 36.3 ± 11.0 3.0 (−2.6, 8.5) 0.41 
−0.0 (−5.6, 5.5) 1.00 
−3.0 (−8.5, 2.6) 0.40 
  <3.9 mmol/L 2.5 (1.4, 3.0) 3.0 (1.7, 4.4) 3.2 (2.2, 4.9)  0.07 
0.008 
0.71 
  <2.8 mmol/L 0.2 (0.0, 0.4) 0.2 (0.0, 0.4) 0.5 (0.2, 0.8)  0.59 
0.07 
0.44 
 No. of hypoglycemic events per week      
  <3.9 mmol/L 1.8 (1.5, 3.9) 2.4 (1.5, 3.2) 2.4 (1.5, 4.0)  0.88 
0.61 
0.88 
  <2.8 mmol/L 0.5 (0.1, 0.8) 0.5 (0.2, 0.8) 0.9 (0.4, 1.4)  0.94 
0.047 
0.10 
 Blood glucose indices      
  Low 0.6 (0.4, 0.8) 0.7 (0.4, 1.0) 0.8 (0.7, 1.1)  0.07 
0.001 
0.42 
  High 7.7 (6.3, 10.5) 8.5 (6.3, 10.5) 7.7 (6.5, 8.9)  0.51 
0.80 
0.19 
 Insulin need, IU/afternoon 15.6 (11.5, 22.6) 14.0 (12.0, 16.8) 17.3 (13.8, 18.5)  0.73 
0.73 
0.28 
 Time spent in closed-loop over afternoon, % 75.5 ± 14.3 11.7 ± 7.6 – – – 
Intention-to-treat analysis
24-h AP (D/N-AP)E/N-APControl period (SAP)Paired differences (with CI)* E/N-AP – D/N-AP SAP – D/N-AP SAP – E/N-APP value
(n = 20)(n = 20)(n = 20)(n = 20)
Daytime (0800–2000)      
 Mean glucose, mmol/L 9.0 ± 0.5 9.2 ± 1.2 9.1 ± 1.0 0.3 (−0.2, 0.7) 0.38 
0.1 (−0.4, 0.6) 0.83 
−0.1 (−0.6, 0.3) 0.73 
 SD of glucose, mmol/L 3.2 ± 0.6 3.4 ± 0.7 3.3 ± 0.6 0.3 (0.1, 0.5) 0.003 
0.2 (−0.0, 0.4) 0.15 
−0.2 (−0.3, 0.1) 0.25 
 Time spent at glucose concentration, %      
  4.4–7.8 mmol/L 35.6 ± 6.5 34.1 ± 9.3 33.4 ± 8.8 −1.4 (−5.8, 3.0) 0.72 
−2.2 (−6.6, 2.3) 0.46 
−0.75 (−5.2, 3.7) 0.91 
  3.9–10 mmol/L 64.9 ± 8.1 61.2 ± 11.7 60.7 ± 10.3 −3.7 (−8.4, 1.0) 0.15 
−4.2 (−8.9, 0.6) 0.09 
−0.5 (−5.2, 4.3) 1.00 
  >10 mmol/L 32.8 ± 7.8 35.9 ± 12.1 35.8 ± 11.4 3.1 (−2.1, 8.2) 0.32 
3.0 (−2.1, 8.2) 0.34 
−0.1 (−5.2, 5.1) 1.00 
  <3.9 mmol/L 2.3 ± 1.3 2.9 ± 1.9 3.4 ± 2.2 0.6 (−0.3, 1.6) 0.25 
1.2 (0.2, 2.1) 0.01 
0.5 (−0.4, 1.4) 0.39 
  <2.8 mmol/L 0.2 (0.1, 0.3) 0.1 (0.0, 0.3) 0.4 (0.2, 0.6)  0.79 
0.27 
0.64 
 No. of hypoglycemic events per week      
  <3.9 mmol/L 3.3 ± 1.8 3.4 ± 1.9 3.9 ± 2.3 0.1 (−0.9, 1.2) 0.94 
0.6 (−0.4, 1.7) 0.34 
0.5 (−0.6, 1.5) 0.54 
  <2.8 mmol/L 0.9 (0.4, 1.1) 0.5 (0.3, 1.2) 0.9 (0.6, 1.7)  0.99 
0.35 
0.27 
 Blood glucose indices      
  Low 0.6 ± 0.3 0.7 ± 0.4 0.8 ± 0.4 0.1 (−0.1, 0.3) 0.31 
0.2 (0.0, 0.4) 0.02 
0.1 (−0.1, 0.3) 0.37 
  High 7.2 (6.1, 8.8) 7.5 (5.9, 10.1) 7.4 (6.7, 8.8)  0.51 
0.71 
0.95 
 Insulin need, IU/day 19.3 (16.1, 31.8) 18.5 (15.5, 24.9) 22.9 (18.2, 27.5)  0.74 
0.71 
0.28 
 Time in closed-loop over daytime, % 73.9 ± 14.3 10.4 ± 6.1 – – – 
Morning (0800–1200)      
 Mean glucose, mmol/L 8.5 ± 0.8 8.7 ± 1.0 9.1 ± 1.3 0.2 (−0.3, 0.7) 0.60 
0.6 (0.1, 1.1) 0.03 
0.4 (−0.2, 0.9) 0.22 
 SD of glucose, mmol/L 2.7 ± 0.5 3.1 ± 0.5 2.9 ± 0.5 0.3 (0.1, 0.6) 0.02 
0.2 (−0.1, 0.4) 0.30 
−0.2 (−0.4, 0.1) 0.36 
 Time spent at glucose concentration, %      
  4.4–7.8 mmol/L 42.4 ± 12.4 40.6 ± 12.9 34.5 ± 12.5 −1.8 (−8.0, 4.5) 0.77 
−7.9 (−14.1,-1.6) 0.01 
−6.1 (−12.3, 0.1) 0.06 
  3.9–10 mmol/L 72.3 ± 10.6 68.6 ± 9.6 62.7 ± 15.4 −3.7 (−10.3, 2.9) 0.36 
−9.6 (−16.2, −3.0) 0.003 
−5.9 (−12.5, 0.7) 0.09 
  >10 mmol/L 25.6 ± 10.7 29.1 ± 10.2 35.1 ± 16.4 3.5 (−3.4, 10.3) 0.44 
9.5 (2.6, 16.3) 0.005 
6.0 (−0.9, 12.8) 0.10 
  <3.9 mmol/L 1.5 (0.3, 3.0) 1.4 (0.8, 3.2) 1.7 (0.9, 3.1)  0.88 
0.88 
1.00 
  <2.8 mmol/L 0.0 (0.0, 0.3) 0.0 (0.0, 0.1) 0.0 (0.0, 0.3)  0.78 
0.88 
1.00 
 No. of hypoglycemic events per week      
  <3.9 mmol/L 0.9 ± 0.8 1.0 ± 0.8) 1.0 ± 0.7 0.1 (−0.4, 0.5) 0.93 
0.0 (−0.4, 0.5) 0.98 
−0.0 (−0.5, 0.4) 0.99 
  <2.8 mmol/L 0.1 (0.0, 0.5) 0.0 (0.0, 0.3) 0.1 (0.0, 0.3)  0.72 
0.60 
0.98 
 Blood glucose indices      
  Low 0.6 ± 0.4 0.6 ± 0.5) 0.6 ± 0.4 0.1 (−0.1, 0.3) 0.74 
0.0 (−0.2, 0.2) 0.94 
−0.0 (−0.2, 0.2) 0.91 
  High 5.4 (3.9, 6.2) 6.8 (4.4, 8.2) 7.0 (5.8, 8.9)  0.51 
0.19 
0.80 
 Insulin need, IU/morning 6.0 ± 2.4 5.2 ± 2.5 6.9 ± 3.5 −0.8 (−2.1, 0.5) 0.32 
0.9 (−0.4, 2.3) 0.23 
1.7 (0.4, 3.1) 0.009 
 Time in closed-loop over morning, % 70.7 ± 15.0 8.2 ± 8.1 – – – 
Afternoon (1200–2000)      
 Mean glucose, mmol/L 9.2 ± 0.7 9.5 ± 1.4 9.1 ± 1.0 0.3 (−0.3, 0.8) 0.40 
−0.1 (−0.7, 0.4) 0.88 
−0.4 (−1.0, 0.1) 0.19 
 SD of glucose, mmol/L 3.3 ± 0.6 3.5 ± 0.8 3.4 ± 0.6  0.07 
0.25 
0.80 
 Time spent at glucose concentration, %      
  4.4–7.8 mmol/L 32.2 ± 7.0 31.0 ± 9.1 32.8 ± 9.0 −1.3 (−6.3, 3.8) 0.81 
0.6 (−4.4, 5.6) 0.95 
1.9 (−3.1, 6.9) 0.64 
  3.9–10 mmol/L 61.2 ± 9.7 57.5 ± 13.7 59.6 ± 10.1 −3.8 (−8.9, 1.4) 0.19 
−1.6 (−6.8, 3.6) 0.73 
2.1 (−3.0, 7.3) 0.57 
  >10 mmol/L 36.3 ± 9.4 39.3 ± 14.1 36.3 ± 11.0 3.0 (−2.6, 8.5) 0.41 
−0.0 (−5.6, 5.5) 1.00 
−3.0 (−8.5, 2.6) 0.40 
  <3.9 mmol/L 2.5 (1.4, 3.0) 3.0 (1.7, 4.4) 3.2 (2.2, 4.9)  0.07 
0.008 
0.71 
  <2.8 mmol/L 0.2 (0.0, 0.4) 0.2 (0.0, 0.4) 0.5 (0.2, 0.8)  0.59 
0.07 
0.44 
 No. of hypoglycemic events per week      
  <3.9 mmol/L 1.8 (1.5, 3.9) 2.4 (1.5, 3.2) 2.4 (1.5, 4.0)  0.88 
0.61 
0.88 
  <2.8 mmol/L 0.5 (0.1, 0.8) 0.5 (0.2, 0.8) 0.9 (0.4, 1.4)  0.94 
0.047 
0.10 
 Blood glucose indices      
  Low 0.6 (0.4, 0.8) 0.7 (0.4, 1.0) 0.8 (0.7, 1.1)  0.07 
0.001 
0.42 
  High 7.7 (6.3, 10.5) 8.5 (6.3, 10.5) 7.7 (6.5, 8.9)  0.51 
0.80 
0.19 
 Insulin need, IU/afternoon 15.6 (11.5, 22.6) 14.0 (12.0, 16.8) 17.3 (13.8, 18.5)  0.73 
0.73 
0.28 
 Time spent in closed-loop over afternoon, % 75.5 ± 14.3 11.7 ± 7.6 – – – 

E/N-AP and control period data come from initial randomized clinical trial, and 24-h AP data come from nonrandomized extension in the same patients (n = 20).

Mean variables are shown with ± SD and median variables with 25th, 75th percentile.

*95% CI of paired difference is given when data and residual are normally distributed.

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