Table 1

Comparisons of insulin-alone artificial pancreas, rapid insulin-and-pramlintide artificial pancreas, and regular insulin-and-pramlintide artificial pancreas

Rapid insulin-alone (n = 28)Rapid insulin-and-pramlintide (n = 27)Regular insulin-and-pramlintide (n = 26)Rapid insulin-and-pramlintide minus insulin-alone (n = 27), P valueRegular insulin-and-pramlintide minus insulin-alone (n = 26), P value¥
24-h outcomes (0800–0800 h)
 Time spent at glucose levels (%) (mmol/L)
  3.9–10.074 (18)84 (13)69 (19)11 (16), 0.0014−6 (20), 0.22
  3.9–7.854 (18)55 (17)50 (19)2 (17), 0.50−4 (17), 0.34
  <2.80.0 (0.0–0.0)0.0 (0.0–0.0)0.0 (0.0–0.6)0.0 (0.0–0.0), 0.340.0 (0.0–0.0), 0.29
  <3.30.0 (0.0–2.6)0.0 (0.0–1.5)1.2 (0.0–3.8)0.0 (−0.5 to 0.0), 0.780.1 (0.0–3.1), 0.027
  <3.91.2 (0.0–7.0)0.0 (0.0–8.4)7.3 (3.4–10.7)0.0 (−1.8 to 0.5), 0.433.3 (0.0–7.5), 0.0084
  >7.842 (19)40 (19)43 (20)−2 (15), 0.501 (18), 0.86
  >10.022 (17)12 (12)24 (20)−10 (13), 0.000123 (18), 0.49
  >13.90 (0–6)0 (0–0)1 (0–10)0 (−6 to 0), 0.00190 (−1 to 5), 0.37
 Mean glucose (mmol/L)8.0 (1.4)7.4 (1.0)8.0 (1.4)−0.6 (0.9), 0.00140.0 (1.5), 0.95
 SD of glucose (mmol/L)2.4 (0.9)2.0 (0.5)2.8 (1.2)−0.5 (0.9), 0.00530.4 (1.3), 0.17
 CV of glucose (mmol/L)30.3 (9.1)26.8 (6.9)34.0 (10.5)−4.2 (9.3), 0.0354.6 (12.0), 0.090
 Total basal insulin (units)24.5 (9.5)23.8 (8.9)27.5 (10.9)−0.7 (4.2), 0.352.8 (6.2), 0.048
 Total bolus insulin (units)23.1 (6.1)22.6 (7.4)25.5 (8.2)−0.5 (3.1), 0.352.8 (4.1), 0.0028
 Total pramlintide (µg)278 (92)318 (106)
Day outcomes (0800–2300 h)
 Time spent at glucose levels (%) (mmol/L)
  3.9–10.063 (23)78 (16)61 (26)16 (22), 0.0004−3 (27), 0.67
  3.9–7.840 (22)44 (21)39 (24)6 (23), 0.18−1 (20), 0.90
  <2.80.0 (0.0–0.0)0.0 (0.0–0.0)0.0 (0.0–0.0)0.0 (0.0–0.0), 0.340.0 (0.0–0.0), 0.13
  <3.30.0 (0.0–0.3)0.0 (0.0–1.9)0.0 (0.0–1.6)0.0 (0.0–0.0), 0.500.0 (0.0–0.0), 0.89
  <3.90.0 (0.0 –6.6)0.0 (0.0–6.5)0.4 (0.0–6.2)0.0 (−2.7 to 0.5), 0.660.0 (−1.3 to 4.7), 0.76
  >7.856 (24)51 (24)57 (27)−6 (23), 0.171 (23), 0.93
  >10.032 (24)17 (16)34 (29)−16 (21), <0.00013 (28), 0.70
  >13.90 (0–10)0 (0–0)2 (0–16)0 (−10 to 0), 0.0020 (−2 to 7), 0.34
 Mean glucose (mmol/L)8.7 (1.9)7.9 (1.3)8.9 (2.2)−0.9 (1.4), 0.00110.2 (2.3), 0.70
 SD of glucose (mmol/L)2.5 (0.9)2.0 (0.6)2.5 (1.0)−0.6 (0.9), 0.00190.1 (1.2), 0.81
 CV of glucose (mmol/L)29.3 (10.0)25.6 (8.0)28.7 (9.3)−4.4 (8.8), 0.0170.4 (9.3), 1.00
 Total basal insulin (units)15.3 (6.7)15.3 (6.2)19.4 (9.5)−0.1 (3.4), 0.793.8 (6.7), 0.016
 Total bolus insulin (units)23.1 (6.1)22.6 (7.4)25.5 (8.2)−0.5 (3.1), 0.352.8 (4.1), 0.0028
 Total pramlintide (µg)228 (76)269 (99)
Overnight outcomes (2300–0800 h)
 Time spent at glucose levels (%) (mmol/L)
  3.9–10.094 (11)95 (9)83 (13)1 (12), 0.65−11 (15), 0.0024
  3.9–7.880 (18)77 (23)73 (18)−4 (25), 0.39−7 (25), 0.14
  <2.80.0 (0.0–0.0)0.0 (0.0–0.0)0.0 (0.0–0.0)0.0 (0.0–0.0), NA0.0 (0.0–0.0), 0.019
  <3.30.0 (0.0–0.0)0.0 (0.0–0.0)0.0 (0.0–7.8)0.0 (0.0–0.0), 0.370.0 (0.0–3.3), 0.013
  <3.90.0 (0.0–1.1)0.0 (0.0–0.0)11.3 (0.0–22.6)0.0 (0.0–0.0), 0.710.0 (0.0–14.8), 0.0063
  >7.816 (15)19 (22)16 (20)5 (20), 0.230 (24), 0.92
  >10.02 (5)2 (5)5 (11)−1 (6), 0.653 (11), 0.18
  >13.90 (0–0)0 (0–0)0 (0–0)0 (0–0), 0.350 (0–0), NA
 Mean glucose (mmol/L)6.6 (0.9)6.5 (1.0)6.2 (1.1)0.0 (0.9), 0.83−0.4 (1.4), 0.20
 SD of glucose (mmol/L)2.5 (0.9)2.0 (0.6)2.5 (1.0)−0.6 (0.9), 0.00190.1 (1.2), 0.81
 CV of glucose (mmol/L)15.9 (10.2)17.4 (7.6)24.6 (9.3)1.2 (10.3), 0.569.2 (12.5), 0.0011
 Total basal insulin (units)9.2 (3.5)8.5 (3.5)8.1 (3.3)−0.6 (1.7), 0.67−0.9 (2.7), 0.11
 Total bolus insulin (units)0.0 (0.0)0.0 (0.0)0.0 (0.0)0.0 (0.0), NA0.0 (0.0), NA
 Total pramlintide (µg)51 (21)49 (20)
  • Data are displayed as mean (SD) or median (IQR). A P value <0.05 is regarded as significant. CV, coefficient of variation. NA, not applicable.

  • Primary comparisons.

  • Paired comparisons included participants that completed insulin-alone and rapid insulin-and-pramlintide interventions (n = 27).

  • ¥ Paired comparisons included participants that completed insulin-alone and regular insulin-and-pramlintide interventions (n = 26).