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Table 1

Results

Metric nameOpen loopClosed loopP value
Overall (0000–2400)    
 Time-in-hypo (%) 6.7 (2.3–11.5) 2.0 (1.2–4.5) <0.001 
 Number of SMBG <70 mg/dL 3.5 (2.0–6.0) 1.5 (0.0–4.0) <0.001 
 LBGI (–) 1.7 (0.7–2.6) 0.5 (0.3–1.2) <0.001 
 Time <50 mg/dL (%) 0.9 (0.0–2.2) 0.1 (0.0–0.4) <0.001 
 Time-in-target (%) 63.1 (11.0) 56.8 (13.5) 0.022 
 Mean glucose (mg/dL) 147 (23) 169 (23) <0.001 
 SD glucose (mg/dL) 58 (10) 61 (11) 0.173 
 Number of hypotreatments 5 (4–8) 3.5 (1–7) 0.018 
 Total amount of CHO    
  Hypotreatments (g/kg per day) 0.61 (0.36–0.96) 0.33 (0.17–0.87) 0.005 
  Meal (g/kg per day) 7.74 (1.67) 8.03 (1.56) 0.053 
 Mean basal insulin (units/h) 0.35 (0.12) 0.26 (0.09) <0.001 
 SD basal insulin (units/h) 0.16 (0.06) 0.24 (0.05) <0.001 
 Total basal insulin (units/kg per day) 0.32 (0.10) 0.24 (0.08) <0.001 
 Total amount of insulin    
  Boluses (units/kg per day) 0.46 (0.14) 0.48 (0.12) 0.269 
  Basal and boluses (units/kg per day) 0.78 (0.15) 0.72 (0.14) 0.001 
Night (0000–0730)    
 Time-in-hypo (%) 2.2 (0.0–12.3) 0.0 (0.0–2.2) 0.002 
 Number of SMBG <70 mg/dL 0.0 (0.0–2.0) 0.0 (0.0–0.0) 0.005 
 LBGI (–) 0.8 (0.1–3.0) 0.1 (0.0–0.6) <0.001 
 Time <50 mg/dL (%) 0.0 (0.0–2.7) 0.0 (0.0–0.0) 0.008 
 Time-in-target (%) 59.7 (21.2) 56.0 (22.5) 0.430 
 Time-in-tight-target (%) 33.0 (19.8) 31.3 (20.2) 0.694 
 Mean glucose (mg/dL) 150 (39) 173 (36) 0.002 
 SD glucose (mg/dL) 44 (14) 47 (14) 0.244 
 Number of hypotreatments 0 (0–2) 0 (0–0) 0.005 
 Total amount of CHO for hypotreatment (g/kg per day) 0.00 (0.00–0.20) 0.00 (0.00–0.00) 0.011 
 Mean basal insulin (units/h) 0.35 (0.12) 0.37 (0.12) 0.085 
 SD basal insulin (units/h) 0.10 (0.05–0.13) 0.20 (0.17–0.25) <0.001 
 Total basal insulin (units/kg per day) 0.10 (0.03) 0.11 (0.03) 0.120 
 Total amount of insulin    
  Boluses (units/kg per day) 0.00 (0.00–0.01) 0.00 (0.00–0.00) 0.123 
  Basal and boluses (units/kg per day) 0.11 (0.03) 0.11 (0.03) 0.601 
Wake-up (0630–0730)    
 Time-in-hypo (%) 0.0 (0.0–0.0) 0.0 (0.0–0.0) 0.604 
 LBGI (–) 0.0 (0.0–0.3) 0.0 (0.0–0.1) 1.000 
 Time <50 mg/dL (%) 0.0 (0.0–0.0) 0.0 (0.0–0.0) 0.063 
 Time-in-target (%) 66.7 (42.6–77.8) 80.0 (66.7–100.0) 0.096 
 Time-in-tight-target (%) 31.3 (27.0) 47.7 (33.1) 0.024 
 Mean glucose (mg/dL) 149 (46) 152 (37) 0.590 
 SD glucose (mg/dL) 34 (19) 27 (15) 0.122 
System functioning    
 Time in closed loop (%) — 96.8 (93.5–98.4) — 
 DiAs-pump successful communications (%) — 99.2 (99.0–99.2) — 
 CGM-DiAs successful communications (%) — 98.3 (96.3–99.2) — 
 CGM MAD (mg/dL) 17.9 (3.7) 19.0 (6.0) 0.369 
 CGM MARD (%) 14.5 (4.7) 13.4 (4.0) 0.309 
Metric nameOpen loopClosed loopP value
Overall (0000–2400)    
 Time-in-hypo (%) 6.7 (2.3–11.5) 2.0 (1.2–4.5) <0.001 
 Number of SMBG <70 mg/dL 3.5 (2.0–6.0) 1.5 (0.0–4.0) <0.001 
 LBGI (–) 1.7 (0.7–2.6) 0.5 (0.3–1.2) <0.001 
 Time <50 mg/dL (%) 0.9 (0.0–2.2) 0.1 (0.0–0.4) <0.001 
 Time-in-target (%) 63.1 (11.0) 56.8 (13.5) 0.022 
 Mean glucose (mg/dL) 147 (23) 169 (23) <0.001 
 SD glucose (mg/dL) 58 (10) 61 (11) 0.173 
 Number of hypotreatments 5 (4–8) 3.5 (1–7) 0.018 
 Total amount of CHO    
  Hypotreatments (g/kg per day) 0.61 (0.36–0.96) 0.33 (0.17–0.87) 0.005 
  Meal (g/kg per day) 7.74 (1.67) 8.03 (1.56) 0.053 
 Mean basal insulin (units/h) 0.35 (0.12) 0.26 (0.09) <0.001 
 SD basal insulin (units/h) 0.16 (0.06) 0.24 (0.05) <0.001 
 Total basal insulin (units/kg per day) 0.32 (0.10) 0.24 (0.08) <0.001 
 Total amount of insulin    
  Boluses (units/kg per day) 0.46 (0.14) 0.48 (0.12) 0.269 
  Basal and boluses (units/kg per day) 0.78 (0.15) 0.72 (0.14) 0.001 
Night (0000–0730)    
 Time-in-hypo (%) 2.2 (0.0–12.3) 0.0 (0.0–2.2) 0.002 
 Number of SMBG <70 mg/dL 0.0 (0.0–2.0) 0.0 (0.0–0.0) 0.005 
 LBGI (–) 0.8 (0.1–3.0) 0.1 (0.0–0.6) <0.001 
 Time <50 mg/dL (%) 0.0 (0.0–2.7) 0.0 (0.0–0.0) 0.008 
 Time-in-target (%) 59.7 (21.2) 56.0 (22.5) 0.430 
 Time-in-tight-target (%) 33.0 (19.8) 31.3 (20.2) 0.694 
 Mean glucose (mg/dL) 150 (39) 173 (36) 0.002 
 SD glucose (mg/dL) 44 (14) 47 (14) 0.244 
 Number of hypotreatments 0 (0–2) 0 (0–0) 0.005 
 Total amount of CHO for hypotreatment (g/kg per day) 0.00 (0.00–0.20) 0.00 (0.00–0.00) 0.011 
 Mean basal insulin (units/h) 0.35 (0.12) 0.37 (0.12) 0.085 
 SD basal insulin (units/h) 0.10 (0.05–0.13) 0.20 (0.17–0.25) <0.001 
 Total basal insulin (units/kg per day) 0.10 (0.03) 0.11 (0.03) 0.120 
 Total amount of insulin    
  Boluses (units/kg per day) 0.00 (0.00–0.01) 0.00 (0.00–0.00) 0.123 
  Basal and boluses (units/kg per day) 0.11 (0.03) 0.11 (0.03) 0.601 
Wake-up (0630–0730)    
 Time-in-hypo (%) 0.0 (0.0–0.0) 0.0 (0.0–0.0) 0.604 
 LBGI (–) 0.0 (0.0–0.3) 0.0 (0.0–0.1) 1.000 
 Time <50 mg/dL (%) 0.0 (0.0–0.0) 0.0 (0.0–0.0) 0.063 
 Time-in-target (%) 66.7 (42.6–77.8) 80.0 (66.7–100.0) 0.096 
 Time-in-tight-target (%) 31.3 (27.0) 47.7 (33.1) 0.024 
 Mean glucose (mg/dL) 149 (46) 152 (37) 0.590 
 SD glucose (mg/dL) 34 (19) 27 (15) 0.122 
System functioning    
 Time in closed loop (%) — 96.8 (93.5–98.4) — 
 DiAs-pump successful communications (%) — 99.2 (99.0–99.2) — 
 CGM-DiAs successful communications (%) — 98.3 (96.3–99.2) — 
 CGM MAD (mg/dL) 17.9 (3.7) 19.0 (6.0) 0.369 
 CGM MARD (%) 14.5 (4.7) 13.4 (4.0) 0.309 

Normally distributed data are reported as mean (SD), nonnormally distributed as median (25th–75th) percentile. Time-in-hypo indicates the percentage of time with CGM <70 mg/dL; time-in-target indicates the percentage of time with CGM in the range 70–180 mg/dL; time-in-tight-target is the percentage of time with CGM in the range 80–140 mg/dL.

CGM MAD, mean absolute deviation of CGM reading from self-monitored blood glucose; CGM MARD, mean absolute relative deviation; SMBG, self-monitored blood glucose.

Highlights outcome metrics affected by carryover.

Highlights outcome metrics affected by significant period effect.

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