Table 1

Summary of study outcomes

MetricOLClosed loopP level
Primary outcomes: reduction in hypoglycemia    
 LBGI 1.12 0.64 0.003 
 Percentage of time below 3.9 mmol/L (70 mg/dL) 1.25 0.70 >0.1 
 Number of hypoglycemic episodes/person/session requiring carbohydrate treatment 2.39 1.22 0.021 
 Grams of carbohydrate/person/session used for treatment of hypoglycemia 39.7 17.6 0.022 
Secondary outcomes: glucose control    
 Percentage of time in the target range of 3.9–10 mmol/L (70–180 mg/dL) 70.7 66.1 >0.1 
 Percentage of time above 180 mg/dL 28.0 33.1 >0.1 
 Average BG 8.45 mmol/L (152.1 mg/dL) 8.96 mmol/L (161.3 mg/dL) 0.042 
 Glucose variability (SD) 2.44 mmol/L (43.9 mg/dL) 2.49 mmol/L (44.9 mg/dL) >0.1 
 Total meal carbohydrate content/person/session 272.5 g 266.2 g >0.1 
 Total insulin delivered/person/session 62.6 units 59.2 units >0.1 
MetricOLClosed loopP level
Primary outcomes: reduction in hypoglycemia    
 LBGI 1.12 0.64 0.003 
 Percentage of time below 3.9 mmol/L (70 mg/dL) 1.25 0.70 >0.1 
 Number of hypoglycemic episodes/person/session requiring carbohydrate treatment 2.39 1.22 0.021 
 Grams of carbohydrate/person/session used for treatment of hypoglycemia 39.7 17.6 0.022 
Secondary outcomes: glucose control    
 Percentage of time in the target range of 3.9–10 mmol/L (70–180 mg/dL) 70.7 66.1 >0.1 
 Percentage of time above 180 mg/dL 28.0 33.1 >0.1 
 Average BG 8.45 mmol/L (152.1 mg/dL) 8.96 mmol/L (161.3 mg/dL) 0.042 
 Glucose variability (SD) 2.44 mmol/L (43.9 mg/dL) 2.49 mmol/L (44.9 mg/dL) >0.1 
 Total meal carbohydrate content/person/session 272.5 g 266.2 g >0.1 
 Total insulin delivered/person/session 62.6 units 59.2 units >0.1 
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