| Outcome Measures: |
Primary: Percentage of time spent in sensor glucose target range defined as between 3.9 and 7.8 mmol/L compared between 4- weeks AP on empagliflozin and 4-weeks AP with placebo, Percentage of time spent in sensor glucose target range defined as between 3.9 and 7.8 mmol/L compared between 4- weeks AP on empagliflozin and 4-weeks AP with placebo., 20 weeks|Percentage of time spent in sensor glucose target range defined as between 3.9 and 7.8 mmol/L compared between 4- weeks conventional pump therapy on empagliflozin and 4- weeks conventional pump therapy with placebo, Percentage of time spent in sensor glucose target range defined as between 3.9 and 7.8 mmol/L compared between 4- weeks conventional pump therapy on empagliflozin and 4- weeks conventional pump therapy with placebo., 20 weeks|Percentage of time spent in sensor glucose target range defined as between 3.9 and 7.8 mmol/L on 4- weeks automated AP on empagliflozin when compared to 4-weeks conventional pump therapy on empagliflozin, Percentage of time spent in sensor glucose target range defined as between 3.9 and 7.8 mmol/L on 4- weeks automated AP on empagliflozin when compared to 4-weeks conventional pump therapy on empagliflozin., 20 weeks|Percentage of time spent in sensor glucose target range defined as between 3.9 and 7.8 mmol/L on 4- weeks automated AP on empagliflozin when compared to 4-weeks conventional pump therapy with placebo, Percentage of time spent in sensor glucose target range defined as between 3.9 and 7.8 mmol/L on 4- weeks automated AP on empagliflozin when compared to 4-weeks conventional pump therapy with placebo., 20 weeks | Secondary: Percentage of time spent in sensor glucose target range defined as between 3.9 and 10.0 mmol/L compared between 4- weeks conventional pump therapy on empagliflozin and 4-weeks AP on empagliflozin, Percentage of time spent in sensor glucose target range defined as between 3.9 and 10.0 mmol/L compared between 4- weeks conventional pump therapy on empagliflozin and 4-weeks AP on empagliflozin, 20 weeks|Percentage of time spent in sensor glucose target range defined as between 3.9 and 10.0 mmol/L compared between 4- weeks AP on empagliflozin and 4- weeks AP with placebo, Percentage of time spent in sensor glucose target range defined as between 3.9 and 10.0 mmol/L compared between 4- weeks AP on empagliflozin and 4- weeks AP with placebo., 20 weeks|Hypoglycemia: Percentage of time with glucose <3.9 mmol/L applied to each of the primary and secondary outcome comparator groups, Hypoglycemia: Percentage of time with glucose \<3.9 mmol/L applied to each of the primary and secondary outcome comparator groups., 20 weeks|Percentage of time spent in hypoglycemia, euglycemia and hyperglycemia, Percentage of time spent in the different glucose sensor levels characterized by amount spent between 3.9 and 10.0 mmol/L, 3.9 and 7.8 mmol/L, above 10.0 mmol/L, above 13.9 mmol/L, above 16.7 mmol/l, below 3.9 mmol/L, below 3.3 mmol/L, below 2.8 mmol/L, 20 weeks|Absolute number of hypoglycemia events I., Number of hypoglycemic events (\> 20 minutes) below 3.3 mmol/L based on sensor glucose levels, 20 weeks|Absolute number of hypoglycemia events II., Number of symptomatic hypoglycemic events \< 3.9 mmol/l or below 3.3 mmol/l without symptoms, 20 weeks|Absolute number of hypoglycemia events III., Number of treated hypoglycemic events, 20 weeks|Statistical characteristics of glucose profile I., Area under the curve of hypoglycemic glucose values (below 3.9 mmol/L, 3.3 mmol/L and 2.8 mmol/L), 20 weeks|Statistical characteristics of glucose profile II., Standard deviation of glucose levels, 20 weeks|Amount of total insulin delivery during interventions, Total insulin delivery measured by mean of units per day, 20 weeks|Change in HbA1c, Change in HbA1c from baseline to after the first intervention and from the end of the first intervention to the end of the treatment period., 20 weeks|Mean fasting capillary ketone levels, Mean fasting capillary ketone levels., 20 weeks|Number of episodes of diabetic ketoacidosis, Number of episodes of diabetic ketoacidosis, 20 weeks|Number of technical adverse events, Number of events when algorithm crashes or needs to be overridden for safety reasons., 20 weeks
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| Locations: |
Sinai Health System, Toronto, Ontario, M5T 3L9, Canada|McGill University, Montréal, Quebec, H3A 2B4, Canada
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