| Outcome Measures: |
Primary: Time in Low Interstitial Glucose (Defined as Below 54 mg/dL [3 mmol/L]) From Initiation of Treatment (Day 1) to End of Treatment (Day 7) (Percentage), Interstitial glucose: glucose measured in interstitial fluid. Time in low interstitial glucose (defined as below 54 mg/dL \[3 mmol/L\]) from initiation of treatment (day 1) to end of treatment (day 7). Time spent in low interstitial glucose is calculated as the percentage of available interstitial glucose values below the threshold., Day 1 to day 7|Time in Low Interstitial Glucose (Defined as Below 54 mg/dL [3 mmol/L]) From Initiation of Treatment (Day 1) to End of Treatment (Day 7) (Percentage) - Median, Interstitial glucose: glucose measured in interstitial fluid. Time in low interstitial glucose (defined as below 54 mg/dL \[3 mmol/L\]) from initiation of treatment (day 1) to end of treatment (day 7). Time spent in low interstitial glucose is calculated as the percentage of available interstitial glucose values below the threshold., Day 1 to day 7 | Secondary: Number of Treatment Emergent Severe Hypoglycaemic Episodes, Number of treatment emergent severe hypoglycaemic episodes from initiation of treatment (day 1) to end of treatment (day 7). Treatment emergent is defined as an episode that has onset in the period from initiation of treatment to end of treatment. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following the return of PG to normal is considered sufficient evidence that the event was induced by a low PG concentration., Day 1 to day 7|Number of Self-manageable (Able to Self-treat) Treatment Emergent Hypoglycaemic Episodes That Require Oral Carbohydrate Intervention Per Day, Mean number of self-manageable (able to self-treat) treatment emergent hypoglycaemic episodes that require oral carbohydrate intervention per day. Self-manageable (able to self-treat) hypoglycaemic episodes that require oral carbohydrate intervention per day is calculated as the sum of all hypoglycaemic episodes where the subject is able to self-treat and that require oral carbohydrate intervention divided by the actual duration of the treatment period in days. Treatment emergent is defined as an episode that has onset in the period from initiation of treatment to end of treatment., Day 1 to day 7|Number of Treatment Emergent Overall Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition, ADA classification of hypoglycaemia: 1. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. 2. Asymptomatic hypoglycaemia: An episode not accompanied by typical symptoms of hypoglycaemia, but with a measured PG concentration ≤3.9 mmol/L (70 mg/dL). 3. Documented symptomatic hypoglycaemia: An episode during which typical symptoms of hypoglycaemia are accompanied by a measured PG concentration ≤ 3.9 mmol/L (70 mg/dL). 4. Pseudo-hypoglycaemia: An episode during which the person with diabetes reports any of the typical symptoms of hypoglycaemia with a measured PG concentration \> 3.9 mmol/L (70 mg/dL) but approaching that level. 5. Probable symptomatic hypoglycaemia: An episode during which symptoms of hypoglycaemia are not accompanied by a PG determination but that was presumably caused by a PG concentration ≤ 3.9 mmol/L (70 mg/dL)., Day 1 to day 7|Number of Treatment Emergent Overall Hypoglycaemic Episodes Classified According to the Novo Nordisk Classification, Overall hypoglycaemia count according to Novo Nordisk classification. Novo Nordisk classification of hypoglycaemia: 1. Severe hypoglycaemia according to the ADA classification. 2. Symptomatic BG confirmed hypoglycaemia: An episode that is BG confirmed by PG value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. 3. Asymptomatic BG confirmed hypoglycaemia: An episode that is BG confirmed by PG value \<3.1 mmol/L (56 mg/dL) without symptoms consistent with hypoglycaemia. 4. BG confirmed hypoglycaemia: The union of 2. and 3. 5. Severe or BG confirmed symptomatic hypoglycaemia: The union of 1. and 2. 6. Severe or BG confirmed hypoglycaemia: The union of 1., 2. and 3., Day 1 to day 7|Number of Treatment Emergent Daytime Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition, ADA classification of hypoglycaemia: 1. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. 2. Asymptomatic hypoglycaemia: An episode not accompanied by typical symptoms of hypoglycaemia, but with a measured PG concentration ≤3.9 mmol/L (70 mg/dL). 3. Documented symptomatic hypoglycaemia: An episode during which typical symptoms of hypoglycaemia are accompanied by a measured PG concentration ≤ 3.9 mmol/L (70 mg/dL). 4. Pseudo-hypoglycaemia: An episode during which the person with diabetes reports any of the typical symptoms of hypoglycaemia with a measured PG concentration \> 3.9 mmol/L (70 mg/dL) but approaching that level. 5. Probable symptomatic hypoglycaemia: An episode during which symptoms of hypoglycaemia are not accompanied by a PG determination but that was presumably caused by a PG concentration ≤ 3.9 mmol/L (70 mg/dL)., Day 1 to day 7 (in both the treatment periods)|Number of Treatment Emergent Daytime Hypoglycaemic Episodes Classified According to the Novo Nordisk Classification, Number of daytime hypoglycaemic episodes according to Novo Nordisk classification. Novo Nordisk classification of hypoglycaemia: 1. Severe hypoglycaemia according to the ADA classification. 2. Symptomatic BG confirmed hypoglycaemia: An episode that is BG confirmed by PG value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. 3. Asymptomatic BG confirmed hypoglycaemia: An episode that is BG confirmed by PG value \<3.1 mmol/L (56 mg/dL) without symptoms consistent with hypoglycaemia. 4. BG confirmed hypoglycaemia: The union of 2. and 3. 5. Severe or BG confirmed symptomatic hypoglycaemia: The union of 1. and 2. 6. Severe or BG confirmed hypoglycaemia: The union of 1., 2. and 3., Day 1 to day 7|Number of Treatment Emergent Nocturnal Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition, ADA classification of hypoglycaemia: 1. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. 2. Asymptomatic hypoglycaemia: An episode not accompanied by typical symptoms of hypoglycaemia, but with a measured PG concentration ≤3.9 mmol/L (70 mg/dL). 3. Documented symptomatic hypoglycaemia: An episode during which typical symptoms of hypoglycaemia are accompanied by a measured PG concentration ≤ 3.9 mmol/L (70 mg/dL). 4. Pseudo-hypoglycaemia: An episode during which the person with diabetes reports any of the typical symptoms of hypoglycaemia with a measured PG concentration \> 3.9 mmol/L (70 mg/dL) but approaching that level. 5. Probable symptomatic hypoglycaemia: An episode during which symptoms of hypoglycaemia are not accompanied by a PG determination but that was presumably caused by a PG concentration ≤ 3.9 mmol/L (70 mg/dL)., Day 1 to day 7|Number of Treatment Emergent Nocturnal Hypoglycaemic Episodes Classified According to the Novo Nordisk Classification, Number of nocturnal (from time 00:01-05:59 both inclusive) hypoglycaemic episodes according to Novo Nordisk classification. Novo Nordisk classification of hypoglycaemia: 1. Severe hypoglycaemia according to the ADA classification. 2. Symptomatic BG confirmed hypoglycaemia: An episode that is BG confirmed by PG value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. 3. Asymptomatic BG confirmed hypoglycaemia: An episode that is BG confirmed by PG value \<3.1 mmol/L (56 mg/dL) without symptoms consistent with hypoglycaemia. 4. BG confirmed hypoglycaemia: The union of 2. and 3. 5. Severe or BG confirmed symptomatic hypoglycaemia: The union of 1. and 2. 6. Severe or BG confirmed hypoglycaemia: The union of 1., 2. and 3., Day 1 to day 7 (in both the treatment periods)|Time in Interstitial Glucose Range Was Defined as 70-180 mg/dL (3.9-10 mmol/L) From Initiation of Treatment (Day 1) to End of Treatment (Day 7) (Percentages), Time in interstitial glucose range defined as 70-180 mg/dL (3.9-10 mmol/L) from initiation of treatment (day 1) to end of treatment (day 7). Time spent in interstitial glucose range is calculated as the percentage of available interstitial glucose values above or equal to the low threshold and below or equal to the high threshold., Day 1 to day 7|Mean Interstitial-glucose Level, Mean interstitial glucose level is calculated as the average of the available interstitial glucose values., Day 1 to day 7|Number of Treatment Emergent Adverse Events, Number of treatment emergent adverse events from initiation of treatment (day 1) to end of treatment (day 7). Treatment emergent is defined as an event that has onset in the period from initiation of treatment to end of treatment., Day 1 to day 7|Number of Treatment Emergent Infusion Site Reactions, Number of treatment-emergent infusion site reactions from initiation of treatment (day 1) to end of treatment (day 7). Treatment emergent is defined as an event that has onset in the period from initiation of treatment to end of treatment., Day 1 to day 7|Total Insulin Dose Per Day, Total insulin dose (U/kg) per day from initiation of treatment (day 1) to end of treatment (day 7). Total daily insulin dose is calculated as the sum of all insulin doses delivered by the iLet™ divided by the actual duration of the treatment period in days., Day 1 to day 7
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