| Outcome Measures: |
Primary: Percentage of patients reaching fasting SMPG target range 90-130 mg/dL (5.0-7.2 mmol/L) at Week 16 (mean of the last 5 readings recorded over the last 2 weeks) without a severe hypoglycemic episode during the 16-week on-treatment period, Baseline to Week 16 | Secondary: Percentage of patients reaching fasting SMPG target range of 90-130 mg/dL (5.0-7.2 mmol/L), (mean of the last 5 readings recorded over the last 2 weeks) without severe and/or confirmed hypoglycemic events, Baseline to Week 16|Percentage of patients reaching laboratory FPG target range (90-130 mg/dL) without severe hypoglycemia, Baseline to Week 16|Mean FSMPG glucose change from baseline (mean of the last 5 readings recorded over the last 2 weeks), Baseline to Week 16|Time to reach the first fasting SMPG target range of 90-130 mg/dL (5.0-7.2 mmol/L), Baseline to Week 16|Mean FPG glucose change from baseline, Baseline to Week 16|Mean HbA1c change from baseline, Baseline to Week 16|Percentage of patients reaching HbA1c of <7.5% and <7%, Week 16|Percentage of patients with hypoglycemic events, Baseline to Week 16|Number of hypoglycemic events, Baseline to Week 16|Percentage of patients with adverse events, Baseline to Week 16|Percentage of patients with serious adverse events, Baseline to Week 16|Assessment of satisfaction with diabetes treatment using Diabetes Treatment Satisfaction Questionnaire, Baseline to Week 16|Assessment of fear of hypoglycemia using Hypoglycemia Fear Survey-II, Baseline to Week 16|Assessment of emotional well-being using WHO-5 well-being index, Baseline to Week 16|Assessment of diabetes-related emotional stress using Diabetes Distress Scale, Baseline to Week 16|Assessment of satisfaction with glucose monitoring using the Glucose Monitoring Satisfaction Survey, Baseline to Week 16|Assessment of device Ease of Use using Ease of Use questionnaire, Baseline to Week 16
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| Locations: |
Investigational Site Number 276002, Berlin, 10115, Germany|Investigational Site Number 276001, Dresden, 01307, Germany|Investigational Site Number 276007, Essen, 45359, Germany|Investigational Site Number 276003, Heidelberg, 69115, Germany|Investigational Site Number 276010, Künzing, 94550, Germany|Investigational Site Number 276005, Neumünster, 24534, Germany|Investigational Site Number 276004, Oldenburg In Holstein, 23758, Germany|Investigational Site Number 276006, Pirna, 01796, Germany|Investigational Site Number 276008, Sulzbach-Rosenberg, 92237, Germany|Investigational Site Number 826003, Airdrie, ML6 OJS, United Kingdom|Investigational Site Number 826002, Belfast, BT12 6BA, United Kingdom|Investigational Site Number 826011, Bristol, BS10 5NB, United Kingdom|Investigational Site Number 826001, Chester, CH2 1UL, United Kingdom|Investigational Site Number 826006, Dumfries, DG1 4AP, United Kingdom|Investigational Site Number 826008, East Kilbride, G75 8RG, United Kingdom|Investigational Site Number 826005, Larbert, FK5 4WR, United Kingdom|Investigational Site Number 826010, Londonderry, BT47 6SB, United Kingdom|Investigational Site Number 826009, Swansea, SA6 6NL, United Kingdom|Investigational Site Number 826007, Taunton, TA1 5DA, United Kingdom
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