Secondary Outcome(s)
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Incidence of all hypoglycaemic episodes associated with a blood glucose measurement below 3.1 mmol/L (56 mg/dl) irrespective of symptoms
[Time Frame: In the 4 weeks following the baseline visit (day 1)]
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Incidence of hypoglycaemic episodes
[Time Frame: Between midnight and 6 a.m. in the 4 weeks before and 4 weeks after the baseline visit (day 1)]
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Proportion of patients consulting a doctor
[Time Frame: Over one day]
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Patient reported fear of hypoglycaemia
[Time Frame: Over one day]
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Patient reported recovery times
[Time Frame: One day]
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Proportion of patients avoiding physical exercise
[Time Frame: Over one day]
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Incidence of any hypoglycaemic episodes
[Time Frame: In the 4 weeks before and 4 weeks after the baseline (day 1)]
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Incidence of documented symptomatic hypoglycaemic episodes
[Time Frame: In the 4 weeks after the baseline visit (day 1)]
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Incidence of severe hypoglycaemic episodes
[Time Frame: In the 6 months before and 4 weeks after the baseline (day 1)]
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Proportion of patients increasing the number of blood glucose monitoring as a result of fear of hypoglycaemia or hypoglycaemic episodes
[Time Frame: Over one day]
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DSQOLS (Diabetes-Specific Quality-of-Life Scale) scores
[Time Frame: Over last 4 weeks]
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Incidence of non-severe hypoglycaemic episodes
[Time Frame: In the 4 weeks before and 4 weeks after the baseline (day 1)]
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Incidence of probable symptomatic hypoglycaemia
[Time Frame: In the 4 weeks following the baseline visit (day 1)]
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Proportion of patients increasing calorie intake
[Time Frame: Over one day]
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Proportion of patients taking any sick leave, sick days or short days as a result of hypoglycaemic episodes
[Time Frame: Over one day]
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Frequency of blood glucose monitoring
[Time Frame: Over 1 day]
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Incidence of hypoglycaemic episodes requiring hospital admission
[Time Frame: In the 6 months before and 4 weeks after the baseline (day 1)]
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Proportion of patients reducing or skipping insulin dose
[Time Frame: Over one day]
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