Hypoglycaemia is categorized as follows: confirmed hypoglycaemia is defined as a measured blood glucose level ≤ 3.9 mmol/l with or without clinical symptoms of hypoglycaemia; nocturnal hypoglycaemia is defined as hypoglycaemia (blood glucose level ≤ 3.9 mmol/l) that occurs during sleep (0:00–5:59 a.m.) and responds to ingestion of carbohydrates; severe hypoglycaemia is defined as an event with clinical symptoms resulting from hypoglycaemia in which the study subject requires assistance for the administration of carbohydrate, glucagon or other treatments and a measured blood glucose level < 2 mmol/l or prompt recovery following oral carbohydrate, intravenous glucose or glucagon administration.
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