Study ID	Publication	Study author request	Trials register	Clinical study report	Clinical study synopsis	EMA report	FDA report
Bartley 2008	Hypoglycaemia between 23:00 to 06:00	—	ND	Hypoglycaemia between 23:00 to 06:00	Hypoglycaemia between 23:00 to 06:00	—	—
BEGIN Basal‐Bolus Type 1	Hypoglycaemic episodes occurring from 00:01 to 05:59	—	Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.	Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.	Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.	Hypoglycaemic episodes occurring from 00:01 to 05:59	Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.
BEGIN Flex T1	Episodes occurring between 00:01 and 05:59 (inclusive)	—	Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.	Hypoglycaemia between 00:01 to 05:50 a.m.	"A hypoglycaemic episode with time of onset between 00:01 and 05:59 (both included) was considered nocturnal"	Hypoglycaemic episodes occurring from 00:01 to 05:59	Hypoglycaemic episodes in the timeframe 00:00 to 06:00
BEGIN Young	Hypoglycaemic episodes occurring between 11 p.m. and 7 a.m. inclusive were classified as nocturnal	—	Hypoglycaemia from 11 p.m. ‐ 7 a.m./23:00 ‐ 07:00	"Hypoglycaemic episodes were defined as nocturnal if the time of onset was between 11 p.m.‐7 a.m./23:00‐7:00"	"Nocturnal (11 p.m. ‐ 7 a.m.]"	Hypoglycaemia from 11 p.m. ‐ 7 a.m.	Hypoglycaemia from 11 p.m. ‐ 7 a.m.
Bolli 2009	Hypoglycaemia which occurred between bedtime and before getting up in the morning	—	—	—	—	—	—
Chase 2008	Hypoglycaemia from midnight and 6 a.m.	—	ND	Hypoglycaemia from midnight and 6 a.m.	ND	—	—
Davies 2014	Hypoglycaemia between 00:01 and 05:59 hours	Hypoglycaemia between 00:01 and 05:59 hours	Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.	"The nocturnal period was considered as the period between 00:01 and 05:59 a.m."	Nocturnal hypoglycaemia (00:01‐05:59 a.m.)	Hypoglycaemic episodes occurring from 00:01 to 05:59 h	Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.
Fulcher 2005	Hypoglycaemia occurring after the evening insulin injection and before the morning insulin dose	—	—	"Nocturnal hypoglycaemia was defined as hypoglycaemia occurring between bedtime after the evening injection and before getting up in the morning (i.e. before the morning determination of fasting blood glucose and before any morning insulin dose)"	—	—	—
Heller 2009	Hypoglycaemia between 23:00 and 06:00	—	ND	Hypoglycaemia between 23:00 and 06:00	Hypoglycaemia between 23:00 and 06:00	—	—
Home 2005	Symptomatic hypoglycaemia occurring during sleep between bedtime and rising in the morning, or before the morning pre‐breakfast self‐blood glucose measurement and the morning insulin injection. Only participants with confirmed blood glucose < 2.0 mmol/L were considered clinically relevant			"Nocturnal hypoglycemia was defined as hypoglycemia occurring while the participant was asleep, between bedtime after the evening injection and before getting up in the morning, i.e. before the morning determination of FBG and before the morning injection"		ND	ND
Kobayashi 2007	Hypoglycaemia between 00:01 and 05:59	—	ND	Nocturnal hypoglycaemia	Hypoglycaemia between 23:00 and 06:00	—	—
Liu 2016	Hypoglycaemia occurring between 23:00–07:00	—	"Any asymptomatic and/or symptomatic hypoglycemic event that occurred between 23:00 to 07:00"	"Any asymptomatic and/or symptomatic hypoglycemic event that occurred between 23:00 to 07:00"	Nocturnal hypoglycaemia	Any asymptomatic and/or symptomatic hypoglycaemic event that occurred between 23:00 to 07:00	—
NCT00595374	—	—	ND	—	Nocturnal hypoglycaemia	—	—
NCT00605137	—	—	ND	Nocturnal hypoglycaemia	Hypoglycaemia from 23:00 ‐ 06:00, inclusive	—	—
Pieber 2007	Hypoglycaemia between 23:00 and 06:00	—	ND	Hypoglycaemia between 23:00 and 06:00	Hypoglycaemia between 23:00 and 06:00	—	ND
Porcellati 2004	Nocturnal episodes of hypoglycaemia were calculated from values measured at 03.00 or any time between 01.00 and 07.30 when participants awoke with symptoms suggestive of hypoglycaemia	—	—	—	—	—	—
PRESCHOOL	Hypoglycaemia between 23:00 hours and 07:00	—	"Nocturnal hypoglycemia: any event from the "all hypoglycemia" total that occurred between 23:00 and 07:00"	"Nocturnal hypoglycemia: any event from the “all hypoglycemia” total that occurred between 23:00 and 07:00"	—	ND	—
Ratner 2000	Hypoglycaemia occurring while asleep after the bedtime insulin dose and before the morning insulin dose and before the morning blood glucose measurement	—	—	"Nocturnal hypoglycemia was defined as hypoglycemia which occurred while the participant was asleep between bedtime after the evening injection and before getting up in the morning (i.e. before the morning determination of fasting blood glucose and before the morning injection)"	—	ND	ND
Robertson 2007	Hypoglycaemic between 22.00 (included) − 07.00(excluded)	ND	ND	Hypoglycaemic between 22.00 (included) − 07.00(excluded)	Hypoglycaemia between (22:00 to 07:00)	—	ND
Russell‐Jones 2004	Hypoglycaemia between 11 p.m. to 6 a.m.	ND	ND	Hypoglycaemia from 23:00 to 06:00	Hypoglycaemia from 23:00 to 06:00	Hypoglycaemia episodes occurring between 23:00 and 6:00	Hypoglycaemia episodes occurring between 23:00 and 06:00
Schober 2002	Nocturnal hypoglycaemia was defined as hypoglycaemia while the participants was sleeping between bedtime and after the evening injection and before getting up in the morning			"Nocturnal hypoglycemia was defined as hypoglycemia occurring while the participant was asleep, between bedtime after the evening injection and before getting up in the morning, i.e. before the morning determination of FBG and before the morning injection"		—	ND
Standl 2004	Hypoglycaemia between 23:00 to 06:00	—	—	Hypoglycaemia from 23:00 to 06:00	Hypoglycaemia from 23:00 to 06:00	Hypoglycaemia episodes occurring between 23:00 and 6:00	Hypoglycaemia episodes occurring between 23:00 and 6:00
SWITCH 1	Episodes between 12:01 a.m. and 5:59 a.m.	ND	Hypoglycaemia between 00:01 and 05.59 a.m.	Hypoglycaemia between 00:01 and 05.59 a.m.	Nocturnal hypoglycaemia	—	ND
Thalange 2013	Nocturnal if they occurred between 22:00 and 07:00	—	ND	"Episodes occurring between 22:00 (included) and 07:00 (excluded) were defined as nocturnal"	ND	ND	—
Urakami 2017	Hypoglycaemia occurring between 22:00 – 06:59	Hypoglycaemia occurring between 22:00 – 06:59	—	—	—	—	—
Vague 2003	Hypoglycaemia between 23:00 to 06:00	—	—	Hypoglycaemia between 23:00 (included) and 06:00 (excluded)	Hypoglycaemia between 23:00 to 06:00	Hypoglycaemia episodes occurring between 23:00 and 6:00 hours	Hypoglycaemia episodes occurring between 23:00 and 6:00
—: indicates source not available a.m.: ante meridiem; EMA: European Medicines Agency; FBG: fasting blood glucose; FDA: Food and Drug Administration; ND: not defined; p.m.: post meridiem.