Hypoglycemia: a review of definitions used in clinical trials evaluating antihyperglycemic drugs for diabetes

Figures & data

Figure 1 Overall hypoglycemia definitions.

Figure 2 Overall hypoglycemia definitions in treatment classes.

Note: *Trials were double counted for treatment.

Table 1 Definitions of severe hypoglycemia

Reference	Severe hypoglycemia definition
Ross et al^Citation14	Any hypoglycemic event requiring assistance by another person, coma, or seizure
Defronzo et al^Citation15	Subjects required the assistance of another person to obtain treatment for their hypoglycemia, including intravenous glucose or intramuscular glucagon
Marre et al^Citation16	Severe hypoglycemia (grade 3 or 4 on a scale of 1–4, on which a score of 1 was given for symptoms that did not sufficiently interfere with normal activities and a score of 4 indicated symptoms that required hospitalization)
Bergenstal et al^Citation17	Major hypoglycemia was defined as loss of
Diamant et al^Citation10	consciousness, seizure, or coma that resolved after treatment with glucagon or glucose, or severe impairment that required third-party assistance to resolve the episode
Aschner et al^Citation18 Barnett et al^Citation19 Cho et al^Citation20 Davies et al^Citation9	As an event that required assistance, with a low PG/BG value or recovery after oral carbohydrate, intravenous glucose or glucagon administration.
Esposito et al^Citation11 Gao et al^Citation21 Heine et al^Citation22 Janka et al^Citation23 Nauck et al^Citation24 Rosenstock et al^Citation13 Yki-Jarvinen et al^Citation25	PG/BG values ranged from <3.3 to <3.0 mmol/L

Abbreviations: PG, plasma glucose; BG, blood glucose.

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