Table 1.

Definition of SH Events and Serious Hypoglycemic Events.

Definition	Susceptibility to systematic bias
Severea: Hypoglycemic event “Requiring assistance from another person”b or specific neuroglycopenic symptoms (eg, impaired level of consciousness or confusion), “Requiring assistance from another person”c	Possible, because based on information provided by patient(s) or parents of patient(s)
Seriousd: Hypoglycemic events with hypoglycemic seizure or coma	Unlikely

^aIn the publication, defined as moderate hypoglycemia, although it better suits the definition of sum of severe and moderate hypoglycemia. It corresponds to the definition of SH events for all other studies included in the IQWiG CGM report, as well as the definition by the ADA 2013. ^bPatients >12 years. ^cPatients ≤12 years. ^dIn the publication, defined as SH. The definition in the publication exclusively includes hypoglycemic events that fulfilled at least 1 criterion for serious adverse events. For this reason, these hypoglycemic events are defined as serious hypoglycemic events in this report.