Influence of severe hypoglycemia definition wording on reported prevalence in adults and adolescents with type 1 diabetes: a cross-sectional analysis from the BETTER patient-engagement registry analysis

Severe (level 3) hypoglycaemia occurrence in a real‐world cohort of adults with type 1 or 2 diabetes mellitus (iNPHORM, United States)

“…Evidence asserts that the accuracy of past‐year SH recall is 90%, 40 an estimate that may be even higher in our study as events were elicited up to monthly. To promote respondent comprehension and reduce misclassification, a level 3 case definition (in line with the ADA 2 and a recent post factum validation survey 60 ) was carefully crafted by our team of diabetes clinical and methodological experts and included in each questionnaire.…”

“…prehension and reduce misclassification, a level 3 case definition (in line with the ADA 2 and a recent post factum validation survey60 ) was carefully crafted by our team of diabetes clinical and methodological experts and included in each questionnaire.Fourth, by collating responses over 1 year, we were able to reduce the risk of extrapolation bias. The global HAT study (which excluded the United States) is one of few other investigations to assess the frequency of past month SH 41.…”

Development and validation of a real‐world model to predict 1‐year Level 3 (severe) hypoglycaemia risk in adults with diabetes (theiNPHORMstudy, United States)

“…Monthly questionnaires collated responses over the duration of our target prediction window (1 year), mitigating recall and extrapolation error, while permitting the analysis of time‐dependent variables and outcome recurrence. Conduct of a panel survey enabled us to obtain detailed, up‐to‐date information on Level 3 hypoglycaemia—carefully defined per guidelines and a post factum validation study by Madar et al 52 —with a possible participant recall accuracy >90% 53 . We also examined a host of clinically plausible predictors.…”

“…a Incidence proportions do not account for zero-risk or unobserved periods.T A B L E 8For example, based on predicted risks, clinicians and patients could modify glycaemic goals or opt to deintensify, simplify, or change medications. Use of hybrid closed-loop pumps or C/FGM could also be considered, as well as other non-therapeutic interventions, such as impaired awareness of hypoglycaemia screening and structured diabe-Level 3 hypoglycaemia-carefully defined per guidelines and a post factum validation study by Madar et al52 -with a possible participant recall accuracy >90% 53. We also examined a host of clinically plausible predictors.…”