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Adults (18\u201090\u2009years old) with type 1 diabetes mellitus or insulin\u2010 and\/or secretagogue\u2010treated type 2 diabetes mellitus were recruited from a nationwide, probability\u2010based internet panel. Among participants completing 1 follow\u2010up questionnaire(s), we modelled 1\u2010year Level 3 hypoglycaemia risk using Andersen and Gill's Cox survival and penalized regression with multiple imputation. Candidate variables were selected for their clinical relevance and ease of capture at point\u2010of\u2010care.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>In total, 986 participants [type 1 diabetes mellitus: 17%; men: 49.6%; mean age: 51 (SD: 14.3)\u2009years] were analysed. Across follow\u2010up, 035.1 (95% CI: 32.2\u201038.1)% reported \u22651 Level 3 event(s), and the rate was 5.0 (95% CI: 4.1\u20106.0) events per person\u2010year. Our final model showed strong discriminative validity and parsimony (optimism corrected c\u2010statistic: 0.77). Numerous variables were selected: age; sex; body mass index; marital status; level of education; insurance coverage; race; ethnicity; food insecurity; diabetes type; glycated haemoglobin value; glycated haemoglobin variability; number, type and dose of various medications; number of SH events requiring hospital care (past year and over follow\u2010up); type and number of comorbidities and complications; number of diabetes\u2010related health care visits (past year); use of continuous\/flash glucose monitoring; and general health status.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>iNPHORM is the first US\u2010based primary prognostic study on Level 3 hypoglycaemia. Future model implementation could potentiate risk\u2010tailored strategies that reduce real\u2010world event occurrence and overall diabetes burden.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/dom.15186","type":"journal-article","created":{"date-parts":[[2023,7,6]],"date-time":"2023-07-06T05:55:17Z","timestamp":1688622917000},"page":"2910-2927","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Development and validation of a real\u2010world model to predict 1\u2010year Level 3 (severe) hypoglycaemia risk in adults with diabetes (the\n                    <scp>iNPHORM<\/scp>\n                    study, United States)"],"prefix":"10.1111","volume":"25","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9474-7900","authenticated-orcid":false,"given":"Alexandria A.","family":"Ratzki\u2010Leewing","sequence":"first","affiliation":[{"name":"Department of Family Medicine, Schulich School of Medicine and 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