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

Diabetes Obes MetabPublished Prognostic model development and internal validation study

Authors' conclusion

iNPHORM is the first US-based primary prognostic study on Level 3 hypoglycaemia. Future model implementation could potentiate risk-tailored strategies that reduce real-world event occurrence and overall diabetes burden.

Study context

Population
Adults (18–90 years) with T1D or insulin- and/or secretagogue-treated T2D, recruited from a US nationwide probability-based internet panel; completed ≥1 follow-up questionnaireanalysed
Participants
986 adults
Outcome
Level 3 (severe) hypoglycaemia risk
Follow-up
1 year
Methodological details12-month panel survey, US-based, nationwide probability-based internet panel, Andersen and Gill's Cox survival and penalized regression with multiple imputation, Participant characteristics: T1D 17%; men 49.6%; mean age 51 (SD 14.3) years
  • 12-month panel survey
  • US-based
  • Nationwide probability-based internet panel
  • Andersen and Gill's Cox survival and penalized regression with multiple imputation
  • Participant characteristics: T1D 17%; men 49.6%; mean age 51 (SD 14.3) years

Performance

As reported in the abstract

Model discrimination for 1-year Level 3 hypoglycaemia risk

Optimism corrected c-statistic

0.77

Further findings

≥1 Level 3 hypoglycaemia event(s) reported · across follow-up

Proportion with ≥1 Level 3 event(s)
035.1% (95% CI 32.2-38.1)

Level 3 hypoglycaemia event rate · across follow-up

Events per person-year
5.0 (95% CI 4.1-6.0)

Original publication

Development and validation of a real‐world model to predict 1‐year Level 3 (severe) hypoglycaemia risk in adults with diabetes (the iNPHORM study, United States). Diabetes Obes Metab. Published 6 July 2023. doi:10.1111/dom.15186

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