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

Abstract

AimsAmong adults with insulin‐ and/or secretagogue‐treated diabetes in the United States, very little is known about the real‐world descriptive epidemiology of iatrogenic severe (level 3) hypoglycaemia. Addressing this gap, we collected primary, longitudinal data to quantify the absolute frequency of events as well as incidence rates and proportions.Materials and MethodsiNPHORM is a US‐wide, 12‐month ambidirectional panel survey (2020‐2021). Adults with type 1 diabetes mellitus (T1DM) or insulin‐ and/or secretagogue‐treated type 2 diabetes mellitus (T2DM) were recruited from a probability‐based internet panel. Participants completing ≥1 follow‐up questionnaire(s) were analysed.ResultsAmong 978 respondents [T1DM 17%; mean age 51 (SD 14.3) years; male: 49.6%], 63% of level 3 events were treated outside the health care system (e.g. by family/friend/colleague), and <5% required hospitalization. Following the 12‐month prospective period, one‐third of individuals reported ≥1 event(s) [T1DM 44.2% (95% CI 36.8%‐51.8%); T2DM 30.8% (95% CI 28.7%‐35.1%), p = .0404, α = 0.0007]; and the incidence rate was 5.01 (95% CI 4.15‐6.05) events per person‐year (EPPY) [T1DM 3.57 (95% CI 2.49‐5.11) EPPY; T2DM 5.29 (95% CI 4.26‐6.57) EPPY, p = .1352, α = 0.0007]. Level 3 hypoglycaemia requiring non‐transport emergency medical services was more common in T2DM than T1DM (p < .0001, α = 0.0016). In total, >90% of events were experienced by <15% of participants.ConclusionsiNPHORM is one of the first long‐term, prospective US‐based investigations on level 3 hypoglycaemia epidemiology. Our results underscore the importance of participant‐reported data to ascertain its burden. Events were alarmingly frequent, irrespective of diabetes type, and concentrated in a small subsample.

Clinical perspectives on the frequency of hypoglycemia in treat-to-target randomized controlled trials comparing basal insulin analogs in type 2 diabetes: a narrative review

“… 10 Recent real-world analyses in the USA show alarmingly high rates of level 3 or severe hypoglycemia, supporting the urgent need for hypoglycemia-mitigating interventions. 11 …”

“…Clinical care/Education/Nutrition alarmingly high rates of level 3 or severe hypoglycemia, supporting the urgent need for hypoglycemia-mitigating interventions. 11 Over the past three decades, there have been major improvements in the pharmacokinetic (PK) and pharmacodynamic (PD) properties of basal insulins, starting with first-generation basal insulin analogs (ie, insulin detemir (detemir) and insulin glargine U100 (glargine U100)), generating more predictable, longer-acting soluble formulations with flatter PK and PD profiles among insulin analogs, resulting in reduced hypoglycemia risk compared with neutral protamine Hagedorn (NPH) insulin. [12][13][14] The 'Treat-To-Target' Study published in 2003, comparing glargine U100 with NPH insulin, led to a paradigm shift in the accepted standard of care regarding insulin therapy for T2D.…”