Prevalence and patterns of medication deintensification following severe hypoglycemia among older adults with diabetes

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Diabetes mellitus

  Hypoglycaemia

Population studied

• Age groups:
  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Renal impaired

  Hepatic impaired

  Immunocompromised
• Estimated number of subjects:
  350000

Study design details

• Main study objective:
  The main objective of this study is to understand insulin and sulfonylurea prescription practices after an episode of severe hypoglycemia.
• Outcomes:
  Deintensification of insulin and/or sulfonylurea therapy following hypoglycemia-related ED visit or hospitalization, Describing prescription patterns of glucose-lowering drugs before and after hypoglycemia-related ED visit or hospitalization event.
• Data analysis plan:
  Aim 1 We will determine crude cumulative incidence of deintensification following hypoglycemia. Multivariate logistic regression modelling will be used to assess the relationship between patient factors and deintensification versus no deintensification following hypoglycemia. Successively complex models will be built to capture individual demographic and clinical factors, diabetes complications and comorbidities, medication use, and health-care utilization. Aim 2: We will estimate the probability of filling each glucose-lowering drug before and after hypoglycemia-related ED visit (i.e. index event). This will be done in a) the full sample, and b) by baseline diabetes regimen (e.g. basal/bolus, basal only, premixed, oral agents only). We will also use a latent class analysis approach to characterize latent groups of diabetes medication trajectories pre- and post-index event.