Incidence of Diabetic Ketoacidosis among Patients with Type 2 Diabetes in the United States

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (A10) DRUGS USED IN DIABETES

  DRUGS USED IN DIABETES
• Medical condition to be studied:
  Diabetic ketoacidosis

Population studied

• Short description of the study population:
  Patients diagnosed with Type 2 Diabetes (T2DM) initiating prescribed diabetes medication overall and by diabetes medication class and combinations of classes
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Type 2 diabetes mellitus patients
• Estimated number of subjects:
  222000

Study design details

• Main study objective:
  The primary objective of this study is to estimate the incidence of diabetic ketoacidosis among patients diagnosed with type 2 diabetes mellitus initiating prescribed diabetes medications overall and by diabetes medication class and combinations of classes.
• Outcomes:
  The primary outcome will be the presence and number of diabetic ketoacidosis events defined as an inpatient or emergency room claim with a diagnosis for diabetic ketoacidosis (ICD-9-CM 250.10, ICD-9-CM 250.12) in any diagnosis field while patient is treated with an antidiabetes medication. The secondary and exploratory outcomes are different versions of the definitions for diabetic ketoacidosis, using ICD-9-CM codes 249.10, 249.11, 276.2 and evaluating claims for all settings (inpatient admissions, emergency room visits, and outpatient visits).
• Data analysis plan:
  The analyses for this study will be unadjusted analyses displaying DKA incidence rates for all patients and for each of the examined diabetes medication classes/pre-specified combinations of classes. Incidence rates will be calculated as the number of patients with a DKA event divided by the sum of person-time of follow up. Incidence rates and 95% confidence intervals will be presented. Incidence rates will be standardized by age and sex. Incidence rates will also be presented for a subset of patients with no prior DKA diagnosis.