Burden of Disease of Chronic Kidney Disease (CKD), Type 2 Diabetes Mellitus (T2DM), and Comorbid T2DM/CKD in Alberta, Canada: A Non-interventional Study using Administrative Health Data

Study type

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

  Disease epidemiology

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Type 2 diabetes mellitus

  Chronic kidney disease

Population studied

• 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)
• Estimated number of subjects:
  400000

Study design details

• Main study objective:
  Describe the burden of disease among three different cohorts of patients: (1) patients diagnosed with CKD, (2) those with T2DM, and (3) those with T2DM and comorbid CKD.
• Outcomes:
  Determine the incidence and prevalence of the three cohorts in Alberta, 1. Comorbidity and complication profiles and rates (diabetic, renal, cardiovascular, mortality, fractures) - All cohorts 2. Factors that influence the progression of CKD in patients 3. Healthcare resource use and associated costs for patients with CKD by stage 4. Stage-to-stage progression of CKD across the follow-up years 5. Treatment patterns by year - All cohorts
• Data analysis plan:
  1. Incidence will be reported as new cases per 100000 2. Prevalence will be reported as cases per 100000 3. Comorbidity and complication profiles and rates will be described using descriptive statistics (means, medians, standard deviation, interquartile range, count, percent as appropriate) 4. Factors that influence the progression of CKD in patients will be assessed using logistic regression models, association of risk will be reported using odds ratios and 95% confidence intervals 5. Healthcare resource use and associated costs will be reported using mean and standard deviation for variables with count data, while the median and interquartile range will be reported for length of stay 6. Stage-to-stage progression across the follow-up years will be described graphically utilizing a Sankey diagram 7. Treatment patterns by year will be described using frequencies and percentages for each medication