Monitoring for proteinuria in patients with type 2 diabetes mellitus (Proteinuria monitoring in type 2 diabetes)

Study type

• Study topic:
  Disease /health condition

  Other
• Study topic, other:
  Disease/Epidemiology study
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  This study aims to describe clinical practice using CPRD, specifically, how general practitioners monitor proteinuria in patients with type 2 diabetes
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Type 2 diabetes mellitus

Population studied

• Short description of the study population:
  Type 2 diabetis mellitis patients who initiated antidiabetic drug therapy during 2007-2013 in the CPRD.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 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:
  Diabetes mellitus patients
• Estimated number of subjects:
  65790

Study design details

• Main study objective:
  The UK National Institute for Health and Care Excellence (NICE) guideline on diabetes recommends at least annual monitoring of type 2 diabetes mellitus patients for proteinuria. To date, little has been published on the frequency of proteinuria monitoring in T2DM, and its association with risk factors for renal complications. This study aimed to describe proteinuria monitoring in T2DM patients.
• Outcomes:
  The primary outcome will be proteinuria monitoring rate, calculated as the number of patients with at least one screening test during follow-up, divided by the sum of time to the first proteinuria test during follow-up. The secondary outcomes will be the proportion of first test results as positive, negative or unknown for albuminuria/proteinuria and the proportion of second test results as positive, negative or unknown for albuminuria/proteinuria between 14 and 90 days after the first screening test.
• Data analysis plan:
  This is a descriptive study. Only univariate analyses will be conducted in this descriptive study. There is no comparison group. Apart from descriptive analysis of primary and secondary outcomes, sensitivity analyses will be conducted to obtain monitoring rate by age, sex, smoking status at cohort entry, and calendar year among patients who did not have a diagnosis of albuminuria, proteinuria, nephritic syndrome or diabetic nephropathy at cohort entry.