Clinical characteristics, anti-hyperglycaemic treatment pattern and target attainment of type 2 diabetes mellitus patients in older population with or without albuminuria in China: A nationwide cross-sectional study

Study type

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

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Medical condition to be studied:
  Type 2 diabetes mellitus

Population studied

• Age groups:
  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  1500

Study design details

• Main study objective:
  to assess the level of blood glucose, measured by the proportion of patients attaining the blood glucose control target defined as HbA1c<7%.
• Outcomes:
  The primary outcome is the proportion of patients attaining blood glucose control target defined as HbA1c<7%, according to 2015 American Diabetes Association (ADA) and 2013 Chinese Diabetes Society (CDS) guidelines. Renal function level of patientsTreatment regimens for T2DM that patient are currently takingProportion of macro vascular and micro vascular diabetic complicationsProportion of Hypoglycaemic occurrenceProportion of Hypoglycaemia leading to therapy changeProportion of Anti-hypertension therapy usageProportion of Lipid Lowering therapy usageProportion of Anti-Platelet therapy usage
• Data analysis plan:
  Descriptive statistics such as mean, standard deviation, median and range (minimum, maximum) will be used to summarize continuous variables. Counts and percentages will be used to summarize categorical variables. The chi-square test will be used to compare the categorical data between groups and the t-test will be used to compare the continuous variables that are normally distributed. For variables that are not normally distributed, non-parametric tests will be used.To identify the factors associated with overall blood glucose control, a stepwise logistic regression will be used.Missing data will not be imputed. Statistical significance will be assessed at a two-sided 0.05 level in an explorative way. All analysis will be conducted using SAS software.