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 topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• Data collection methods:
  Primary data collection

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

• Study design:
  It was a multi-centre, cross-sectional, non-interventional study
• 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%.
• Setting:
  Patients were recruited into the study in the order of their clinical visits scheduled. First 7 consented and suitable patients were recruited for each site on each day, or fewer if without enough patients. One study visit was; planned for each patient. Clinical assessments were performed as part of routine clinical practice. Some laboratory tests results prior to the study were used as source data as specified. All data required were entered into the Electronic Data Capture (EDC) System only after each patient had consented to participation.
• 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. Secondary outcomes:; - Renal function level of patients; - Treatment regimens for T2DM that patient are currently taking; - Proportion of macro vascular and micro vascular diabetic complications; - Proportion of Hypoglycaemic occurrenceProportion of Hypoglycaemia leading to therapy change; - Proportion of Anti-hypertension therapy usage; - Proportion of Lipid Lowering therapy usage; - Proportion 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.