Study type

Study topic

Disease /health condition
Other

Study topic, other

Disease/Epidemiology study

Study type

Non-interventional study
Non-interventional study

Scope of the study

Other

If ‘other’, further details on the scope of the study

Proof of concept study to test a data derivation workflow designed to identify any event of interest from data sources with heterogeneous characteristics

Data collection methods

Secondary data collection

Non-interventional study design

Cross-sectional
Study drug and medical condition

Medical condition to be studied

Type 2 diabetes mellitus
Population studied

Short description of the study population

All active type 2 diabetes mellitus subjects in the participating databases at two distinct index dates: 1st January 2009 and 1st January 2012

Age groups

Term newborn infants (0 – 27 days)
Infants and toddlers (28 days – 23 months)
Children (2 to < 12 years)
Adolescents (12 to < 18 years)
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

Diabetes mellitus patients

Estimated number of subjects

12000000
Study design details

Main study objective

- to establish a set of standard algorithms useful to identify of patients with type 2 diabetes (T2DM) across heterogeneous sources of health data- to describe the data source-tailored combinations of standard algorithms recommended by the relevant local data base experts- to assess the impact of in

Data analysis plan

This is a descriptive, cross-sectional, retrospective multi-database study. The study population will include all active subjects in the participating databases at two distinct index dates: 1st January 2009 and 1st January 2012, respectively. Results from case-identification algorithms will be computed and presented as age band distribution of the percentage of the data base population identified. A validation of the records extracted in the databases will not be performed, since this is out of the scope of this study. Results will not be intended as disease frequency estimates.
Documents
Results tables
English (1.08 MB - PDF)View document