gms | German Medical Science

Background: The aim is to establish a prospective, nationwide type 2 diabetes (T2DM) registry (DIAREG) using an innovative data collection methodology to better understand the epidemiology, treatment patterns and patients’ quality of life.

Materials and Methods: From the physician panel of the IMS Disease Analyzer data base (49 diabetologists and 1,500 general practitioners), a sub-set of 101 physicians have agreed so far to participate in DIAREG. All these practices deliver anonymized retrospective data on a regularly basis. Repressiveness and validity was shown in a scientific cohort study [1].

The inclusion criteria (≥18 years old with T2DM diagnosis) trigger consecutive patient selection for further data collection. Patients regularly complete a validated set of patient reported outcome (PRO) questionnaires (e.g. SF36, WHO-5). Anonymized data from PRO questionnaires, electronic medical records (EMR) and case report forms are linked to provide a consistent picture of disease management.

Structure, expansion, objectives and applications for health service research is coordinated and steered by a scientific advisory board, containing six scientists. The advisory board was also responsible for the ethic votum. DIAREG is registered at ClinicalTrial.gov.

For 10% of the included patients, results will be validated by clinical research associates. Patients will be selected by random.

Results: Between August 2013 and July 2014 DIAREG a total of 1,063 T2DM patients (age: 32-95 years, 54.1% males, insulin therapy: 14.6%; oral anti-diabetics: 49.6%; insulin + OAD: 15.7%) are currently contributing to the registry.

End of July 2014 the first 41 PROs are available for DIRAG. PRo information can be linked to the other parts of the study.

The included physicians report how important defined objectives are in general (not linked to a specific patient), e.g. the prevention of micro- and macrovascular events or hypoglycemia [2].

DIAREG improves completeness of EMR data by adding BMI (mean: 31.0 (SD: 10.1) kg/m2), blood pressure, HbA1C (e.g. completeness of HbA1C records improved from 42% to 83% of patients; HbA1C mean: 7.0% (SD: 1.3 %), range: 4.8-14.0%) and disease duration (<1-56 years) information.

DIAREG enhances breadth of information by collecting data not normally captured in EMR sources, such as physician rationale related to treatment choice or switch, target HbA1C, hypoglycemia, micro- or macrovascular events, and patient reported information (e.g. quality of life, treatment satisfaction and depression).

Conclusion: DIAREG represents a unique capability to research T2DM in Germany through multiple linked longitudinal data sources – benefits from both are captured, from primary and secondary data.