Deterioration of type 2 diabetes mellitus and associated risk factors – a retrospective cohort study based on German claims data, 2008-2019 (WINDSOR-study)

Introduction This study investigates the prevalence and incidence of Type 2 diabetes (T2DM) deterioration and examines factors that influence the risk of disease progression.

Methods Analyses were based on a claims database, representing 13% of the German statutory health insurance population (BARMER). We consider a time horizon of twelve years (2008-2019). Analyses are performed separately for prevalent and incident patients. Patients aged ≥18 years are included based on either a broad (only diagnosis-based) or narrow (based on diagnosis and T2DM-related drug therapy) definition. Deterioration is defined as a treatment intensification or T2DM related complications. For the prevalence cohort, the yearly prevalence of deterioration stratified by age and sex were computed. In the incidence cohort deterioration is quantified quarterly and analyzed jointly across all years under study. With an offset for each patient’s follow-up time, a negative binomial model is used to compute the rate-ratio of deterioration.

Results Up to 505 thousand patients are included in the prevalence cohort and up to 44 thousand patients in the incidence cohort. The overall annual rate of deterioration-events per newly diagnosed patient is 0.15/year which on average results in one deterioration event every 6.6 years. In the incidence cohort, a large share of patients does not experience any deterioration (42.4%) within the observational period.

Conclusion No methodological standards are available for estimating the epidemiology of disease progression in patients with T2DM. The WINDSOR study contributes to the development of data-based approaches to defining patient cohorts, considering disease progression and deterioration.

Interessenskonflikt

DMW reports personal fees from the Novo Nordisk Pharma GmbH for advisory board during the conduct of the study. JW, MB and WG declare no financial and non-financial relationships and activities and no conflicts of interest. EM, LS and RG are employees of the Novo Nordisk Pharma GmbH and do own shares.

Publication History

Article published online:
06 May 2021