The Danish Centre for Strategic Research in Type 2 Diabetes (DD2) study: expected outcome from the DD2 project and two intervention studies

Henning Beck-Nielsen,¹ Thomas PJ Solomon,² Jørgen Lauridsen,⁴ Kristian Karstoft,² Bente K Pedersen,² Søren P Johnsen,³ Jens Steen Nielsen,¹ Tine Bjerregaard Kryger,² Camilla Sortsø,⁴ Allan Vaag<sup>5

1</sup>Diabetes Research Centre, Odense University Hospital, Odense, ²Centre of Inflammation and Metabolism, Rigshospitalet – Copenhagen University Hospital, Copenhagen, ³Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, ⁴Institute of Public Health – Health Economics, University of Southern Denmark, Odense, ⁵Abdominal Centre, Rigshospitalet – Copenhagen University Hospital, Copenhagen, Denmark

Abstract: The overall aim of the Danish Centre for Strategic Research in Type 2 Diabetes (DD2) is to near-normalize metabolic control in newly diagnosed patients with type 2 diabetes (T2D) using an individualized treatment approach. We hypothesize that this will not only prevent complications and improve quality of life for T2D patients but also result in increased cost efficiency compared with current treatment modalities. This paper provides an overview of the expected outcomes from DD2, focusing on the two main intervention studies. The main data for the DD2 project are collected during patient enrollment and stored using the individual civil registration number. This enables subsequent linking to other national databases where supplemental data can be obtained. All data will be used for designing treatment guidelines and continuously monitoring the development of diabetic complications, thereby obtaining knowledge about predictors for the long-term outcome and identifying targets for new interventions. Further data are being collected from two intervention studies. The aim of the first intervention study is to improve T2D treatment using an individualized treatment modality optimizing medication according to individual metabolic responses and phenotypic characteristics. The aim of the second intervention study is to develop an evidence-based training protocol to be implemented as a treatment modality for T2D and used for initiating lifelong changes in physical activity levels in patients with T2D. An initial pilot study evaluating an interval-based walking protocol is ongoing, and preliminary results indicate that this protocol is an optimal “free-living” training intervention. An initial health-economic analysis will also be performed as a basis for analysis of the data collected during the project. A cost-benefit analysis of the two intervention studies will be conducted. The DD2 project is expected to lead to improved treatment modalities and increased knowledge about existing treatment guidelines, and will also provide a solid base for health-economic decision-making.

Keywords: type 2 diabetes, epidemiological methods, exercise intervention, clinical intervention, individualized treatment, treatment guidelines