Search

Charlotte Steffensen,1 Reimar W Thomsen,2 Allan Vaag,3 Henning Beck-Nielsen,4 Jens Sandahl Christiansen,1 Torben Hansen,5,6 Oluf Borbye Pedersen,5,6 Jørgen Rungby11Aarhus University Hospital, Department of Medicine, Aarhus, 2Aarhus University Hospital, Institute of Clinical Medicine, Department of Clinical Epidemiology, Aarhus, 3Copenhagen University Hospital "Rigshospitalet", Department of Endocrinology, Copenhagen, 4Odense University Hospital, Department of Endocrinology, Odense, 5The Novo Nordisk Foundation Centre for Basic Metabolic Research, Faculty of Health Sciences, University of Copenhagen, Copenhagen, 6Faculty of Health Sciences, University of Aarhus, Aarhus, DenmarkAbstract: Here we provide an overview of the rationale and methods of a series of planned population based studies within the Danish Centre for Strategic Research in Type 2 Diabetes (DD2) Project. The project aims to support and evaluate ongoing political and administrative efforts to implement nationwide guidelines for maintaining metabolic control in newly diagnosed type 2 diabetes (T2D) patients to prevent diabetic complications and improve quality of life. The DD2 is designed as a prospective cohort study (collection of epidemiological data) supplemented by randomized clinical intervention trials (on physical exercise and individualized pharmacological treatment) and the establishment of a biobank comprised of material from a large number of newly diagnosed T2D patients. Inclusion of the majority of newly diagnosed T2D patients as they are diagnosed at their general practitioner or diabetes hospital outpatient clinics and entered into the DD2 cohort will establish a nationwide database comprising a large number of future incident cases of T2D in Denmark. These cases will form the project cohort of the DD2. Within the first 6 months of diagnosis, all patients will be invited to contribute to a biobank of DNA, plasma, urine, and tissue sampling. The DNA biobank will enable future studies of the effect of pharmacological treatment and outcome in subsets of patients with specific genetic risk profiles covering disease etiology and specific drug kinetics and metabolism. We will also perform two clinical intervention trials examining: the effectiveness of physical exercise on diabetes-related outcomes and the impact of trial outcomes on individualized pharmacological treatment. Moreover, the DD2 will serve as a platform for testing and developing new antidiabetic drugs. All together, we expect this study to contribute to substantially improved diabetes care in T2D patients locally and abroad.Keywords: type 2 diabetes, prognosis, intervention, physical exercise

Jens Steen Nielsen,1 Reimar W Thomsen,2 Charlotte Steffensen,2 Jens S Christiansen31Department of Endocrinology M, Odense University Hospital, Odense, 2Department of Clinical Epidemiology, 3Department of Endocrinology, Aarhus University Hospital, Aarhus, DenmarkAbstract: This paper aims to describe the patient enrollment system and implementation strategy for the new nationwide Danish Centre for Strategic Research in Type 2 Diabetes (DD2) project. The paper will also describe the design, current content, and pilot testing of the DD2 registration form. The challenge of the DD2 project was to construct a registration system functioning in the entire Danish health care system, where new type 2 diabetes patients are initially met, and with the capacity to enroll 200 newly diagnosed diabetes patients per week nationwide. This requires a fast and simple registration that is part of everyday clinical practice in hospital outpatient clinics and general practitioner (GP) clinics. The enrollment system is thus built on a tested, rational design where patients need only one visit and only specific limited data about physical activity, anthropometric measures, and family history of diabetes are collected during a brief patient interview. Later, supplemental data will be extracted by computerized linkage with existing databases. The feasibility of this strategy was verified in a pilot study. For maximum flexibility, three different ways to fill in the DD2 registration form were provided and an interactive webpage was constructed. The DD2 project also involves collection of blood and urine samples from each diabetes patient, to be stored in a biobank. Clinicians may obtain the samples themselves or refer patients to the nearest clinical biochemical department. GPs have the additional option of referring patients to the nearest hospital outpatient diabetes clinic to obtain interview data, clinical data, and samples. At present, the enrollment system is in use at 17 hospital outpatient diabetes clinics and 45 GP clinics nationwide, together enrolling 40 new type 2 diabetes patients per week in the DD2 project. A total of 990 patients have now been enrolled and the DD2 is ready to expand nationwide.Keywords: DD2, type 2 diabetes, logistics, implementation, data registration, health information technology