New national Biobank of The Danish Center for Strategic Research on Type 2 Diabetes (DD2)

Henry Christensen,¹ Jens Steen Nielsen,² Karina Meden Sørensen,³ Mads Melbye,³ Ivan Brandslund<sup>1,4

1</sup>Department of Clinical Biochemistry, Vejle Hospital, Vejle, Denmark; ²The Danish Centre for Strategic Research in Type 2 Diabetes (DD2), Department of Endocrinology M, Diabetes Research Centre, Odense University Hospital, Odense, Denmark; ³Department of Epidemiology Research, Statens Serum Institut, Copenhagen, Denmark; ⁴Institute of Regional Health Research, University of Southern Denmark, Odense, Denmark

Abstract: Long-term storage of biological samples from patients has become increasingly important in studies of disease control and treatment. The first nationwide Danish diabetes project, ie, The Danish Center for Strategic Research in Type II Diabetes (DD2), aims to improve treatment and the long-term outcome of patients with newly diagnosed type 2 diabetes (T2D). The DD2 project includes establishment of a biobank with samples from 50,000 patients with newly diagnosed T2D. This paper describes how blood and urine samples from 10,000 patients per year are collected, handled, and stored. The biobank includes whole blood, DNA, and plasma and urine samples, all frozen at −80°C. Sampling tubes have been standardized and are sent to hospital outpatient clinics and general practitioners where samples are taken, handled, aliquoted, and returned by mail overnight in standardized cryostorage tubes. When received at the biobank, samples are frozen without further treatment. From each patient, 24 cryostorage tubes are stored. Each tube is labeled with a barcode that links the data to other information available in a clinical databank registry. When patients are enrolled in DD2, a questionnaire is filled out and a quality monitoring system ensures that patients, samples, and questionnaires can be linked together at all times. The biobank is located at Vejle Hospital and the Danish National Biobank at Statens Serum Institut. As of the end of March 2012, samples from 1186 patients have been stored, and currently samples from 8–10 patients arrive per day. We have established the first national biobank in Denmark where blood, DNA, and plasma and urine samples from patients with newly diagnosed T2D are systematically collected and stored. This biobank enables sophisticated analysis of genetic variation and response to treatment, as well as disease marker studies that better classify disease status, progression, and complications.

Keywords: DD2, biobank, type 2 diabetes, logistics, implementation, biorepository, data registration