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Henrik Toft Sørensen,1 Søren Friborg,2 Jørgen Rungby,3 Jens Sandahl Christensen,4 Allan Vaag,5 Henning Beck-Nielsen61Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, 2Department of Endocrinology M, Odense University Hospital, Odense, Denmark, 3Department of Pharmacology, University of Aarhus, Aarhus, 4Department of Internal Medicine and Endocrinology, Aarhus University Hospital, Aarhus, 5Department of Endocrinology, Rigshospitalet and Copenhagen University, 6Diabetes Research Centre, Department of Endocrinology, Odense University Hospital, Odense, DenmarkType 2 diabetes is a pandemic and an enormous public health problem. This supplemental issue of Clinical Epidemiology describes the rationale, design, and implementation of the establishment of a large cohort of all Danes with type 2 diabetes (the DD2 study) and of a biobank to bridge the scientific disciplines of epidemiology, clinical medicine, genetics, epigenetics, and pharmacology. This will most likely result in great benefits for the application of evidence-based medicine to the care of, and improved outcomes for, Danish type 2 diabetes patients.

Reimar Wernich Thomsen,1 Søren Friborg,2,3 Jens Steen Nielsen,2 Henrik Schroll,4 Søren Paaske Johnsen11Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark; 2Department of Endocrinology, Odense University Hospital, Odense, Denmark; 3Danish Clinical Registers, Aarhus, Denmark; 4Danish Quality Unit of General Practice, Odense, DenmarkAbstract: This paper provides a short overview of the Danish health care system and the organization of care for type 2 diabetes patients in Denmark. It also describes the supplementary data sources that are used for collection of baseline data in the nationwide Danish Centre for Strategic Research in Type 2 Diabetes (DD2) Project. The Danish National Health Service provides tax-funded medical care for all 5.6 million Danish residents. The health care system is characterized by extensive individual-level registration of data used for planning, administration, quality improvement, and research. It is estimated that there are currently at least 250,000 individuals with known diabetes in Denmark (approximately 4.5% of the Danish population), of which an estimated 80% are followed and treated by their general practitioners and approximately 20% are followed at hospital specialist outpatient clinics. These health care providers form the basis for recruiting diabetes patients in the DD2 project, and the data sources that these providers use in clinical practice give access to important supplementary patient data. The DD2’s patient-enrollment system is designed to be fast and simple, and thus only collects primary interview data that cannot be extracted from already existing data sources. Thus, in addition to an online DD2 questionnaire filled out by general practitioners and hospital physicians at the time of patient enrollment, supplementary data are obtained from the Danish Diabetes Database for Adults, a nationwide clinical quality improvement registry. Both hospital physicians and a growing number of general practitioners routinely report data to this database. For general practitioners, the Danish General Practice Database acts as an important feeder database for the Danish Diabetes Database for Adults and thereby also for the DD2 project.Keywords: type 2 diabetes, data sources, epidemiology, health care, Danish Diabetes Database for Adults (DDDA), Danish General Practice Database (Dansk AlmenMedicinsk Database [DAMD])

Sørensen HT, Friborg S, Rungby J, Christensen JS, Vaag A, Beck-Nielsen H. The Danish national type 2 diabetes cohort – the DD2 study. Clinical Epidemiology. 2012;4(Suppl 1):1–5.The acknowledgments incorrectly reported the project website as "http://www.DD2.nu""_blank"www.DD2.nu. It should have been http://www.DD2.nu.Read the original article

Aim To examine prescribing practices and predictors of glucose-lowering therapy within the first year following diagnosis of Type 2 diabetes mellitus in a clinical care setting. Methods We followed people enrolled in the Danish Centre for Strategic Research in Type 2 Diabetes (DD2) cohort from outpatient hospital clinics and general practices throughout Denmark in 2010-2013. We used Poisson regression to compute age- and gender-adjusted risk ratios (RRs). Results Among 1158 new Type 2 diabetes mellitus patients, 302 (26%) did not receive glucose-lowering therapy within the first year, 723 (62%) received monotherapy [685 (95%) with metformin], and 133 (12%) received more than one drug. Predictors of receiving any vs. no therapy and combination vs. monotherapy were: age < 40 years [RR: 1.29 (95% CI: 1.16-1.44) and 3.60 (95% CI: 2.36-5.50)]; high Charlson Comorbidity Index [RRs: 1.20 (95% CI: 1.05-1.38) and 2.08 (95% CI: 1.16-3.72)]; central obesity [RRs: 1.23 (95% CI: 1.04-1.44) and 1.93 (95% CI: 0.76-4.94)]; fasting blood glucose of ≥ 7.5 mmol/l [RRs: 1.25 (95% CI: 1.10-1.42) and 1.94 (95% CI: 1.02-3.71)]; and HbA1c = 59 mmol/mol (≥ 7.5%) [RR: 1.26 (95% CI: 1.20-1.32) and 2.86 (95% CI: 1.97-4.14)]. Weight gain = 30 kg since age 20, lack of physical exercise and C-peptide of < 300 pmol/l also predicted therapy. Conclusions Comorbidity, young age, central obesity and poor baseline glycaemic control are important predictors of therapy one year after Type 2 diabetes mellitus debut. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this article is to provide a detailed description of the ongoing nationwide Danish Centre for Strategic Research in Type 2 Diabetes (DD2) project cohort and biobank. The DD2 cohort continuously enrols newly diagnosed patients with type 2 diabetes (T2D) throughout Denmark. The overall goal of the DD2 project is to establish a large and data-rich T2D cohort that can serve as a platform for exhaustive T2D research including (1) improved genotypic and phenotypic characterisation of T2D, (2) intervention studies of more individualised T2D treatment, (3) pharmacoepidemiological studies and (4) long-term follow-up studies on predictors of T2D complications and prognosis., Participants: Between 2010 and 2016, 7011 individuals with T2D have been enrolled and assessed at baseline. Information collected include interview data (eg, body weight at age 20 years, physical activity and alcohol consumption), clinical examination data (eg, hip-waist ratio and resting heart rate) and biological samples (whole blood, DNA, plasma and urine) stored at -80°C and currently analysed for a range of biomarkers and genotypes., Findings to Date: Registry linkage has provided extensive supplemental continuous data on glycosylated haemoglobin A, lipids, albuminuria, blood pressure, smoking habits, body mass index, primary care contacts, hospital diagnoses and procedures, medication use, cancer and mortality. Cross-sectional associations between biomarkers, family history, anthropometric and lifestyle measures and presence of complications at baseline have been reported., Future Plans: During 2016, a detailed follow-up questionnaire has been answered by 85% of initial participants, providing follow-up information on baseline variables and on presence of diabetic neuropathy. The DD2 cohort has now been followed for a total of 18 862 person-years, and nested intervention trials and follow-up studies are ongoing. In the future, the cohort will serve as a strong national and international resource for recruiting patients to nested case studies, clinical trials, postmarketing surveillance, large-scale genome studies and follow-up studies of T2D complications., Competing Interests: Competing interests: The salary of DHC is paid by the International Diabetic Neuropathy Consortium (IDNC) research programme, which is supported by a Novo Nordisk Foundation Challenge Programme grant (grant number NNF14OC0011633). AV started employment at AstraZeneca in March 2016. JSC has served on advisory boards and speaker panels for Novo Nordisk. The remaining authors report no personal conflicts of interest pertaining to this work. Moreover, the Department of Clinical Epidemiology, Aarhus University Hospital, participates in the IDNC research programme and is involved in the Program for Clinical Research Infrastructure (PROCRIN) established by the Lundbeck Foundation and the Novo Nordisk Foundation. The Department of Clinical Epidemiology, Aarhus University Hospital, also receives funding for other studies from companies in the form of research grants to (and administered by) Aarhus University. None of these studies have any relation to the present study., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Aims: To examine the prevalence of micro- and macrovascular complications and their associated clinical characteristics at time of type 2 diabetes (T2D) diagnosis., Methods: We examined the prevalence of complications and associated clinical characteristics among 6958 newly diagnosed T2D patients enrolled in the prospective Danish Center for Strategic Research in T2D cohort during 2010-2016. We calculated age- and gender-adjusted prevalence ratios (aPRs) of complications using log-binomial and Poisson regression., Results: In total, 35% (n=2456) T2D patients had diabetic complications around diagnosis; 12% (n=828) had microvascular complications, 17% (n=1186) macrovascular complications, and 6% (n=442) had both. HbA1c levels of ≥7% were associated with microvascular complications [HbA1c 7%-8%; aPR: 1.35, 95% confidence interval (CI): 1.12-1.62] but not macrovascular complications [aPR: 0.91, 95% CI: 0.76-1.08]. High C-peptide≥800pmol/L was associated with macrovascular [aPR 1.34, 95% CI: 1.00-1.80] but not microvascular [aPR 0.97, 95% CI: 0.71-1.33] complications. Macrovascular complications were associated with male sex, age>50years, obesity, hypertriglyceridemia, low HDL cholesterol, smoking, elevated CRP levels, and anti-hypertensive therapy. Microvascular complications were associated with high blood pressure, hypertriglyceridemia, and absence of lipid-lowering therapy., Conclusions: One-third of patients with T2D had diabetes complications around time of diagnosis. Our findings suggest different pathophysiological mechanisms behind micro- and macrovascular complications., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: The excess risk of antibiotic use and hospital-treated infections in patients with type 2 diabetes (T2D) compared with general population is poorly understood., Methods: In a nationwide cohort of patients with incident T2D (n = 155 158) and an age-, gender-, and residence-matched comparison cohort (n = 774 017), we used Cox regression to compute rates and confounder-adjusted rate ratios (aRRs) of community-based antibiotic prescription redemption and hospital-treated infections during 2004-2012., Results: The rates of community-based antibiotic prescriptions in the T2D and comparison cohorts were 364 vs 275 per 1000 person-years after a median follow-up of 1.1 years (aRR = 1.24; 95% confidence interval [CI], 1.23 to 1.25). The corresponding rates for hospital-treated infection were 58 vs 39 per 1000 person-years after a median follow-up of 2.8 years (aRR = 1.49; 95% CI, 1.47 to 1.52). The aRRs were increased particularly for urinary tract infections (UTIs, 1.41; 95% CI, 1.35 to 1.45), skin infections (1.50; 95% CI, 1.45 to 1.55), septicemia (1.60; 95% CI, 1.53 to 1.67), and tuberculosis (1.61; 95% CI, 1.25 to 2.06) and of community-based antibiotics prescribed for UTIs (1.31; 95% CI, 1.29 to 1.33), Staphylococcus aureus infections (1.32; 95% CI, 1.30 to 1.34), and mycobacterial infections (1.69; 95% CI, 1.36 to 2.09). The 1-year aRR declined from 1.89 (95% CI, 1.75 to 2.04) in 2004 to 1.59 (95% CI, 1.45 to 1.74) in 2011 for hospital-treated infection (trend P = .007) and from 1.31 (95% CI, 1.27 to 1.36) in 2004 to 1.26 (95% CI, 1.22 to 1.30) in 2011 for community-based antibiotic prescriptions (trend P = .006)., Conclusions: Patients with T2D have rates of community-based antibiotic prescriptions and hospital-treated infections that are higher than for the general population., (© The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.)

Background: We investigated whether parental history of type 2 diabetes mellitus (T2D) is associated with age, lifestyle, anthropometric factors, and clinical severity at the time of T2D diagnosis., Methods: We conducted a cross-sectional study based on the Danish Centre for Strategic Research in Type 2 Diabetes cohort. We examined the prevalence ratios (PR) of demographic, lifestyle, anthropometric, and clinical factors according to parental history, using Poisson regression adjusting for age and gender., Results: Of 2825 T2D patients, 34% (n = 964) had a parental history of T2D. Parental history was associated with younger age at diagnosis [adjusted (a)PR 1.66, 95% confidence interval: 1.19, 2.31) for age <40 years; aPR 1.36 (95% confidence interval: 1.24, 1.48) for ages 40-59 years] and with higher baseline fasting plasma glucose [≥7.5 mmol/L, aPR 1.47 (95% confidence interval: 1.20, 1.80)], and also tended to be associated with lower beta cell function. In contrast, patients both with and without a parental history had similar occurrence of central obesity [91% vs. 91%], weight gain ≥30 kg since age 20 [52% vs. 53%], and lack of regular physical activity [60% vs. 58%]. Presence of diabetes complications or comorbidities at T2D diagnosis was not associated with parental history., Conclusions: The lack of an association between parental history and adverse lifestyle factors indicates that T2D patients do not inherit a particular propensity for overeating or inactivity, whereas patients with a parental history may have more severe pancreatic beta cell dysfunction at diagnosis., (Copyright © 2015 John Wiley & Sons, Ltd.)

Background: Current literature lacks data on markers of non-alcoholic fatty liver disease (NAFLD) in newly diagnosed type 2 diabetes mellitus (T2DM) patients. We therefore, conducted a cross-sectional study to examine modifiable clinical and lifestyle factors associated with elevated alanine aminotransferase (ALT) levels as a marker of NAFLD in new T2DM patients., Methods: Alanine aminotransferase levels were measured in 1026 incident T2DM patients enrolled in the nationwide Danish Centre for Strategic Research in Type 2 Diabetes (DD2) cohort. We examined prevalence of elevated ALT (>38 IU/L for women and >50 IU/L for men) and calculated prevalence ratios associated with clinical and lifestyle factors using Poisson regression. We examined the association with other biomarkers by linear regression., Results: The median value of ALT was 24 IU/L (interquartile range: 18-32 IU/L) in women and 30 IU/L (interquartile range: 22-41 IU/L) in men. Elevated ALT was found in 16% of incident T2DM patients. The risk of elevated ALT was increased in patients who were <40 years old at diabetes debut [adjusted prevalence ratio (aPR): 1.96, 95% confidence interval (CI): 1.15-3.33], in those with alcohol overuse (>14/>21 drinks per week for women/men) (aPR: 1.60, 95% CI: 1.03-2.50), and in those with no regular physical activity (aPR: 1.42, 95% CI: 1.04-1.93). Obesity and metabolic syndrome per se showed no association with elevated ALT when adjusted for other markers, whereas we found positive associations of ALT with increased C-peptide (β = 0.14, 95% CI: 0.06-0.21) and fasting blood glucose (β = 0.07, 95% CI: 0.03-0.11)., Conclusions: Among newly diagnosed T2DM patients, several modifiable clinical and lifestyle factors are independent markers of elevated ALT levels., (Copyright © 2014 John Wiley & Sons, Ltd.)

Background: We aimed to examine the prevalence of and modifiable factors associated with elevated C-reactive Protein (CRP), a marker of inflammation, in men and women with newly diagnosed Type 2 Diabetes mellitus (DM) in a population-based setting., Methods: CRP was measured in 1,037 patients (57% male) with newly diagnosed Type 2 DM included in the prospective nationwide Danish Centre for Strategic Research in Type 2 Diabetes (DD2) project. We assessed the prevalence of elevated CRP and calculated relative risks (RR) examining the association of CRP with lifestyle and clinical factors by Poisson regression, stratified by gender. We used linear regression to examine the association of CRP with other biomarkers., Results: The median CRP value was 2.1 mg/L (interquartile range, 1.0 - 4.8 mg/L). In total, 405 out of the 1,037 Type 2 DM patients (40%) had elevated CRP levels (>3.0 mg/L). More women (46%) than men (34%) had elevated CRP. Among women, a lower risk of elevated CRP was observed in patients receiving statins (adjusted RR (aRR) 0.7 (95% confidence interval (CI) 0.6-0.9)), whereas a higher risk was seen in patients with central obesity (aRR 2.3 (95% CI 1.0-5.3)). For men, CRP was primarily elevated among patients with no regular physical activity (aRR 1.5 (95% CI 1.1-1.9)), previous cardiovascular disease (aRR1.5 (95% CI 1.2-1.9) and other comorbidity. For both genders, elevated CRP was 1.4-fold increased in those with weight gain >30 kg since age 20 years. Sensitivity analyses showed consistent results with the full analysis. The linear regression analysis conveyed an association between high CRP and increased fasting blood glucose., Conclusions: Among newly diagnosed Type 2 DM patients, 40% had elevated CRP levels. Important modifiable risk factors for elevated CRP may vary by gender, and include low physical activity for men and central obesity and absence of statin use for women.

Background. Sentinel Data Capture is an IT program designed to collect data automatically from GPs' electronic health record system. Data include ICPC diagnoses, National Health Service disbursement codes, laboratory analysis, and prescribed drugs. Quality feedback reports are generated individually for each practice on the basis of the accumulated data and are available online only for the specific practice. Objective. To describe the development of the quality of care concerning drug prescriptions for diabetes patients listed with GPs using the Data Capture module. Methods. In a cohort study, among 8320 registered patients with diabetes, we analyzed the change in the proportion of medication for uncontrolled cases of diabetes. Results. From 2009 to 2010, there was an absolute risk reduction of 1.35% (0.89-1.81: P < 0.001) in proportion of persons not in antidiabetic medication despite an HbA1c above 7.0. Similarly, there was a 4.51% (3.42-5.61: P < 0.001) absolute risk reduction in patients not in antihypertensive treatment despite systolic blood pressure above 130 mm Hg and 4.73% (3.56-5.90: P < 0.001) absolute risk reduction in patients with total cholesterol level above 4.5 mmol/L and not receiving lipid-lowering treatment. Conclusions. Structured collection of electronic data from general practice and feedback with reports on quality of care for diabetes patient seems to give a significant reduction in proportion of patients with no medical treatment over one year for participating GPs. Due to lack of a control group, we are, however, not able to say if the drop in the proportion of uncontrolled cases is a result of participation in collection of electronic data and feedback alone.

An accreditation system for Danish general practices is an important element in the Danish Healthcare Quality Programme. In the present article the Danish Quality Unit of General Practice (DAK-E) and the Danish Institute for Quality and Accreditation in Heath Care (IKAS) recommend a comprehensive and information and communication technology-based system of accreditation, feedback and facilitated systematic development and continuous medical education. The overall goal is to further a learning culture in the primary sector based on accountability, transparency and collaboration across sectors.

By means of a multipractice investigation in which 347 general practitioners participated, 293 schemata were collected about patients who had undertaken suicidal acts. The material consists of 66 suicides and 227 attempted suicides. By and large, the sex and age distributions correspond to those in previous investigations. The number of attempted suicides in this investigation was only half of that anticipated. This may be due to lapse, seasonal variations, underrepresentation of urban practice etc. Strikingly many patients undertook acts in this material without having psychiatric diagnoses and the psychiatric diagnosis did not appear to play any part as regards whether the suicidal act lead to suicide. The methods employed appear otherwise to reflect development in society and pharmacotherapy. Where men were concerned, it appears that suicide is relatively most common among widowers, unemployed and early retirees while, where women were concerned, divorcees and early retirees were most frequently involved. Attempted suicide is most frequently carried out by unemployed men and by divorced and early retirees of both sexes. This investigation cannot indicate any definite occupational group which involves a risk as regards suicidal acts and economical factors appear only to play a part where attempted suicide is concerned.

A multipractice investigation was undertaken concerning suicidal behaviour. Sixty-six patients committed suicide and 227 attempted suicide. During the month prior to the suicidal actions, 2/3 of the patients had had contact with their general practitioners. Only very few had been in contact with a psychiatric department or with a practising psychiatrist during the same period. In a few cases, the general practitioner found that the most recent consultation was relevant in cases of patients who committed suicide. 28% of the patients who committed suicide and also were seen by their general practitioners within the last month suffered from serious somatic disease. Where the cases of attempted suicide were concerned, the general practitioners considered that 40% of the most recent consultations were relevant. In order to improve attention to suicidal signals, other forms of cooperation between the primary sector and hospitals, eg in the form of district psychiatric teams, are suggested.