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The importance of chronic low-grade inflammation in the pathology of numerous age-related chronic conditions is now clear. An unresolved inflammatory response is likely to be involved from the early stages of disease development. The present position paper is the most recent in a series produced by the International Life Sciences Institute's European Branch (ILSI Europe). It is co-authored by the speakers from a 2013 workshop led by the Obesity and Diabetes Task Force entitled ‘Low-grade inflammation, a high-grade challenge: biomarkers and modulation by dietary strategies’. The latest research in the areas of acute and chronic inflammation and cardiometabolic, gut and cognitive health is presented along with the cellular and molecular mechanisms underlying inflammation–health/disease associations. The evidence relating diet composition and early-life nutrition to inflammatory status is reviewed. Human epidemiological and intervention data are thus far heavily reliant on the measurement of inflammatory markers in the circulation, and in particular cytokines in the fasting state, which are recognised as an insensitive and highly variable index of tissue inflammation. Potential novel kinetic and integrated approaches to capture inflammatory status in humans are discussed. Such approaches are likely to provide a more discriminating means of quantifying inflammation–health/disease associations, and the ability of diet to positively modulate inflammation and provide the much needed evidence to develop research portfolios that will inform new product development and associated health claims. [ABSTRACT FROM AUTHOR]

In type 1 diabetes an absolute deficiency of insulin secretion requires exogenous insulin supply to guarantee the patient's life avoiding ketoacidotic coma and to prevent the chronic complications of diabetes. In order to obtain a more physiological replacement therapy different approaches have been pursued since the early 70s to create an artificial wearable pancreas able to deliver insulin according to the blood glucose values as determined by continuous monitoring. Four components are considered essential for the realisation of an artificial pancreas: the sampling system, the glucose sensor, the mathematical models and the related algorithms for the calculation of the insulin doses and the infusion system for the insulin delivery. At present the still unsolved issues are mainly represented by the availability of reliable continuous glucose monitor and control algorithms, while the new technologies allow for the miniaturisation of the system. [ABSTRACT FROM AUTHOR]

In PROactive (PROspective pioglitAzone Clinical Trial In macroVascular Events), a long-term cardiovascular (CV) events trial in patients with type 2 diabetes (T2D) and macrovascular disease, pioglitazone (PIO) was associated with a 10% reduction in the primary endpoint (P=0.09) and a 16% reduction in the key secondary cardiovascular endpoint (P=0.03) vs placebo (PBL) when administered on top of existing diabetes and CV therapies, including statins. The aim of this study was to apply PROactive outcome data to the validated CORE Diabetes Model (CDM) in order to estimate the long-term clinical and economic outcomes associated with PIO vs PLB for the German setting. The CDM was modified to accommodate data from PROactive and included 18 relevant disease and procedure specific interdependent Markov sub-models to simulate disease progression over patient lifetimes. Direct medical costs (treatment, management and complication) were derived from published German sources and expressed in 2005 Euros (€). Health utilities were taken from the Cost of Diabetes in Europe - Type 2 study (CODE-2). Clinical and economic outcomes were discounted at 5% per annum (per the Hannover Consensus Group Statement for Economic Evaluations). PIO was projected to have an additional discounted life expectancy of 0.172 years over PLB at an additional direct cost of €1,599 giving an incremental cost-effectiveness ratio (ICER) of €9,281 per life year gained. PIO was also associated with an additional 0.120 QALYs generating an ICER of €13,294 per QALY gained. Probabilistic sensitivity analysis demonstrated that, at a willingness to pay of €50,000 per QALY gained, there was a 78.2% probability of PIO being cost-effective. Univariate sensitivity analyses showed that the results were most sensitive to the time horizon and duration of PIO benefit. Addition of PIO to existing therapies in patients with T2D and pre-existing macrovascular disease leads to improved life expectancy, quality-adjusted life expectancy and reduced incidence of most diabetes-related complications compared to PLB. This health economic analysis demonstrates that the addition of PIO is cost-effective and is likely to represent good value for money in the German setting. [ABSTRACT FROM AUTHOR]

Background: Registries and data sources contain information that can be used on an ongoing basis to improve quality of care and outcomes of people with diabetes. As a specific task of the EU Bridge Health project, we carried out a survey of diabetes-related data sources in Europe., Objectives: We aimed to report on the organization of different sources of diabetes information, including their governance, information infrastructure and dissemination strategies for quality control, service planning, public health, policy and research., Methods: Survey using a structured questionnaire to collect targeted data from a network of collaborating institutions managing registries and data sources in 17 countries in the year 2017., Results: The 18 data sources participating in the study were most frequently academic centres (44.4%), national (72.2%), targeting all types of diabetes (61.1%) covering no more than 10% of the target population (44.4%). Although population-based in over a quarter of cases (27.8%), sources relied predominantly on provider-based datasets (38.5%), fewer using administrative data (16.6%). Data collection was continuous in the majority of cases (61.1%), but 50% could not perform data linkage. Public reports were more frequent (72.2%) as well as quality reports (77.8%), but one third did not provide feedback to policy and only half published ten or more peer reviewed papers during the last 5 years., Conclusions: The heterogeneous implementation of diabetes registries and data sources hampers the comparability of quality and outcomes across Europe. Best practices exist but need to be shared more effectively to accelerate progress and deliver equitable results for people with diabetes., Competing Interests: SL is the Director of the RCGP RSC, as part of his academic work. He has received grants through his institution from AstraZeneca, Eli Lilly, Novo, and Sanofi, for diabetes related research. SC is employed by My Digital Health. CI is employed by Serectrix snc. SP was employed by Telemedica Consulting. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Carinci, Štotl, Cunningham, Poljicanin, Pristas, Traynor, Olympios, Scoutellas, Azzopardi, Doggen, Sandor, Adany, Løvaas, Jarosz-Chobot, Polanska, Pruna, de Lusignan, Monesi, Di Bartolo, Scheidt-Nave, Heidemann, Zucker, Maurina, Lepiksone, Rossing, Arffman, Keskimäki, Gudbjornsdottir, Di Iorio, Dupont, de Sabata, Klazinga and Benedetti.)

Background: Data processing of health research databases often requires a Data Protection Impact Assessment to evaluate the severity of the risk and the appropriateness of measures taken to comply with the European Union (EU) General Data Protection Regulation (GDPR). We aimed to define and apply a comprehensive method for the evaluation of privacy, data governance and ethics among research networks involved in the EU Project Bridge Health., Methods: Computerised survey among associated partners of main EU Consortia, using a targeted instrument designed by the principal investigator and progressively refined in collaboration with an international advisory panel. Descriptive measures using the percentage of adoption of privacy, data governance and ethical principles as main endpoints were used for the analysis and interpretation of the results., Results: A total of 15 centres provided relevant information on the processing of sensitive data from 10 European countries. Major areas of concern were noted for: data linkage (median, range of adoption: 45%, 30%-80%), access and accuracy of personal data (50%, 0%-100%) and anonymisation procedures (56%, 11%-100%). A high variability was noted in the application of privacy principles., Conclusions: A comprehensive methodology of Privacy and Ethics Impact and Performance Assessment was successfully applied at international level. The method can help implementing the GDPR and expanding the scope of Data Protection Impact Assessment, so that the public benefit of the secondary use of health data could be well balanced with the respect of personal privacy., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.)

Review of literature has shown an increased rate of thrombotic complications in diabetic patients with frequent episodes of hyperketonemia. However, the mechanisms by which ketosis promotes vascular disease in diabetic patients are unclear. It was the aim of this study to investigate early changes in haemostatic parameters and oxidative stress markers during the hyperketonemic status which follows the interruption of continuous subcutaneous insulin infusion (CSII) in type I diabetic patients. Eight CSII-treated type I diabetic patients underwent a 4-hour pump arrest. Blood glucose, insulin and 3-hydroxybutirate were measured to verify the metabolic response. A vein-occlusive (VO) test was performed for the determination of tPA and PAI-1 activities and their antigen levels before and after the CSII arrest. Coagulation factor VII and VIII were evaluated by one-stage PT and PTT method, respectively. TF, vWF, tPA and PAI-1 antigens were determined by ELISA, whereas tPA and PAI-1 activities using chromogenic methods. Plasma malondialdehyde (MDA) and protein carbonyl groups (PCG) levels were determined by HPLC and spectrophotometry, respectively. After the insulin deprivation phase, post-VO tPA antigen level significantly decreased (P = 0.0391), whereas TF and post-VO PAI-1 activity and antigen levels significantly increased (P = 0.0156 and P = 0.0234, respectively). Plasma MDA and PCG levels were 1.88-fold and 1.74-fold higher than baseline values, respectively. In conclusion, the impairment of the fibrinolytic potential and the increases in TF, MDA and PCG levels may enhance the risk of both arterial and venous thrombosis during ketosis. Thus, early detection of hyperketonemia in DM patients could contribute to the prevention of life-threatening vascular events.