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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.)

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.