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Aims: Aim of the current study was to describe the prevalence, incidence, and severity of diabetes mellitus type 2 (T2D) in a cohort of older men and women aged 60 years and above over the course of on average 7 years, since longitudinal data on this topic are scarce for this age group in Germany. Methods: Baseline data of 1671 participants of the Berlin Aging Study II (BASE‐II; 68.8 ± 3.7 years) and follow‐up data assessed 7.4 ± 1.5 years later were analysed. The BASE‐II is an exploratory, observational study on cross‐sectional and longitudinal data of an older population. T2D was diagnosed based on self‐report, antidiabetic medication use and laboratory parameters. T2D severity was determined by the diabetes complications severity index (DCSI). Prognostic capacity of laboratory parameters was evaluated. Results: The proportion of participants with T2D increased from 12.9% (37.3% women) at baseline to 17.1% (41.1% women) with 74 incident cases and 22.2% not being aware of the disease at follow‐up. The incidence rate is 10.7 new T2D diagnoses per 1000 person‐years. More than half of the 41 newly identified incident T2D cases were diagnosed solely by the 2 h‐plasma glucose test (OGTT) and diagnosis based on OGTT as the only criterion among incident cases was found more frequently in women (p = 0.028). T2D severity expressed by the DCSI significantly increased from baseline to follow‐up (mean DCSI 1.1 ± 1.2 vs. 2.0 ± 1.8; range 0–5 vs. 0–6). Cardiovascular complications had the highest impact (43.2% at baseline and 67.6% at follow‐up). Conclusions: A comprehensive picture of T2D with respect to prevalence, incidence, and severity in older people of the Berlin Aging Study II is provided. [ABSTRACT FROM AUTHOR]

Background: Type 2 diabetes mellitus (T2DM) is a major health problem in the western world. Despite a widespread implementation of integrated care programs there are still patients with poorly controlled T2DM. Shared goal setting within the process of Shared Decision Making (SDM) may increase patient's compliance and adherence to treatment regimen. In our secondary analysis of the cluster-randomized controlled DEBATE trial, we investigated if patients with shared vs. non-shared HbA1c treatment goal, achieve their glycemic goals. Methods: In a German primary care setting, we collected data before intervention at baseline, 6, 12 and 24 months. Patients with T2DM with an HbA1c ≥ 8.0% (64 mmol/mol) at the time of recruitment and complete data at baseline and after 24 months were eligible for the presented analyses. Using a generalized estimating equation analysis, we analysed the association between the achievement of HbA1c goals at 24 months based on their shared vs. non-shared status, age, sex, education, partner status, controlled for baseline HbA1c and insulin therapy. Results: From N = 833 recruited patients at baseline, n = 547 (65.7%) from 105 General Practitioners (GPs) were analysed. 53.4% patients were male, 33.1% without a partner, 64.4% had a low educational level, mean age was 64.6 (SD 10.6), 60.7% took insulin at baseline, mean baseline HbA1c was 9.1 (SD 1.0). For 287 patients (52.5%), the GPs reported to use HbA1c as a shared goal, for 260 patients (47.5%) as a non-shared goal. 235 patients (43.0%) reached the HbA1c goal after two years, 312 patients (57.0%) missed it. Multivariable analysis shows that shared vs. non-shared HbA1c goal setting, age, sex, and education are not associated with the achievement of the HbA1c goal. However, patients living without a partner show a higher risk of missing the goal (p =.003; OR 1.89; 95% CI 1.25–2.86). Conclusions: Shared goal setting with T2DM patients targeting on HbA1c-levels had no significant impact on goal achievement. It may be assumed, that shared goal setting on patient-related clinical outcomes within the process of SDM has not been fully captured yet. Trial registration: The trial was registered at ISRCTN registry under the reference ISRCTN70713571. [ABSTRACT FROM AUTHOR]

Background: We investigate whether an educational intervention of GPs increases patient-centeredness and perceived shared decision making in the treatment of patients with poorly controlled type 2 diabetes mellitus? Methods: We performed a cluster-randomized controlled trial in German primary care. Patients with type 2 diabetes mellitus defined as HbA1c levels ≥ 8.0% (64 mmol/mol) at the time of recruitment (n = 833) from general practitioners (n = 108) were included. Outcome measures included subjective shared decision making (SDM-Q-9; scale from 0 to 45 (high)) and patient-centeredness (PACIC-D; scale from 1 to 5 (high)) as secondary outcomes. Data collection was performed before intervention (baseline, T0), at 6 months (T1), at 12 months (T2), at 18 months (T3), and at 24 months (T4) after baseline. Results: Subjective shared decision making decreased in both groups during the course of the study (intervention group: -3.17 between T0 and T4 (95% CI: -4.66, -1.69; p < 0.0001) control group: -2.80 (95% CI: -4.30, -1.30; p = 0.0003)). There were no significant differences between the two groups (-0.37; 95% CI: -2.20, 1.45; p = 0.6847). The intervention's impact on patient-centeredness was minor. Values increased in both groups, but the increase was not statistically significant, nor was the difference between the groups. Conclusions: The intervention did not increase patient perceived subjective shared decision making and patient-centeredness in the intervention group as compared to the control group. Effects in both groups might be partially attributed to the Hawthorne-effect. Future trials should focus on patient-based intervention elements to investigate effects on shared decision making and patient-centeredness. Trial registration: The trial was registered on March 10th, 2011 at ISRCTN registry under the reference ISRCTN70713571. [ABSTRACT FROM AUTHOR]

Background: Type 2 diabetes represents an increasingly critical challenge for health policy worldwide. It absorbs massive resources from both patients and national economies to sustain direct costs of the treatment of type 2 diabetes and its complications and indirect costs related to work loss and wages. More recently, there are innovations based on remote control and personalised programs that promise a more cost-effective diabetes management while reducing diabetes-related complications. In such a context, this work attempts to update cost analysis reviews on type 2 diabetes, focusing on France and Germany, in order to explore most significant cost drivers and cost-saving opportunities through innovations in diabetes care. Although both countries approach care delivery differently, France and Germany represent the primary European markets for diabetes technologies.Methods: A systematic review of the literature listed in MEDLINE, Embase and EconLit has been carried out. It covered interventional, observational and modelling studies on expenditures for type 2 diabetes management in France or Germany published since 2012. Included articles were analysed for annual direct, associated and indirect costs of type 2 diabetes patients. An appraisal of study quality was performed. Results were summarised narratively.Results: From 1260 records, the final sample was composed of 24 papers selected according to predefined inclusion/exclusion criteria. Both France and Germany revealed a predominant focus on direct costs. Comparability was limited due to different study populations and cost categories used. Indirect costs were only available in Germany. According to prior literature, reported cost drivers are hospitalisation, prescriptions, higher HbA1c and BMI, treatment with insulin and complications, all indicators of disease severity. The diversity of available data and included costs limits the results and may explain the differences found.Conclusions: Complication prevention and glycaemic control are widely recognized as the most effective ways to control diabetes treatment costs. The value propositions of self-based supports, such as hybrid closed-loop metabolic systems, already implemented in type 1 diabetes management, are the key points for further debates and policymaking, which should involve the perspectives of caregivers, patients and payers. [ABSTRACT FROM AUTHOR]

Background: An association between desaturase activity and risk of type 2 diabetes (T2D) has been found in epidemiologic studies, but little is known about potential mediators of this association. Objective: We aimed to investigate the potential role of diabetes-related biomarkers as mediators of the association between estimated Δ5 desaturase (D5D), D6 desaturase (D6D), and stearoyl-CoA desaturase (SCD) activity and T2D risk. Design: We analyzed a case-cohort study (subcohort: n = 1533; verified incident T2D cases: n = 400), nested within the European Prospective Investigation into Cancer and Nutrition-Potsdam Study involving 27,548 middle-aged participants. We evaluated the impact of adjustment for several T2D-related biomarkers reflecting liver fat accumulation [reflected by g-glutamyltransferase (GGT), alanine transaminase (ALT), fetuin-A, and the algorithm-based fatty liver index (FLI)], dyslipidemia (high-density lipoprotein cholesterol, triglycerides), inflammation [C-reactive protein (CRP)], and adipo-nectin on the association between D5D, D6D, and SCD activity, estimated with fatty acid product-to-precursor ratios derived from erythrocyte membrane proportions, and T2D risk. Results: Estimated D5D activity was inversely associated with T2D risk, whereas D6D and SCD activities were positively associated with risk of T2D [HRs (95% CIs) (highest vs. lowest tertile): 0.51 (0.36, 0.73), 1.68 (1.18, 2.39), and 1.82 (1.29, 2.58), respectively]. The association between estimated D5D, D6D, and SCD activities and risk of T2D was statistically significantly and markedly attenuated after adjustment for the FLI and, to a lesser extent, after adjustment for triglycerides, whereas adjustment for other desaturase-associated biomarkers (CRP, fetuin-A, ALT, and GGT) did not lead to appreciable attenuations. Conclusions: Liver fat accumulation, as reflected by the FLI, and dyslipidemia, as reflected by triglycerides, may partly explain the association between estimated D5D, D6D, and SCD activity and T2D risk. [ABSTRACT FROM AUTHOR]

Background One of the most widely used self-reporting tools assessing diabetes self-management in English is the Summary of Diabetes Self-Care Activities (SDSCA) measure. To date there is no psychometric validated instrument in German to assess self-management in patients with diabetes mellitus. Therefore, this study aimed to translate the SDSCA into German and examine its psychometric properties. Methods The English version of the SDSCA was translated into German following the guidelines for cultural adaptation. The German version of the SDSCA (SDSCA-G) was administered to a random sample of 315 patients with diabetes mellitus type 2. Reliability was analyzed using Cronbach's alpha coefficient and item characteristics were assessed. Exploratory and confirmatory factor analysis (EFA and CFA) were carried out to explore the construct validity. A multivariable linear regression model was used to identify the influence of predictor variables on the SDSCA-G sum score. Results The Cronbach's alpha for the SDSCA-G (all items) was α = 0.618 and an acceptable correlation between the SDSCA-G and Self-management Diabetes Mellitus-Questionnaire (SDQ) (⇔ = 0.664) was identified. The EFA suggested a four factor construct as did the postulated model. The CFA showed the goodness of fit of the SDSCA-G. However, item 4 was found to be problematic regarding the analysis of psychometric properties. The omission of item 4 yielded an increase in Cronbach's alpha (a = 0.631) and improvements of the factor structure and model fit. No statistically significant influences of predictor variables on the SDSCA-G sum score were observed. Conclusion The revised German version of the SDSCA (SDSCA-G) is a reliable and valid tool assessing self-management in adults with type 2 diabetes in Germany. [ABSTRACT FROM AUTHOR]

Background: There is growing evidence that air pollutants are associated with the risk of type 2 diabetes. Subclinical inflammation may be a mechanism linking air pollution with diabetes. Information is lacking whether air pollution also contributes to worse metabolic control in newly diagnosed type 2 diabetes. We examined the hypothesis that residential particulate matter (PM10) is associated with HbA1c concentration in newly diagnosed type 2 diabetes. Methods: Nationwide regional levels of particulate matter with a diameter of ≤10 µm (PM10) were obtained in 2009 from background monitoring stations in Germany (Federal Environmental Agency) and assigned to place of residency of 9,102 newly diagnosed diabetes patients registered in the DPV database throughout Germany (age 65.5±13.5 yrs; males: 52.1%). Mean HbA1c (%) levels stratified for air pollution quartiles (PM10 in µg/m3) were estimated using linear regression models adjusting for age, sex, BMI, diabetes duration, geographic region, year of ascertainment, and social indicators. Findings: In both men and women, adjusted HbA1c was significantly lower in the lowest quartile of PM10 exposure in comparison to quartiles Q2–Q4. Largest differences in adjusted HbA1c (95% CI) were seen comparing lowest quartiles of exposure with highest quartiles (men %: −0.42 (−0.62; −0.23)/mmol/mol: −28.11 (−30.30; −26.04), women, %: −0.28 (−0.47; −0.09)/mmol/mol: −0.28 (−0.47; −0.09)). Interpretation: Air pollution may be associated with higher HbA1c levels in newly diagnosed type 2 diabetes patients. Further studies are warranted to examine this association. [ABSTRACT FROM AUTHOR]

Background: Since 2004, a national Disease Management Program (DMP) has been implemented in Germany, which includes educational measures aimed at patients with type-2 diabetes (T2D). However, about 15-20% of T2D patients remain in poor metabolic control. Qualitative research shows that one reason for this might be an increasing frustration of general practitioners (GPs) with the management of their poorly regulated T2D patients over time. We aim at approaching this problem by improving the GP-patient-communication and fostering shared decision-making. Methods/Design: An educative intervention will be tested within a multi-centred cluster-randomized controlled trial (RCT) in Germany. We include 20 GPs in three regions. Each of the 60 GPs will recruit about 13 patients meeting the inclusion criteria (total of 780 patients). GPs allocated to the intervention group will receive a peer-visit from a specifically trained GP-colleague who will motivate them to apply patient-centred communication techniques including patient-centred decision aids. GPs allocated to the control group will not take part in any intervention program, but will provide care as usual to their patients. The primary inclusion criterion for patients at the time of the recruitment is an HbA1c-level of over 8.0. Primary outcome is the change of HbA1c at 6, 12, 18, and 24 months compared to HbA1c at baseline. Secondary outcomes include patient's participation in the process of shared decision-making and quality of life. Discussion: If this intervention proves to be effective it may be integrated into the existing Disease Management Program for T2D in Germany. [ABSTRACT FROM AUTHOR]

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Avoiding serious complications such as stroke, myocardial infarction, and amputations in diabetes patients is the main interest of long-term treatment. Given the considerable prevalence of diabetes type 2 in industrialized countries this is a major public health concern as well as a burden to health care systems. The present study estimated the current risk of major complications occurring in the German diabetes type 2 population and explored the potential for further risk reduction. Risk reduction can be achieved when physiological and behavioral parameters (HbA1c, blood pressure, cholesterol level, body mass index, smoking) are set to target values recommended in guidelines. To estimate individual risk and potential risk reduction the multifactor disease model Mellibase was employed. Data were obtained from the German Health Survey of 1998, which includes a sample of 7,124 individuals representative of the German population. The survey shows a prevalence rate of 6.3% for diabetes type 2 in persons older than 35 years. The analyses reveal that the overall potential for risk reduction is moderate (e.g., the average reduction potential of the 10-year risk of stroke is 5.7%). A majority of parameter ranges found in the patient population are either already close to the recommended values (HbA1c), are not alarmingly higher than in the general population (blood pressure) or have little impact on risk reduction. In addition nonmodifiable risk factors such as duration of the illness and advanced age constrain possible improvements. However, there is a wide variation in the actual risk between individuals (e.g., the 10-year risk of stroke varies between 2.2% and 79.8%), and thus a wide variation in potential risk reduction (the risk reduction potential for stroke varies between 0% and 53.4%). Intensified treatment should therefore (a) focus on relevant subgroups of patients taking their risk reduction potential into account and (b) aim at improvement in the overall metabolic profile rather than concentrating on single risk factors. [ABSTRACT FROM AUTHOR]

Gouni-Berthold I, Giannakidou E, Müller-Wieland D, Faust M, Kotzka J, Berthold HK, Krone W (University of Cologne and Center of Molecular Medicine Cologne, Leibniz Institute at the Heinrich-Heine University of Düsseldorf, and Drug Commission of the German Medical Association, Berlin, Germany). The Pro387Leu variant of protein tyrosine phosphatase-1B is not associated with diabetes mellitus type 2 in a German population.J Intern Med2005;257:272–280.Diabetes mellitus type 2 (DM-2) is a complex disorder with a strong genetic background. Protein tyrosine phosphatase-1B (PTP-1B) dephosphorylates various receptor protein kinasesin vitro, including theβ subunit of the insulin receptor, therefore representing a potential candidate to be involved in the polygenic pathogenesis of DM-2. Recently a Pro387Leu variant of the PTP-1B gene has been associated with an increased risk of DM-2 in a Danish population. Reports from China and Finland failed to confirm this association.The purpose of the present study was to examine the possible association between the presence of DM-2 and the Pro387Leu polymorphism in a German Caucasian population. A total of 836 subjects (age 20–92 years) participated in the study. The presence of the Pro387Leu variant of the PTP-1B gene was investigated using polymerase chain reaction (PCR) restriction fragment-length polymorphism in 402 subjects with DM-2 (231 men, 171 women, age 63.1 ± 10.8 years, BMI 28.7 ± 5.1 kg m−2) and in 434 normoglycemic age- and sex-matched control subjects (248 men, 186 women, age 64.4 ± 6.5 years, BMI 26.5 ± 3.7 kg m−2).Nine subjects in the control group and nine in the diabetic group (allelic frequency 0.99% in both groups) carried the Pro387Leu polymorphism. A meta-analysis on published data of>3000 subjects including our own data did not find an association between the polymorphism and DM-2. In addition, the polymorphism had no significant influence on the presence of atherosclerotic disease, whilst the influence of other known cardiovascular risk factors was confirmed. Furthermore, the impact of the mutation on metabolic and anthropometric parameters in both groups was examined. Amongst the controls there were no significant differences in BMI, HDL and LDL cholesterol or blood pressure between the two groups with or without the Pro387Leu polymorphism. The same was true for the diabetic group. Interestingly, in both diabetics and controls, Pro387Leu carriers had significantly higher triglycerides. In a logistic regression model only BMI and family history but not polymorphism were predictors of DM-2.In conclusion, the present data suggest that in a German Caucasian population the Pro387Leu polymorphism of the PTP-1B gene is not associated with DM-2 but may play a role in other metabolic phenotypes. [ABSTRACT FROM AUTHOR]

Introduction and Objectives: More than 50% of the type-2 Diabetes (T2DM) mortality is due to cardiovascular disease. Current treatment guidelines recommend an increasingly differentiated and comprehensive management of cardiovascular risk factors. This study aims to measure the extent to which T2DM care is currently adjusted for cardiovascular risks in clinical practice., Methods: This observational study included 123 T2DM patients of nine outpatient diabetology specialist clinics in Southern Germany. Guideline adherence was measured based on selected aspects of the joint guideline of the European Society of Cardiology (ESC) and the European Society for the Study of Diabetes (EASD). The proportion of patients with treatment target adherence, monitoring adherence, and therapy adherence for the areas of blood pressure and lipid metabolism management was determined, and the correlation between adherence and treatment outcome was assessed by comparing treatment target achievement rates between the group that received guideline-adherent care and the group with no guideline-adherent care., Results: The combined adherence rates were 39% for blood pressure management and 10% for lipid management. 70% of the participants with adherent blood pressure management and 56% with non-adherent blood pressure management achieved the blood pressure target (p=0.165). 50% of the patients with guideline-adherent lipid management and 17% with not guideline-adherent lipid management achieved the LDL cholesterol target (p=0.032)., Discussion: Less than half of the study population received care that was adequately adjusted for cardiovascular risks. Participants that received risk-adjusted care achieved their treatment target for blood pressure and LDL cholesterol more often. In order to validate methods and results, the study should be repeated with routine care data from a larger study population., Conclusion: Guideline-adherent care pays off: cardiovascular risk-adjusted care, especially following the more differentiated ESC/EASC guideline 2019, increases the chance for T2DM patients to avoid or delay cardiovascular complications., (Copyright © 2021. Published by Elsevier GmbH.)

Background: The global prevalence of diabetes mellitus is nearly 9%, with an upward trend in type 2 and gestational diabetes mellitus (T2DM/GDM). Evidence shows that vulnerable groups are affected disproportionally. Therefore, there is an increasing need to implement policies to prevent risk factors for T2DM/GDM and to promote a healthy lifestyle. However, up to now, no gold standard in terms of communication strategies and/or public awareness campaigns is known. Methods/design: We will conduct a systematic scoping review to evaluate communication strategies in the prevention of T2DM/GDM in vulnerable groups. Two reviewers will independently screen the results of the electronic literature search in PubMed, EMBASE, PsycINFO, PSYNDEX, Social Science Citation Index, and CINAHL. Extracted data will be charted, categorized, and summarized. Discussion: The results will be used to inform the National education and communication strategy on diabetes mellitus in Germany. In particular, the results will be discussed in focus groups of experts to develop recommendations for communication strategies. Systematic review registration: PROSPERO does not register scoping reviews. [ABSTRACT FROM AUTHOR]

Background: Diabetes mellitus type 2 is a central challenge for health policy and healthcare in all advanced countries. For the affected persons, living with a diagnosis of type 2 diabetes is difficult because the disease and its treatment have a considerable effect on daily life. The aim of this study was to investigate the challenges associated with a diagnosis of type 2 diabetes for those affected and the range, depth and complexities of the subjective perspectives of the patients under the conditions of the German healthcare system. Methods: A cross-sectional qualitative study was conducted using a sample of 19 adult patients with type 2 diabetes mellitus. Patients were recruited successively from two specialized diabetological practices, three general practitioner's offices, and two hospitals. The patients were interviewed once in person using semi-structured interviews. All interviews were recorded, transcribed, and analysed based on grounded theory. Results: Persons affected by diabetes mellitus type 2 seem to feel responsible for managing their disease. Two strategies of action could be identified: 1) patients strictly followed the recommendations of the physicians, or 2) they showed that they are knowledgably managing their diabetes mellitus type 2. The action strategy to address the disease seemed to be influenced by patients' confidence in themselves, the effectiveness of the interventions, or the patients' locus of control. Minor differences in educational status could be discovered, and patients who were less educated tended to follow the recommendations of the physicians very strictly and seemed to place more emphasis on being compliant, which goes hand in hand with a life with prohibitions and restrictions. In contrast, being perceived as competent patients who make their own rules to manage the disease in daily life appeared to be more important for people with higher education levels. Conclusion: Patient education and self-management programmes for diabetes mellitus type 2 should take different types of learners into account. Giving less-educated patients specific recommendations for successful diabetes self-management is particularly important. Trial registration: German clinical trial register (DRKS-ID: DRKS00007847). [ABSTRACT FROM AUTHOR]

Background: High intake of cereal fibre is associated with reduced risk for type 2 diabetes and long-term complications. Within the first long-term randomized controlled trial specifically targeting cereal fibre, the Optimal Fibre Trial (OptiFiT), intake of insoluble oat fibre was shown to significantly reduce glycaemia. Previous studies suggested that this effect might be limited to subjects with impaired fasting glucose (IFG)., Aim: We stratified the OptiFiT cohort for normal and impaired fasting glucose (NFG, IFG) and conducted a secondary analysis comparing the effects of fibre supplementation between these subgroups., Methods: 180 Caucasian participants with impaired glucose tolerance (IGT) were randomized to twice-a-day fibre or placebo supplementation for 2 years ( n  = 89 and 91, respectively), while assuring double-blinded intervention. Fasting blood sampling, oral glucose tolerance test and full anthropometry were assessed annually. At baseline, out of 136 subjects completing the first year of intervention, 72 (54 %) showed IFG and IGT, while 64 subjects had IGT only (labelled "NFG"). Based on these two groups, we performed a stratified per-protocol analysis of glycometabolic and secondary effects during the first year of intervention., Results: The NFG group did not show significant differences between fibre and placebo group concerning anthropometric, glycometabolic, or other biochemical parameters. Within the IFG stratum, 2-h glucose, HbA1c, and gamma-glutamyl transferase levels decreased more in the fibre group, with a significant supplement x IFG interaction effect for HbA1c. Compared to NFG subjects, IFG subjects had larger benefits from fibre supplementation with respect to fasting glucose levels. Results were robust against adjustment for weight change and sex. An ITT analysis did not reveal any differences from the per-protocol analysis., Conclusions: Although stratification resulted in relatively small subgroups, we were able to pinpoint our previous findings from the entire cohort to the IFG subgroup. Cereal fibre can beneficially affect glycemic metabolism, with most pronounced or even isolated effectiveness in subjects with impaired fasting glucose., Competing Interests: S.K. and C.H. received a travel grant from Rettenmaier & Soehne, Holzmuehle, Germany, including conference fees and acccomodation. The authors declare no further conflicts of interest associated with this manuscript. The sponsors were neither involved in study design, data collection nor publication.

Background: Does an intervention designed to foster patient-centered communication and shared decision making among GPs and their patients with poorly controlled type 2 diabetes mellitus reduce the level of HbA1c., Methods: The DEBATE trial is a cluster-randomized controlled trial conducted in German primary care and including patients with type 2 diabetes mellitus having an HbA1c level of 8.0% (64 mmol/mol) or above at the time of recruitment. Data was measured before intervention (baseline, T0), 6-8 months (T1), 12-14 months (T2), 18-20 months (T3), and 24-26 months (T4) after baseline. Main outcome measure is the level of HbA1c., Results: In both, the intervention and the control group the decline of the HbA1c level from T0 to T4 was statistically significant (- 0.67% (95% CI: - 0.80,-0.54%; p < 0.0001) and - 0.64% (95% CI: - 0.78, - 0.51%; p < 0.0001), respectively). However, there was no statistically significant difference between both groups., Conclusions: Although the DEBATE trial was not able to confirm effectiveness of the intervention tested compared to care as usual, the results suggest that patients with poorly controlled type 2 diabetes are able to improve their blood glucose levels. This finding may encourage physicians to stay on task to regularly approach this cohort of patients., Trial Registration: The trial was registered at ISRCTN registry under the reference ISRCTN70713571 .

Background: Empagliflozin has been shown to reduce cardiovascular mortality, but the underlying pathogenetic mechanisms are poorly understood. It was previously demonstrated that empagliflozin improved arterial stiffness., Methods: Our analysis comprising 58 patients with type 2 diabetes mellitus identifies factors triggering the improvement of arterial stiffness. All patients participated in an investigator-initiated, prospective, double-blind, randomized, placebo-controlled, interventional clinical trial ( http://www.ClinicalTrials.gov : NCT02471963, registered 15th June 2015, retrospectively registered) and received either 6-weeks treatment with 25 mg empagliflozin orally once daily or placebo (crossover). Central systolic pressure and central pulse pressure were recorded by the SphygmoCor System (AtCor Medical). Now, we investigated the impact of parameters of glucose metabolism, volume status, sympathetic activation, lipids, uric acid, blood pressure and inflammation on vascular parameters of arterial stiffness using multivariate regression analysis., Results: As previously reported, therapy with empagliflozin improved arterial stiffness as indicated by reduced central systolic blood pressure (113.6 ± 12.1 vs 118.6 ± 12.9 mmHg, p < 0.001), central pulse pressure (39.1 ± 10.2 vs 41.9 ± 10.7 mmHg, p = 0.027) forward (27.1 ± 5.69 vs 28.7 ± 6.23 mmHg, p = 0.031) as well as reflected wave amplitude (18.9 ± 5.98 vs 20.3 ± 5.97 mmHg, p = 0.045) compared to placebo. The multivariate regression analysis included age, sex and change between empagliflozin and placebo therapy of the following parameters: HbA1c, copeptin, hematocrit, heart rate, LDL-cholesterol, uric acid, systolic 24-h ambulatory blood pressure and high sensitive CRP (hsCRP). Besides the influence of age (beta = - 0.259, p = 0.054), sex (beta = 0.292, p = 0.040) and change in systolic 24-h ambulatory blood pressure (beta = 0.364, p = 0.019), the change of hsCRP (beta = 0.305, p = 0.033) emerged as a significant determinant of the empagliflozin induced reduction in arterial stiffness (placebo corrected). When replacing HbA1c with fasting plasma glucose in the multivariate regression analysis, a similar effect of the change in hsCRP (beta = 0.347, p = 0.017) on arterial stiffness parameters was found., Conclusion: Besides age and sex, change in systolic 24-h ambulatory blood pressure and change in hsCRP were determinants of the empagliflozin induced improvement of vascular parameters of arterial stiffness, whereas parameters of change in glucose metabolism and volume status had no significant influence. Our analysis suggests that empagliflozin exerts, at least to some extent, its beneficial vascular effects via anti-inflammatory mechanisms. Trial registration http://www.ClinicalTrials.gov : NCT02471963, registered 15th June 2015, retrospectively registered.

Background: There is a significant worldwide increase in type 2 diabetes mellitus and gestational diabetes (T2DM/GDM) linked to a range of associated comorbidities and rising healthcare costs. It has been shown that an increase in physical activity, healthy nutrition, and weight loss may prevent or delay T2DM/GDM manifestation. Despite this, it remains a key challenge to reach various populations, in particular so-called vulnerable groups, mostly with a migration background and/or low socio-economic status., Methods/design: We will conduct a scoping review to identify barriers and facilitating factors in the prevention of T2DM/GDM in vulnerable groups. An electronic literature search will be performed in MEDLINE, EMBASE, PsycINFO, PSYNDEX, Social Science Citation Index, and CINAHL. Two reviewers will independently select studies for inclusion. Extracted data will be charted, categorized, and summarized., Discussion: The results will be used to inform the National education and communication strategy on diabetes mellitus in Germany. In particular, the results will be discussed in focus groups of experts to develop recommendations for developing preventive measures targeting vulnerable groups., Systematic Review Registration: PROSPERO does not register scoping reviews.

Objective: In the last 20 years, patient involvement in clinical decision-making has continuously gained traction in scientific and clinical (including general practice, GP) discussions. Patients with chronic conditions in particular may benefit from active involvement. Referring to existing studies on shared decision making and regional differences; patients with poorly controlled diabetes mellitus type 2 (DM2) were used as an example to investigate the perceived involvement during clinical decision making in general practice. Differences in treatment options based on the patients' place of residence (East- and West Germany) were compared., Methods: 501 West- (North-Rhine-Westphalia, NRW) and 338 East-German (Mecklenburg-Western Pomerania, MWP) patients with DM2 and HbA 1c levels≥8.0 were assessed during the cluster-randomised controlled trial DEBATE, which was conducted between 2011 and 2012. The questionnaire to measure participatory decision making (Q-PDM) was used in order to provide an estimate of their involvement in clinical decision making processes, and baseline data was analysed before intervention. The standardised Q-PDM summed value was compared among the different subgroups (i. e., place of residence, age, sex) using bivariate group analyses (t tests), and a multivariate regression analysis was conducted., Results: Patients living in the MWP region perceived a higher level of involvement in GP decision making than NRW residents. Younger patients with DM2 showed higher Q-PDM summed values than older patients. When all variables, including 'GP practice' (number of patients per GP/cluster), were considered together in the multivariate regression analysis, the place of residence would no longer show an independent effect on perceived decision making. The expected difference between MWP and NRW (i. e. East/West Germany) could not be confirmed, while a significant difference remained with regard to age. Education, population density, sex and marital status did not show any relevant differences., Conclusion: Patient age remains an important factor influencing the perceived involvement in joint decision making and should be taken into account while implementing clinical decision making processes in the future. It is possible that patients of different age and with different chronic diseases may need different decision support offerings (e. g., educational videos, booklets or computer-based decision aids). Trainings in communication skills or in the implementation of patient-centred communication might be effective on the GP level to reduce possible barriers to shared decision making., (Copyright © 2018. Published by Elsevier GmbH.)

Background: A novel-approach for treatment of obesity and diabetes mellitus type 2 (T2DM) is represented by the endoscopic duodenal-jejunal bypass liner (DJBL). Recent data from the German DJBL registry provide evidence for substantial efficacy of the DJBL during the implantation period in obese patients with T2DM. However, little is known about the trends of glycemic control, BMI, and comorbidities after explantation of the DJBL, which have been investigated in the registry in this report., Methods: Patients were selected from the registry if they had a dataset at implantation, explantation, and at least one time point after explantation of the DJBL (n = 77). We also investigated a subgroup of patients with available data at least 1 year (-2 weeks) after explantation of the DJBL (n = 32)., Results: For a mean BMI at implantation and a mean follow-up period, an increase of BMI of 2.1 kg/m 2 (CI 0.8-3.2; p = 0.013) had to be expected (for HbA1c 0.3% (CI - 0.0-0.7; p = n.s.), respectively). In the subgroup analysis, HbA1c and BMI increased after explantation of the DJBL but stayed significantly below baseline levels. Meanwhile, the mean number of antidiabetic drugs slightly increased. There was deterioration seen for blood pressure and LDL cholesterol over the postexplantation period to approximately baseline levels (or higher)., Conclusion: With this data, we show that improvement of HbA1c and BMI can be partly maintained over a time of nearly 1-year postexplantation of the DJBL. However, for HbA1c, this may be biased by intensified medical treatment and effects deteriorated with time after explantation. These results suggest that implantation of the DJBL needs to be integrated in a long-term weight management program as most of other interventions in obese patients with T2DM., Trial Registration: ClinicalTrials.gov Identifier: NCT02731859.

Abstract: Objective: To investigate the persistence of basal supported oral therapy (BOT) with either insulin glargine (GLA) or insulin detemir (DET) in type 2 diabetics and to assess long-term costs associated with the initiation of respective treatment regimens. Study Design: A cost comparison was conducted from the perspective of the German statutory health insurance, applying a Markov model. Two base case scenarios were conducted. Transition probabilities from BOT to intensified conventional therapy (ICT) for scenario 1 were obtained from 5-year persistence data on BOT of the IMS Disease Analyzer (IMS Health Inc. Frankfurt am Main, Germany). Transition probabilities applied for scenario 2 were based on a regression equation of extrapolated persistence data for 10 years. A BOT initiation using GLA and DET at a ratio of 1:1 was assumed. Treatment costs of BOT and ICT with GLA and DET were derived from published sources. Estimation of type 2 diabetics starting a BOT was based on epidemiologic data from the literature. The model was operated over 5 and 10 years for scenarios 1 and 2, respectively. Costs were discounted by 5% per annum in the base case analyses, and varied to 0% and 10%. Multiple one-way sensitivity analyses were conducted varying input cost data. Results: Based on the persistence data, the cumulative 5-year costs for a cohort of 44,366 type 2 diabetics were 134 million € (GLA) versus 179 million € (DET), resulting in savings of 45 million € in favor of insulin glargine. Total 10-year treatment costs based on the regression equation were 272 million € (GLA) versus 338 million € (DET), resulting in savings of 66 million € in favor of insulin glargine. In sensitivity analyses, cost savings over 10 years for GLA versus DET ranged from € 53 to € 97 million. Conclusions: Starting an insulin therapy with GLA- rather than DET-based BOT results in a later initiation of ICT in type 2 diabetics. Because treatment costs of an ICT are roughly twice that of a BOT, the longer persistence using GLA shows potential cost savings of € 67 million for the German statutory health insurance within 10 years compared with DET. [Copyright &y& Elsevier]

Objectives: Illness perceptions are usually conceptualized using the self-regulatory model of illness. Although a few examinations of illness perceptions among Turkish language populations exist, the validity of the self-regulatory model of illness has never been confirmed for this population group. The aim of our study was to explore the validity of the self-regulatory model of illness in chronically ill Turkish migrants residing in Germany using diabetes mellitus type 2 as an example., Methods: Qualitative semi-structured interviews were conducted with 24 Turkish migrants with self-reported diabetes who were recruited through key persons. The core aspects of the qualitative data were extracted through a hermeneutic approach. Subsequently, a system of categories and sub-categories was developed by means of content analysis., Results: Seven distinct core dimensions of illness perceptions, each with a different number of sub-domains, could be identified in the sample. They comprised the perceived timeline of diabetes, its consequences, its causes, its controllability as well as the identity/coherence and the emotional response with respect to the condition., Discussion: As regards the conceptualization of illness perceptions, the dimensions identified are in line with the self-regulatory model of illness. Addressing illness perceptions through tailored interventions may contribute to improving health care and health outcomes in Turkish migrants.