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Competing Interests: Bernhard Kulzer declares the following potential conflicts of interest: Advisory boards: Bayer, Becton Dickinson, Berlin Chemie, Novo Nordisk, Sanofi, Roche. Lectures, study projects (FIDAM): Abbott, AstraZeneca, Bayer, Becton Dickinson, Berlin Chemie, Dexcom, Novo Nordisk, Sanofi, Roche. Jens Aberle declares the following conflicts of interest: Advisory boards and lecturer for: Astra Zeneca, Berlin-Chemie, Boehringer-Ingelheim, Eli Lilly & Co, Novo Nordisk, Roche Diabetes Care. Institutional research funding: Astra Zeneca. Thomas Haak declares the following conflicts of interest: Advisory boards: MSD, AstraZeneca, Roche, Abbott. Paid lecturing or training: Diabetes Academy Bad Mergentheim e.V., Abbott. Research project/implementation of clinical trials: Boehringer Ingelheim, Principal Investigator, AstraZeneca, Abbott REPLACE study. Matthias Kaltheuner declares that he has no conflicts of interest. Jens Kröger declares the following potential conflicts of interest: Advisory boards: Abbott GmbH, AstraZeneca, BD, MSD, Novo-Nordisk, Lilly; lectures, study projects: Abbott GmbH & Co. KG, AstraZeneca, Bayer vital, Boehringer-Ingelheim, Boehringer-Mannheim, BERLIN-CHEMIE, Dexcom, Glaxo, Medtronic, MSD, Novo-Nordisk, Lilly, Roche, Sanofi-Aventis, Vitalaire; Shareholdings, shares: none; volunteer work: Chairman of the Board diabetesDE – German Diabetes Aid Rüdiger Landgraf declares the following potential conflicts of interest: Advisory boards: Lilly Deutschland, Novo Nordisk Pharma; lecture fees: AstraZeneca, Bayer Vital, Berlin Chemie, Lilly Deutschland, Novo Nordisk Pharma. Other activities: Trustee of the German Diabetes Foundation, member of the steering group for the development and updating of the National Healthcare Guidelines on Diabetes. Monika Kellerer declares the following potential conflicts of interest: research support (RCT): AstraZeneca; Lilly; Novo Nordisk; membership in advisory bodies: Abbott, AstraZeneca, Bayer, Boehringer Ingelheim, Lilly, MSD, Novo Nordisk, Sanofi. Lecture fees: Bayer Boehringer Ingelheim, BMS, Novartis, MSD, Novo Nordisk.

Background: Digital health applications (DiGA) supporting the management of diabetes are among the most commonly available digital health technologies. However, transparent quality assurance of DiGA and clinical proof of a positive healthcare effect is often missing, which creates skepticism of some stakeholders regarding the usage and reimbursement of these applications., Methods: This article reviews the recently established fast-track integration of DiGA in the German reimbursement market, with emphasis on the current impact for manufacturers, healthcare providers, and people with diabetes. The German DiGA fast track is contextualised with corresponding initiatives in Europe., Results: The option of a provisional prescription and reimbursement of DiGA while proving a positive healthcare effect in parallel may expedite the adoption of DiGA in Germany and beyond. However, hurdles for a permanent prescription and reimbursement of DiGA are high and only one of 12 that have achieved this status specifically addresses people with diabetes., Conclusion: The DiGA fast track needs to be further enhanced to cope with remaining skepticism and contribute even more to a value-based diabetes care., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: F.S. and T.A.D. are full-time employees of Profil Institut für Stoffwechselforschung GmbH. L.H. is a shareholder of Profil Institut für Stoffwechselforschung GmbH. F.S. is a member of the EIT Health Supervisory Board. J.-M.B. and N.G. are full-time employees of the EIT Health e.V. and the EIT Health Colocation Center Germany–Switzerland, respectively. F.S., T.A.-D., C.S., J.S., M.J., and D.M.-W. are part of the EIT Health-funded RealWorld4Clinic consortium.

In this review, we aim to show how person-reported outcomes (PROs) and person-reported experiences (PREs) can significantly contribute to the way diabetes care is delivered, the involvement of people with diabetes in diabetes care, and the collaboration between health care professionals and people with diabetes. This review focuses on the definition and measurement of PROs and PREs, the importance of PROs and PREs for person-centred diabetes care, and integrating the perspectives of people with diabetes in the evaluation of medical, psychological and technological interventions. PROs have been increasingly accepted by Health Technology Assessment bodies and are therefore valued in the context of reimbursement decisions and consequently by regulators and other health care stakeholders for the allocation of health care resources. Furthermore, the review identified current challenges to the assessment and use of PROs and PREs in clinical care and research. These challenges relate to the combination of questionnaires and ecological momentary assessment for measuring PROs and PREs, lack of consensus on a core outcome set, limited sensitivity to change within many measures and insufficient standardization of what can be considered a minimal clinically important difference. Another issue that has not been sufficiently addressed is the involvement of people with diabetes in the design and development of measures to assess PROs and PREs., (© 2024 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.)

Cognitive dysfunction, dementia and depression are typical comorbidities of diabetes and are more common in older people with diabetes than in the general population. Both comorbid diseases have a substantial impact on the therapy of diabetes and lead to a reduction of the functional level in everyday life, the quality of life and are associated with increased mortality. This article summarizes the most important results on the etiology of cognitive dysfunction and depression and their consequences for clinical practice., (© 2024. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

Innovations in syringe and pen needle (PN) technology over the last 100 years have led to important advances in insulin delivery for people with diabetes, paralleling the strides made in developing recombinant DNA human insulin and insulin analogs with varying onset and duration of action. In this review, the history of advances in insulin delivery is described, focusing on progress in syringe, needle, and PN technologies. The early glass and metal syringes that required sterilization by boiling have been replaced by disposable, single-use syringes or pens with clear labeling for precise insulin dosing. The early needles ranging in length from 19 to 26 mm that required manual sharpening against a whetstone have been replaced by syringe needles of 6 mm and PNs of 4 mm in length as slender as 34 gauge. Imaging studies using ultrasound and computed tomography measured the thickness of skin and subcutaneous tissue layers to show feasibility of targeted insulin administration with shorter needles. These developments, coupled with innovations in needle/PN wall and tip structure, have led to improved injection experience for people with diabetes. It is also important to acknowledge the role of injection technique education, together with these advances in injection technology, for improving clinical outcomes and patient satisfaction. With continued projected growth of diabetes prevalence, particularly in developing countries where expensive and complex insulin delivery systems may not be practical, insulin syringes and pens will continue to serve as reliable and cost-effective means of insulin delivery for people with diabetes.

Monitoring of glucose plays an essential role in the management of diabetes. However, to fully understand and meaningfully interpret glucose levels, additional information on context is necessary. Important contextual factors include data on behaviours such as eating, exercise, medication-taking and sleep, as well as data on mental health aspects such as stress, affect, diabetes distress and depressive symptoms. This narrative review provides an overview of the current state and future directions of precision monitoring in diabetes. Precision monitoring of glucose has made great progress over the last 5 years with the emergence of continuous glucose monitoring (CGM), automated analysis of new glucose variables and visualisation of CGM data via the ambulatory glucose profile. Interestingly, there has been little progress in the identification of subgroups of people with diabetes based on their glycaemic profile. The integration of behavioural and mental health data could enrich such identification of subgroups to stimulate precision medicine. There are a handful of studies that have used innovative methodology such as ecological momentary assessment to monitor behaviour and mental health in people's everyday life. These studies indicate the importance of the interplay between behaviour, mental health and glucose. However, automated integration and intelligent interpretation of these data sources are currently not available. Automated integration of behaviour, mental health and glucose could lead to the identification of certain subgroups that, for example, show a strong association between mental health and glucose in contrast to subgroups that show independence of mental health and glucose. This could inform precision diagnostics and precision therapeutics. We identified just-in-time adaptive interventions as a potential means by which precision monitoring could lead to precision therapeutics. Just-in-time adaptive interventions consist of micro-interventions that are triggered in people's everyday lives when a certain problem is identified using monitored behaviour, mental health and glucose variables. Thus, these micro-interventions are responsive to real-life circumstances and are adaptive to the specific needs of an individual with diabetes. We conclude that, with current developments in big data analysis, there is a huge potential for precision monitoring in diabetes., (© 2022. The Author(s).)

Competing Interests: Bernhard Kulzer: Advisory Boards: Bayer, Becton Dickinson, Berlin Chemie, Novo Nordisk, Sanofi, Roche. Lectures, study projects (FIDAM): Abbott, AstraZeneca, Bayer, Becton Dickinson, Berlin Chemie, Dexcom, Novo Nordisk, Sanofi, Roche.

Background: Diabetes self-management is a mainstay of diabetes care, but the implementation of self-management regimens into daily life is complex and often results in discouragement and distress. Modern approaches such as smartphone-based self-management applications are therefore needed to support people with diabetes. Since reimbursability would increase the availability of such digital applications to people with diabetes, we designed a study that meets all scientific and methodological requirements set by the German Digital Healthcare Act to allow reimbursement for a specific application (mySugr PRO). Here, we report the protocol of this study that aims at evaluating the efficacy of the digital self-management application with regard to patient-reported outcomes and medical benefits., Methods/design: This multicenter, open-label, randomized, parallel-group, controlled trial will evaluate the health care effects and medical benefits of mySugr PRO. A total of 466 people with diabetes will be randomly allocated (2:1 randomization) to the interventional group (n = 311) that will use the digital self-management application during the 12-week study period or the control group (n = 155; no usage of the application). Baseline and follow-up examinations will assess diabetes distress as the primary endpoint as well as empowerment, HbA1c, blood glucose data, self-management, general well-being, and treatment satisfaction as secondary endpoints. Statistical analyses will use an intention-to-treat procedure (using multiple imputation for missing values) as well as a per-protocol approach for sensitivity analysis., Discussion: To the best of our knowledge, this study will be one of the largest diabetes-specific evaluations of a digital health application supporting people with diabetes in their diabetes self-management that follow the requirements of the German Digital Healthcare Act., Trial Registration: German Clinical Trial Register DRKS00022923 . Registered on 22 October 2020., (© 2022. The Author(s).)

Background: New diagnostic and therapeutic technologies are increasingly changing the treatment of people with diabetes (PWD), along with increased usage of digital tools. To date, however, there is little data to which level and how diabetologists and PWD implement digitalization. Also, not much is known about the view of diabetologists on the current status and future developments in this respect., Method: In an online survey, diabetologists working in clinics and practices across Germany provided responses regarding their view on digitalization and the adoption of new technologies in diabetology to 56 questions. These comments reflect the opinion of several experts about the current importance and use of specific digital/technological topics., Results: Overall, 326 diabetologists took part in the survey. They reported a positive attitude (75.8%) toward new technologies and digitalization, and they see more advantages rather than disadvantages. Younger age of the diabetologists was significantly associated with a more positive attitude ( r = -0.176; P < .01), and there was no gender effect ( P = .738). On average, in each practice, 5.5% of PWD are using an insulin pump for therapy, 4.8% a real-time continuous glucose monitoring system, 16.9% an intermittent scanning continuous glucose monitoring system, and 0.3% an automated insulin delivery (AID) system. With respect to digitalization, the three most important current topics are software for glucose data analysis (average rank on a scale from one to six, with one being the most important: 2.4), compatibility with other systems (2.9), and AID systems (3.8))., Conclusions: This survey, which is going to be repeated annually, showed that the diabetologists who participated predominantly have a positive attitude toward new technologies and digital applications and were aware of the associated advantages. However, perceived disadvantages need to be addressed to enable wider adoption of new technologies and digital solutions.

Background: Continuous subcutaneous insulin infusion is the most advanced and demanding form of insulin therapy. Various positive and negative expectations, attitudes and experiences can occur, influencing adherence to and efficacy of continuous subcutaneous insulin infusion therapy. A new questionnaire was developed to systematically assess perceived benefits, perceived barriers and handling of continuous subcutaneous insulin infusion therapy., Methods: The Insulin Pump Attitude Questionnaire was tested in two samples (n=265/452) comprising pump users and non-pump users. Reliability was assessed using Cronbach's Alpha estimation. Exploratory and confirmatory factor analyses were conducted to establish the factorial structure. Correlations with other questionnaires as well as group differences between pump users and non-pump users were used to assess validity., Results: Exploratory factor analysis revealed 26 items comprising six subscales: "Glycaemic Control", "Flexibility", "Impaired Body Image", "Technology Dependency", "Ease Of Use" and "Functionality". Confirmatory factor analysis confirmed this factor structure. The IPA sum score correlated significantly with diabetes distress (r=-0.30), self-efficacy (r=0.22), diabetes empowerment (r=0.36), psychological well-being (r=0.16) and treatment dissatisfaction (r=-0.24), supporting criterion validity with small to medium effect sizes. Furthermore, the IPA was able to differentiate between pump users and non-pump users with higher scores for pump users regarding "Glycaemic Control", "Flexibility", "Ease of use" and "Functionality" and lower scores for pump users regarding "Impaired Body Image" and "Technology Dependency"., Conclusions: The Insulin Pump Attitude Questionnaire is a reliable and valid new instrument to assess attitudes towards continuous subcutaneous insulin infusion. With six scales, the Insulin Pump Attitude Questionnaire provides a comprehensive analysis of possible benefits, barriers, and handling problems of continuous subcutaneous insulin infusion therapy. In clinical practice, the Insulin Pump Attitude Questionnaire might be used to address the different attitudes in pump users but also in people considering continuous subcutaneous insulin infusion therapy., Competing Interests: DB received speakers’ honoraria from Merck KGaA, Synlab Holding and MSD Germany. TR declared no conflicts of interest. DE received speakers’ honoraria from Berlin Chemie, Sanofi, and Roche Diabetes Care. AS declared no conflicts of interest. BK is an advisory board member of Berlin Chemie, Roche Diabetes Care, Novo Nordisk, Medtronic, and Ascensia Diabetes Care. He received speakers’ honoraria from Berlin Chemie, Novo Nordisk, Roche Diabetes Care, Abbott, Lilly, and Ascensia Diabetes Care. He has received grants in support of investigator trials from Berlin Chemie, Abbott, and Roche Diabetes Care. MS received speakers’ honoraria from Medtronic and Lilly. TH is an advisory board member of MSD, AstraZeneca, Roche Diabetes Care, and Abbott. He received speakers’ honoraria from Novo Nordisk, Lilly, AstraZeneca, Abbott, and Berlin Chemie. He has received grants in support of investigator trials from Abbott, Boehringer Ingelheim, and AstraZeneca. NH is an advisory board member of Novo Nordisk, Abbott, Lilly, Roche Diabetes Care, and Ypsomed. He received speakers’ honoraria from Novo Nordisk, Abbott, Berlin Chemie, Lilly, and Ypsomed. He has received grants in support of investigator trials from Dexcom, Berlin Chemie, Ypsomed, Abbott, and Roche Diabetes Care., (© Georg Thieme Verlag KG Stuttgart · New York.)

Competing Interests: The authors state that there is no conflict of interest.

Background: Preulcerous risk situations in patients with diabetes are often undiagnosed and care administered too late. Even with regular medical check-ups and status documentation, foot examinations have not been given enough attention. Diagnosing an individual patients' risk of developing diabetic foot ulcers may increase vigilance for diabetic foot syndrome (DFS), and the appropriate prevention measures matching the risk involved may prevent the emergence of diabetic ulcers. The classical DFS risk factors are well established and have been extensively covered in the literature; however, there is a lack of efficient screening tools that could be used for a rapid assessment of diabetic foot ulcer risk., Methods: A methodical literature search was conducted to assess relevant publications for the preparation of a simple risk score for amputation related to diabetic foot ulcer. We then analyzed the risk factors for predictive value as odds ratios in foot ulcers and/or amputation. We used the available data to deduce a mean value to reflect the authors' consensus., Results: In view of the current literature on the matter, we have developed a semi-quantitative scoring system using just a few items to allow rapid and visual risk assessment for diabetic foot ulcers alongside recommendations for prevention and a sensible follow-up strategy to match the risk., Conclusion: This relatively simple score enables rapid risk classification for patients that can ease the way for both physicians and patients in gaining an insight into individual risk situations. The score provides more effective preventative measures for high-risk patients against future complications.

Aims: To summarize the history, development and efficacy of diabetes self-management education on glycaemic control and mental health in adults and children or adolescents with type 1 diabetes and people with type 2 diabetes. A further aim was to review the status of implementation of diabetes self-management education into routine care and outline current gaps in implementation and research., Methods: We searched PubMed and Google scholar for German- and English-language articles regarding diabetes self-management education, glycaemic control and mental health, and restricted this search to meta-analyses., Results: Diabetes education has evolved from a compliance- and knowledge-oriented approach to an empowerment- and self-management-oriented approach. Diabetes self-management education seems to have a greater impact on glycaemic outcomes than on mental health outcomes, but the latter are rarely assessed. Technological development and digitalization can provide chances and challenges for diabetes self-management education. Digital solutions show promising results and great potential for improving the efficacy of diabetes self-management education further and providing ongoing support. The implementation of diabetes self-management education into routine clinical care frequently remains a challenge., Conclusion: Diabetes self-management education has been acknowledged as an essential part of diabetes therapy; however, current gaps regarding the efficacy of diabetes self-management education on mental health, and the need for education on the use of diabetes technology, are future avenues for research., (© 2020 Diabetes UK.)

Objective: To compare the efficacy of an education program for people with diabetes and insulin pump treatment (INPUT) in a randomized controlled trial (RCT) to the effectiveness in an implementation trial (IT)., Methods: 135 people with diabetes on insulin pump treatment (CSII) underwent structured education with INPUT under RCT-conditions, 191 people with diabetes on CSII underwent structured education with INPUT under IT-conditions. Baseline characteristics and treatment outcomes at the 6-month follow-up were compared., Results: At baseline, RCT-participants were younger (42.7 ± 14.2 vs. 47.2 ± 14.1 years, p = 0.005), had higher HbA1c-values (8.3 ± 0.8% vs. 7.8 ± 1.2%, p = 0.001) and had more diabetes-related distress (27.8 ± 16.4 vs 22.4 ± 14.4, p = 0.002). At follow-up, INPUT results were comparable under the RCT and IT settings. After adjustment for baseline HbA1c, reduction of HbA1c in the IT was significantly greater than in the RCT (Δ0.17%; 95% CI 0.023-0.319%, p = 0.024). Participants with higher HbA1c-levels, more diabetes-related distress and more hypoglycemia problems were most likely to benefit from INPUT regardless of the trial setting., Conclusions: Efficacy of the INPUT program for people with CSII was demonstrated under RCT- and routine care conditions., Practice Implications: Education with the INPUT program is effective not only under standardized RCT conditions but also under conditions of routine care., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Aims: Flash sensor-based glucose monitoring (FSGM) provides people with diabetes considerably more information on their glycaemic control. We have developed and evaluated a structured education and treatment programme, termed FLASH, to assist FSGM users to understand and use the available glycaemic information for optimization of their diabetes treatment., Methods: We report on a multi-centre, randomized, parallel trial with a six-month follow-up involving 216 eligible participants (16-75 years old) on intensive insulin therapy. The primary outcome was HbA1c change from baseline to six months. Secondary outcomes were measures of glucose control as assessed by FSGM, as well as changes in behavioural and psychosocial measures., Results: At six months, the between-group difference in HbA1c reduction was significant, favouring FLASH education compared to the control group receiving no FLASH education (-0.28%, 95% CI -0.16% to -0.40% vs.-0.11%, 95% CI 0.00% to -0.22%; with a between-group difference of -0.17%, 95% CI -0.01% to -0.33%; p = 0.033). Participation in FLASH education also resulted in significant improvements in time spent in the target glucose range, in diabetes-related distress scores and in satisfaction with the glucose monitoring method. FLASH education also resulted in significant improvements in the use of glycaemic information provided by FSGM and in reduced self-monitoring of blood glucose (SMBG) fingerstick testing., Conclusion: FLASH is an effective programme to improve glycaemic control and lower diabetes-related distress in users of FSGM. The study was registered in ClinicalTrials: NCT03175315., (Copyright © 2019 The Authors. Published by Elsevier B.V. All rights reserved.)

Objective: Continuous subcutaneous insulin infusion (CSII) is the most advanced form of insulin delivery, but it requires structured education to provide users with the necessary knowledge/skills and to support their motivation. Currently, no structured education program designed to provide this training has been evaluated. We developed a CSII-specific, structured education program (Insulin Pump Treatment [INPUT]) and evaluated its impact on glycemic control, behavior, and psychosocial status., Research Design and Methods: This was a multicenter, randomized, parallel trial with a 6-month follow-up. Eligible participants (age 16-75 years) currently were treated with insulin pump therapy. Participants were randomly assigned (1:1) to the INPUT program or to usual care using a computer-generated algorithm, with study center as the stratification factor. The primary outcome was HbA 1c change from baseline to 6 months. Secondary outcomes were incidence of severe hypoglycemia and changes in behavioral and psychosocial measures., Results: Between 1 April 2016 and 26 April 2016, 268 people with diabetes and a mean duration of CSII therapy of 9.5 years were randomly assigned to the INPUT group ( n = 135) or control group ( n = 133). At 6 months, HbA 1c improved in the INPUT group (8.33 ± 0.8 vs. 8.04 ± 0.9; P < 0.0001) but not in the control group (8.33 ± 1.0 vs. 8.27 ± 1.0; P = 0.11). The between-group difference in HbA 1c reduction was significant, favoring INPUT (-0.28% vs. -0.06%, Δ -0.22%, 95% CI -0.38 to -0.06; P = 0.0029). The incidence rate ratio of severe hypoglycemia was 3.55 times higher for participants in the control group than for those in the INPUT group (95% CI 1.50-8.43; P = 0.0041)., Conclusions: The INPUT education program led to a significant improvement in glycemic control and incidence of severe hypoglycemia in insulin pump users., (© 2018 by the American Diabetes Association.)

Diabetes mellitus and other noncommunicable diseases (NCDs) represent an emerging global public health challenge. In Germany, about 6.7 million adults are affected by diabetes according to national health surveys, including 1.3 million with undiagnosed diabetes. Complications of diabetes result in an increasing burden for individuals and society as well as enormous costs for the health care system. In response, the Federal Ministry of Health commissioned the Robert Koch Institute (RKI) to implement a diabetes surveillance system and the Federal Center for Health Education (BZgA) to develop a diabetes prevention strategy. In a two-day workshop jointly organized by the RKI and the BZgA, representatives from public health institutes in seven countries shared their expertise and knowledge on diabetes prevention and surveillance. Day one focused on NCD surveillance systems and emphasized both the strengthening of sustainable data sources and the timely and targeted dissemination of results using innovative formats. The second day focused on diabetes prevention strategies and highlighted the importance of involving all relevant stakeholders in the development process to facilitate its acceptance and implementation. Furthermore, the effective translation of prevention measures into real-world settings requires data from surveillance systems to identify high-risk groups and evaluate the effect of measures at the population level based on analyses of time trends in risk factors and disease outcomes. Overall, the workshop highlighted the close link between diabetes prevention strategies and surveillance systems. It was generally stated that only robust data enables effective prevention measures to encounter the increasing burden from diabetes and other NCDs.

Aims: We conducted a qualitative study to expand our current understanding of the potential link between psychosocial working conditions and diabetes self-management at work., Methods: Thirty employed adults with diabetes mellitus living in Germany (n = 19 with type 1, n = 11 with type 2, 57% female, aged 24-64 years) were recruited. Using a topic guide, we carried out in-depth interviews in face-to-face contact or by telephone. Interviews were transcribed and content-analyzed using MaxQDA., Results: Psychosocial working conditions perceived to detrimentally affect self-management activities included, amongst others, a high workload, poor job control, unhygienic working environments, the requirement to work under high or fluctuating temperature, perceived social norms at the workplace, and the attitude to prioritize work-related demands as opposed to diabetes-related demands. The types of self-management activities considered to be adversely affected related to glucose monitoring, insulin injections, dietary control, the ability to recognize hypoglycemia and health care use., Conclusions: Various types of occupational psychosocial factors may determine diabetes self-management practices at the workplace. Quantitative studies are needed to confirm our observations. Subsequently, interventions could be developed and evaluated to improve opportunities to adequately engage into diabetes self-management at work., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Background: People with diabetes on intensive insulin therapy need sufficient glycaemic control to prevent the onset or progression of diabetic complications. The burden of multiple daily blood glucose self-testing can be lessened by novel diabetes technology like flash glucose monitoring systems which provide more information compared to self-monitoring of blood glucose. Despite this delivered additional information studies are showing no significant effect on HbA 1c reduction, but a reduced time spent in a hypoglycaemic glucose range. We assume that users of these devices need additional education and training to integrate the delivered information into treatment decisions. Therefore, FLASH, an education and treatment programme, was developed. The programme evaluation follows herein., Methods/design: Patients are recruited through 40 diabetes outpatient study centres located across Germany. They will be randomly assigned to participate in the education and treatment programme (intervention group) or to obtain treatment as usual (control group). All patients have to give blood samples and to answer a bench of questionnaires during baseline assessment, at the end of the intervention, and 6 months after the end of the intervention. Physicians will be asked to declare some additional clinical data (such as details of the diabetes therapy) for every patient at every one of the three assessment points., Discussion: This study is conducted as a randomised controlled trial to test the hypothesis that the newly developed education and treatment programme combined with the use of a flash glucose monitoring device (intervention group) is superior to reduce HbA 1c compared to the use of flash glucose monitoring alone (control group). The first results will be expected in 2018., Trial Registration: ClinicalTrials.gov, ID: NCT03175315 . Registered on 2 May 2017.

Background: Optimal usage of continuous glucose monitoring (CGM) requires adequate training of the users. Providing patients with a CGM system without such a training usually doesn't lead to the intended improvement in metabolic control., Methods: In Germany we developed a structured training program ("SPECTRUM") to ensure a high quality standard for the use of CGM systems., Results: This program is suitably for patients of all age groups and is applicable to all CGM systems and all forms of insulin therapy. A curriculum was also developed so that training centers with less experience with CGM could become capable of offering comprehensive CGM training., Conclusions: We believe that usage of such a program can be an important step forward in achieving more widespread acceptance and use of CGM systems. Translations in other languages and evaluation with a controlled clinical trial are planned.

The estimation is that every third to fourth patient with diabetes suffers from some degree of diabetic retinopathy. Medical products for insulin administration (such as insulin pens and pumps) or glucose monitoring not optimized to the needs of these patients' represent a high barrier for optimal diabetes therapy in daily practice. To date, the number of devices suitable for visually impaired and blind patients with diabetes is scarce. This manuscript outlines the specific needs of this patient group with regard to systems for insulin administration, blood glucose measurement, and continuous glucose monitoring. We see the clear need for a policy requirement for manufacturers to provide accessible/user friendly technical aids for visually impaired and blind patients with diabetes. This would represent an important step toward improving the situation for this impressively large patient group., Competing Interests: Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: LH is consultant for a number of companies that are developing novel diagnostic and therapeutic options for the treatment of diabetes. He is shareholder of Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany and Profil Institute for Clinical Research, San Diego, CA, USA. DD has no conflict of interest in connection with this manuscript. GF is general manager of the IDT (Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany), which carries out clinical studies on the evaluation of BG meters and medical devices for diabetes therapy on its own initiative and on behalf of various companies. BK is general manager of the FIDAM (Forschungsinstitut der Diabetes-Akademie Bad Mergentheim), which is engaged in clincal studies with medical devices on behalf of various research-institutions and companies., (© 2016 Diabetes Technology Society.)

In general, patients with diabetes performing self-monitoring of blood glucose (SMBG) can strongly rely on the accuracy of measurement results. However, various factors such as application errors, extreme environmental conditions, extreme hematocrit values, or medication interferences may potentially falsify blood glucose readings. Incorrect blood glucose readings may lead to treatment errors, for example, incorrect insulin dosing. Therefore, the diabetes team as well as the patients should be well informed about limitations in blood glucose testing. The aim of this publication is to review the current knowledge on limitations and interferences in blood glucose testing with the perspective of their clinical relevance., Competing Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: RH is an employee of Roche Diabetes Care GmbH, Mannheim, Germany. GF, BK, RZ, LH, and OS are members of national and international advisory boards of Roche Diabetes Care GmbH, Mannheim, Germany, (© 2016 Diabetes Technology Society.)

Background: Though several questionnaires on self-care and regimen adherence have been introduced, the evaluations do not always report consistent and substantial correlations with measures of glycaemic control. Small ability to explain variance in HbA1c constitutes a significant limitation of an instrument's use for scientific purposes as well as clinical practice. In order to assess self-care activities which can predict glycaemic control, the Diabetes Self-Management Questionnaire (DSMQ) was designed., Methods: A 16 item questionnaire to assess self-care activities associated with glycaemic control was developed, based on theoretical considerations and a process of empirical improvements. Four subscales, 'Glucose Management' (GM), 'Dietary Control' (DC), 'Physical Activity' (PA), and 'Health-Care Use' (HU), as well as a 'Sum Scale' (SS) as a global measure of self-care were derived. To evaluate its psychometric quality, 261 patients with type 1 or 2 diabetes were assessed with the DSMQ and an established analogous scale, the Summary of Diabetes Self-Care Activities Measure (SDSCA). The DSMQ's item and scale characteristics as well as factorial and convergent validity were analysed, and its convergence with HbA1c was compared to the SDSCA., Results: The items showed appropriate characteristics (mean item-total-correlation: 0.46 ± 0.12; mean correlation with HbA1c: -0.23 ± 0.09). Overall internal consistency (Cronbach's alpha) was good (0.84), consistencies of the subscales were acceptable (GM: 0.77; DC: 0.77; PA: 0.76; HU: 0.60). Principal component analysis indicated a four factor structure and confirmed the designed scale structure. Confirmatory factor analysis indicated appropriate fit of the four factor model. The DSMQ scales showed significant convergent correlations with their parallel SDSCA scales (GM: 0.57; DC: 0.52; PA: 0.58; HU: n/a; SS: 0.57) and HbA1c (GM: -0.39; DC: -0.30; PA: -0.15; HU: -0.22; SS: -0.40). All correlations with HbA1c were significantly stronger than those obtained with the SDSCA., Conclusions: This study provides preliminary evidence that the DSMQ is a reliable and valid instrument and enables an efficient assessment of self-care behaviours associated with glycaemic control. The questionnaire should be valuable for scientific analyses as well as clinical use in both type 1 and type 2 diabetes patients.

Objective: The objective of this study was to determine the risk for the development of high depressive symptoms in study participants with diagnosed and previously undetected diabetes mellitus compared to those without diabetes in a prospective population-based cohort study in Germany., Methods: We estimated the 5-year cumulative incidence of high depressive symptoms in participants without high depressive symptoms at baseline (n = 3,633, 51.4% men, mean age (SD) 59.1 (7.6) years, 7.0% diagnosed diabetes, 5.3% previously undetected diabetes) from the population-based Heinz Nixdorf Recall study. Diabetes was assessed by self-report, medication, and blood glucose. High depressive symptoms were assessed using CES-D. We calculated odds ratios and their corresponding 95% confidence interval, using multiple logistic regression analyses., Result: Cumulative 5-year incidences (95% CI) of high depressive symptoms in participants with diagnosed, undetected, and without diabetes were 7.1 (4.2-10.9), 4.1 (1.8-8.0), and 6.5 (5.6-7.4), respectively. The age-sex-adjusted OR for developing high depressive symptoms was 1.22 (0.74-2.03) in participants with diagnosed compared to those without diabetes, and 1.00 (0.59-1.68) after adjustment for BMI, physical activity, education, stroke, and myocardial infarction. The age-sex adjusted OR for developing high depressive symptoms in participants with previously undetected diabetes compared to those without diabetes was 0.72; 0.35-1.48; and fully adjusted 0.62; 0.30-1.30., Conclusion: We found no significant associations, maybe due to low power. However, our results are in line with a recent meta-analysis suggesting that risk of developing high depressive symptoms in patients with diagnosed diabetes may be moderately higher than in those without diabetes, and that comorbidity may explain in part this association. In participants with previously undetected diabetes, this first longitudinal study indicates that the risk is not increased or may even be decreased. These results support the hypothesis that high depressive symptoms develop due to diabetes-related burden and comorbidity and not due to hyperglycemia or hyperinsulinaemia.

As non-communicable or chronic diseases are a growing threat to human health and economic growth, political stakeholders are aiming to identify options for improved response to the challenges of prevention and management of non-communicable diseases. This paper is intended to contribute ideas on personalized chronic disease management which are based on experience with one major chronic disease, namely diabetes mellitus. Diabetes provides a pertinent case of chronic disease management with a particular focus on patient self-management. Despite advances in diabetes therapy, many people with diabetes still fail to achieve treatment targets thus remaining at risk of complications. Personalizing the management of diabetes according to the patient's individual profile can help in improving therapy adherence and treatment outcomes. This paper suggests using a six-step cycle for personalized diabetes (self-)management and collaborative use of structured blood glucose data. E-health solutions can be used to improve process efficiencies and allow remote access. Decision support tools and algorithms can help doctors in making therapeutic decisions based on individual patient profiles. Available evidence about the effectiveness of the cycle's constituting elements justifies expectations that the diabetes management cycle as a whole can generate medical and economic benefit., (Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.)

Aims/hypothesis: The primary aim of this study was to compare the results of HbA(1c) measurements with those of an OGTT for early diagnosis of 'silent diabetes' in patients with coronary artery disease (CAD) undergoing angiography without prediagnosed diabetes. A secondary aim was to investigate the correlation between the extent of CAD and the glycaemic status of the patient., Methods: Data from 1,015 patients admitted for acute (n = 149) or elective (n = 866) coronary angiography were analysed. Patients with known diabetes were excluded from the study. Using the OGTT results, patients were classified as having normal glucose tolerance (NGT), impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or diabetes. According to the results of the HbA(1c) measurements, patients were classified into three groups: normal (HbA(1c) <5.7% [<39 mmol/mol]), borderline (HbA(1c) 5.7-6.4% [39-47 mmol/mol]) and diabetes (HbA(1c) ≥6.5% [≥48 mmol/mol])., Results: Based on the OGTT, 513 patients (51%) were classified with NGT, 10 (1%) with IFG, 349 (34%) with IGT and 149 (14%) were diagnosed with diabetes. According to HbA(1c) measurements, 588 patients (58%) were classified as normal, 385 (38%) as borderline and 42 (4%) were diagnosed with diabetes. The proportion of patients with IGT and diabetes increased with the extent of CAD (IGT ρ = 0.14, p < 0.001, diabetes ρ = 0.09, p = 0.01). No differences in HbA(1c) were seen among the groups with different extents of CAD (p = 0.652)., Conclusions/interpretation: An OGTT should be performed routinely for diagnosis of diabetes in patients with CAD undergoing coronary angiography, since HbA(1c) measurement alone appears to miss a substantial proportion of patients with silent diabetes. A limitation of the study is that the OGTT was not performed before the angiography.

Objective: To evaluate the efficacy of the group program PREDIAS for diabetes prevention., Research Design and Methods: PREDIAS consists of 12 lessons and aims at lifestyle modification. The control group received written information about diabetes prevention. In this study, a total of 182 persons with an elevated diabetes risk participated (aged 56.3 +/- 10.1 years, 43% female, and BMI 31.5 +/- 5.3 kg/m(2))., Results: After 12 months, weight loss was significantly higher (P = 0.001) in PREDIAS than in the control group (-3.8 +/- 5.2 vs. -1.4 +/- 4.09 kg). There were also significant effects (P = 0.001) on fasting glucose (control group 1.8 +/- 13.1 mg/dl vs. PREDIAS -4.3 +/- 11.3 mg/dl), duration of physical activity per week (control group 17.9 +/- 63.8 min vs. PREDIAS 46.6 +/- 95.5 min; P = 0.03), and eating behavior., Conclusions: PREDIAS significantly modified lifestyle factors associated with an elevated diabetes risk.

Background: This randomized crossover trial examines the effect of continuous glucose monitoring (CGM) with real-time access (RTA) to glucose data versus CGM with a retrospective analysis (RA) of glucose data regarding satisfaction with CGM and other patient-reported outcomes., Methods: Participants used the CGM device (GlucoDay, Menarini Diagnostics, Florence, Italy) twice. In one study phase, patients were allowed RTA to, and in the other phase RA of, current glucose values. The order of these two conditions was randomized. At baseline and after the first and second trials, subjects completed questionnaires (Continuous Glucose Monitoring Satisfaction Scale) about perceived satisfaction with CGM. They also completed the Problem Areas in Diabetes Questionnaire, a state anxiety scale (State-Trait Anxiety Inventory), and a depression scale (Center of Epidemiological Studies-Depression Scale)., Results: Fifty patients with type 1 diabetes (41.7 +/- 12.3 years old, diabetes duration of 14.75 +/- 11.9 years, 48% female, hemoglobin A1c 8.1 +/- 1.5%, years of education 10.3 +/- 2.1 years) participated in this study. At baseline patients perceived CGM as rather advantageous, but after RA and RTA the perceived benefits were reduced (baseline, 101.0 +/- 16.0; RA, 95.7 +/- 20.2; RTA, 93.6 +/- 22.8; P < 0.01). However, there was no significant difference between RA and RTA. Also, there was no significant effect on diabetes-related distress or state anxiety, but a positive effect on depression scores., Conclusions: There was no specific, significant, negative or positive effect of RA versus RTA on satisfaction with CGM. Exposing patients with type 1 diabetes to their current glucose values does not seem to have a specific negative impact on the appraisal of CGM or more generic patient-reported outcomes.

Background: Pen devices can help to overcome some of the barriers associated with insulin therapy. The present study evaluated the accuracy of dose delivery by people with diabetes using the novel prefilled, disposable SoloSTAR device with insulin glargine (Lantus) and insulin glulisine (Apidra) (all from sanofi-aventis, Paris, France)., Methods: People with type 1 or type 2 diabetes (insulin users or insulin naive) were eligible to participate in this randomized, single-center, open-label study. Each participant delivered six separate insulin doses into a sponge using SoloSTAR (three with glargine [10, 40, and 80 units] and three with glulisine [5, 15, and 30 units]). Pens were weighed before and after each test dose to determine the dose delivered. Thresholds for dosing accuracy were calculated according to the 2000 International Organization for Standardization (ISO) recommendations (Guideline 11608-1)., Results: All doses of glargine and glulisine delivered (60 participants; 360 individual doses) were within the ISO limits. Mean (standard deviation) glargine doses delivered were 9.87 (0.24), 39.63 (0.36), and 79.02 (0.62) units for 10, 40, and 80 units, respectively. Insulin glulisine doses delivered were 4.98 (0.20), 14.87 (0.29), and 29.67 (0.34) units for 5, 15, and 30 units, respectively., Conclusions: The SoloSTAR pen allows people with diabetes to achieve a dosing accuracy with glargine and glulisine similar to that achieved in laboratory conditions. The dosing accuracy and ease of use of SoloSTAR may provide greater confidence in the precision and accuracy of the device while titrating glargine and/or glulisine to goal.

The aim of this project was to develop evidence-based guidelines regarding psychosocial aspects of diabetes mellitus in an effort to help the clinician bridge the gap between research and practice. Recommendations address the following topics: patient education, behavioural medicine, and psychiatric disorders of particular relevance to diabetes: depression, anxiety disorders, eating disorders, and dependence on alcohol and nicotine. The present guidelines were developed through an interdisciplinary process of consensus according to the specifications of evidence-based medicine and are recognized by the German Diabetes Association and the German College for Psychosomatic Medicine as their official guidelines.

Aims: The aims of this study were to examine (1) the prevalence of clinical and subclinical anxiety and affective disorders in a sample of diabetic patients attending a secondary care clinic in Germany and (2) risk factors associated with the occurrence of these disorders., Methods: Four hundred and twenty diabetic patients (36.9% Type 1; 24.7% Type 2; 38.4% Type 2 with insulin) participated in a questionnaire-based screening survey. Those who screened positive received a diagnostic interview., Results: Prevalence of clinical affective disorders was 12.6%, with an additional 18.8% of patients reporting depressive symptoms without fulfilling all criteria for a clinical affective disorder. The prevalence of anxiety disorders was 5.9%, with an additional 19.3% of patients reporting some anxiety symptoms. The comorbidity rate of affective and anxiety disorders was 1.8%, whereas 21.4% of the diabetic patients reported elevated affective as well as anxiety symptomatology. Logistic regression established demographic variables such as age, female gender and living alone as well as diabetes-specific parameters such as insulin treatment in Type 2 diabetes, hypoglycaemia problems and poor glycaemic control as risk factors for affective disorders. For anxiety symptoms female gender, younger age and Type 2 diabetes were significant independent variables., Conclusion: The prevalence of affective disorders in diabetic patients was twofold higher than in the non-diabetic population, whereas prevalence for anxiety disorders was not increased. Analysis of risk factors can facilitate the identification of patients who are at a greater risk for these disorders.