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Objectives: The objective of this study is to elicit health care preferences of people with diabetes and identify classes of people with different preferences., Methods: A discrete choice experiment was conducted among people with diabetes in Germany comprising attributes of role division in daily diabetes care planning, type of lifestyle education, support for correct medication intake, consultation frequency, emotional support, and time spent on self-management. A conditional logit model and a latent class model were used to elicit preferences toward diabetes care and analyze preference heterogeneity., Results: A total of 76 people with diabetes, recruited in two specialized diabetes care centers in Germany (mean age 51.9 years, 37.3% women, 49.1% type 2 diabetes mellitus, 50.9% type 1 diabetes mellitus), completed the discrete choice experiment. The most important attributes were consultation frequency, division in daily diabetes care planning, and correct medication intake. The latent class model detected preference heterogeneity by identifying two latent classes which differ mainly with respect to lifestyle education and medication intake., Conclusion: While the majority of people with diabetes showed preferences in line with current health care provision in Germany, a relevant subgroup wished to strengthen lifestyle education and medication intake support with an aid or website.

Background: Optimal insulin titration is essential in helping people with type 2 diabetes mellitus (T2DM) to achieve adequate glycemic control. Barriers of people with diabetes to implementation of titration include lack of self-efficiency and self-management skills, increased diabetes-related distress, low treatment satisfaction, poor well-being, as well as concerns about hypoglycemia and insulin overdose. My Dose Coach is a digital health tool for optimizing titration of basal insulin that combines a smartphone app for patients with T2DM and a Web portal for healthcare professionals., Methods/design: This is a prospective, open-label, multicenter, randomized controlled parallel study conducted in approximately 50 centers in Germany that are specialized in the treatment of diabetes. Patients in the intervention group will use the titration app and will be registered on the Web portal by their treating physician. Control group patients will continue their current basal insulin titration without using the app. The primary outcome is the mean change in HbA1c levels at the 12-week follow-up. The secondary outcome measures include patient-reported outcomes such as diabetes-related distress, self-management, empowerment, self-efficacy, treatment satisfaction, and psychological well-being as well as fasting blood glucose values., Conclusion: This digital health tool has been previously implemented in several independent pilot studies. The findings from this multicenter randomized controlled trial can provide further evidence supporting the effectiveness of this tool in patients with T2DM and serve as a basis for its clinical integration., Trial Registration: German Register for Clinical Studies-DRKS-ID: DRKS00024861., 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: N.H. has received fees for Advisory Board Participation from Abbott. He also received fees for lectures from Berlin Chemie, Sanofi, and Novo Nordisk. He also reports research support from Sanofi, Berlin Chemie, Roche, and mySugr. D.E. has received fees for Advisory Board participation from Dexcom, Roche Diabetes Care, mySugr, and Medtronic. He also received fees for lectures from Dexcom and Berlin-Chemie AG. K.F.G has no conflict of interest. T.R has no conflict of interest. G.F. is general manager of the Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm (IfDT, 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. G.F./IfDT has received grants, speakers’ honoraria, or consulting fees from Abbott, Agamatrix, Ascensia, Berlin-Chemie, Beurer, Boydsens, CRF Health, Dexcom, i-SENS, LifeScan, Lilly, Metronom Health, Medtronic, Menarini, mySugr, Novo Nordisk, PharmaSens, Roche, Sanofi, Sensile, and Ypsomed. B.K. reports grants from AstraZeneca, Berlin-Chemie, Roche Diabetes Care, Abbott Diabetes Care, AstraZeneca, Dexcom, and Ypsomed, and personal fees from Berlin-Chemie, Roche Diabetes Care, Novo Nordisk, Medtronic, Ascensia Diabetes Care, Abbott Diabetes Care, and Eli Lilly.

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.

Background: Little is little known about how people with diabetes experience advancing digitization and new technologies in diabetes., Research Question: What are the attitudes of people with diabetes (or, in the case of children with diabetes, their parents) toward digitization and advancing technology in diabetology? What significant advantages and disadvantages do they see, and how do they assess current developments of digitization in diabetology (eg, hybrid closed-loop systems, do-It-Yourself (DIY) closed-loop systems, data protection, and data donation)?, Material and Method: 3,427 people with diabetes (47.7% female, 65.6% type 1 diabetes (T1D), 25.5% type 2 diabetes (T2D), 8.1% parents of children with diabetes; 0.8% other type of diabetes, age 49.2 ± 19.3 years) were interviewed with an online survey., Results: Overall, survey participants had a very positive attitude toward digitization (82.6%) and considered the potential for optimizing diabetology through digitization to be very high (78.8%). The highest rated advantages of digitization were "greater personal responsibility and self-determination in therapy" (80.0%), "better quality of treatment" (80.0%), and "better communication with the doctor/diabetes team" (77.3%), while the highest rated disadvantages were the "error-proneness of digital applications" (35.9%), the "risk of misuse of patient data" (32.3%) and the "fear that digitization will replace the doctor in many cases" (31.1%). The possibility of evaluating and analyzing glucose data by means of software, and AID systems, and the possibility of improving the interoperability of the various applications are currently rated as the most significant topics., Conclusions: The vast majority of people with diabetes are very positive about new technologies in diabetology and expect that it will improve and simplify their diabetes therapy and reduce the burdens associated with diabetes. In particular, people with type 1 diabetes have high expectations for AID systems, viewing them as a kind of "technical cure" for their diabetes.

Despite improvements in the treatment of diabetes and better care conditions, those affected still have a significantly increased risk of physical and psychological complications and a reduced quality of life compared to the general population. About 21% of all deaths in Germany are due to diabetes and its complications, and the mortality risk for people with diabetes is more than 1.5 times higher than for people without diabetes. This review describes the prevalence and risk factors for the most common physical and psychological complications of diabetes as well as their influences on patients' quality of life. Associations between the complications and increased mortality are shown.In large intervention studies, the importance of good glucose control - especially at the beginning of the disease - has been shown regarding a reduction in the mortality rate. Other important influencing factors include blood pressure, blood lipids, and smoking. Worldwide study results indicate a stable trend about improved life expectancy of people with diabetes in recent years. In the future, the positive trend could be continued through better care structures and new technologies as well as digital devices in research and therapy. With the help of precision medicine, individual risk factors and protective factors could be identified to even better prevent the development of complications., (© 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.

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

Background: Integrated personalized diabetes management (iPDM) is a digitally supported therapeutic concept to improve patient-physician interaction to overcome the aspects of clinical inertia. Integrated personalized diabetes management can support decision making and improve therapeutic outcomes of suboptimally controlled persons with insulin-treated type 2 diabetes (T2D). In this paper, we report the results of an analysis of the PDM-ProValue study program on the effectiveness and perceived benefit of this approach, with a focus on how physicians used and assessed the digital tools provided for the iPDM process., Materials and Methods: The study program included two 12-month, prospective, controlled, cluster-randomized multicenter trials. A total of 101 practices participated with 907 patients. Practices were cluster-randomized to an intervention group and a control group. Digital tools for data visualization and analysis applied were used. HCP were asked to assess the use, relevance, and usefulness of the tools., Results: A clear preference was stated for the visual overview over more statistically complex analyses. A total of 83% of the participants rated a high relevance of the "daily profile," 81% of the "total profile," and 68% the "risk illustrated by traffic light symbols" for the therapy decision. The overall iPDM process was very favorably rated with respect to structuredness and potential for personalized treatment and well accepted among health care professionals (HCP)., Conclusions: Embedding digital tools in a structured process (iPDM) were proved to provide a benefit for insulin-treated T2D patients and their physicians. These results offer insight for further development and improvement of the tools and add information on how to overcome clinical inertia.

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.

Background: Carbohydrate estimation and bolus calculation are two important skills for handling intensive insulin therapy and effectively using bolus calculators. Structured assessment of both skills is lacking. A new tool for the assessment of skills in carbohydrate estimation and bolus calculation was developed and evaluated., Materials and Methods: A new assessment tool (SMART) was developed that included 10 items for bolus calculation and 12 items for carbohydrate estimation. In total, 411 patients on intensive insulin treatment were recruited. Different parameters of glycemic control were used as validity criteria., Results: The SMART tool achieved good reliability for the assessment of bolus calculation (Cronbach's α = 0.78) and sufficient reliability for the assessment of carbohydrate estimation (Cronbach's α = 0.67). A good bolus calculation skill was significantly associated with lower glycated hemoglobin values (r = -0.27), lower mean blood glucose levels (r = -0.29), and higher fluctuation of blood glucose control (r = -0.43). A good carbohydrate estimation skill was significantly associated with a lower frequency of severe hyperglycemia (r = -0.27) and a higher frequency of euglycemia (r = 0.26)., Conclusions: SMART is a reliable and valid tool for the assessment of both skills. Bolus calculation as well as carbohydrate estimation was associated with glycemic control. With the help of SMART, important skills for the management of intensive insulin therapy can be assessed separately. Thus, in clinical practice patients in need of assistance from a bolus calculator can be identified.

Aims: To estimate the associations between insufficient diabetes acceptance and relevant diabetes outcomes., Methods: A total of 320 patients completed questionnaires on diabetes non-acceptance (the Acceptance and Action Diabetes Questionnaire), diabetes distress (the Problem Areas in Diabetes Scale), depressive mood (the Center for Epidemiologic Studies Depression Scale), coping with illness (the Freiburg Questionnaire of Coping with Illness), self-care activities (the Summary of Diabetes Self-Care Activities Measure) and quality of life (the Short Form-36 Health Questionnaire). A six-item version of the Acceptance and Action Diabetes Questionnaire showing good reliability and validity was established, and the associations between insufficient acceptance and clinical outcomes were estimated., Results: Higher diabetes non-acceptance correlated significantly with less active coping (-0.37), reduced self-care (-0.43) and higher HbA1c levels (0.31), higher diabetes distress (0.53) and more depressive symptoms (0.36). Correlations of diabetes non-acceptance with diabetes self-care/glycaemic control were significantly higher than were those of depressive mood or diabetes distress with these criteria., Conclusions: Low diabetes acceptance is associated with impaired self-care and glycaemic control. Assessment of diabetes acceptance may facilitate the detection of patients at high risk and may present an essential target for treatments to improve diabetes control that is more relevant than elevated depressive mood or diabetes distress., (© 2014 The Authors. Diabetic Medicine © 2014 Diabetes UK.)

Objective: In a randomized, multi-centre trial, the efficacy of a self-management-oriented education programme (PRIMAS) for people with type 1 diabetes was compared with an established education programme as control group (CG). Primary outcome was the effect on glycaemic control in a 6-month follow-up. Secondary outcomes were the impact on emotional aspects, self-management related aspects and hypoglycaemia problems., Methods: The study was conducted in an outpatient setting. 160 participants were randomized. Baseline characteristics in PRIMAS and CG were similar (age 45.1±13.5 vs. 45.9±13.1 years, p=.716; diabetes duration 18.8±12.3 vs. 19.8±13.4 years, p=.615; BMI 26.5±4.6 vs. 27.5±5.0kg/m(2), p=.236; HbA1c 8.3±1.1 vs. 8.1±1.0%, p=.236)., Results: At follow-up there was a significant 0.4 percentage points greater reduction of HbA1c in PRIMAS compared to CG (Δ -0.4±1.0% vs. Δ 0.0±0.6%; p=.012). Also, diabetes-related distress (Δ -0.3±0.7 vs. -0.1±0.4, p=.032) and dissatisfaction with diabetes treatment (Δ -3.3±6.9 vs. -1.9±5.6, p=.024) decreased more in PRIMAS. Diabetes empowerment (Δ 2.6±5.9 vs. 0.8±5.1, p=.037) and diabetes self-efficacy (Δ 1.4±3.6 vs. 0.2±4.0, p=.013) increased in PRIMAS. Incidence of severe hypoglycemia, hypoglycemia awareness, diabetes knowledge, and self-care behaviour improved in both groups with no significant differences between groups., Conclusion: PRIMAS is more effective in lowering HbA1c than a previously established education programmes and also showed superiority in reducing diabetes-related distress and increasing diabetes empowerment, diabetes self-efficacy and satisfaction with insulin therapy., (Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.)

Background: The course of barriers towards insulin therapy was analysed in three different groups of type 2 diabetic patients. This observational longitudinal study surveyed a three-month follow-up., Methods: Participants in this study totalled 130 type 2 diabetic patients. The first subgroup was on insulin therapy at baseline (group 1: n = 57, age 55.6 ± 8.7 yrs, disease duration 12.7 ± 7.2 yrs, HbA1c 8.5 ± 1.6%) and remained on insulin at follow-up. Of an initial 73 insulin-naïve patients, 44 were switched to insulin therapy (group 2: age 58.1 ± 6.8 yrs, disease duration 7.7 ± 5.0 yrs, HbA1c 9.1 ± 1.7%) and 29 patients remained on an oral regimen (group 3: age 52.7 ± 10.7 yrs, disease duration 5.3 ± 4.6 yrs, HbA1c 8.3 ± 1.4%). Barriers towards insulin therapy were measured using the Insulin Treatment Appraisal Scale (ITAS). As generic instruments of health related quality of life patients completed also the Problem Areas of Diabetes Questionnaire (PAID), the WHO-5 Well-Being Scale (WHO-5), the Centre for Epidemiologic Studies Depression Scale (CES-D) and the Trait Version of the State Trait Anxiety Inventory (STAI) at baseline and at three-month follow-up., Results: At the three-month follow-up, HbA1c had improved in all three groups (7.7 ± 1.2% vs. 7.1 ± 1.1% vs. 6.7 ± 0.8%). The course of negative appraisal of insulin therapy was significantly different in the three groups (p > .003): the ITAS score increased in patients remained on oral antidiabetic drugs (51.2 ± 12.2 to 53.6 ± 12.3), whereas it decreased in patients switched to insulin therapy (49.2 ± 9.8 to 46.2 ± 9.9) or remained on insulin treatment (45.8 ± 8.3 to 44.5 ± 8.0). Diabetes-related distress, trait anxiety, and well-being, showed a similar course in all three groups. The depression score improved significantly in patients switched to insulin treatment compared with patients remaining on insulin therapy., Conclusions: In summary, this study suggests that a negative appraisal of insulin treatment is modifiable by the initiation of insulin therapy. This finding indicates that barriers to insulin are a rather temporary than a stable phenomenon.

Objective: Aim of this study was to investigate the effectiveness of a patient education program for the treatment of hypoglycemia-associated problems in type 1 diabetic inpatients., Methods: In this observational controlled pre-post study, the intervention group (IG; N = 105) participated in the new program, controls (control group CG; N = 102) received conventional patient education on hypoglycemia., Results: Follow-up data (mean follow-up: 6.63 months) were obtained from 177 patients (85.6%). Though severe hypoglycemia also decreased in CG to some degree, the decrease in IG was higher than in CG, but fails to reach significance between groups. Hypoglycemia awareness remained constant in IG, whereas some deterioration was observed in CG (p = 0.06). Prevalence of hypoglycemia-related problems decreased in IG, whereas in CG it remained constant. No differential effects with regard to psychological well being, fear of hypoglycemia and late complications, and control beliefs were observed., Conclusion: The results suggest that the new intervention program is an effective treatment. The effectiveness should be confirmed, however, in a randomized controlled trial, also incorporating outpatient settings., Practice Implications: A self-management intervention targeting the patients' health beliefs and attitudes towards hypoglycemia and their diabetes self-management, rather than knowledge-centered patient education, can help to ameliorate or even prevent hypoglycemia-associated problems.

Background: Previous studies indicate a high prevalence of psychiatric disorders in adults with type 1 diabetes mellitus. The aim of our study was to determine if newly diagnosed adults with type 1 diabetes already have an elevated rate of psychiatric disorders at the beginning of their physical illness., Methods: The authors consecutively recruited 313 newly diagnosed, adult inpatients with type 1 diabetes (age 17-40 years) from 12 hospitals. A national, representative population sample of 2046 persons of a similar age range served as the reference group. Psychiatric disorders were measured in both groups using structured interviews that provided diagnoses according to DSM-IV., Results: There was a point prevalence of 12.5% for psychiatric disorders in the sample. The most frequent conditions were anxiety and affective disorders. Subjects with type 1 diabetes demonstrated a rate of major depressive episodes twice that of the reference group (5.8% vs 2.7%, p < 0.003; corrected for confounders). Apart from this finding, there was no significantly increased prevalence of psychiatric disorders in the diabetes sample as compared to the general German population., Conclusion: The rate of major depressive episodes in the new onset cohort of type 1 diabetes patients was double that of the population as a whole. However, the hypothesis, that newly diagnosed type 1 diabetes patients have more psychiatric disorders than the general population, was not confirmed., (Copyright 2003 John Wiley & Sons, Ltd.)