Current Practice of Podiatrists in Testing for Diabetic Polyneuropathy and Implementing Foot Care (PROTECT Study Survey 2).

AIMS: Podiatrists constitute a key member of a multidisciplinary foot care team, but their services remain underutilized. We sought to gain insights into the daily practice of podiatrists focusing on screening for and monitoring of diabetic sensorimotor polyneuropathy (DSPN) as well as foot management. METHODS: This cross-sectional survey included 125 podiatrists from 12 federal states across Germany who responded to an online questionnaire. RESULTS: The majority of patients treated in podiatry practices were referred by general practitioners and diabetologists. Screening for or follow-up of DSPN was performed by 36% of the respondents at least once a year, by 28% only at initial examination, by 21% only at suspicion, and by 10% basically at each treatment visit. Instruments to assess vibration, touch/pressure, and temperature sensation were used by 81% to 94% of the podiatrists. Previously undiagnosed DSPN and foot ulcers were detected frequently/very frequently (≥6 cases/mo) by 24.0 and 18.4% of the podiatrists, respectively. Almost all podiatrists advised daily self-monitoring of feet and appropriate foot care and >50% gave advice on medical treatment. CONCLUSIONS: Podiatrists play an important role in the detection, monitoring, and management of both DSPN and diabetic foot ulcers, suggesting that the utilization of their services should be fostered.

Validation of a risk prediction model for early chronic kidney disease in patients with type 2 diabetes: Data from the German/Austrian Diabetes Prospective Follow-up registry.

AIM: To validate a recently proposed risk prediction model for chronic kidney disease (CKD) in type 2 diabetes (T2D). MATERIALS AND METHODS: Subjects from the German/Austrian Diabetes Prospective Follow-up (DPV) registry with T2D, normoalbuminuria, an estimated glomerular filtration rate of 60 ml/min/1.73m2 or higher and aged 39-75 years were included. Prognostic factors included age, body mass index (BMI), smoking status and HbA1c. Subjects were categorized into low, moderate, high and very high-risk groups. Outcome was CKD occurrence. RESULTS: Subjects (n = 10 922) had a mean age of 61 years, diabetes duration of 6 years, BMI of 31.7 kg/m2 , HbA1c of 6.9% (52 mmol/mol); 9.1% had diabetic retinopathy and 16.3% were smokers. After the follow-up (~59 months), 37.4% subjects developed CKD. The area under the curve (AUC; unadjusted base model) was 0.58 (95% CI 0.57-0.59). After adjustment for diabetes and follow-up duration, the AUC was 0.69 (95% CI 0.68-0.70), indicating improved discrimination. After follow-up, 15.0%, 20.1%, 27.7% and 40.2% patients in the low, moderate, high and very high-risk groups, respectively, had developed CKD. Increasing risk score correlated with increasing cumulative risk of incident CKD over a median of 4.5 years of follow-up (P < .0001). CONCLUSIONS: The predictive model achieved moderate discrimination but good calibration in a German/Austrian T2D population, suggesting that the model may be relevant for determining CKD risk.

Effects of the COVID-19 pandemic on clinically diagnosed psychiatric disorders in persons with type 2 diabetes.

AIMS: To examine whether the incidence rates of diagnosed depression, anxiety disorders and stress reactions, as well as prescription rates of antidepressants and anxiolytics were higher during the COVID-19 pandemic than before in persons with type 2 diabetes in Germany. Contrary to earlier studies, clinical diagnoses of psychiatric disorders (ICD classification) were used. METHODS: The German Disease Analyzer (DA) database is an outpatient database containing routine data on patients´ diseases and treatments provided by a representative panel of physician practices selected from across Germany. We assessed incidence rates of depressive disorders (ICD-10: F32, F33), anxiety disorders (F41) and stress reactions (F43) in quarters from January 2019 to March 2021 in 95,765 people with type 2 diabetes included in the DA in 2019 (mean age 68.9 years, 58% men). Prescription rates of antidepressants and anxiolytics in quarters from January 2020 to March 2021 were compared with prescription rates from 1 year earlier. RESULTS: During the study period, the incidence rate of newly diagnosed depressive disorders in persons with type 2 diabetes declined slightly, while the incidence rates of anxiety and stress disorders remained largely constant. The rates of new prescriptions for antidepressants and anxiolytics were lower in all quarters of 2020 and in the first quarter of 2021 than in the quarters 1 year earlier. Diabetes-related complications were more prevalent in persons with incident psychiatric disorders than in those without. CONCLUSIONS: No increase in the incidence rates of clinically diagnosed psychiatric disorders was observed during the COVID-19 pandemic in Germany in persons with type 2 diabetes.

[Young People with Type 1 Diabetes: Prevalence of Disturbed Eating Behaviour and Psychosocial Care]. / Gestörtes Essverhalten und psychosoziale Versorgungssituation junger Menschen mit Typ 1 Diabetes.

INTRODUCTION: Disturbed eating behaviour or clinically relevant eating disorders associated with type 1 diabetes have serious consequences for the metabolism and long-term health prognosis of those affected. Early diagnosis and qualified therapeutic interventions may help to prevent microvascular complications. In this study, the prevalence of eating disorders and the status of psychosocial care are assessed for a group of young people with type 1 diabetes, participating in a 4 days diabetes camp. MATERIAL AND METHODS: During a diabetes camp for young people (16-29 years) in Germany, the participants completed a questionnaire on their current diabetes therapy, their diabetes-specific distress (PAID-5), and their psychosocial outpatient care. Symptoms of disturbed eating were assessed by a diabetes-specific screening questionnaire, the Diabetes Eating Problem Survey-Revised (DEPS-R). RESULTS: Overall 308 young people with type 1 diabetes (age 21.4±3.4 years, 73% female, diabetes duration 10.2±5.9 years, 74% in adult diabetes out-patient care) answered the questionnaire. In 28.2% of respondents, the cut-off of DEPS-R was exceeded (17% of men, 32% of women). Only 7% of the participants with symptoms of disturbed eating behaviour received appropriate psychological care. Multiple regress analysis indicates that HbA1c, BMI, diabetes-specific distress, age, diabetes duration, and sex account for the level of disturbed eating behaviour. DISCUSSION: Among the participants of a diabetes camp for young people, more than a quarter presented symptoms of disturbed eating behaviour. Overall, young women were affected more frequently; further risk factors were higher BMI, elevated HbA1c and diabetes-distress. Only a very small proportion of young adults with type 1 diabetes and disturbed eating behaviour received psychological support. CONCLUSION: Diabetes-specific screening instruments and/or specific screening questions should be used in outpatient routine care for young adults in a standardized manner, especially among young women, and the results should be discussed with the patients to initiate further treatment.

Higher HbA1c Measurement Quality Standards are Needed for Follow-Up and Diagnosis: Experience and Analyses from Germany.

Measurement of HbA1c is an essential laboratory measure for the follow-up and therapy decision-making in patients with diabetes. HbA1c is one of the measurands in laboratory medicine that have to be successfully checked according to the criteria of the guidelines of the German Medical Association (Rili-BAEK) in external quality assurance using the reference method value concept, when applied in patient care. The allowed deviation of ±18% in external quality assessment (EQA) and ± 10% in internal quality control has been ultimately met by virtually all the different manufacturers and methods. However, such broad limits for permissible deviations are not suitable in view of medical requirements in patient care. The low-level acceptance criteria also depends on the previously used EQA materials used in Germany. In fact, HbA1c measurement results that are imprecisely measured or come from incorrectly calibrated devices are difficult to identify. With implementation of unprocessed fresh EDTA blood, the situation has changed. Until now systems with unit use reagents for point-of-care testing (POCT) of HbA1c are not mandatory to participate in EQA schemes in Germany. This paper outlines why there was a need to narrow the acceptance limits listed within the Rili-BAEK for HbA1c's internal (to ± 3%) and external (to ± 8%) quality controls in EQA schemes for Germany, which will take place after a transition period in the next years. Higher quality in HbA1c measurements will help to avoid misdiagnosis of diabetes as well as potential over- or undertreatment of patients at risk for diabetes.

Voluntary industry initiatives to promote healthy diets: a case study on a major European food retailer.

OBJECTIVE: To analyse the scope and content of the nutrition pledge announced by Lidl. DESIGN: We applied the approach recommended by the private-sector module of the INFORMAS (International Network for Food and Obesity Research, Monitoring and Action Support) food environment monitoring framework and qualitative content analysis to Lidl's nutrition pledge. SETTING: Global. SUBJECTS: The nutrition pledge of Lidl, Europe's largest food retailer. RESULTS: Lidl pledges to reduce the average sales-weighted content of added sugar and added salt in its own-brand products by 20 % until 2025, using 2015 as a baseline, starting in Germany. Moreover, it vows to reduce the saturated and trans-fatty acid contents of its own-brand products, without specifying targets or timelines. To achieve these targets, it pledges to apply a number of approaches, including reformulation, promotion of healthier products, reduction of package and portion sizes, and provision of nutrition information and education. Strengths of Lidl's pledge are its extensive scope, the quantification of some targets, and its partially evidence-based approach to the selection of targets and interventions. Key limitations include the vagueness of many targets, a lack of transparency and the absence of independent monitoring and evaluation. CONCLUSIONS: Lidl's pledge, while commendable for its scope, does not meet current best practice guidelines. Given their current limitations, industry initiatives of this kind are likely to fall short of what is needed to improve population-level nutrition.

Routine care for people with newly diagnosed type 2 diabetes before and during the SARS-CoV-2 pandemic - results from the German Disease Analyzer database.

AIM: To investigate whether the SARS-CoV-2 pandemic affected care for people with newly diagnosed type 2 diabetes in Germany. METHODS: The Disease Analyzer database (IQVIA, Germany) contains routine data on diagnoses and treatments (ICD-10 and ATC codes) from patients followed in selected physician practices across Germany. We compared 21,747 individuals with a first diagnosis of type 2 diabetes between January 2018 and September 2019 with 20,513 individuals with a first diabetes diagnosis between March 2020 and November 2021. RESULTS: In March and April 2020, the number of new diagnoses of diabetes decreased by 18.3% and 35.7%, respectively, compared to March and April of the previous two years. The previous diabetes incidence level was reached again in June 2020. Mean pre-treatment glucose levels were higher during the pandemic than before (fasting plasma glucose: +6.3 mg/dl (95% confidence interval: 4.6-8.0)). In the first six months after diabetes diagnosis, the mean number of GP visits, specialist referrals and HbA1c measurements decreased. CONCLUSION: We observed a decrease in diabetes incidence in the early phase of the pandemic and slightly higher pretreatment blood glucose levels during the pandemic than before. Care for newly diagnosed diabetes was slightly worse during the pandemic than before.

Diabetes incidence before and after COVID-19 vaccination - Results from the German Disease Analyzer database.

Objective: We investigated whether COVID-19 vaccination had an impact on diabetes risk. Methods: We used data of 6,198 patients (mean age 64.3 years) from the nationwide Disease Analyzer database, a representative panel of physicians' practices in Germany. Patients received their first COVID-19 vaccination between 1 April 2021 and 31 March 2022, and all were newly diagnosed with diabetes within 183 days before or after this vaccination. Incident rates of diabetes after vaccination were compared to incident rates before vaccination. Results: The incidence rate of diabetes was lower after vaccination than before vaccination (incidence rate ratio = 0.79, 95% confidence interval: 0.75-0.83). The number of incident cases of diabetes was not greater in 2021 than in 2019. Conclusion: Our study did not confirm an increased risk of diabetes after COVID-19 vaccination. Further studies are needed to show whether the vaccination may be associated with a reduced diabetes risk.

Shared Decision Making, Diagnostic Evaluation, and Pharmacotherapy in Type 2 Diabetes.

BACKGROUND: Type 2 diabetes is one of the most important widespread diseases worldwide. In Germany, nearly one in five persons over age 65 has type 2 diabetes. The German National Disease Management Guideline for Type 2 Diabetes (NDMG; in German: Nationale Versorgungsleitlinie, NVL) contains updated recommendations for the diagnostic evaluation and pharmacotherapy of this disease as well as information about specific groups of people for whom early detection may be useful. METHODS: The guideline has been updated, chapter by chapter, since 2018. Its recommendations are based on systematically searched and evaluated scientific evidence, the clinical expertise of a multidisciplinary panel of experts, and patient perspectives. RESULTS: The new chapter on shared decision making includes a description of a structured approach that can be used when individual treatment goals have not been achieved. The diagnosis of diabetes newly requires at least two abnormally elevated laboratory values: e.g., fasting plasma glucose ≥ 126 mg/dL (≥ 7.0 mmol/L), HbA1c ≥ 6.5 % (≥ 48 mmol/mol) and/or casual plasma glucose ≥ 200 mg/dL (≥ 11.1 mmol/L). Cardiovascular and renal risks are to be considered in the choice of drug. Studies have shown that, in persons with cardiovascular disease, treatment with GLP-1 receptor agonists (GLP-1, glucagon-like peptide-1) or SGLT2 inhibitors (SGLT2, sodium-glucose co-transporter-2) was less likely than the comparison intervention to lead to certain patient-relevant endpoints, including all-cause mortality (OR = 0.88 and 0.84, respectively), hospitalization for heart failure (SGLT2 inhibitors: OR = 0.65), and worsening of renal function (OR = 0.61 and 0.59, respectively). CONCLUSION: Current evidence continues to support the recommendations on pharmacotherapy of the 2021 guideline. The Guideline Group did not find evidence of adequate certainty to inform recommendations about the screening of persons at risk, HbA1c target values, or screening for sequelae and comorbidities. Better evidence on these matters would be desirable.

[Diabetes and cardiovascular health literacy in childhood and adolescence - a 12-year follow-up]. / Diabetes- und kardiovaskuläre Gesundheitskompetenz im Kindes- und Jugendalter ­ ein 12-Jahres-Follow-up.

BACKGROUND: The incidence of diabetes mellitus and cardiovascular diseases is increasing worldwide and also in Germany. The aim of the study was to assess the health literacy regarding these diseases in childhood and adolescence. METHODS: Students of the 5th-12th grade (grammar school ("Gymnasium"), secondary school forms ("Realschule" and "Hauptschule")) were interviewed in 2007 (n = 4383) and 2019 (n = 572) about diabetes and secondary complications. In addition, questions about other cardiovascular risk factors were asked in 2019. RESULTS: Diabetes-related questions were answered correctly by 56 % in 2007 as well as 53 % in 2019. Among others, 70 % (2007) as well as 75 % (2019) of the students stated "ate too much sugar" as a cause for type 1 diabetes. Further, questions about major risk factors for heart attack and stroke were answered correctly by only 33 % (for diabetes) and 43 %-53 % (for smoking) of students.Across all questions, a positive association indicated between the rate of correct answers and the educational level of the school institution; however, the differences remained marginal at 5-19 % between Gymnasium and Hauptschule or Realschule at both survey time points. A difference between genders was indicated in 2007 (girls: 59 % vs. boys: 52 %) and 2019 (girls: 56 % vs. boys: 51 %). CONCLUSION: Changes in health literacy regarding diabetes and other cardiovascular risk factors among 5th-12th grade students over the past 12 years could not be observed. The assumed self-infliction of type 1 diabetes may be perceived as discrimination by those affected.

Screening and diagnosis of diabetic polyneuropathy in clinical practice: A survey among German physicians (PROTECT Study Survey).

AIMS: We sought to obtain detailed information on the procedures and appraisal of screening for and diagnosing diabetic sensorimotor polyneuropathy (DSPN) in clinical practice. METHODS: This cross-sectional survey included 574 physicians from 13 federal states across Germany who responded to a tripartite questionnaire. RESULTS: The vast majority of the respondents reported to screen for DSPN at least once a year (87 %), while 65 % reported to examine the feet of DSPN patients at least twice a year. However, only 28 % and 20 % of the respondents used questionnaires and scores to assess the severity of neuropathic symptoms and signs, respectively. The rates of participants reporting that they do not use a standardized testing procedure were 58 % for pressure sensation, 62 % for pain sensation, and 54 % for thermal sensation. The rates of respondents reporting that they do not deploy a standardized assessment were 41 % for vibration sensation, 73 % for pressure sensation, 77 % for pain sensation, and 66 % for thermal sensation. Half of the physicians oriented themselves towards clinical guidelines when diagnosing DSPN. CONCLUSIONS: Despite relatively high screening rates, the willingness to implement both standardized testing procedures and assessment and to follow guidelines is low among physicians when screening for and clinically diagnosing DSPN.

Effects of the COVID-19 lockdown on primary health care for persons with type 2 diabetes - Results from the German Disease Analyzer database.

OBJECTIVES: To identify the effects of the first lockdown in Germany (March to May 2020) on glycemic control, BMI, and cardiovascular risk factors in persons with type 2 diabetes. METHODS: The nationwide Disease Analyzer database includes a representative panel of physicians practices in Germany providing anonymized real-world patient data. For metabolic and renal factors, we estimated absolute changes of means comparing outcomes from June to November 2020 to outcomes in the same persons from June to November 2019, and June to November 2018, respectively. RESULTS: In 32,399 patients with type 2 diabetes, HbA1c change between 2019 and 2020 was + 0.04% (95 %CI: 0.03%; 0.05%) compared to -0.02% (95 %CI: -0.03%; -0.01%) between 2018 and 2019. Metabolic risk factors and creatinine changed only little between June to November 2019 and June to November 2020. The proportions of patients with BMI ≥ 30 kg/m2 were 56%, 55%, and 54% in June to November 2018, 2019, and 2020, respectively. The corresponding proportions for HbA1c > 53 mmol/mol Hb (>7.0%) were 39%, 39%, and 40%. CONCLUSIONS: There is little evidence that the first COVID-19 lockdown in Germany had a short-term harmful influence on acute health care outcomes and vascular risk factors in people with type 2 diabetes.

COVID-19 and metabolic disease: mechanisms and clinical management.

Up to 50% of the people who have died from COVID-19 had metabolic and vascular disorders. Notably, there are many direct links between COVID-19 and the metabolic and endocrine systems. Thus, not only are patients with metabolic dysfunction (eg, obesity, hypertension, non-alcoholic fatty liver disease, and diabetes) at an increased risk of developing severe COVID-19 but also infection with SARS-CoV-2 might lead to new-onset diabetes or aggravation of pre-existing metabolic disorders. In this Review, we provide an update on the mechanisms of how metabolic and endocrine disorders might predispose patients to develop severe COVID-19. Additionally, we update the practical recommendations and management of patients with COVID-19 and post-pandemic. Furthermore, we summarise new treatment options for patients with both COVID-19 and diabetes, and highlight current challenges in clinical management.

Polyneuropathy is inadequately treated despite increasing symptom intensity in individuals with and without diabetes (PROTECT follow-up study).

AIMS/INTRODUCTION: Despite its major clinical impact, distal symmetric polyneuropathy remains frequently undiagnosed and undertreated in clinical practice. We previously reported in the PROTECT Study that 70% of type 2 diabetes patients with distal symmetric polyneuropathy were unaware of having the latter condition. MATERIALS AND METHODS: In the present follow up after 2.5 ± 0.7 years, 122 and 85 participants with and without type 2 diabetes, respectively, completed questionnaires to obtain information about the further course of disease and its management. RESULTS: At follow up, 49 and 48% of the respondents with type 2 diabetes and without diabetes, respectively, reported that the intensity of paresthesia or numbness in the feet increased, whereas for burning and pain in the feet the corresponding percentages were 56 and 61%. However, 33 and 40% of the respondents with type 2 diabetes and without diabetes, respectively, reporting neuropathic symptoms at follow up did not receive any pharmacotherapy. Pharmacotherapy of neuropathic symptoms at follow up among participants with type 2 diabetes and without diabetes included mainly World Health Organization Step 1 analgesics (17% each; excluding acetylsalicylic acid), pregabalin/gabapentin (20 and 12%), vitamin B complex (13 and 22%), benfotiamine (13 and 2%), opioids (7 and 12%), antidepressants (4 and 5%) and α-lipoic acid (4 and 2%). CONCLUSIONS: These findings point to insufficient care, inadequate treatment adherence or limited efficacy of treatments in patients with polyneuropathy, suggesting that effective measures should be implemented to correct these healthcare deficits.

Measurement Uncertainty Impacts Diagnosis of Diabetes Mellitus: Reliable Minimal Difference of Plasma Glucose Results.

INTRODUCTION: The diagnosis of diabetes mellitus is based on suitable cut-off values of specific biomarkers, such as the concentration of glucose in plasma. The German Diabetes Association has very recently published a clinical practice guideline on the definition, classification and diagnosis of diabetes mellitus that recommends measurements of plasma glucose concentration have an imprecision defined as a minimal difference (MD) of at a fasting plasma glucose concentration of 7.0 mmol/L. To obtain reliable values for the MD, we investigated long-term and short-term measurement uncertainty. METHODS: The imprecision was determined by two approaches: (1) a long-term dataset with imprecision based on the Guideline of the German Medical Association on Quality Assurance in Medical Laboratory Examinations (Rili-BAEK), in a medical laboratory operating 24/7, using internal quality control (IQC) data for four concentrations during a 10-year period; and (2) a detailed short-term dataset with imprecision assessed by hourly measurements of control materials. These datasets were used to calculate the MD cut-off (MDcut-off) as: [Formula: see text] = 2  [Formula: see text], where SD is the standard deviation and k = 2 represents a confidence level of 95%. RESULTS: The MDcut-off of ≤ 0.7 mmol/L at a fasting plasma glucose concentration of 7.0 mmol/L (MDcut-off 7.0) for the long-term and the short-term approaches were 0.44 and 0.40 mmol/L, respectively. The MDcut-off 7.0 from both approaches was therefore below the recommended value of 0.7 mmol/L. It was noted that the variability in performance within and between instruments can be covered by reporting the long-term MDcut-off 7.0 across all connected instruments. In this study, stable results for the MDcut-off 7.0 were obtained after 1 year. CONCLUSION: Imprecision as measured by IQC data is remarkably stable over many years of operation. Current imprecision assessment usually focuses on only single instruments, whereas clinicians perceive the measurement as the result of the combined analytical performance of all instruments used for a certain assay. In the clinical setting, the MD may be a more useful measure of imprecision, and we suggest deriving the MDcut-off combined from all instruments and control cycles that are used in the patient care setting for a given analyte.