Salvation Expectations of Patients of Medicine, Complementary and Alternative Medicine and Religion.

Health and holistic quality of life, physical and emotional needs, somatic and spiritual aspects contain a comprehensive promise of healing. The aim of the current study is to measure the expectations of patients of medicine, alternative medicine and religion related to health and illness. The survey was carried out among 103 patients of a rural general practitioner from May to June 2013 and among 103 patients of the outpatient department for endocrinology and metabolic disease of the Jena University Hospital in 2013. All patients were asked by one interviewer (HM) on fears in relation to health/illness and expectations of help for its own life, medicine, alternative medicine and religion. The biggest fear of patients is "being in need of help of others." There is no significant difference between religious and non-religious patients. Overall, the expectations of medicine were significantly higher in all sectors than in alternative medicine or religion. Comparing alternative medicine and religion, the expectations of alternative medicine were significantly higher excluding consolation and inner peace. The expectations for medicine in general and for the physician are very high and comprehensive and go beyond diagnosis and realization of therapies. Patients expect hope, guidance, support, comfort, inner peace and advice most from medicine. This results in considerable challenges for the physician, especially in a healthcare system with limited resources and without suitable offers. There is an urgent need to integrate these requirements into daily routine.

Preventing misdiagnosis of diabetes in the elderly: age-dependent HbA1c reference intervals derived from two population-based study cohorts.

BACKGROUND: Measurement of gylcated hemoglobin A1c (HbA1c) plays a central role in monitoring quality of antidiabetic therapy and in the diagnosis of diabetes. Several studies report increased levels of HbA1c in nondiabetic elderly. However, this observation did not reach incorporation into daily clinical practice or the respective guidelines. The present study aimed to evaluate HbA1c levels in relation to age in two independent population-based cohorts and to derive age-specific reference intervals. METHODS: Four thousand two hundred sixty three participants from the Study of Health in Pomerania (SHIP-0) and 4402 participants from the independent study SHIP-Trend were included. HbA1c was determined by means of high-performance liquid chromatography. Multivariable linear regression models were performed. Reference intervals for HbA1c were determined. RESULTS: Reference intervals were derived from a healthy subpopulation with the upper reference limit (URL) for HbA1c of 42.1 mmol/Mol (6.0%) for individuals aged 20-39 years increasing to 43.2 mmol/Mol (6.1%) for individuals aged 40-59 years. For people aged ≥60 years the URL was 47.5 mmol/Mol (6.5%). In both study populations an increase in HbA1c with age was observed. ANOVA revealed up to 8.5 mmol/Mol (0.77%) or 7.3 mmol/Mol (0.68%) higher estimated mean levels of HbA1c in the oldest compared to the youngest age group in SHIP-0 or SHIP-trend, respectively. Linear regression analyses confirmed the positive associations of HbA1c with age which was independent of BMI CONCLUSION: The present study confirmed the previously observed increase of HbA1c with increasing age in non-diabetic individuals. As a consequence age-dependent reference values for HbA1c were derived from two large and well defined reference populations. Implementation of them into daily practice may improve patient care and diagnosis of diabetes and reduce the risk of misdiagnosis and subsequent overtreatment of diabetes in elderly patients.

An informed shared decision making programme on the prevention of myocardial infarction for patients with type 2 diabetes in primary care: protocol of a cluster randomised, controlled trial.

BACKGROUND: International and national societies claim a patient centred approach including shared decision making (SDM) in diabetes care. In a previous project, a SDM programme on the prevention of myocardial infarction has been developed. It is aimed at supporting patients with type 2 diabetes to make informed choices on preventive options, to share the decision making process with the health care team, and to improve adherence to the chosen treatment. In this study, the programme will be implemented and evaluated in primary care practices. METHODS/DESIGN: A cluster randomised, controlled trial will be conducted to compare the SDM programme with standard care enrolling patients with type 2 diabetes (N = 306) from primary care practices (N = 24). The intervention programme comprises a six hours provider training, a patient decision aid including evidence-based information, a 90 minutes structured teaching session provided by medical assistants, a sheet to document the patients' individual treatment goals, and a structured consultation with the general practitioner for sharing information, setting treatment goals, and for adapting treatment regimens if necessary. Patients in the control group receive a brief extract of recommendations of the German National Disease Management Guideline on the treatment of patients with type 2 diabetes. Primary outcome measure is adherence to blood pressure treatment and statin treatment at 6 months follow-up. Secondary outcome measures comprise informed choice and the achievement of patients' treatment goals. Analyses will be carried out on intention-to-treat basis. Concurrent qualitative methods will be used to explore the implementation processes. DISCUSSION: At the end of this study, information on the efficacy of the SDM programme in the primary care context will be available. In addition, processes that might interfere with or that might promote a successful implementation will be identified. TRIAL REGISTRATION: ISRCTN77300204 .

An evidence-based shared decision making programme on the prevention of myocardial infarction in type 2 diabetes: protocol of a randomised-controlled trial.

BACKGROUND: Lack of patient involvement in decision making has been suggested as one reason for limited treatment success. Concepts such as shared decision making may contribute to high quality healthcare by supporting patients to make informed decisions together with their physicians.A multi-component shared decision making programme on the prevention of heart attack in type 2 diabetes has been developed. It aims at improving the quality of decision-making by providing evidence-based patient information, enhancing patients' knowledge, and supporting them to actively participate in decision-making. In this study the efficacy of the programme is evaluated in the setting of a diabetes clinic. METHODS/DESIGN: A single blinded randomised-controlled trial is conducted to compare the shared decision making programme with a control-intervention. The intervention consists of an evidence-based patient decision aid on the prevention of myocardial infarction and a corresponding counselling module provided by diabetes educators. Similar in duration and structure, the control-intervention targets nutrition, sports, and stress coping. A total of 154 patients between 40 and 69 years of age with type 2 diabetes and no previous diagnosis of ischaemic heart disease or stroke are enrolled and allocated either to the intervention or the control-intervention. Primary outcome measure is the patients' knowledge on benefits and harms of heart attack prevention captured by a standardised knowledge test. Key secondary outcome measure is the achievement of treatment goals prioritised by the individual patient. Treatment goals refer to statin taking, HbA1c-, blood pressure levels and smoking status. Outcomes are assessed directly after the counselling and at 6 months follow-up. Analyses will be carried out on intention-to-treat basis. Concurrent qualitative methods are used to explore intervention fidelity and to gain insight into implementation processes. DISCUSSION: Interventions to facilitate evidence-based shared decision making represent an innovative approach in diabetes care. The results of this study will provide information on the efficacy of such a concept in the setting of a diabetes clinic in Germany. TRIAL REGISTRATION: ISRCTN84636255.

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.

The Sodium-Glucose Co-Transporter 2 (SGLT2) Inhibitor Empagliflozin Reverses Hyperglycemia-Induced Monocyte and Endothelial Dysfunction Primarily through Glucose Transport-Independent but Redox-Dependent Mechanisms.

PURPOSE: Hyperglycaemia-induced oxidative stress and inflammation contribute to vascular cell dysfunction and subsequent cardiovascular events in T2DM. Selective sodium-glucose co-transporter-2 (SGLT-2) inhibitor empagliflozin significantly improves cardiovascular mortality in T2DM patients (EMPA-REG trial). Since SGLT-2 is known to be expressed on cells other than the kidney cells, we investigated the potential ability of empagliflozin to regulate glucose transport and alleviate hyperglycaemia-induced dysfunction of these cells. METHODS: Primary human monocytes were isolated from the peripheral blood of T2DM patients and healthy individuals. Primary human umbilical vein endothelial cells (HUVECs) and primary human coronary artery endothelial cells (HCAECs), and fetoplacental endothelial cells (HPECs) were used as the EC model cells. Cells were exposed to hyperglycaemic conditions in vitro in 40 ng/mL or 100 ng/mL empagliflozin. The expression levels of the relevant molecules were analysed by RT-qPCR and confirmed by FACS. Glucose uptake assays were carried out with a fluorescent derivative of glucose, 2-NBDG. Reactive oxygen species (ROS) accumulation was measured using the H2DFFDA method. Monocyte and endothelial cell chemotaxis were measured using modified Boyden chamber assays. RESULTS: Both primary human monocytes and endothelial cells express SGLT-2. Hyperglycaemic conditions did not significantly alter the SGLT-2 levels in monocytes and ECs in vitro or in T2DM conditions. Glucose uptake assays carried out in the presence of GLUT inhibitors revealed that SGLT-2 inhibition very mildly, but not significantly, suppressed glucose uptake by monocytes and endothelial cells. However, we detected the significant suppression of hyperglycaemia-induced ROS accumulation in monocytes and ECs when empagliflozin was used to inhibit SGLT-2 function. Hyperglycaemic monocytes and endothelial cells readily exhibited impaired chemotaxis behaviour. The co-treatment with empagliflozin reversed the PlGF-1 resistance phenotype of hyperglycaemic monocytes. Similarly, the blunted VEGF-A responses of hyperglycaemic ECs were also restored by empagliflozin, which could be attributed to the restoration of the VEGFR-2 receptor levels on the EC surface. The induction of oxidative stress completely recapitulated most of the aberrant phenotypes exhibited by hyperglycaemic monocytes and endothelial cells, and a general antioxidant N-acetyl-L-cysteine (NAC) was able to mimic the effects of empagliflozin. CONCLUSIONS: This study provides data indicating the beneficial role of empagliflozin in reversing hyperglycaemia-induced vascular cell dysfunction. Even though both monocytes and endothelial cells express functional SGLT-2, SGLT-2 is not the primary glucose transporter in these cells. Therefore, it seems likely that empagliflozin does not directly prevent hyperglycaemia-mediated enhanced glucotoxicity in these cells by inhibiting glucose uptake. We identified the reduction of oxidative stress by empagliflozin as a primary reason for the improved function of monocytes and endothelial cells in hyperglycaemic conditions. In conclusion, empagliflozin reverses vascular cell dysfunction independent of glucose transport but could partially contribute to its beneficial cardiovascular effects.

Is there an HbA1c Threshold for Symptoms of Chronic Hyperglycemia?

AIMS OF THE STUDY: The minimum therapeutic goal regarding metabolic control for people with diabetes mellitus is the "absence of symptoms of hyperglycemia." However, it is uncertain whether a level of HbA1c can be defined that guarantees the absence of these symptoms. The aim was to define an HbA1c threshold above which most patients show hyperglycemic symptoms. METHODS: In a multicenter cross-sectional study, 137 patients with type 1 and 285 with type 2 diabetes were asked about their symptoms during periods of hyperglycemia with a standardized questionnaire. Seventeen symptoms of hyperglycemia were summarized to the total hyperglycemia symptom score (THSS; min. 0; max. 68). The answers could be given according to the frequency and intensity in the last 4 - 6 weeks. RESULTS: The HbA1c threshold above which most patients showed hyperglycemic symptoms was 10.05% for patients with diabetes type 1 and 8.9%. for patients with type 2. Most confidence was reached on the symptoms of frequent urination" and "tiredness." The mean THSS was 19.4 (±9.0) and showed a positive correlation with age (r=0.167; p<0.001) and HbA1c (r=0.254; p<0.001). CONCLUSIONS: We identified an HbA1c threshold above which most patients show symptoms of hyperglycemia. In the treatment of people with diabetes mellitus, a safety margin to this threshold should be maintained to preserve well-being and avoid distress. However, since hyperglycemia symptoms are subject to many influencing factors, an adjustment of the therapy-both intensification and de-intensification-should always be carried out in combination with the requested hyperglycemia symptoms and HbA1c value.

The High-Resolution Three-Dimensional Magnetic Detector System 3D-Magma Accurately Measures Gastric and Small Bowel Motility in People with Type 2 Diabetes with Neuropathy.

Gastroparesis is an important complication of diabetes. Motility disorders are underdiagnosed and can lead to unexplained hypoglycemia. Currently diagnostic options are limited. All established methods harbor certain disadvantages. The 3D-MAGMA system is capable of reliably measuring gastric and small intestinal motility. The aim of the current study was to determine if 3D-MAGMA is able to detect changes in intestinal motility in people with type 2 diabetes. 18 healthy volunteers and 19 people with type 2 diabetes underwent motility testing by 3D-MAGMA. In the control group the retention time in the stomach was 33.0 [min] compared to 75.3 [min] in the diabetes group. The median time in the duodenum was 12.7 [min] compared to 8.1 [min]. The time for the first 50 cm of the jejunum was 29.9 [min] compared to 28.2 [min]. Discussion and conclusion: 3D-MAGMA is able to detect changes in intestinal motility. Its clinical value might be useful in patients with fluctuating blood glucose levels and unexplained hypoglycemic episodes.

Progression of Diabetic Complications in Subgroups of People with Long Term Diabetes Type 1 According to Clinical Course.

AIMS: Prevention and prediction of microvascular complications are important aims of medical care in people with type 1 diabetes. Since the course of the disease is heterogenous, we tried to identify subgroups with specific risk profiles for microvascular complications. METHODS: Retrospective analysis of a cohort of 285 people (22637 consultations) with >10 years of type 1 diabetes. Persons were grouped into slow (<15 years), fast (>15 years) and non progressors according to the average onset of microvascular complications. Generalized estimating equations for binary outcomes were applied and pseudo coefficients of determination were calculated. RESULTS: Progression to microvascular disease was associated with age (OR: 1.034 [1.001-1.068]; p=0.04), diabetes duration (OR: 1.057 [1.021-1.094]; p=0.002), HbA1c (OR: 1.035 [1.011-1.060]; p=0.005), BMI (OR: 0.928 [0.866-0.994]; p=0.034) and the social strata index (OR: 0.910 [0.830-0.998]; p=0.046). Generalized estimating equations predicted 31.02% and exclusion of HbA1c marginally reduced the value to 28.88%. The proportion of patients with LADA was higher in fast than slow progressors [13 (26.5%) vs. 14 (11.9%); p=0.019]. A generalized estimating equation comparing slow to fast progressors revealed no significant markers. CONCLUSION: In our analysis, we were able to confirm known risk factors for microvascular disease in people with type 1 diabetes. Overall, prediction of individual risk was difficult, the effect of individual markers minor and we could not find differences regarding slow or fast progression. We therefore emphasis the need for additional markers to predict individual risk for microvascular disease.