Evaluating Diagnostic Ultrasound of the Vagus Nerve as a Surrogate Marker for Autonomic Neuropathy in Diabetic Patients.

Background and Objectives: Diagnostic ultrasound of the vagus nerve has been used to examine different polyneuropathies, and it has been suggested to be useful as a marker of autonomic dysfunction in diabetic patients. Materials and Methods: We analyzed the cross-sectional area (CSA) of the right vagus nerve of 111 patients with type 2 diabetes in comparison to 104 healthy adults and 41 patients with CIDP (chronic inflammatory demyelinating polyneuropathy). In the diabetes group, sympathetic skin response (SSR) was measured as an indicator for autonomic neuropathy. Carotid intima-media thickness (CIMT) was measured as a surrogate for atherosclerosis. Clinical symptoms of polyneuropathy were assessed using the Neuropathy Symptom Score and the Neuropathy Disability Score. Results: In total, 61.3% of the diabetes patients had clinical signs of polyneuropathy; 23.4% had no SSR at the feet as an indicator of autonomic neuropathy. Mean vagus nerve CSA did not differ in patients with and without diabetic polyneuropathy or in diabetic patients with and without SSR at the feet. No significant correlation was found between vagus nerve CSA and CIMT or SSR parameters in diabetic patients. Mean CSA of the right vagus nerve was slightly larger in diabetic patients (p = 0.028) and in patients with CIDP (p = 0.015) than in healthy controls. Conclusions: Effect sizes and mean differences were rather small so that a reliable diagnosis cannot be performed based on the vagus nerve measurement of a single person alone. Vagus nerve CSA seems not suitable as an indicator of autonomic dysfunction or cardiovascular risk in diabetic patients.

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.

A retrospective study on the incidence and risk factors of severe hypoglycemia in primary care.

AIMS: To investigate the incidence and risk factors of severe hypoglycemia (SH) in primary care. SH was defined as hypoglycemia with coma, or the need of glucose or glucagon injection. METHODS: We performed a cross-sectional retrospective study in patients with diabetes treated in primary care in Germany. We analyzed an unselected sample of participants with type 1 (n = 373) and type 2 diabetes (n = 4481) who participated in an insurance plan from the health care insurer Deutsche BKK. Data of participants with type 1 diabetes are as follows: women, n = 155 (42%); age, 49±16 years; diabetes duration, 20+13 years; BMI, 28±6 kg/m2; GHb, 7.1+1.5%; GHb≤7%, n = 263 (71%); GHb≥8.5%, n = 48 (13%). Data of participants with type 2 diabetes: women, n = 1979 (44%); age, 66±10 years; diabetes duration, 8±7 years; BMI, 30±5 kg/m2; GHb, 6.6±1.3%; GHb≤7%, n = 3747 (84%); GHb≥8.5%, n = 360 (8%); insulin therapy, n = 1175 (26%). RESULTS: The incidence of SH in type 1 diabetes: 1.3% (CI: 0.4%, 3.1%) per year; type 2 diabetes with insulin therapy: 0.9% (CI: 0.5%, 1.7%); without insulin therapy: 0.3% (CI: 0.1%, 0.6%). The event rate was 0.02 SH per patient/year in type 1 diabetes and 0.01 in type 2 diabetes, respectively. Low BMI, GHb, insulin therapy and female gender were associated with an increased risk of SH. CONCLUSIONS: In primary care, patients with diabetes can achieve good glycemic control with very rare events of SH. Due to low incidence, SH would have been an inappropriate parameter to evaluate the outcome quality of diabetes therapy in primary care.

Nephroprotective Properties of Antidiabetic Drugs.

Chronic kidney disease (CKD) is associated with increased morbidity and mortality, especially from cardiovascular (CV) causes, and especially in people with diabetes mellitus (DM). Already the presence of DM increases CV risk and potentiates the risk of CKD. Therefore, besides glycemic control, prevention and treatment of CKD to slow its progression are of clinical importance. A significant nephroprotective effect of novel antidiabetic drugs, namely sodium-glucose cotransporter 2 inhibitors (SGLT2-I) and glucagon-like peptide 1 receptor agonists (GLP1-RA), has been shown on top of their glucose-lowering effects and was confirmed in cardiovascular outcome trials. GLP1-RA mainly reduced the risk of macroalbuminuria, whereas SGLT2-I were also associated with a lower risk of declining glomerular filtration rate (GFR) over time. The nephroprotective effects of SGLT2-I are also evident in people without DM. According to current guidelines, SGLT2-I and/or GLP1-RA are recommended for people with DM who have chronic kidney disease and/or increased cardiovascular risk. However, other antidiabetic drugs offer nephroprotective properties, which will also be discussed in this review.

Assessing fear of complications in people with type 1 and type 2 diabetes with the Fear of Diabetes Complications Questionnaire.

OBJECTIVE: Fear of diabetes complications (FDC) is a common source of emotional distress in people with diabetes across types and treatments and may affect health outcomes. To assess FDC, the Fear of Diabetes Complications Questionnaire (FDCQ) was developed. This study evaluates the FDCQ's German version in people with type 1 diabetes (T1D) and type 2 diabetes (T2D). METHOD: A German version of the FDCQ was developed and administered as part of four different studies sampling people with T1D and T2D. Measurement properties were evaluated across studies using factor analyses, reliability estimates, and associations of the measure within a network of variables. A cutoff criterion for elevated FDC was derived. A short form scale was also developed. RESULTS: High reliability and validity were supported. FDC as measured by the FDCQ was independently associated with higher diabetes distress and depressive symptoms. A cut-off score for elevated FDC was set at ≥30 in the 15-item FDCQ. Elevated FDCQ scores were detected in 36% of participants in secondary diabetes care and up to 46% of those in tertiary care. CONCLUSIONS: FDC is prevalent in people with T1D and T2D and associated with diabetes distress and depressive symptoms. The FDCQ is a reliable and valid tool for assessing FDC in research and practice. It may help identify persons in need of tailored education and care and monitor effects following treatment. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Metabolic Control, Diabetic Complications and Drug Therapy in a Cohort of Patients with Type 1 and Type 2 Diabetes in Secondary and Tertiary Care between 2004 and 2019.

This paper studies the features of metabolic parameters, diabetic complications and drug therapy of a single-centre cohort of patients with type 1 diabetes (T1DM) or type 2 diabetes (T2DM) in secondary care and tertiary care over a 15-year period. METHODS: Retrospective cross-sectional analysis of four single-centre cohorts between 2004 and 2019. All patients with T1DM or T2DM in secondary care (n = 5571) or tertiary care (n = 2001) were included. Statistical analyses were performed using linear mixed models. RESULTS: Diabetes duration increased in both patients with T1DM and T2DM in secondary care and tertiary care (p < 0.001). Patients in secondary care consistently showed good glycaemic control, while patients in tertiary care showed inadequate glycaemic control. All four cross-sectional cohorts showed a significant increase in the prevalence of nephropathy over time and three out of four cohorts (T1DM and T2DM in secondary care and T2DM in tertiary care) showed an increase in the prevalence of neuropathy (all p < 0.001). The incidence of severe hypoglycaemia was consistently low. The use of insulin pumps and insulin analogues in the therapy of T1DM increased significantly. CONCLUSIONS: The increased prevalence of complications is likely due to older age and longer diabetes duration. Low rates of hypoglycaemia, lower limb amputations and good glycaemic control in secondary care patients indicate a good structure of patient care.

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.

Efficacy of DiaLife, an Education Program for Relatives of Adults with Diabetes - A Cluster Randomized Controlled Trial.

OBJECTIVE: Diabetes affects the lives of patients and their close relatives. Considering the proven benefit of patient education programs, DiaLife was elaborated as the first German education program addressing the needs of relatives. The objective of this study was to investigate its efficacy. METHODS: The evaluation was implemented in the form of a cRCT with longitudinal design and waiting list condition.In total, 179 relatives were recruited. Participants' diabetes-related knowledge was defined as the primary outcome. Diabetes-related strains, family interaction and other psychosocial factors were determined as secondary outcomes. RESULTS: A generalized estimating equation model showed a persistent increase of diabetes-related knowledge in the intervention group compared to the control group regardless of the type of diabetes. Concerning secondary outcomes, mixed linear models showed an improvement for relatives of people with type 2 diabetes who participated in the DiaLife program. CONCLUSION: This study provides evidence of DiaLife's efficacy regarding a persistent increase of diabetes-related knowledge and a positive effect on psychosocial outcomes in relatives of people with type 2 but not in type 1 diabetes. Adding (an)other psychosocial module(s) might improve their well-being and psychosocial outcomes. PRACTICE IMPLICATIONS: Diabetes centers should consider implementing an education program for relatives, such as DiaLife, in their curriculum. TRIAL REGISTRATION: The study was registered at the German Clinical Trials Register (DRKS00015157; date of registration: 24.08.2018).

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.

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.

Electrodiagnostic Testing and Nerve Ultrasound of the Carpal Tunnel in Patients with Type 2 Diabetes.

In diabetic patients, controversies still exist about the validity of electrodiagnostic and nerve ultrasound diagnosis for carpal tunnel syndrome (CTS). We analyzed 69 patients with type 2 diabetes. Nerve conduction studies and peripheral nerve ultrasound of the median nerve over the carpal tunnel were performed. CTS symptoms were assessed using the Boston Carpal Tunnel Questionnaire. Polyneuropathy was assessed using the Neuropathy Symptom Score and the Neuropathy Disability Score. Although 19 patients reported predominantly mild CTS symptoms, 37 patients met the electrophysiological diagnosis criteria for CTS, and six patients were classified as severe or extremely severe. The sonographic cross-sectional area (CSA) of the median nerve at the wrist was larger than 12 mm2 in 45 patients (65.2%), and the wrist-to-forearm-ratio was larger than 1.4 in 61 patients (88.4%). Receiver operating characteristic analysis showed that neither the distal motor latency, the median nerve CSA, nor the wrist-to-forearm-ratio could distinguish between patients with and without CTS symptoms. Diagnosis of CTS in diabetic patients should primarily be based upon typical clinical symptoms and signs. Results of electrodiagnostic testing and nerve ultrasound have to be interpreted with caution and additional factors have to be considered especially polyneuropathy, but also body mass index and hyperglycemia.

Prevalence of Impairment of Visual Acuity and Severity of Retinopathy in Patients with Diabetes Mellitus.

AIMS: No information exists on the frequency of visual impairment in people with diabetes mellitus (DM) in Germany. In this study, the prevalence of vision impairment in those individuals was investigated. METHODS: We retrospectively analyzed a cohort of 295 people (14221 consultations) at a university outpatient clinic with any type of DM and an available ETDRS-Score and visual acuity. The primary outcome was the prevalence of visual impairment, the secondary outcome was the correlation of the ETDRS-Score and limitations of visual acuity and the prevalence of higher ETDRS-Score with a visual impairment defined as a decimal-visus

Association between socioeconomic status and renal function in a population of German patients with diabetic nephropathy treated at a tertiary centre.

BACKGROUND: Diabetic nephropathy is the most common disease leading to end-stage renal disease (ESRD) in many countries including Germany. Some previous studies, mainly from the US, suggest that low socioeconomic status (SES) may increase the risk of ESRD. No data are available whether the SES influences the development of diabetic nephropathy in patients with diabetes mellitus in Germany. METHODS: This cross-sectional study was performed on patients treated at a large university outpatient department for endocrinology and metabolic diseases. A total of 174 patients with type 1 and 651 patients with type 2 diabetes and chronic preterminal diabetic nephropathy were studied [mainly chronic kidney disease (CKD) Stages 2 and 3]. Only very few CKD Stage 5 patients were included. Patients with acute kidney injury or abnormal urinary sediment were excluded. Patients were asked about their social status using a questionnaire. Social status was determined by three components: education, highest professional position achieved and household net income. Each component was assessed by a score with 1 to 7 points to generate a total score with a minimum of 3 up to maximum of 21 points. Smoking habits were also assessed by questionnaire. HbA1c, systolic and diastolic blood pressure and body mass index from the last observation were recorded. Estimated glomerular filtration rate (eGFR) was calculated according to the modified equation 7 MDRD formula. Patients were grouped into the CKD stages according to eGFR and presence of albuminuria. Multivariate analysis was used for data analysis. RESULTS: Patients were grouped in tertiles according to their social status (Tertile 1: 307, Tertile 2: 269, Tertile 3: 269 patients). The majority of type 1 (50.9%) and type 2 (64.9%) patients were in CKD Stages 2 and 3. Multivariate analysis revealed that SES is an independent predictor of renal function in all patients as well as in type 2 diabetic patients with diabetic nephropathy. This relationship was independent of smoking behaviour, duration of diabetes and HbA1c values. There was no association between renal function and SES in type 1 diabetic patients, but a type 2 error caused by low patient number cannot be excluded. Furthermore, no significant association between SES and albuminuria (defined ≥20 mg/L) existed. There was no significant difference in the number of visits to the clinic in regard to SES excluding referral bias. CONCLUSIONS: A lower SES was associated with the presence of diabetic nephropathy in patients with type 2 diabetes in a German population. The causes for this association are likely multiple.

Effectiveness and Safety of SGLT2 Inhibitors in Clinical Routine Treatment of Patients with Diabetes Mellitus Type 2.

The aim of this study was to investigate the effectiveness of SGLT2 inhibitors with regard to metabolic parameters and patient safety under routine ambulatory conditions. Retrospective longitudinal study of 95 patients with type 2 diabetes (diabetes duration 13.3 y; HbA1c 8.9%; eGFR 80.1 mL/min) receiving SGLT-2-inhibitors. Metabolic control and adverse event profile were evaluated. The mean follow-up time was 1.2 ± 0.8 years. The following changes were observed: HbA1c -1.0% ± 1.9 (p < 0.001), eGFR -7.0 mL/min ± 13.3 (p < 0.001), albuminuria -23.9 mg/g creatinine ± 144.5 (p = 0.118), bodyweight -3.0 kg ± 5.8 (p < 0.001), systolic blood pressure -6 mmHg ± 22 (p = 0.01), diastolic blood pressure -2 mmHg ± 14 (p = 0.243). 53 participants continuously applied the therapy. Twenty-eight participants discontinued SGLT-2-inhibitors due to various reasons: 20 participants because of genital- or urinary tract infections. One for dysuria, seven due to reduced eGFR below 45 mL/min. This study showed a considerable reduction of HbA1c and a modest reduction of eGFR, bodyweight and systolic blood pressure under clinical routine conditions. Genital infections occurred markedly more often than in randomized controlled trials. To apply SGLT-2-inhibitors more safely in clinical routine individual risks for genital and urinary tract infections should be considered and re-evaluated during therapy.

Reduction of Severe Hypoglycaemia in People with Type 2 Diabetes after a Structured Inpatient Intervention.

OBJECTIVE: The aim of this longitudinal study was to assess outcomes before and one year after participation in a structured inpatient intervention including participation in an education programme for people with type 2 diabetes. METHODS: In 2014, 81 individuals, who were admitted to optimise insulin therapy, participated in a structured inpatient intervention and were invited to participate in a follow-up visit after one year. RESULTS: Seventy participants (46.9% female, age 68.3 y, diabetes duration 17.9 y, HbA1c 9.7%/82.5 mmol/mol) were followed-up after 1.2 y (3 died by non-diabetic causes, 8 declined/were not available). HbA1c decreased by 1.1% (p<0.001) without change of insulin dose (79.7 vs. 79.3 IU, n.s.) or BMI (33.6 vs. 33.8 kg/m2, n.s.). 5 people admitted because of severe hypoglycaemia (one person with 5 episodes and 4 with one episode in the year prior to participation) did not experience another event in the evaluation period, nor did anyone in the rest of the cohort (frequency of severe hypoglycaemia 0.12 events/year before and 0.0 after intervention). CONCLUSIONS: In people admitted for optimising insulin therapy or severe hypoglycaemia, metabolic control improved substantially and frequency of severe hypoglycaemia was significantly reduced after participation in a structured inpatient intervention. Reasons could be motivational and better adapted eating habits, tailoring individual therapy solutions and deescalating diabetes therapy in people after severe hypoglycaemia.

Antidiabetic Therapy and Rate of Severe Hypoglycaemia in Patients with Type 2 Diabetes and Chronic Kidney Disease of Different Stages - A Follow-up Analysis of Health Insurance Data from Germany.

BACKGROUND: The presence of chronic kidney disease (CKD) influences the type of antiglycaemic therapy and the risk for hypoglycaemia. METHODS: In 2006, 2011 and 2016 health insurance data of people with diabetes type 2 were screened for CKD and the presence of severe hypoglycaemia (sHypo). The type of antihyperglycaemic therapy was recorded due to Anatomical Therapeutic Chemical (ATC) codes up to 3 months before suffering sHypo. RESULTS: The prevalence of CKD increased from 5.3% in 2006 to 7.3% in 2011 and 11.2% in 2016. Insulin-based therapies were used in 39.0, 39.1, and 37.9% of patients with, but only in 17.7, 17.4, and 18.8% of patients without CKD. Although the proportion of the CKD stages 1, 2 and 5 decreased, CKD stages 3 and 4 increased. The proportion of sHypo in CKD declined from 2006 (3.5%) to 2011 (3.0%) and 2016 (2.2%) but was still more than 10 times higher as compared to type 2 diabetic patients without CKD (0.3/0.2/0.2%) conferring a significantly higher probability of sHypo (OR 9.30, 95%CI 9.07-9.54) in CKD. The probability of sHypo was significantly lower in 2016 than in 2006 both in patients with (OR 0.58; CI 0.55-0.61) and without CKD (OR 0.70; CI 0.68-0.73). CONCLUSION: The prevalence of CKD increased from 2006 to 2016. Patients with CKD exhibited a 9-fold increased probability of sHypo, especially in patients treated with insulin plus oral anti-diabetic drugs. However, the rate and risk for sHypo decreased over time, probably as a consequence of new antidiabetic treatment options, better awareness of sHypo, and changed therapy goals.

Adequate Structured Inpatient Diabetes Intervention in People With Type 1 Diabetes Improves Metabolic Control and Frequency of Hypoglycaemia.

OBJECTIVE: Several studies evaluated inpatient diabetes teaching and treatment programmes (DTTP) in diabetes type 1 (DM1) many years ago, but in these studies insulin treatment was not yet intensified before the DTTP. Today, most patients are already on intensified insulin treatment before entering a DTTP. The aim of this trial was to evaluate the outcome one year after participation in an inpatient intervention including a DTTP in a longitudinal study. METHODS: 109 patients participated in an inpatient intervention in 2014. All individuals were invited to participate in an outpatient follow-up visit after one year. RESULTS: Ninety participants (52.2% female, age 48.0 y, diabetes duration 19.1 y, 31.1% CSII, HbA1c 7.9% / 63.3 mmol/mol) were followed-up after 1.2±0.3 y [1 died, 18 declined / were not available]. 83 / 90 individuals participated to optimise diabetes therapy, 7 / 90 had newly-diagnosed DM1. In the optimisation group, HbA1c decreased by 0.4% (p=0.009) without change of insulin dose (54 IU/day before and after) or BMI (26 kg/m2 before and after). In people with baseline HbA1c ≥7.5% (n=26 / 83), HbA1c decreased by 0.9%. The frequency of severe hypoglycaemia decreased from 0.22 to 0.05 events / year (p=0.045). In people with frequent non severe hypoglycaemia (n=8), events decreased from 4.5±2.0 to 2.8±0.9 / week (p=0.358). Systolic (-6.5 mmHg, p=0.035) and diastolic (-3.4 mmHg, p=0.003) blood pressure improved without change of number of antihypertensive medication (1.9±2.1 vs. 1.8±2.0, p=0.288). CONCLUSIONS: In people with DM1, metabolic control improved after the inpatient intervention without increasing insulin dosage or BMI. The inpatient intervention remains effective to substantially improve metabolic control under the present circumstances of care.

Diabetic foot syndrome and renal function in type 1 and 2 diabetes mellitus show close association.

BACKGROUND: Diabetic nephropathy and diabetic foot syndrome (DFS) are two major complications of diabetes. Surprisingly, little is known of a potential relationship between renal function and the development of DFS in patients with preterminal renal insufficiency. A retrospective cohort study at a single tertiary university centre caring for a large collective of patients with type 1 and 2 diabetes was performed. Patients and methods. All patients with type 1 or 2 diabetes from 1989 to 2007 on the electronic patient sheet who had standardized food examination, albuminuria and serum creatinine were analysed. A total number of 899 patients with type 1 and 4007 individuals with type 2 diabetes were studied. Estimated glomerular filtration rate (eGFR) was calculated according to the modified equation 7 MDRD formula. Patients were grouped into the chronic kidney disease (CKD) stages according to the eGFR and presence of albuminuria. DFS was classified according to Wagner as well as Armstrong stages. RESULTS: Forty-six patients (5.1%) of 899 patients with type 1 diabetes have active or a history of DFS. Patients with type 1 diabetes and DSF had significantly higher serum creatinine levels, lower eGFR, higher systolic blood pressure and higher HbA1c levels compared to those without DFS. There was a significant negative correlation between eGFR and the presence of DFS in patients with type 1 diabetes (r = -0.155, P < 0.01). In type 1 diabetes patients, there was a significant negative correlation (Spearman test) between eGFR and Wagner stages (r = -0.218, P = 0.01) as well as Armstrong stages (r = -0.255, P = 0.01). Multiple logistic regression analysis revealed a significant association between the presence of DFS and eGFR (odds ratio 0.696 per 10 ml/min increase, 95% confidence interval 0.627-0.773, P < 0.001). A total of 532 type 2 patients from 4007 patients had DFS (13.7%). Compared with type 2 patients without DFS, those with DFS were significantly older (P < 0.005), exhibited a higher HbA1c, had a longer duration of diabetes (P < 0.005), higher serum creatinine levels (P < 0.005) and a lower eGFR (P < 0.005). There was a significant negative correlation between the Wagner stages and eGFR (r = -0.104, P < 0.01) as well as Armstrong stages and eGFR (r = -0.125, P < 0.01) in all patients with type 2 diabetes (Spearman test). Multiple logistic regression analysis revealed a significant association between the presence of DFS and eGFR (odds ratio 0.873 per 10 ml/min increase, 95% confidence interval 0.842-0.904, P < 0.001). There were also significant associations between DFS and duration of diabetes as well as diastolic blood pressure. In addition, the Jonckheere-Terpstra test confirmed the decrease of eGFR with increasing Wagner and Armstrong stages in patients with type 2 diabetes. Smoking was not associated with a higher prevalence of DFS in type 1 and 2 diabetic patients. CONCLUSION: There was a strong association between the degree of renal function impairment and DFS in this observational study. Data show that diabetics with DFS undergo a higher incidence of amputation; thus, it should be recommended that diabetic patients with renal insufficiency should be regularly screened for the presence of DFS.