Summary Background The relative safety of drug-eluting stents and bare-metal stents, especially with respect to stent thrombosis, continues to be debated. In view of the overall low frequency of ...stent thrombosis, large sample sizes are needed to accurately estimate treatment differences between stents. We compared the risk of thrombosis between bare-metal and drug-eluting stents. Methods For this network meta-analysis, randomised controlled trials comparing different drug-eluting stents or drug-eluting with bare-metal stents currently approved in the USA were identified through Medline, Embase, Cochrane databases, and proceedings of international meetings. Information about study design, inclusion and exclusion criteria, sample characteristics, and clinical outcomes was extracted. Findings 49 trials including 50 844 patients randomly assigned to treatment groups were analysed. 1-year definite stent thrombosis was significantly lower with cobalt-chromium everolimus eluting stents (CoCr-EES) than with bare-metal stents (odds ratio OR 0·23, 95% CI 0·13–0·41). The significant difference in stent thrombosis between CoCr-EES and bare-metal stents was evident as early as 30 days (OR 0·21, 95% CI 0·11–0·42) and was also significant between 31 days and 1 year (OR 0·27, 95% CI 0·08–0·74). CoCr-EES were also associated with significantly lower rates of 1-year definite stent thrombosis compared with paclitaxel-eluting stents (OR 0·28, 95% CI 0·16–0·48), permanent polymer-based sirolimus-eluting stents (OR 0·41, 95% CI 0·24–0·70), phosphorylcholine-based zotarolimus-eluting stents (OR 0·21, 95% CI 0·10–0·44), and Resolute zotarolimus-eluting stents (OR 0·14, 95% CI 0·03–0·47). At 2-year follow-up, CoCr-EES were still associated with significantly lower rates of definite stent thrombosis than were bare-metal (OR 0·35, 95% CI 0·17–0·69) and paclitaxel-eluting stents (OR 0·34, 95% CI 0·19–0·62). No other drug-eluting stent had lower definite thrombosis rates compared with bare-metal stents at 2-year follow-up. Interpretation In randomised studies completed to date, CoCr-EES has the lowest rate of stent thrombosis within 2 years of implantation. The finding that CoCr-EES also reduced stent thrombosis compared with bare-metal stents, if confirmed in future randomised trials, represents a paradigm shift. Funding The Cardiovascular Research Foundation.
Physical exercise is an important component in the management of type 1 diabetes across the lifespan. Yet, acute exercise increases the risk of dysglycaemia, and the direction of glycaemic excursions ...depends, to some extent, on the intensity and duration of the type of exercise. Understandably, fear of hypoglycaemia is one of the strongest barriers to incorporating exercise into daily life. Risk of hypoglycaemia during and after exercise can be lowered when insulin-dose adjustments are made and/or additional carbohydrates are consumed. Glycaemic management during exercise has been made easier with continuous glucose monitoring (CGM) and intermittently scanned continuous glucose monitoring (isCGM) systems; however, because of the complexity of CGM and isCGM systems, both individuals with type 1 diabetes and their healthcare professionals may struggle with the interpretation of given information to maximise the technological potential for effective use around exercise (i.e. before, during and after). This position statement highlights the recent advancements in CGM and isCGM technology, with a focus on the evidence base for their efficacy to sense glucose around exercise and adaptations in the use of these emerging tools, and updates the guidance for exercise in adults, children and adolescents with type 1 diabetes.
Graphical abstract
Regular exercise is important for health, fitness and longevity in people living with type 1 diabetes, and many individuals seek to train and compete while living with the condition. Muscle, liver ...and glycogen metabolism can be normal in athletes with diabetes with good overall glucose management, and exercise performance can be facilitated by modifications to insulin dose and nutrition. However, maintaining normal glucose levels during training, travel and competition can be a major challenge for athletes living with type 1 diabetes. Some athletes have low-to-moderate levels of carbohydrate intake during training and rest days but tend to benefit, from both a glucose and performance perspective, from high rates of carbohydrate feeding during long-distance events. This review highlights the unique metabolic responses to various types of exercise in athletes living with type 1 diabetes.
Graphical abstract
Micro- and macrovascular complications are a major burden for individuals with diabetes and can already arise in a prediabetic state. To allocate effective treatments and to possibly prevent these ...complications, identification of those at risk is essential.
This study aimed to build machine learning (ML) models that predict the risk of developing a micro- or macrovascular complication in individuals with prediabetes or diabetes.
In this study, we used electronic health records from Israel that contain information about demographics, biomarkers, medications, and disease codes; span from 2003 to 2013; and were queried to identify individuals with prediabetes or diabetes in 2008. Subsequently, we aimed to predict which of these individuals developed a micro- or macrovascular complication within the next 5 years. We included 3 microvascular complications: retinopathy, nephropathy, and neuropathy. In addition, we considered 3 macrovascular complications: peripheral vascular disease (PVD), cerebrovascular disease (CeVD), and cardiovascular disease (CVD). Complications were identified via disease codes, and, for nephropathy, the estimated glomerular filtration rate and albuminuria were considered additionally. Inclusion criteria were complete information on age and sex and on disease codes (or measurements of estimated glomerular filtration rate and albuminuria for nephropathy) until 2013 to account for patient dropout. Exclusion criteria for predicting a complication were diagnosis of this specific complication before or in 2008. In total, 105 predictors from demographics, biomarkers, medications, and disease codes were used to build the ML models. We compared 2 ML models: logistic regression and gradient-boosted decision trees (GBDTs). To explain the predictions of the GBDTs, we calculated Shapley additive explanations values.
Overall, 13,904 and 4259 individuals with prediabetes and diabetes, respectively, were identified in our underlying data set. For individuals with prediabetes, the areas under the receiver operating characteristic curve for logistic regression and GBDTs were, respectively, 0.657 and 0.681 (retinopathy), 0.807 and 0.815 (nephropathy), 0.727 and 0.706 (neuropathy), 0.730 and 0.727 (PVD), 0.687 and 0.693 (CeVD), and 0.707 and 0.705 (CVD); for individuals with diabetes, the areas under the receiver operating characteristic curve were, respectively, 0.673 and 0.726 (retinopathy), 0.763 and 0.775 (nephropathy), 0.745 and 0.771 (neuropathy), 0.698 and 0.715 (PVD), 0.651 and 0.646 (CeVD), and 0.686 and 0.680 (CVD). Overall, the prediction performance is comparable for logistic regression and GBDTs. The Shapley additive explanations values showed that increased levels of blood glucose, glycated hemoglobin, and serum creatinine are risk factors for microvascular complications. Age and hypertension were associated with an elevated risk for macrovascular complications.
Our ML models allow for an identification of individuals with prediabetes or diabetes who are at increased risk of developing micro- or macrovascular complications. The prediction performance varied across complications and target populations but was in an acceptable range for most prediction tasks.
Context:
The polyuria-polydipsia syndrome comprises primary polydipsia (PP) and central and nephrogenic diabetes insipidus (DI). Correctly discriminating these entities is mandatory, given that ...inadequate treatment causes serious complications. The diagnostic “gold standard” is the water deprivation test with assessment of arginine vasopressin (AVP) activity. However, test interpretation and AVP measurement are challenging.
Objective:
The objective was to evaluate the accuracy of copeptin, a stable peptide stoichiometrically cosecreted with AVP, in the differential diagnosis of polyuria-polydipsia syndrome.
Design, Setting, and Patients:
This was a prospective multicenter observational cohort study from four Swiss or German tertiary referral centers of adults >18 years old with the history of polyuria and polydipsia.
Measurements:
A standardized combined water deprivation/3% saline infusion test was performed and terminated when serum sodium exceeded 147 mmol/L. Circulating copeptin and AVP levels were measured regularly throughout the test. Final diagnosis was based on the water deprivation/saline infusion test results, clinical information, and the treatment response.
Results:
Fifty-five patients were enrolled (11 with complete central DI, 16 with partial central DI, 18 with PP, and 10 with nephrogenic DI). Without prior thirsting, a single baseline copeptin level >21.4 pmol/L differentiated nephrogenic DI from other etiologies with a 100% sensitivity and specificity, rendering a water deprivation testing unnecessary in such cases. A stimulated copeptin >4.9 pmol/L (at sodium levels >147 mmol/L) differentiated between patients with PP and patients with partial central DI with a 94.0% specificity and a 94.4% sensitivity. A stimulated AVP >1.8 pg/mL differentiated between the same categories with a 93.0% specificity and a 83.0% sensitivity.
Limitation:
This study was limited by incorporation bias from including AVP levels as a diagnostic criterion.
Conclusion:
Copeptin is a promising new tool in the differential diagnosis of the polyuria-polydipsia syndrome, and a valid surrogate marker for AVP.
Primary Funding Sources:
Swiss National Science Foundation, University of Basel.
In recent years, several treatment modalities have proved to be effective in the treatment of neuroendocrine tumours (NETs). However, there is currently no consensus on the sequence in which these ...options are best used.
In this observational study, we analysed the treatment modalities and sequences of all patients included in the Swiss NeuroEndocrine Tumour registry (SwissNET). SwissNET is a national registry, which has prospectively included patients with a NET from all regions of Switzerland since 2008.
The registry includes 1366 patients; 1063 had documented therapies after the main diagnosis and were included in the analysis. The median follow-up time was 1.86 years. The most common primary site was the small intestine (291 patients, 27%) followed by pancreas (254 patients, 24%), lung (172 patients, 16%) and appendix (163 patients, 15%). A total of 167 different therapy sequences were observed. In 708 (67%) patients, surgery was the only treatment. The sequence of surgery followed by chemotherapy was most frequently documented in poorly (G3) differentiated (24 patients, 60%) and pancreatic (15 patients, 34%) NETs. Tumours treated with surgery followed by biotherapy or followed by peptide receptor radionuclide therapy (PRRT) were predominantly well-differentiated G1 NETs of the small intestine. In patients who were treated with either PRRT or systemic therapy (chemotherapy or molecular therapy) or both, PRRT was used more frequently than systemic therapy in patients with a small intestinal NET (35 patients, 62% vs 30, 54%), whereas the opposite held true in pancreatic (44 patients, 59% vs 56, 70%) and lung NETs (6 patients, 14% vs 40, 97%). If both chemotherapy and molecular therapy were used, chemotherapy was applied prior to molecular therapy in 13 of 19 (68%) patients with a pancreatic NET.
Surgery represents the treatment of choice in most patients with a NET irrespective of tumour stage. In patients receiving additional treatment, an impressive variety of treatment sequences were documented. In small intestinal NETs, patients received PRRT more often than chemotherapy, whereas the opposite holds true for patients with pancreatic and lung NETs.
To assess glucose levels in adults with diabetes at a Swiss tertiary hospital when transitioning from insulin delivery with a sensor-augmented pump with (predictive) low-glucose suspend (PLGS) to a ...hybrid-closed loop (HCL) and from a HCL to an advanced hybrid-closed loop (AHCL).
Continuous glucose monitoring data for 44 adults with type 1 diabetes transitioning from (P)LGS to hybrid-closed loop and from hybrid-closed loop to advanced hybrid-closed loop were analysed, including the percentage of time spent within, below, and above glucose ranges. In addition, a subgroup analysis (n = 14) of individuals undergoing both transitions was performed.
The transition from a (P)LGS to a hybrid-closed loop was associated with increased time in range (6.6% 2.6%-12.7%, p <0.001) and decreased time above range (5.6% 2.3%-12.7%, p <0.001). The transition from a hybrid-closed loop to an advanced hybrid-closed loop was associated with increased time in range (1.6% -0.5%-4.5%, p = 0.046) and decreased time above range (1.5% -1.8%-5.6%, p = 0.050). Both transitions did not change the time below range. In the subgroup analysis (PLGS → HCL → AHCL), the time in range increased from 69.4% (50.3%-79.2%) to 76.5% (65.3%-81.3%) and 78.7% (69.7%-85.8%), respectively (p <0.001).
Glucose levels significantly improved when transitioning from a (P)LGS to a hybrid-closed loop. Glucose levels improved further when switching from a hybrid-closed loop to an advanced hybrid-closed loop. However, the added benefit of an advanced hybrid-closed loop was comparably smaller. This pattern was also reflected in the subgroup analysis.
Background Exercise rehabilitation is highly recommended by current guidelines on prevention of cardiovascular disease, but its implementation is still poor. Many clinicians experience difficulties ...in prescribing exercise in the presence of different concomitant cardiovascular diseases and risk factors within the same patient. It was aimed to develop a digital training and decision support system for exercise prescription in cardiovascular disease patients in clinical practice: the European Association of Preventive Cardiology Exercise Prescription in Everyday Practice and Rehabilitative Training (EXPERT) tool. Methods EXPERT working group members were requested to define (a) diagnostic criteria for specific cardiovascular diseases, cardiovascular disease risk factors, and other chronic non-cardiovascular conditions, (b) primary goals of exercise intervention, (c) disease-specific prescription of exercise training (intensity, frequency, volume, type, session and programme duration), and (d) exercise training safety advices. The impact of exercise tolerance, common cardiovascular medications and adverse events during exercise testing were further taken into account for optimized exercise prescription. Results Exercise training recommendations and safety advices were formulated for 10 cardiovascular diseases, five cardiovascular disease risk factors (type 1 and 2 diabetes, obesity, hypertension, hypercholesterolaemia), and three common chronic non-cardiovascular conditions (lung and renal failure and sarcopaenia), but also accounted for baseline exercise tolerance, common cardiovascular medications and occurrence of adverse events during exercise testing. An algorithm, supported by an interactive tool, was constructed based on these data. This training and decision support system automatically provides an exercise prescription according to the variables provided. Conclusion This digital training and decision support system may contribute in overcoming barriers in exercise implementation in common cardiovascular diseases.
Introduction
The COVID‐19 pandemic has forced rapid reconsideration as to the way in which health care is delivered. One potential means to provide care while avoiding unnecessary person‐to‐person ...contact is to offer remote services (telemedicine). This study aimed to (1) gather real‐time information on the use and perception of telemedicine in people living with type 1 diabetes and (2) assess the challenges, such as restricted access to health care and/or medical supplies.
Methods
An anonymous questionnaire was widely distributed between 24 March and 5 May 2020 using an open‐access web‐based platform. Data were analysed descriptively, and results were stratified according to age, sex and HbA1c.
Results
There were 7477 survey responses from individuals in 89 countries. Globally, 30% reported that the pandemic had affected their healthcare access due to cancelled physical appointments with their healthcare providers. Thirty‐two per cent reported no fundamental change in their medical follow‐up during this period, with 9% stating that no personal contact was established with their doctors over the duration of the study. Twenty‐eight per cent received remote care through telephone (72%) or video‐calls (28%). Of these, 86% found remote appointments useful and 75% plan to have remote appointments in the future. Glucose control, indicated by HbA1c, was positively associated with positive perception of telemedicine. In males, 45% of respondents with an HbA1c > 9% rated telemedicine not useful compared to those with lower HbA1c, while 20% of females with an HbA1c > 9% rated it not useful (χ2 = 14.2, P = .0016).
Conclusion
Remote appointments have largely been perceived as positive in people with type 1 diabetes with the majority (75%) stating that they would consider remote appointments beyond the pandemic. Age and level of education do not appear to influence perception of telemedicine, whereas poor glucose control, particularly in males, seems to negatively affect perception.
This study aimed to gather information on the use and perception of telemedicine in people living with type 1 diabetes during the COVID‐19 pandemic. An anonymous questionnaire was widely distributed. Data were analysed descriptively and the mean population responses were summarised and stratified based on country, age, sex, health status and HbA1c. Age and level of education do not appear to influence perception of telemedicine, whereas poor glucose control, particularly in males, seems to negatively affect perception.
IntroductionMedical devices, including high-risk medical devices, have greatly contributed to recent improvements in the management of diabetes. However, the clinical evidence that is submitted for ...regulatory approval is not transparent, and thus a comprehensive summary of the evidence for high-risk devices approved for managing diabetes in Europe is lacking. In the framework of the Coordinating Research and Evidence for Medical Devices group, we will, therefore, perform a systematic review and meta-analysis, which will evaluate the efficacy, safety and usability of high-risk medical devices for the management of diabetes.Method and analysisThis study has been reported according to the guidelines of the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. We will search Embase (Elsevier), Medline All (Ovid), Cochrane Library (Wiley), Science Citation Index Expanded and Emerging Sources Citation Index (Web of Science) to identify interventional and observational studies that evaluate the efficacy and/or safety and/or usability of high-risk medical devices for the management of diabetes. No language or publication dates’ limits will be applied. Animal studies will be excluded. In accordance with the Medical Device Regulation in European Union, high-risk medical devices are those in classes IIb and III. The following medical devices for diabetes management are considered as having a high risk: implantable continuous glucose monitoring systems, implantable pumps and automated insulin delivery devices. Selection of studies, data extraction and quality of evidence assessment will be performed independently by two researchers. Sensitivity analysis will be performed to identify and explain potential heterogeneity.Ethics and disseminationNo ethical approval is needed for this systematic review, as it is based in already published data. Our findings will be published in a peer-reviewed journal.PROSPERO registration numberCRD42022366871.
PDF
