Aim: Analyse the effects of professional flash glucose monitoring system (FreeStyle Libre Pro™) on glycaemic control in insulin-treated type 2 diabetes. Methods: Primary (n = 17) and secondary care centres (n = 5) randomised 148 type 2 diabetes patients into three groups: (A) self-monitoring of blood glucose (n = 52), (B) self-monitoring of blood glucose and two Libre Pro sensor wears (n = 46) or (C) self-monitoring of blood glucose and four sensor wears (n = 50). Primary endpoint was time in range (glucose 3.9–10 mmol/L) within group C comparing baseline with days 172–187. Predefined secondary endpoints included HbA1c, hypoglycaemia and quality of life measures analysed within and between groups (clinicaltrials.gov, NCT02434315). Results: In group C, time in range in the first 14 days (baseline) and days 172–187 was similar at 15.0 ± 5.0 and 14.1 ± 4.7 h/day (mean ± SD), respectively, (p = 0.1589). In contrast, HbA1c reduced from baseline to study end within group C by 4.9 ± 8.8 mmol/mol (0.44% ± 0.81%; p = 0.0003). HbA1c was also lower in group C compared with A at study end by 5.4 ± 1.79 mmol/mol (0.48% ± 0.16%; p = 0.0041, adjusted mean ± SE), without increased time in hypoglycaemia ( p = 0.1795). Treatment satisfaction scores improved in group C compared with A ( p = 0.0225) and no device-related serious adverse events were reported. Conclusions: Libre Pro can improve HbA1c and treatment satisfaction without increasing hypoglycaemic exposure in insulin-treated type 2 diabetes individuals managed in primary/secondary care centres.
The definition of risk in surgical patients is a complex and controversial area. Generally risk is poorly understood and depends on past individual and professional perception, and societal norms. In medical use the situation is further complicated by practical considerations of the ease with which risk can be measured; and this seems to have driven much risk assessment work, with a focus on objective measurements of cardiac function. The usefulness of risk assessment and the definition of risk is however in doubt because there are very few studies that have materially altered patient outcome based on information gained by risk assessment. This paper discusses these issues, highlights areas where more research could usefully be performed, and by defining limits for high surgical risk, suggests a practical approach to the assessment of risk using risk assessment tools.
Due to the increasing demand for natural gas in many locations, there is often a need to increase the capacity of existing and future gas transmission pipeline networks. In some situations, there may be a possibility of increasing the operating pressure (e.g. uprating), but in others there may be no alternative but to lay new pipelines, often along the same route as an existing pipeline. If one pipeline fails in this situation, it is possible that a second parallel pipeline may also fail as a result. However, there is also increasing pressure on the use of land and therefore the minimum separations with which pipelines may be laid and operated safely when in parallel to other pipelines need to be considered. This paper describes work carried out as a collaborative project supported by gas transmission pipeline operators to provide guidance on the likelihood of failure of a pipeline, for a range of different conditions, following failure of an adjacent pipeline. A framework has been developed that identifies the sequence of events that could lead to failure of a parallel pipeline, including the possibility of escalation from a leak (or puncture) to a full bore rupture. Work has been carried out including large scale experiments and CFD (Computational Fluid Dynamics) modelling to enable the critical processes in the framework to be quantified. This methodology has been used to produce general guidelines for parallel pipeline assessments, in order to support the design of new parallel pipeline installations. The methodology has been developed specifically for parallel natural gas transmission pipelines. However, the principles are relevant to parallel pipelines transporting other substances, and consideration is given to how the methodology may be adapted for such circumstances. The methodology provides input to any risk assessments of parallel pipeline installations, to quantify the possible contribution to the failure frequency from escalation. General guidance developed using the methodology presented in this paper, has recently been included in the recommendations for steel transmission pipelines, IGEM/TD/1 (Edition 5), published by the Institution of Gas Engineers and Managers. However, where general recommendations are not achievable, the methodology may be applied to take site and pipeline-specific factors into account.
The United Kingdom Onshore Pipeline Operators Association (UKOPA) is developing supplements to the UK pipeline codes BSI PD 8010 and IGE/TD/1. These supplements will provide a standardized approach for the application of quantified risk assessment to pipelines. UKOPA has evaluated and recommended a methodology: this paper covers the background to, and justification of, this methodology. The most relevant damage mechanism which results in pipeline failure is external interference. Interference produces a gouge, dent or a dent-gouge. This paper describes the fracture mechanics model used to predict the probability failure of pipelines containing dent and gouge damage and contains predictions of failure frequency obtained using the gas industry failure frequency prediction methodologies FFREQ and operational failure data from the UKOPA fault database. The failure model and prediction methodology are explained and typical results are presented and discussed.
Background: Whole body hyperthermia induced by radiative systems has been used in therapy of malignant diseases for more than ten years. Von Ardenne and co-workers have developed the 'systemiche Krebs-Mehrschritt-Therapic' (sKMT), a combined regime including whole body hyperthermia of 42°C, induced hyperglycaemia and relative hyperoxaemia with additional application of chemotherapy. This concept has been employed in a phase I/II clinical study for patients with metastatic colorectal carcinoma at the Virchow-Klinikum since January 1997. Methods: The sKMT concept was performed eleven times under intravenous general anaesthesia, avoiding volatile anaesthetics. Core temperatures of up to 42°C were reached stepwise by warming with infrared-A-radiation (IRATHERM 2000®). During the whole procedure blood glucose levels of 380-450 mg/dl were maintained as well as PaO 2 levels above 200 mmHg. Extensive invasive monitoring was performed in all patients including measurements with the REF-Ox-Pulmonary artery catheter with continuous measuring of mixed venous saturation (Baxter Explorer®) and invasive monitoring of arterial blood pressure. Data for calculation of hemodynamic and gas exchange parameters were collected four times, at temperatures of 37°C, 40°C, 41.8-42°C and 39°C, during measurements FiO 2 was 1.0 at all times. Fluids were given in order to keep central-venous and Wedge pressure within normal range during the whole procedure. Statistics were performed using the Wilcoxon Test. Results: Statistically significant differences were found between heart rate, cardiac index and systemic vascular resistance comparing data at 37°C and 42°C. Heart rate and cardiac index increased to a maximum at 42°C (P < 0.0001) whereas systemic vascular resistance had its minimum at 42°C (P < 0.0001). Mean arterial pressure dropped with increasing temperature, differences were not significant. Calculation of stroke volume index and ventricular volumes showed only a slight decrease in endsystolic volumes with increasing temperature, the resulting differences in right ventricular ejection fraction were marginally significant (P = 0.038) comparing 42°C to baseline. Right ventricular stroke work index as well as mean pulmonary arterial pressure increased at 42°C (P = 0.0115 and P = 0.0037), pulmonary vascular resistance only dropped little compared to systemic vascular resistance, left ventricular stroke work index even dropped with increasing temperature, though showing no significant difference. Values for mixed venous oxygen saturation did not vary during therapy, pulmonary right-left shunt showed a temperature associated increase (P = 0.0323) to a maximum at 42°C. Conclusion: Under the procedure of sKMT cardiac function in patients, who do not have any pre-existing cardiac impairment, can be maintained almost unchanged, ie with normal right and left ventricular pressure, despite an increase in right ventricular stroke work Acknowledegment: Supported by Deutsche Krebshilfe.
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