Safety, efficacy and clinical generalization of the STAR protocol: a retrospective analysis

Stewart, Kent W.; Pretty, Christopher G.; Tomlinson, Hamish; Thomas, Felicity; Homlok, József; Noémi, Szabó Némedi; Illyés, Attila; Shaw, Geoffrey M.; Benyó, Balázs; Chase, J. Geoffrey

doi:10.1186/s13613-016-0125-9

Cited by 104 publications

(129 citation statements)

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“…In this regard, model-based glycaemic control methods have recently shown good safety and performance [28][29][30][31][32][33]. Their main advantage is the use of a computer model to identify patient-specific insulin sensitivity (SI), which quantitatively describes patient response to insulin.…”

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confidence: 99%

Generalisability of a Virtual Trials Method for Glycaemic Control in Intensive Care

Dickson

Stewart

Pretty

et al. 2018

IEEE Trans. Biomed. Eng.

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Abstract-Background: Elevated blood glucose (BG) concentrations (Hyperglycaemia) are a common complication in critically ill patients. Insulin therapy is commonly used to treat hyperglycaemia, but metabolic variability often results in poor BG control and low BG (hypoglycaemia). Objective: This paper presents a modelbased virtual trial method for glycaemic control protocol design, and evaluates its generalisability across different populations. Methods: Model-based insulin sensitivity (SI) was used to create virtual patients from clinical data from three different ICUs in New Zealand, Hungary, and Belgium. Glycaemic results from simulation of virtual patients under their original protocol (self-simulation) and protocols from other units (cross-simulation) were compared. Results: Differences were found between the three cohorts in median SI and inter-patient variability in SI. However, hour-to-hour intra-patient variability in SI was found to be consistent between cohorts. Self and crosssimulation results were found to have overall similarity and consistency, though results may differ in the first 24-48 hours due to different cohort starting BG and underlying SI. Conclusions and significance: Virtual patients and the virtual trial method were found to be generalisable across different ICUs. This virtual trial method is useful for in silico protocol design and testing, given an understanding of the underlying assumptions and limitations of this method.

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confidence: 99%

Generalisability of a Virtual Trials Method for Glycaemic Control in Intensive Care

Dickson

Stewart

Pretty

et al. 2018

IEEE Trans. Biomed. Eng.

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“…Now a retrospective analysis is published proving the safety and efficacy of the therapy, as well as showing similarities and differences between patient groups [120].…”

Section: Biomedical Engineering Labmentioning

confidence: 99%

BME VIK Annual Research Report on Electrical Engineering and Computer Science 2016

Charaf

Harsányi

Poppe

et al. 2017

Period. Polytech. Elec. Eng. Comp. Sci.

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Preface Since being established in 1949, the Faculty of Electrical Engineering and Informatics (VIK) BME has played a flagship role in the development of electronics, IT and computer science in Hungary.We László Jakab (dean, BME VIK) János Levendovszky (vice-dean in charge of scientific affairs, BME VIK) are proud of combining engineering applications with sound scientific results, which is the assurance of high-level industrial collaboration leading to novel results and innovation. The various collaborations with our industrial partners has made it clear that the industry expects methods and results which make their industrial processes more effective and increase productivity and quality. Thus, participation in these collaborations give a competitive edge and ensure the continuous development of VIK. These factors have positioned our Department of Automation and Applied InformaticsDepartment of Automation and Applied Informatics (AUT) is one of the largest and dynamically developing departments at BME with diverse scope competences such as control theory, embedded systems, software modelling, applied software development, Internet of Things, power electronics, mechatronics, and many others. The department's main activities are education, research and development. Training versatile electrical and software engineers with solid practical knowledge is our top priority. Our profile also includes developing high quality software and hardware solutions for industry partners. All of our activities are backed by strong research background.In 2016, the department organized and hosted a number of domestic and international events. In cooperation with the industry, AUT has organized the IoT4U conference. It was dedicated to Internet of Things, cloud and data management as well as the integration of IoT into various formats. RobonAUT, the yearly domestic amateur robotics contest was organized by the department in February 2016. The yearly contest is open to teams of students, organized either in student projects within the department or independent research teams.The next sections summarize the key research results of the department in year 2016. Software Development Methods and Mobile PlatformsThe diversity of mobile platforms necessitates the development of the same mobile application for all major mobile platforms, what requires considerable development effort. Mobile application developers are multiplatform developers, but they still prioritize the platforms, therefore, not all platforms are equally important for them. Appropriate methods, processes and tools are required to support the development in order to achieve better productivity.The research on educational mobile applications that adapt to the mental state of the user required a method for estimating the difficulty of tasks found in the serious games. There are generated or random assignments where the effort required from the user is not known or cannot be estimated in advance.61 (2) IoT and Smart CityThe Internet of Things (IoT) is transforming the surroun...

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“…Insulin is administered as boluses and enteral nutrition is modulated between 30-100% goal feed (Fisk et al, 2012), although actual delivery averaged ~90% of goal feed of ~2000kcal/day for the average individual (Stewart et al, 2016).…”

Section: Nice-sugar and Star Protocolsmentioning

confidence: 99%

“…In these 443 patients, gaps were removed and only patients that had an initial BG > 7 mmol/L (125 mg/dL) were included (Stewart et al, 2016).…”

Section: Virtual Patientsmentioning

confidence: 99%

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Virtual Trials of the NICE-SUGAR Protocol: The Impact on Performance of Protocol and Protocol Compliance

et al. 2017

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Hypoglycaemia, hyperglycaemia and blood glucose (BG) variability are associated with worsened outcomes in critical care. However, NICE-SUGAR trial showed no clinical benefit from intensive insulin therapy. This study compares the table-based NICE-SUGAR and model-based STAR protocols to assess their relative capability to achieve safe, effective control for all patients. Validated virtual patients (n=443) were used to simulate glycaemic outcomes of the NICE-SUGAR and STAR protocols. Key outcomes evaluate tightness and safety of control for all patients: %BG in 80-144 mg/dL range (PTR); PerPatient Mean BG (PPM_BG); and Incidence of Hypoglycaemia (BG<40 mg/dL). These metrics determine performance overall, for each patient, and safety. Results are assessed for NICE-SUGAR measuring perprotocol (~24/day) and at reported average rate (~3-hourly; ~8/day). STAR measures 1-3-hourly, averaging 12/day. Glycaemic control protocols need to be both safe and effective for all patients before potential clinical benefits can be assessed. NICE-SUGAR clinical results do not match results expected from their protocol, and show reduced safety and performance in comparison to STAR.

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Safety, efficacy and clinical generalization of the STAR protocol: a retrospective analysis

Cited by 104 publications

References 50 publications

Generalisability of a Virtual Trials Method for Glycaemic Control in Intensive Care

Generalisability of a Virtual Trials Method for Glycaemic Control in Intensive Care

BME VIK Annual Research Report on Electrical Engineering and Computer Science 2016

Virtual Trials of the NICE-SUGAR Protocol: The Impact on Performance of Protocol and Protocol Compliance

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