Results of a multicenter prospective pivotal trial of the first inline continuous glucose monitor in critically ill patients

Bochicchio, Grant V.; Nasraway, Stan; Moore, Laura J.; Furnary, Anthony P.; Nohra, Eden; Bochicchio, Kelly

doi:10.1097/ta.0000000000001444

Cited by 22 publications

(18 citation statements)

References 19 publications

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“…In Europe, there are currently four CGM systems approved for intravenous use in hospitals: 1 ) GlucoClear by Edwards Lifesciences (Irvine, CA), 2 ) Glysure System by Glysure (Abingdon, U.K.), 3 ) Eirus by Maquet Getinge Group (Rastatt, Germany), and 4 ) OptiScanner 5000 by OptiScan (Hayward, CA); in addition, there is one CGM system approved for subcutaneous use in hospitals: Sentrino by Medtronic (Northridge, CA). Two CGM systems are FDA-approved for use in U.S. hospitals: GlucoScout (International Biomedical, Austin, TX) and recently the OptiScanner 5000 (83,90).…”

Section: Cgmmentioning

confidence: 99%

Diabetes Technology Update: Use of Insulin Pumps and Continuous Glucose Monitoring in the Hospital

2018

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The use of continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring (CGM) systems has gained wide acceptance in diabetes care. These devices have been demonstrated to be clinically valuable, improving glycemic control and reducing risks of hypoglycemia in ambulatory patients with type 1 diabetes and type 2 diabetes. Approximately 30–40% of patients with type 1 diabetes and an increasing number of insulin-requiring patients with type 2 diabetes are using pump and sensor technology. As the popularity of these devices increases, it becomes very likely that hospital health care providers will face the need to manage the inpatient care of patients under insulin pump therapy and CGM. The American Diabetes Association advocates allowing patients who are physically and mentally able to continue to use their pumps when hospitalized. Health care institutions must have clear policies and procedures to allow the patient to continue to receive CSII treatment to maximize safety and to comply with existing regulations related to self-management of medication. Randomized controlled trials are needed to determine whether CSII therapy and CGM systems in the hospital are associated with improved clinical outcomes compared with intermittent monitoring and conventional insulin treatment or with a favorable cost-benefit ratio.

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Section: Cgmmentioning

confidence: 99%

Diabetes Technology Update: Use of Insulin Pumps and Continuous Glucose Monitoring in the Hospital

2018

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“…Many of the devices reported in peer-reviewed literature (using different probe location sites and measurement techniques) fail to meet the mean absolute relative difference (MARD) point accuracy standard adopted by a previous consensus panel [ 54 ]. One exception is the Optiscanner® (OptiScan Biomedical Corporation, Hayward, CA, USA), which has been reported to have MARD < 10% [ 53 , 55 ], although other consensus requirements for CGM devices were not met or not reported. Importantly, comparisons, including MARD and Clark error grids, are based on evaluation of differences in values at a single time point, and do not take the trend factor into account.…”

Section: Moving Forward … and How To Keep The Industry On Board?mentioning

confidence: 99%

Continuous glucose monitoring in the ICU: clinical considerations and consensus

et al. 2017

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Glucose management in intensive care unit (ICU) patients has been a matter of debate for almost two decades. Compared to intermittent monitoring systems, continuous glucose monitoring (CGM) can offer benefit in the prevention of severe hyperglycemia and hypoglycemia by enabling insulin infusions to be adjusted more rapidly and potentially more accurately because trends in glucose concentrations can be more readily identified. Increasingly, it is apparent that a single glucose target/range may not be optimal for all patients at all times and, as with many other aspects of critical care patient management, a personalized approach to glucose control may be more appropriate. Here we consider some of the evidence supporting different glucose targets in various groups of patients, focusing on those with and without diabetes and neurological ICU patients. We also discuss some of the reasons why, despite evidence of benefit, CGM devices are still not widely employed in the ICU and propose areas of research needed to help move CGM from the research arena to routine clinical use.

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“…An advantage the EIRUS CGM has over other CE-marked CGM systems [31,32] is that its microdialysis sensing method does not require aspiration of blood across an ex-vivo glucose sensor. Systems that require aspiration of blood will be more prone to failure from inability to aspirate blood from the catheter due to biofilm, thrombus, or position of the catheter against the venous/arterial wall [33][34][35][36][37]. Although the EIRUS CGM demonstrated a MARD of 15.33% in the treated group, a recent clinical study done over a longer period in cardiac surgery patients demonstrated a MARD of 6.5% across 514 paired samples [23].…”

Section: Discussionmentioning

confidence: 99%

Performance of a closed-loop glucose control system, comprising a continuous glucose monitoring system and an AI-based controller in swine during severe hypo- and hyperglycemic provocations

DeJournett

Nekludov

DeJournett

et al. 2020

J Clin Monit Comput

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Intensive care unit (ICU) patients develop stress induced insulin resistance causing hyperglycemia, large glucose variability and hypoglycemia. These glucose metrics have all been associated with increased rates of morbidity and mortality. The only way to achieve safe glucose control at a lower glucose range (e.g., 4.4-6.6 mmol/L) will be through use of an autonomous closed loop glucose control system (artificial pancreas). Our goal with the present study was to assess the safety and performance of an artificial pancreas system, composed of the EIRUS (Maquet Critical Care AB) continuous glucose monitor (CGM) and novel artificial intelligence-based glucose control software, in a swine model using unannounced hypo-and hyperglycemia challenges. Fourteen piglets (6 control, 8 treated) underwent sequential unannounced hypoglycemic and hyperglycemic challenges with 3 IU of NovoRapid and a glucose infusion at 17 mg/kg/min over the course of 5 h. In the Control animals an experienced ICU physician used every 30-min blood glucose values to maintain control to a range of 4.4-9 mmol/L. In the Treated group the artificial pancreas system attempted to maintain blood glucose control to a range of 4.4-6.6 mmol/L. Five of six Control animals and none of eight Treated animals experienced severe hypoglycemia (< 2.22 mmol/L). The area under the curve 3.5 mmol/L was 28.9 (21.1-54.2) for Control and 4.8 (3.1-5.2) for the Treated animals. The total percent time within tight glucose control range, 4.4-6.6 mmol/L, was 32.8% (32.4-47.1) for Controls and 55.4% (52.9-59.4) for Treated (p < 0.034). Data are median and quartiles. The artificial pancreas system abolished severe hypoglycemia and outperformed the experienced ICU physician in avoiding clinically significant hypoglycemic excursions.

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Results of a multicenter prospective pivotal trial of the first inline continuous glucose monitor in critically ill patients

Abstract: Diagnostic study, level I.

Cited by 22 publications

References 19 publications

Diabetes Technology Update: Use of Insulin Pumps and Continuous Glucose Monitoring in the Hospital

Diabetes Technology Update: Use of Insulin Pumps and Continuous Glucose Monitoring in the Hospital

Continuous glucose monitoring in the ICU: clinical considerations and consensus

Performance of a closed-loop glucose control system, comprising a continuous glucose monitoring system and an AI-based controller in swine during severe hypo- and hyperglycemic provocations

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