Point and trend accuracy of a continuous intravenous microdialysis-based glucose-monitoring device in critically ill patients: a prospective study

Leopold, Jan Hendrik; Hooijdonk, Roosmarijn T. M. van; Boshuizen, Margit; Winters, Tineke; Bos, Lieuwe; Abu‐Hanna, Ameen; Hoek, A. M. T.; Fischer, J. C.; Dongen-Lases, Edmée C. van; Schultz, Marcus J.

doi:10.1186/s13613-016-0171-3

Cited by 23 publications

(26 citation statements)

References 16 publications

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“…The results of the testing are in accordance with the established assumptions, and the analysis of the relevant literature [11][12][13]15,16,18]. It unambiguously confirms the results of other studies that also highlight the shortcomings that the current proposal eliminates, comprehensive diabetes management [42], individualizing the content [43,44], and synchronization with one of the external devices for measuring blood glucose levels [45,46]. At the same time, the proposed solution, and especially the research to verify the solution has certain limits.…”

Section: Discussionsupporting

confidence: 84%

Prototypes of User Interfaces for Mobile Applications for Patients with Diabetes

2018

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We live in a heavily technologized global society. It is therefore not surprising that efforts are being made to integrate current information technology into the treatment of diabetes mellitus. This paper is dedicated to improving the treatment of this disease through the use of well-designed mobile applications. Our analysis of relevant literature sources and existing solutions has revealed that the current state of mobile applications for diabetics is unsatisfactory. These limitations relate both to the content and the Graphical User Interface (GUI) of existing applications. Following the analysis of relevant studies, there are four key elements that a diabetes mobile application should contain. These elements are: (1) blood glucose levels monitoring; (2) effective treatment; (3) proper eating habits; and (4) physical activity. As the next step in this study, three prototypes of new mobile applications were designed. Each of the prototypes represents one group of applications according to a set of given rules. The most optimal solution based on the users’ preferences was determined by using a questionnaire survey conducted with a sample of 30 respondents participating in a questionnaire after providing their informed consent. The age of participants was from 15 until 30 years old, where gender was split to 13 males and 17 females. As a result of this study, the specifications of the proposed application were identified, which aims to respond to the findings discovered in the analytical part of the study, and to eliminate the limitations of the current solutions. All of the respondents expressed preference for an application that includes not only the key functions, but a number of additional functions, namely synchronization with one of the external devices for measuring blood glucose levels, while five-sixths of them found suggested additional functions as being sufficient.

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Section: Discussionsupporting

confidence: 84%

Prototypes of User Interfaces for Mobile Applications for Patients with Diabetes

2018

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“…A prospective study assessing the performance of a continuous intravenous microdialysis-based glucose monitoring device showed good sensor accuracy when tested in 12 critically ill patients 37 . When comparing the results of our study with the results reported by Leopold et al sensor performance of the novel sensor was slightly superior (MARD 4.3% vs. 7.5%; 100% of values in zone A of Parks vs. 93.6% of values in zone A of Clarke Error Grid).…”

Section: Discussionmentioning

confidence: 99%

Accuracy and stability of an arterial sensor for glucose monitoring in a porcine model using glucose clamp technique

Aberer

Theiler‐Schwetz

Ziko

et al. 2020

Sci Rep

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intravascular glucose sensors have the potential to improve and facilitate glycemic control in critically ill patients and might overcome measurement delay and accuracy issues. this study investigated the accuracy and stability of a biosensor for arterial glucose monitoring tested in a hypo-and hyperglycemic clamp experiment in pigs. 12 sensors were tested over 5 consecutive days in 6 different pigs. Samples of sensor and reference measurement pairs were obtained every 15 minutes. 1337 pairs of glucose values (range 37-458 mg/dl) were available for analysis. The systems met ISO 15197:2013 criteria in 99.2% in total, 100% for glucose <100 mg/dl (n = 414) and 98.8% for glucose ≥100 mg/dl (n = 923). The mean absolute relative difference (MARD) during the entire glycemic range of all sensors was 4.3%. the MARDs within the hypoglycemic (<70 mg/dl), euglycemic (≥70-180 mg/dl) and hyperglycemic glucose ranges (≥180 mg/dl) were 6.1%, 3.6% and 4.7%, respectively. Sensors indicated comparable performance on all days investigated (day 1, 3 and 5). None of the systems showed premature failures. in a porcine model, the performance of the biosensor revealed a promising performance. the transfer of these results into a human setting is the logical next step. Hyperglycemia is common in critical illness irrespective of the presence of preexisting diabetes. Several theories have been raised claiming the activation of the hypothalamic-pituitary-adrenal-axis to be the main cause of so-called stress hyperglycemia, but also inflammatory processes, concomitant medication and acute renal impairments represent prominent triggers provoking hyperglycemia 1. Hyperglycemia is a well-known risk factor for complications and increased mortality in both critically-and not critically ill medical and surgical patients 2-5. Moreover, the degree of hyperglycemia has been associated with increased risk for unfavorable outcomes 6,7. Today, repetitive point-of-care measurements of capillary, venous or arterial blood samples in varying intervals is the recommended and established method to evaluate and steer glycemic control in the hospital both on the general ward and in critical care. These measurements are cheap and precise, but are associated with increased work-load of nursing staff, are-depending on blood-withdrawal method-associated with blood loss, can result in data transfer errors and only show glucose values in a low resolution without the availability of a continuous glucose profile. Continuous glucose monitoring (CGM) systems which provide glucose measurements obtained from the interstitial fluid of subcutaneous tissue display glucose values in real time and have gained significant importance in the management of diabetes in the outpatient setting providing sufficient sensor accuracy for treatment decisions 8,9. To date, various subcutaneous CGM systems were evaluated at general wards and in intensive care unit settings and were considered safe and effective for glucose monitoring in inpatients 10-14. However, sensor performance data report...

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“…the main impediment to bringing such a system to the market is lack of collaboration between the companies that have either already developed the necessary components [7,14] or are in an earlier stage in development [15]. If the best in class of available ICU based glucose sensors is combined with the best in class of available ICU based glucose controllers and the overall system is properly designed and engineered by a known engineering firm with class III medical device experience, the road to obtaining regulatory approval and bringing a safe and effective closed loop glucose control device to market will become much shorter.…”

Section: Journal Of Intensive and Critical Care Issn 2471-8505mentioning

confidence: 99%

“…Current CE marked blood based glucose sensors designed for use in the ICU setting have already been shown to be both highly accurate and reliable, with an uptime rate that exceeds 99% [7]. In addition, the next generation interstitial continuous glucose monitoring (CGM) system that Dexcom is developing with assistance from Google will not be affected by acetaminophen, making it a potential excellent candidate as the second sensor in a glucose array [8].…”

mentioning

confidence: 99%

Is Closed Loop Glucose Control for ICU Patients Just Around the Corner?

DeJournett¹,

DeJournett²

2017

J Intensive Crit Care

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Effective glucose control in the Intensive Care Unit (ICU) setting has the potential to lower mortality rates [1], shorten length of stay [2] and decrease overall cost of care [3]. Yet the goal of achieving this control remains elusive due to the limitations of our current open loop methods [4] that still require manual testing of glucose values, entry of the measured value into local or web based glucose control software, and manual adjustment of the intravenous pumps infusing insulin into the ICU patient. In order to improve overall glucose control, ICU care givers will need to be empowered with a closed loop glucose control system.The three main components of a closed loop glucose control system are a glucose sensor(s), control algorithm, and intravenous pump(s). Current intravenous pumps are accurate and reliable enough for a closed loop system, so the two components preventing completion of the system are the glucose sensor(s) and controller. An accurate and reliable glucose sensor array is a must, as trying to control a system without real time knowledge of mission critical sensor data will invariably lead to unacceptable outcomes, as has been seen in the aerospace industry [5]. In fact, the aerospace industry provides an excellent example of how to properly engineer a safe and effective control system, as they routinely build in redundancy of mission critical system components to improve reliability and will also use different methods of measurement to improve overall accuracy.Studies on type I diabetics have shown that a multi-sensor array improves overall accuracy of the system [6]. The following equation can be used as a guide to determine the number of sensors N, needed given a known sensor failure rate p and a desired uptime rate q, where p, q ∈ [0,1]:As can be seen from Table 1 if the closed loop system requirement is to have a complete sensor failure rate limited to less than 10 min over a typical 96 h ICU length of stay, which is a greater than 99.8% uptime rate, and the known sensor failure rate is 1%, then the system requirement is to have two independent glucose sensors in place.Current CE marked blood based glucose sensors designed for use in the ICU setting have already been shown to be both highly accurate and reliable, with an uptime rate that exceeds 99% [7]. In addition, the next generation interstitial continuous glucose monitoring (CGM) system that Dexcom is developing with assistance from Google will not be affected by acetaminophen, making it a potential excellent candidate as the second sensor in a glucose array [8]. The ability to avoid interference from acetaminophen is important as this medication is known to affect the accuracy of current interstitial CGM systems, yet is ubiquitously used in the hospital setting. As sensor reliability is far more important than accuracy when it comes to closed loop glucose control [9], the improved uptime rate of a two sensor array will more than offset the decreased accuracy that will occur by averaging simultaneous blood and interstitial glucos...

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Point and trend accuracy of a continuous intravenous microdialysis-based glucose-monitoring device in critically ill patients: a prospective study

Cited by 23 publications

References 16 publications

Prototypes of User Interfaces for Mobile Applications for Patients with Diabetes

Prototypes of User Interfaces for Mobile Applications for Patients with Diabetes

Accuracy and stability of an arterial sensor for glucose monitoring in a porcine model using glucose clamp technique

Is Closed Loop Glucose Control for ICU Patients Just Around the Corner?

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