Effect of Arterialization on Venous Blood Glucose Concentrations and Implications for Observed Continuous Glucose Monitoring Accuracy

Pleus, Stefan; Link, Manuela; Hinzmann, Rolf; Öter, Sükrü; Eichenlaub, Manuel; Baumstark, Annette; Haug, Cornelia; Freckmann, Guido

doi:10.1089/dia.2023.0489

Cited by 4 publications

(8 citation statements)

References 22 publications

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“…The value-based and the episode-based approaches led to different results in previous studies assessing hypoglycemia alerts and detection. 33,34 This was confirmed by post hoc analysis of data from a recently published study, 46 in which four hypoglycemia and four hyperglycemia thresholds were assessed (Table 2, Figure 3). Depending on the design of the CGM performance study in which alerts are evaluated, this difference can vary.…”

Section: Comparison Of the Value-based And Episode-based Approachessupporting

confidence: 62%

A Critical Discussion of Alert Evaluations in the Context of Continuous Glucose Monitoring System Performance

Pleus,

Eichenlaub,

Waldenmaier

et al. 2024

J Diabetes Sci Technol

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Many continuous glucose monitoring (CGM) systems provide functionality which alerts users of potentially unwanted glycemic conditions. These alerts can include glucose threshold alerts to call the user’s attention to hypoglycemia or hyperglycemia, predictive alerts warning about impeding hypoglycemia or hyperglycemia, and rate-of-change alerts. A recent review identified 129 articles about CGM performance studies, of which approximately 25% contained alert evaluations. In some studies, real alerts were assessed; however, most of these studies retrospectively determined the timing of CGM alerts because not all CGM systems record alerts which necessitates manual documentation. In contrast to assessment of real alerts, retrospective determination allows assessment of a variety of alert settings for all three types of glycemic condition alerts. Based on the literature and the Clinical and Laboratory Standards Institute’s POCT05 guideline, two common approaches to threshold alert evaluation were identified, one value-based and one episode-based approach. In this review, a critical discussion of the two approaches, including a post hoc analysis of clinical study data, indicates that the episode-based approach should be preferred over the value-based approach. For predictive alerts, fewer results were found in the literature, and retrospective determination of CGM alert timing is complicated by the prediction algorithms being proprietary information. Rate-of-change alert evaluations were not reported in the identified literature, and POCT05 does not contain recommendations for assessment. A possible approach is discussed including post hoc analysis of clinical study data. To conclude, CGM systems should record alerts, and the episode-based approach to alert evaluation should be preferred.

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Section: Comparison Of the Value-based And Episode-based Approachessupporting

confidence: 62%

A Critical Discussion of Alert Evaluations in the Context of Continuous Glucose Monitoring System Performance

Pleus,

Eichenlaub,

Waldenmaier

et al. 2024

J Diabetes Sci Technol

Self Cite

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“…For physiological reasons, capillary blood glucose (BG) concentrations are, on average, about 6% higher than venous BG concentrations. 4 However, the results reported by Hanson et al indicate the opposite, ie, that capillary BG concentrations were lower than venous BG levels (Figure 1, panel a). It is therefore highly likely that their chosen BGMS had a considerable negative bias, which agrees with previous findings.…”

Section: Letter To the Editormentioning

confidence: 80%

“…Another aspect is the choice of comparator measurement approach that can substantially affect the observed accuracy of a given CGM system. 4 Hanson et al collected both venous and capillary blood for comparator glucose measurements using a laboratory analyzer (Yellow Springs Instruments [YSI], Yellow Springs, Ohio) and a home-use blood glucose measurement system (BGMS), respectively. For physiological reasons, capillary blood glucose (BG) concentrations are, on average, about 6% higher than venous BG concentrations.…”

Section: Letter To the Editormentioning

confidence: 99%

Even Head-to-Head Comparison Studies of Continuous Glucose Monitoring System Performance Can be Biased

Pleus,

Eichenlaub,

Waldenmaier

et al. 2024

J Diabetes Sci Technol

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“…19 Based on this RoC categorization and risk classification, we can introduce the results display of the CTCA which is exemplified in Figure 4. Here we show three examples of CTCA results for the older-generation, seven-arrow Dexcom G5 (based on the previously mentioned study by Freckmann et al 17 and calculated CGM RoCs), the newer-generation, seven-arrow Dexcom G6 (study not published, CGM RoCs were calculated analogous to the Dexcom G5) and the current-generation, five-arrow FreeStyle Libre 3 (based on a study by Pleus et al, 14 CGM RoCs were calculated analogous to the Dexcom G5). For that, we used the calculated trend arrows based on the CGM RoC (as explained above) because the actually displayed trend arrows were retrospectively not available in all example data sets.…”

Section: Clinical Trend Concurrence Analysismentioning

confidence: 94%

“…For a more detailed discussion on the existing approaches to obtain comparator measurements, we refer the reader to previously published articles. 1,9,14 In principle, there are two fundamental approaches to the assessment of trend accuracy which will be discussed in the following sections: treating the CGM and comparator RoCs as continuous or as categorical variables.…”

Section: Introductionmentioning

confidence: 99%

A Proposal for the Clinical Characterization of Continuous Glucose Monitoring Trend Arrow Accuracy

Eichenlaub,

Pleus,

Freckmann

2024

J Diabetes Sci Technol

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The assessment and characterization of trend accuracy, that is, the ability of a continuous glucose monitoring (CGM) system to correctly indicate the direction and rate of change (RoC) of glucose levels, has received comparatively little attention in the overall evaluation of CGM performance. As such, only few approaches that examine the trend accuracy have been put forward. In this article, we review existing approaches and propose the clinical trend concurrence analysis (CTCA) which is an adaptation of the conventional trend concurrence analysis. The CTCA is intended to directly evaluate the trend arrows displayed by the CGM systems by characterizing their agreement to suitably categorized comparator RoCs. Here, we call on manufactures of CGM systems to provide the displayed trend arrows for retrospective analysis. The CTCA classifies any deviations between the CGM trend and comparator RoC according to their risk for an adverse clinical event arising from a possibly erroneous treatment decision. For that, the existing rate error grid analysis and a specific set of trend arrow-based insulin dosing recommendations were used. The results of the CTCA are presented in an accessible graphical display and exemplified on data from three CGM systems. With this article, we hope to increase the awareness for the importance and challenges of assessing the accuracy of trend information displayed by CGM systems.

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Effect of Arterialization on Venous Blood Glucose Concentrations and Implications for Observed Continuous Glucose Monitoring Accuracy

Cited by 4 publications

References 22 publications

A Critical Discussion of Alert Evaluations in the Context of Continuous Glucose Monitoring System Performance

A Critical Discussion of Alert Evaluations in the Context of Continuous Glucose Monitoring System Performance

Even Head-to-Head Comparison Studies of Continuous Glucose Monitoring System Performance Can be Biased

A Proposal for the Clinical Characterization of Continuous Glucose Monitoring Trend Arrow Accuracy

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