Validation of a new generation POCT glucose device with emphasis on aspects important for glycemic control in the hospital care

S, Kos; Meerkerk, Arie van; Linden, Joke van der; Stiphout, Theo; Wulkan, R. W.

doi:10.1515/cclm-2011-0900

Cited by 15 publications

(10 citation statements)

References 13 publications

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“…However, similar deviations in glucose values between the two devices were found before and after the change in lot numbers during the summer. Moreover, good agreement between different HemoCue devices of the same model and lot numbers has been demonstrated previously [29]. According to the manufacturer, it can be expected for both devices to have a lot-to-lot as well as an instrument-to-instrument variation of less than 0.2 mmol/L or a total system variation of less than 0.3 mmol/L at normal glucose levels.…”

Section: Discussionsupporting

confidence: 55%

“…The constant factor 1.11 used by the HemoCue system for automatic conversion of whole blood glucose values to equivalent plasma glucose values is based on the relationship at normal hematocrit (0.43) [10]. Hematocrit levels at the extremes will therefore have an effect on the results [29]. Considering the relative anemia that occurs in pregnancy due to hemodilution, the conversion factor 1.11 may not be optimal [30].…”

Section: Journal Of Diabetes Researchmentioning

confidence: 99%

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Diagnosis of Gestational Diabetes Mellitus with Point-of-Care Methods for Glucose versus Hospital Laboratory Method Using Isotope Dilution Gas Chromatography-Mass Spectrometry as Reference

Kristensen

Wangel

Katsarou

et al. 2020

Journal of Diabetes Research

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Background. In Sweden, both glucose analyzers in accredited laboratories and point-of-care glucose devices are used for gestational diabetes mellitus (GDM) diagnosis. The aim of this study was to compare the diagnostic performance of the HemoCue Glucose 201+ (HC201+) and RT (HC201RT) systems with that of the hospital central laboratory hexokinase method (CL) based on lyophilized citrate tubes, using the isotope dilution gas chromatography-mass spectrometry (ID GC-MS) as reference. Methods. A 75 g oral glucose tolerance test was performed on 135 women screened positive for GDM. Diagnosis was based on the World Health Organization 2013 diagnostic thresholds for fasting (n=135), 1 h (n=52), and 2 h (n=135) glucose measurements. Bland-Altman analysis and surveillance error grids were used to evaluate analytical and clinical accuracy. Results. Significantly more women were diagnosed with GDM by HC201+ (80%) and CL (80%) than with the reference (65%, P<0.001) based on fasting and/or 2 h thresholds, whereas the percentage diagnosed by HC201RT (60%) did not differ significantly from the reference. In Bland-Altman analysis, a positive bias was observed for HC201+ (4.2%) and CL (6.1%) and a negative bias for HC201RT (−1.8%). In the surveillance error grid, 95.9% of the HC201+ values were in the no-risk zone as compared to 98.1% for HC201RT and 97.5% for CL. Conclusions. A substantial positive bias was found for CL measurements resulting in overdiagnosis of GDM. Our findings suggest better performance of HC201RT than HC201+ in GDM diagnosis. The results may have possible implications for GDM diagnosis in Sweden and require further elucidation.

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Section: Discussionsupporting

confidence: 55%

Section: Journal Of Diabetes Researchmentioning

confidence: 99%

Diagnosis of Gestational Diabetes Mellitus with Point-of-Care Methods for Glucose versus Hospital Laboratory Method Using Isotope Dilution Gas Chromatography-Mass Spectrometry as Reference

Kristensen

Wangel

Katsarou

et al. 2020

Journal of Diabetes Research

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“…12 The total measurement error/reproducibility imprecision of HemoCue is less than 6.5%. 13 In earlier studies using both capillary and venous values as a reference when evaluating CGM accuracy, there was a strong correlation between venous and capillary HemoCue concentrations, and capillary concentrations were shown to be a suitable reference. 14 …”

Section: Methodsmentioning

confidence: 95%

A Clinical Trial of the Accuracy and Treatment Experience of the Flash Glucose Monitor FreeStyle Libre in Adults with Type 1 Diabetes

Ólafsdóttir

Attvall

Sandgren

et al. 2017

Diabetes Technology & Therapeutics

156

132

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Background: In Sweden, FreeStyle Libre a flash glucose monitoring system came onto the market in 2014 as a complement to self-monitoring of blood glucose. The aim of this study was to evaluate the accuracy and treatment experience of the FreeStyle Libre system.Methods: Fifty-eight adults with type 1 diabetes used FreeStyle Libre for 10–14 days and measured capillary blood glucose levels with the HemoCue blood glucose measurement system at least six times a day simultaneously.Results: For the entire study period, the mean absolute relative difference (MARD) was 13.2% (95% confidence interval [CI] 12.0%–14.4%). MARD was 13.6% (95% CI 12.1%–15.4%) during week 1 and 12.7% (95% CI 11.5%–13.9%) during week 2. The mean absolute difference (MAD) for the whole study period was 19.8 mg/dL (1.1 mmol/L) (95% CI 17.8–21.8 mg/dL), including 20.5 mg/dL (1.14 mmol/L) during week 1 and 19.0 mg/dL (1.05 mmol/L) during week 2. The overall correlation coefficient was 0.96. For glucose values <72, 72–180, and >180 mg/dL (<4, 4–10, and >10 mmol/L), the MARD was 20.3% (95% CI 17.7%–23.1%), 14.7% (95% CI 13.4%–16%), and 9.6% (95% CI 8.5%–10.8%), respectively, and respective MAD values were 12.3, 17.8, and 23.6 mg/dL (0.69, 0.99, and 1.31 mmol/L). Using the 10-item visual analog scale, patients rated their experience with FreeStyle Libre as generally positive, with mean values ranging from 8.22 to 9.8.Conclusions: FreeStyle Libre had a similar overall MARD as continuous blood glucose monitoring systems in earlier studies when studied in similar at-home conditions. The overall patient satisfaction was high.

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“…The participants were advised to adhere to their usual diet, avoid vigorous physical activity for at least 48 h prior to the scheduled clinic visit, and attend the clinic in the morning after an overnight fasting for 10–12 h. Using finger prick blood in a HemoCue™ 201 glucometer (HemoCue™ Sweden) we measured fasting capillary blood glucose concentration followed 2 hours later by drinking 75 g anhydrous glucose disolved in 200 ml water. HemoCue™ 201 glucometer (HemoCue™ Sweden) is a validated instrument against laboratory value of plasma glucose [ 19 ] which provides a digital display equivalent to plasma glucose concentration.…”

Section: Methodsmentioning

confidence: 99%

Overweight and abdominal obesity as determinants of undiagnosed diabetes and pre-diabetes in Bangladesh

Alam

Talukder²,

Chowdhury

et al. 2016

BMC Obes

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BackgroundType 2 diabetes and pre-diabetes are an increasing pandemic globally and often remain undiagnosed long after onset in low-income settings. The objective of this study is to assess the determinants and prevalence of undiagnosed diabetes and pre-diabetes among adults in Bangladesh.MethodsIn an exploratory study, we performed oral glucose tolerance test on 1243 adults ≥20 years of age from urban Mirpur, Dhaka (n = 518) and rural Matlab, Chandpur (n = 725) who had never been diagnosed with diabetes or pre-diabetes. We collected data on socioeconomic, demographic, past medical history, physical activity, and measured weight, height, waist and hip circumferences, and blood pressure. Risk factors associated with undiagnosed diabetes and pre-diabetes were examined using a multiple logistic regression model.ResultsOverall prevalence of diabetes and pre-diabetes was 6.6 % (95 % CI 5.3, 8.1) and 16.6 % (14.5, 18.7) respectively, with both being significantly higher in urban than rural populations (diabetes 12.2 % vs 2.6 % respectively, p < 0.000; pre-diabetes 21.2 % vs 13.2 %, p < 0.001). After adjustment the variables, urban residence (OR 2.5 [95 % CI 1.02, 5.9]), age group 40–59 y (2.9 [1.7–5.2]), ≥60 y (8.1 [2.8–23.8]), overweight (2.2 [1.3–3.9]), abdominal obesity (3.3 [1.8–6.0]) and high WHR 5.6 (2.7–11.9) were all significant predictors of diabetes. Significant predictors of pre-diabetes included age group 40–59 (1.6 [1.1–2.2]), female sex (1.5 [1.0–2.2]), abdominal obesity (1.7 [1.2–2.4]) and high WHR (1.6 [1.2–2.3]).ConclusionBoth overweight and abdominal obesity contribute to the hidden public health threat of undiagnosed diabetes and pre-diabetes. Awareness raising and screening of high risk groups combined with a tailored approach are essential for halting the epidemic of diabetes and pre-diabetes in Bangladesh.

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Validation of a new generation POCT glucose device with emphasis on aspects important for glycemic control in the hospital care

Abstract: The 201DMRT device can be used for glycemic control based on analytical results presented. However, the clinical applicability for tight glycemic control must be confirmed in a clinical study.

Cited by 15 publications

References 13 publications

Diagnosis of Gestational Diabetes Mellitus with Point-of-Care Methods for Glucose versus Hospital Laboratory Method Using Isotope Dilution Gas Chromatography-Mass Spectrometry as Reference

Diagnosis of Gestational Diabetes Mellitus with Point-of-Care Methods for Glucose versus Hospital Laboratory Method Using Isotope Dilution Gas Chromatography-Mass Spectrometry as Reference

A Clinical Trial of the Accuracy and Treatment Experience of the Flash Glucose Monitor FreeStyle Libre in Adults with Type 1 Diabetes

Overweight and abdominal obesity as determinants of undiagnosed diabetes and pre-diabetes in Bangladesh

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