Accuracy of five systems for self-monitoring of blood glucose in the hands of adult lay-users and professionals applying ISO 15197:2013 accuracy criteria and potential insulin dosing errors

Jendrike, Nina; Baumstark, Annette; Pleus, Stefan; Liebing, Christina; Kamecke, Ulrike; Haug, Cornelia; Freckmann, Guido

doi:10.1080/03007995.2018.1491832

Cited by 7 publications

(5 citation statements)

References 28 publications

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“…However, using only well performing devices for glucose measurement is of particular importance for clinical trials as confirmed in recently published studies. 16,17 Obviously, good device accuracy is a prerequisite to ensure patient safety. However, a suboptimal device performance may lead to other study-related problems such as potential bias in endpoints, potential inconsistencies between SMBG values and HbA1c, and so forth.…”

Section: Discussionmentioning

confidence: 99%

Laboratory Evaluation of Linearity, Repeatability, and Hematocrit Interference With an Internet-Enabled Blood Glucose Meter

Demircik¹,

Kirsch

Ramljak³

et al. 2019

J Diabetes Sci Technol

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Background: In recent clinical trials, use of the MyGlucoHealth blood glucose meter (BGM) and electronic diary was associated with an unusual reporting pattern of glycemic data and hypoglycemic events. Therefore, the performance of representative BGMs used by the patients was investigated to assess repeatability, linearity, and hematocrit interference in accordance with regulatory guidelines. Method: Ten devices and 6 strip lots were selected using standard randomization and repeatability procedures. Venous heparinized blood was drawn from healthy subjects, immediately aliquoted and adjusted to 5 target blood glucose (BG) ranges for the repeatability and 11 BG concentrations for the linearity tests. For the hematocrit interference test, each sample within 5 target BG ranges was split into 5 aliquots and adjusted to hematocrit levels across the acceptance range. YSI 2300 STAT Plus was used as the laboratory reference method in all experiments. Results: Measurement repeatability or precision was acceptable across the target BG ranges for all devices and strip lots with coefficient of variation (CV) between 3.4-9.7% (mean: 5.7%). Linearity was shown by a correlation coefficient of .991; however, a positive bias was seen for BG <100 mg/dL (86% measurements did not meet ISO15197:2015 acceptance criteria). Significant hematocrit interference (up to 20%) was observed for BG >100 mg/dL (ISO15197:2015 acceptance criteria: ±10%), while the results were acceptable for BG <100 mg/dL. Conclusions: The BGM met repeatability requirements but demonstrated a significant measurement bias in the low BG range. In addition, it failed the ISO15197:2015 criteria for hematocrit interference.

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Section: Discussionmentioning

confidence: 99%

Laboratory Evaluation of Linearity, Repeatability, and Hematocrit Interference With an Internet-Enabled Blood Glucose Meter

Demircik¹,

Kirsch

Ramljak³

et al. 2019

J Diabetes Sci Technol

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“…As for non-continuous glucose monitoring devices, most of them were user-friendly and rapid, but accuracy varied. In the case of glucose meters, MARD ranged from 2.3% to 21.2% 42 , 44 - 49 and FLASH from 11.2% to 22%. 23 , 29 , 30 , 50 - 52 None of the devices was equipment free.…”

Section: Resultsmentioning

confidence: 99%

“…In the case of non-continuous monitoring devices, we grouped the devices into 6 categories: glucose meters, 42 - 49 FLASH (Abbott), 23 , 29 , 30 , 50 - 52 TensorTip Combo Glucometer (CNOGA Medical), 48 analysis software that works with a smartphone (iXensor Co), 53 GASA (Guaiacol diazo derivative, 4[(4-Hydroxy-3-methoxyphenyl) azo]-benzenesulfonic acid), 54 and Breathotron for diabetes screening, and hypoglycemia monitoring. 55 , 56 These devices measured glucose levels on capillary blood, breath, saliva and interstitial tissue (see Figure 3 and Supplemental Table 2 ).…”

Section: Resultsmentioning

confidence: 99%

Technologies for Diabetes Self-Monitoring: A Scoping Review and Assessment Using the REASSURED Criteria

Zafra-Tanaka

Beran

Vetter

et al. 2021

J Diabetes Sci Technol

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Background: Self-management is an important pillar for diabetes control and to achieve it, glucose self-monitoring devices are needed. Currently, there exist several different devices in the market and many others are being developed. However, whether these devices are suitable to be used in resource constrained settings is yet to be evaluated. Aims: To assess existing glucose monitoring tools and also those in development against the REASSURED which have been previously used to evaluate diagnostic tools for communicable diseases. Methods: We conducted a scoping review by searching PubMed for peer-review articles published in either English, Spanish or Portuguese in the last 5 years. We selected papers including information about devices used for self-monitoring and tested on humans with diabetes; then, the REASSURED criteria were used to assess them. Results: We found a total of 7 continuous glucose monitoring device groups, 6 non-continuous, and 6 devices in development. Accuracy varied between devices and most of them were either invasive or minimally invasive. Little to no evidence is published around robustness, affordability and delivery to those in need. However, when reviewing publicly available prices, none of the devices would be affordable for people living in low- and middle-income countries. Conclusions: Available devices cannot be considered adapted for use in self-monitoring in resource constraints settings. Further studies should aim to develop less-invasive devices that do not require a large set of components. Additionally, we suggest some improvement in the REASSURED criteria such as the inclusion of patient-important outcomes to increase its appropriateness to assess non-communicable diseases devices.

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“…Some used capillary glucose monitoring devices for comparison, which themselves have accuracy issues even with the use of devices that undergo regular quality control checks. 69 Therefore, for testing accuracy, glucose levels should be checked using a reliable method, and the FDA developed clear guidance on the standards required. 70 Mean average relative difference (MARD) in glucose of a device compared with a reliable standard has been used as a simple measure to assess accuracy, although this is not without flaws.…”

Section: Differences In the Calculation Of Rate Of Change Of Glucosementioning

confidence: 99%

Use of continuous glucose monitoring trend arrows in the younger population with type 1 diabetes

Elbarbary

Moser

Al-Yaarubi

et al. 2021

Diabetes and Vascular Disease Research

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Early control of glycaemia is key to reduce vascular complications in individuals with Type 1 diabetes. Therefore, encouraging children and adolescents with T1DM to take responsibility for controlling glucose levels is an important yet a challenging task. The rapid expansion of continuous glucose monitoring (CGM) systems has allowed for more comprehensive analysis of glycaemia in T1D. Moreover, CGM devices have the ability to calculate rate of change in glucose levels and display the information as trend arrows. In turn, this can help to take evasive actions to return glucose levels to near physiological glycaemia, which can be highly motivating for young people with T1DM. In the absence of standardised, evidence-based guidance, this consensus document, generated by experts from the Arab Society of Paediatric Endocrinology and Diabetes and international advisors, summarises recent literature on the use of trend arrows in young people with T1DM. The use of trend arrows in different CGM systems is reviewed and their clinical significance is highlighted. Adjusting insulin doses according to trend arrows is discussed while also addressing special situations, such as exercise, fasting, nocturnal hypoglycaemia and menstruation. Adequate understanding of trend arrows should facilitate optimisation of glycaemic control in the T1D population.

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Accuracy of five systems for self-monitoring of blood glucose in the hands of adult lay-users and professionals applying ISO 15197:2013 accuracy criteria and potential insulin dosing errors

Abstract: In this study, the systems showed slight differences in the number of results within ISO 15197:2013 accuracy limits. Inaccurate SMBG measurements can result in insulin dosing errors and adversely affect glycemic control.

Cited by 7 publications

References 28 publications

Laboratory Evaluation of Linearity, Repeatability, and Hematocrit Interference With an Internet-Enabled Blood Glucose Meter

Laboratory Evaluation of Linearity, Repeatability, and Hematocrit Interference With an Internet-Enabled Blood Glucose Meter

Technologies for Diabetes Self-Monitoring: A Scoping Review and Assessment Using the REASSURED Criteria

Use of continuous glucose monitoring trend arrows in the younger population with type 1 diabetes

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