Can You Get a Faulty Blood Glucose Reading
J Diabetes Sci Technol. 2016 Sep; ten(5): 1161–1168.
Interferences and Limitations in Claret Glucose Self-Testing
An Overview of the Electric current Noesis
Michael Erbach
1Sciarc Plant, Baierbrunn, Germany
Guido Freckmann
twoInstitut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH, Ulm, Germany
Rolf Hinzmann
3Roche Diabetes Intendance GmbH, Mannheim, Germany
Bernhard Kulzer
4Research Establish of the Diabetes Academy Mergentheim (FIDAM), Bad Mergentheim, Germany
Ralph Ziegler
vDiabetes Dispensary for Children and Adolescents, Muenster, Deutschland
Lutz Heinemann
6Science & Co GmbH, Düsseldorf, Germany
Oliver Schnell
7Forschergruppe Diabetes eastward.5., Munich-Neuherberg, Germany
Abstract
In general, patients with diabetes performing cocky-monitoring of blood glucose (SMBG) can strongly rely on the accurateness of measurement results. However, diverse factors such as application errors, extreme environmental conditions, farthermost hematocrit values, or medication interferences may potentially falsify blood glucose readings. Incorrect blood glucose readings may lead to handling errors, for example, incorrect insulin dosing. Therefore, the diabetes team as well as the patients should be well informed nigh limitations in blood glucose testing. The aim of this publication is to review the electric current knowledge on limitations and interferences in blood glucose testing with the perspective of their clinical relevance.
Keywords: blood glucose testing, diabetes, interference, reliability, self-monitoring of blood glucose, SMBG
Self-monitoring of claret glucose (SMBG) both in insulin-treated and non-insulin-treated people with diabetes is supported by recently published trials, reviews, meta-analyses, and guidelines.1-7 SMBG is recommended to be performed in a structured approach.2,5,8,9 It is reported to be simply useful when blood glucose (BG) data are interpreted and utilized for immediate therapeutic actions.3,4,ten-13 For instance, the need for adequate dosing of insulin heavily depends on reliable glucose information.8 In item, patients with insulin-treated diabetes perform SMBG equally a substantial chemical element of daily management of diabetes.fourteen,15 The term "BG system" denotes the combination of a BG meter and test strips, and both determine analytical performance.8 The analytical and handling functioning of BG systems has largely improved over the past decades. In add-on, the implementation of in-meter rubber features (ie, validity of exam strips cheque) has further increased the prophylactic of these devices.16 Consequently, patients with appropriate training and a good operation of BG testing can typically rely on the precision of BG measurement results. However, in the daily do a range of factors with potential touch on on the reliability of BG measurement needs to be considered. In fact, this is an of import attribute in field of bespeak-of-care (POC) testing.17 Members of the diabetes squad and patients should be well informed about all factors potentially falsifying BG measurement results: human, meter-inherent, test-strip-inherent, environmental, physiological, and medication-related impact factors (Tabular array i).
Table 1.
Factors With a Potential Impact on the Analytical Performance of SMBG.
| Human | Wrong apply of BG meters |
| Incorrect performance of coding | |
| Inappropriate storage and usage of examination strips | |
| Inappropriate teaching of patients and diabetes squad | |
| Meter-inherent | Accuracy |
| User-friendliness | |
| Examination-strip-inherent | Lot-to-lot variances |
| Vial-to-vial variances | |
| Strip-to-strip variances | |
| Environmental | Temperature |
| Humidity | |
| Altitude | |
| Electromagnetic radiation | |
| Physiological | Peripheral blood perfusion |
| Hematocrit | |
| Partial pressure of oxygen (pO2) | |
| Triglycerides | |
| Bilirubin | |
| Uric acid | |
| Medicational | Ascorbic acid (intravenously) |
| Acetaminophen (paracetamol) | |
| Dopamine | |
| Mannitol | |
| Icodextrin |
The risk of misinterpretation of BG readings can be minimized by detailed information on the factors potentially affecting BG measurement. Hence, the aim of this publication is to review the current knowledge on limitations and interferences meaning for reliable BG testing.
Nonetheless, due to the rapid technological progress, it should be kept in heed that performance of nearly more recent BG meters may not ever be reflected past the reviewed literature, since it reports on information generated with older BG generations.17 Moreover, it is of import to note that some studies on limitations of BG meters were performed nether extreme conditions which do not comply with the approved conditions of usage.
Preanalytical Factors
Inappropriate treatment of SMBG has been identified as the most common factor affecting BG results; more than than 90% of overall inaccuracies outcome from incorrect use of BG meters.4,18 Due to the infinitesimal claret samples utilized by modernistic BG systems, fifty-fifty pocket-sized contamination with glucose containing fluids may substantially increase the measurement. Sugar-containing products, such every bit fruits, can leave considerable amounts of glucose on the peel, thereby causing falsely high SMBG results.17,19,20 In daily do, a substantial number of patients practise non wash their hands before performing BG measurements.
The coding procedure is another potential source of mistake. Coding is needed to transfer information from the test strip scale to the BG meter. Wrong coding may lead to measurement errors of ±30% or more.21 However, most modern BG systems no longer require a coding step.22
Furthermore, BG measurement may be compromised by usage of deteriorated test strips, which may event from inappropriate storage, mechanical stress, or usage later on the expiry engagement.xviii,23,24 BG test strips were found to perform more than reliably when stored in airtight vials than in open vials, which is of special importance when used under extreme environmentalconditions.17 The bear on of inappropriate storage of exam strips on BG readings is demonstrated by the case of a 72-twelvemonth-onetime Japanese patient with blazon two diabetes. To simplify the SMBG process, he removed the test strips from the packaging and stored them, together with the BG meter, in a small pouch. Due to repeated pseudohypoglycemic readings, the patient abased his antihyperglycemic medication, thereby reaching a BG level of 21.8 mmol/L (393 mg/dL).24
This case report too exemplifies the importance of patient instruction. Inappropriate patient education has been identified equally a leading cause of inadequate SMBG performance. One study plant that 69% of the patients who had initially failed in their SMBG performance accomplished adequate SMBG results after reeducation.25
Meter-Inherent Factors
Simulations suggest an increasing likelihood of treatment errors in response to decreasing accuracy of BG systems.26 Fifty-fifty when used by trained laboratory professionals, every BG meter entails a certain caste of imprecision and bias associated with it.4 Other inherent system limitations such equally ease of handling, and readability of the numbers shown on the display need to exist considered.4,22 Moreover, data transfer from the internal meter memory into a computer may be a fourth dimension-consuming and cumbersome procedure.4
The usability of BG meters plays a key role in warranting reliable and accurate measurement results.22 Helpful features, for example, are safeguards that betoken test strip expiration, underdosing of blood sample, exposure to abnormal temperature, and so on.17
Beyond these potential technological barriers, at that place is the homo fault factor, for instance, incomplete test strip insertion into the meter, or awarding despite of low-battery condition.27
Hence, even if a given BG meter with a given lot of exam strips fulfils the accuracy requirements of the regulatory government, this does not necessarily imply that all devices and lots will do so after market introduction, particularly under real-life weather.17
To ensure high quality under real-life conditions, and in response to ISO (International Organization for Standardization) 15197:2013 requirements,28 apart from all-encompassing testing, a user performance evaluation is required to show whether patients are able to obtain authentic measurement results with a given arrangement. For this purpose, measurements should be performed by the end users simply following the instructions of apply, without whatever training or assistance.
Exam-Strip-Inherent Factors
Manufacturing of exam strips is a complex process involving various factors, and so it is unreasonable to assume that all test strips—even within a certain make—volition produce (almost) identical measurement results. Requirements for BG systems—including accurateness—are described in detail in the internationally accepted standard EN ISO 15197.29 According to the currently applicable version ISO 15197:2013,28 95% of BG results must autumn within ±xv mg/dL of the reference method at BG concentrations <100 mg/dL and within ±15% at BG concentrations ≥100 mg/dL. In addition, 99% of all values must autumn into zones A and B of the Parkes error grid for type ane diabetes. 3 unlike lots need to be tested and all iii must laissez passer. The previous version, ISO 15197:2003,30 which had less rigorous requirements, may still be referred to for a transitional period.
A potential concern involving examination strips is the variance between exam strip lots (lot-to-lot variation).31 In a study, 4 test strip lots for each of five different BG systems were evaluated, including measurement results ranging from <l mg/dL to >400 mg/dL. The maximum lot-to-lot divergence between any 2 of the 4 evaluated test strip lots per BG system plant ranged between 1.0% and 13.0%.31 Only one of the 5 systems accomplished at to the lowest degree 95% of the measurements within the accuracy limits of ISO 15197:2003 with each test strip lot.
A more recent written report, however, demonstrated that 7 of 9 systems fulfill the accuracy criteria of ISO 15197:2013,28 independent of the comparison measurement method applied. These systems showed, with all 3 tested lots, 95%-100% of results within ±0.83 mmol/Fifty (±15 mg/dL) and ±15% of the comparison measurement results at BG concentrations of <v.55 mmol/L (<100 mg/dL) and ≥five.55 mmol/Fifty (≥100 mg/dL).32
Due to a mandate from the European and US regulatory government, in the time to come 3 dissimilar test strip lots will accept to be included in the accuracy evaluation of BG systems,32 every bit required by ISO 15197:2013.28
Small strip-to-strip variation and vial-to vial variation may occur due to the manufacturing process. For instance, small variations in the reaction well size and/or loss of enzyme coverage may influence the accuracy of BG systems besides every bit reduction of the mediator.23
The activity of the 2 enzymes employed for BG measurement, glucose oxidase (Go) and glucose dehydrogenase (GD) was reported to be potentially susceptible of interference by other substances. GD, notwithstanding, seems less susceptible.33
Environmental Factors
Temperature and Humidity
Like every biochemical process, the exam strip reaction during glucose measurement is influenced by temperature.34 Therefore, BG measurements with currently available test strips is temperature-dependent. BG operation under conditions that do not comply with the approved usage may result in erroneous BG measurements. For this reason, patients should be instructed to utilize BG systems inside the specified operating temperature range just.22 Nowadays, many modern BG systems have a congenital-in temperature sensor that utilizes the measured temperature to correct the glucose measurement result. Still, usually the temperature is measured inside the meter housing and not at the site of the glucose reaction on the exam strip. The temperatures between the meter itself and the tests strip can exist quite dissimilar. A study on 9 SMBG systems available in Norway explored the impact of temperature changes on the accuracy of BG measurements.35 A alter from 5°C to room temperature immediately before measurement, produced upward discrepancies >5% in 4 of these SMBG systems. Conversely, after a rapid change from 30°C to room temperature, 4 of the 9 BG systems presented downward discrepancies >five%.35 A catamenia of acclimatization (upwards to 15-30 minutes) seemed to lessen these effects. A recently published study on v modern BG systems showed that compensating mechanisms within the system allowed a good performance at extreme loftier and low temperatures. Rapid extreme changes in temperature, all the same, may be associated with a time lag of express office from 15 to 30 minutes.36
Erroneous BG results may also result from inadequate correction parameters of the meter-internal temperature sensor due to differences in acclimatization time between meter and examination strip.22 Nonetheless, to a large degree, studies performed under extreme conditions exercise not comply with the approved conditions of usage and, therefore, poor performance at these off-label conditions cannot exist ascribed to the BG meters under review.
In addition, a study on POC testing devices with simulated field weather revealed the impact of extreme temperatures on test strips operation.37 After cold-stressing (−21°C) and heat-stressing (40°C) for upward to 4 weeks, glucose test strips showed an impaired operation, with falsely elevated results after heating and falsely decreased results after cooling.37 A study employing an ecology chamber was conducted to assess the bear upon of short-term exposure (15-60 minutes) to high temperature and humidity on POC glucose test strips (in original vial packaging) and BG meters performance.38 Fifty-fifty after a relatively short exposure (15 minutes) at 42ºC with 83% relative humidity, the tested BG systems produced significantly elevated BG results.38 Measurement discrepancies of 20 mg/dL (BG meter) and 13 mg/dL (exam strip) have been reported, the summed increment of 33 mg/dL can be assumed to potentially lead to inadequate handling decisions.38 Chiefly, as in the previous report, the conditions used in these studies were not in accordance with the approved weather condition for usage.
Another study explored the impact of midterm stress at high temperature and humidity by using an environmental bedroom for 50 days.39 Eight BG meters and their associated exam strips were tested for reliability using the appropriate glucose command solution. Test strip vials were opened every day to simulate real-life usage by patients. Glucose values were recorded at temperatures of 54-87°F (12-31°C) and humidity values ranging from 49% to 100%, resembling the environmental weather experienced by patients performing SMBG.39 High temperature and humidity, but mostly temperature were found to affect the reliability of many BG meters. For case, in 1 BG meter an increment in temperature of 33°F (xviii°C) resulted in a 37 mg/dL overestimation of BG. As stated above, such deviations can pb to significant errors in diabetes management.39 Erroneous BG measurements may particularly occur if BG meters are used under conditions which do not comply with the approved usage.
Altitude
Typical loftier altitude atmospheric condition include a decrease in partial force per unit area of oxygen (pO2), ambient temperature, and relative humidity. Various BG systems have been studied at high altitudes (>2000 1000) nether field as well as under controlled conditions.22 The analytical functioning of most tested BG systems was found to exist compromised by college altitudes, withal, unremarkably only at much higher than 2000 m elevations.twoscore-44 Both, nether- and overestimated BG values have been observed, beingness a relatively lowered pO2 the main reason for these measurement deviations.22 Under decreasing pO2 clinically relevant deviations with a gamble of treatment errors take been demonstrated with some meters,41,45 an effect normally related to increased BG readings. In a study conducted in Tanzania, 3 BG meters taken to Mt Kilimanjaro (>5800 m) showed BG readings of 50, 214, and 367 mg/dL on the same sample.40 Comparable results have been obtained in another study using a hypobaric bedchamber.41,45
Electromagnetic Radiation Emitted From Mobile Phones
Mobile phones emit electromagnetic radiations in the microwave range. A study was performed to evaluate potential furnishings of such waves on the functioning of BG systems.46 In 1 group of participants, blood samples within the normoglycemic range were analyzed in the absence and presence of a ringing mobile phone (located directly next to the BG system). A mean difference of 7.5 ± 4.eight mg/dL betwixt the ii measurements was calculated. In the control group, the mean difference between the two repeated measurements per participant in the absence of electromagnetic fields was 1.1 ± 0.9 mg/dL. In conclusion, electromagnetic interference from mobile phones has been reported to potentially impact the accuracy of abode BG meters. Therefore, the authors recommend the use of mobile phones at least 50 cm away from home BG meters.46
Physiological Factors
A range of physiological factors, such every bit peripheral blood perfusion, hematocrit, pO2, triglycerides, bilirubin, and uric acid, has been observed to potentially impact the operation of BG systems.18,33,47-50
A reduction in peripheral blood perfusion due to hypotension may affect a BG system's performance. In 2007 a review showed that glucose-1-dehydrogenase based POC devices likewise every bit Become-based BG meters may produce wrong results under such atmospheric condition.33 Particularly in critically ill patients, an incorrect diagnosis of hypoglycemia due to poor peripheral perfusion (eg, circulatory stupor) may be harmful.34 Peripheral hypoperfusion may result in an increased tissue glucose extraction and a lower glucose value in capillary in comparing to venous blood. Therefore, information technology is necessary to check whether a item BG meter has been labeled by the manufacturer for use with critically ill patients.
Accuracy of SMBG measurement may as well be affected by high or depression hematocrit values.18,23,33,34,51 Hematocrit levels outside the reference interval are reported to exist more prevalent than expected, even in Western countries.49,52 In general, low hematocrit values (< 35%) oftentimes outcome in too high readings, while an increase in hematocrit is associated with a subtract in BG readings.33,53 A study on 19 SMBG systems found that only a few meters were unaffected past hematocrit interference.49 Nevertheless, modern BG systems correcting automatically for hematocrit are considered to be less susceptible to high or low hematocrit.33
Triglycerides take up book, thereby decreasing the amount of glucose in the capillary book. As a consequence, high levels of triglycerides may result in falsely low BG readings.23
In BG systems utilizing Become-based test strips, the potential interference of pO2 has been reported.18,22,23,54,55 Oxygen acts every bit a competitor to the mediator by taking electrons from the enzyme. Therefore, loftier oxygen values (eg, in patients utilizing oxygen) may deliver falsely low BG readings. On the other mitt, low oxygen levels (eg, in patients with severe chronic obstructive pulmonary disease) might help deliver falsely high BG values.23,56 On the other hand, a study using GD test strips showed them not to be significantly affected by different oxygen force per unit area.54 With a GO-based measurement, however, an increment in pO2 to >100 Torr (eg, in critically ill patients receiving oxygen treatment) may consequence in a remarkable underestimation of BG values.22,54 An evaluation of five SMBG systems utilizing a GO enzyme reaction on test strips showed BG measurements to be affected by pO2 values < 45 and ≥ 150 mmHg in the claret sample.56
The practical relevance of these correlations is highlighted past an investigation of capillary claret samples obtained from the fingertips of 110 patients (31 with blazon ane diabetes mellitus, 69 with type two diabetes, 10 without diabetes, no astute serious diseases). A broad range of capillary pOii values was demonstrated to occur in daily clinical practice.57
Uric acid is a DNA degradation product, and as such, very loftier uric acid concentrations, exceeding 20 mg/dL, tin can be observed in patients under chemotherapy, radiation therapy, or cancers with rapid prison cell turnover, such as certain lymphomas.58
At very loftier levels, uric acid may be oxidized by the electrode, thereby potentially delivering falsely loftier BG results.23 This might entail a considerable clinical significance for patients suffering from severe gout. An extreme case is the clinical case of a 54-twelvemonth-onetime woman with diabetes and chronic kidney affliction who presented a singled-out hypoglycemic encephalopathy despite of BG readings > 160 mg/dL.59 Loftier uric acid and low hematocrit values accept been suggested to cause falsely high BG readings, thereby resulting in inappropriate therapeutic decisions.59
Medication-Related Factors
A number of different substances have been reported to interfere with BG measurement.17,51 A study on xxx substances—including,among others, acetaminophen (paracetamol), acetylsalicylic acid, various antibiotics, heparin, and warfarin—found glucose measurements of half-dozen handheld BG meters to be potentially affected by ascorbic acid, acetaminophen, dopamine, maltose, and mannitol.50 Depending on the BG system and substance, deviations both, up and down, could be demonstrated.
Acetaminophen is used by about 200 meg people worldwide; many acetaminophen-containing drugs are attainable without prescription.17 Elevated acetaminophen plasma levels may bear on BG measurements, causing inaccurately high BG results in certain electrochemical systems. Due to varying individual drug metabolization rates, no concrete acetaminophen threshold level for touch on BG results can be defined.17
Furthermore, presence of the glucose polymer icodextrin has been observed to potentially impact BG meter functioning.60 Icodextrin is employed to amend ultrafiltration in peritoneal dialysis. During peritoneal dialysis, twenty%-30% of icodextrin is absorbed into the systemic circulation and metabolized to oligosaccharides such as maltose.threescore Both GO- and GD-based measurement technologies, are reported to be susceptible to interference with icodextrin metabolites, leading to overestimations of BG.60 Conversely, falsely low BG readings may effect in presence of high bilirubin levels or in monoclonal gammopathies.33
Practical Consequences
Modern BG systems complying with ISO 15197:2013 accuracy criteria28 operate reliably under controlled conditions.32 Withal, a diversity of potential error sources must exist taken into account under daily life atmospheric condition. Erroneous BG readings may result in contraindicated treatment decisions.61,62 Small measurement errors might non affect insulin dosing. However, if they are big, clinically relevant insulin doses might be administered.61 Fifty-fifty relatively small measurement errors may add upwardly to a substancial total deviation (Figure 1). Yet, it is possible that erroneous readings residuum each other out (Figure 2). This implies that possible mistake sources should exist eliminated as comprehensively every bit possible.
Relatively small divergences may sum up to a substancial full divergence of −35 mg/dL.
Deviations may also remainder themselves, resulting in a full deviation of only +5 mg/dL.
Error sources which tin can directly be influenced by the user are, for example, utilization of expired test strips, contamination of the test finger with glucose containing fluids, inappropriate hand washing, bereft blood sample or, in general, failure to comply with operating instructions. Meter-inherent factors commonly are beyond user'due south control. These considerations should exist kept in listen with respect of selection of BG meters too every bit user education.
Selection of BG Meters
BG systems adherent to established standards, such equally ISO 15197:2013,28 accept a greater probability of providing reliable BG values.32 ISO 15197:2013 requirements include the evaluation of influential values, such as hematocrit. Moreover, the use of BG systems which do not need scale by the user ("no-coding" BG systems) may contribute to a reduction in handling errors.28
User-friendly BG systems, providing high accuracy and depression susceptibility to potential disturbance factors, should be preferred. In addition, there is a demand for consummate, comprehensible, and articulate information in the labeling, for instance, virtually an oxygen dependency, operational limits or storage nether extreme weather condition, such as high and low temperature and humidity.22,37 It is pertinent to note, however, that many patients (and members of the diabetes team) do not carefully read the instructions for advisable apply.
Adequate Teaching of Patients and Diabetes Team
To provide reliable BG results, even BG systems with loftier analytical operation require correct handling and appropriate measurement weather condition. Inadequate education has been identified equally a leading crusade of bad SMBG operation.25 Thus, patients need appropriate teaching in the right performance of SMBG as well as for handling and storage of exam strips. Teaching must also include careful interpretation of BG readings, since blind trust in exceptional results may produce wrong and fifty-fifty dangerous handling decisions.
Incidentally, adequate information on physiological and medication factors with a potential impact on BG readings needs to be provided. In addition, at least during grooming time earlier a stay under extreme environmental atmospheric condition, acceptable data on potential physical disturbing factors. For example, patients with diabetes planning activities at loftier altitude should check whether their BG system is proven not to be affected by high distance. At the very to the lowest degree, a careful interpretation of BG readings at high altitude is recommended.17
People with diabetes should too be aware of the possible influence of farthermost temperature variations. Especially when using BG systems without a specific technology for preventing temperature touch on, patients are recommended to perform SMBG not earlier than 15-20 minutes afterwards a substantial shift in temperature.22
Conclusion
Adequate treatment and storage of BG systems inclusive of exam strips, equally well equally proper operation of the quantifying process are mandatory prerequisites for reliable SMBG results. In addition, erroneous BG measurement can be a outcome of physiological, environmental, and medication factors. To avoid clinical risks in response to such incorrect results, appropriate patient education and diabetes direction squad training are mandatory.
Footnotes
Abbreviations: BG, blood glucose; GD, glucose dehydrogenase; Become, glucose oxidase; ISO, International System for Standardization; POC, point-of-care; pOii, partial pressure level of oxygen; SMBG, cocky-monitoring of blood glucose.
Annunciation of Conflicting Interests: The author(due south) declared the following potential conflicts of involvement with respect to the research, authorship, and/or publication of this article: RH is an employee of Roche Diabetes Care GmbH, Mannheim, Germany. GF, BK, RZ, LH, and Bone are members of national and international advisory boards of Roche Diabetes Intendance GmbH, Mannheim, Frg
Funding: The author(s) disclosed receipt of the following fiscal back up for the enquiry, authorship, and/or publication of this commodity: The generation of the manuscript was supported by an unrestricted grant of Roche Diabetes Care GmbH, Mannheim, Germany
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Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5032951/