Portable Glucose Meter Research Articles

The using status quo and analysis of POCT glucose meter

Objective To investigate the problems during using, standard and quality management of the POCT glucose meters in hospital, to analyze the solutions, and to provide reference data for improving the test level of POCT in hospital. Methods The amount, brand and application of portable glucose meters in the hospital were obtained by 3 rounds of surveillance from May to July in 2013. All of those glucose meters were taken part in external quality assessment of Clinical Laboratory Center of National Health and Family Planning Commission. The test results of those glucose meters were compared with that of automatic biochemical analyzer, the comparison results were then analyzed. Results The POCT glucose meters possessed 5 brands in our hospital, and the amount and type of glucose meters in some clinical departments were often changed. When 4 brands which were detected as quality control samples by ministry of health, the accuracy of detection results of 3 concentration of brand Ⅲ were substandard, the CV% of two levels were 11.9% and 10.1% respectively, the remaining 3 brands were in line with the requirements. The qualified percentages of 3 times of comparison were 85.0%, 92.0% and 97.4%. Conclusions The hospital should select the brand of portable glucose meters reasonably, correct use of glucose meters, and it is very necessary to build indoor and interstitial quality evaluation system, at the same time, suggesting the hospital to establish the POCT quality management team, to carry out the instrument comparison periodically, so to guarantee the accurate, reliable results of POCT in hospital.(Chin J Lab Med, 2016, 39: 643-645) Key words: Glucose tolerance test; Monitoring, ambulatory; Point-of-care systems; Quality assurance, health care

Diagnosis of prediabetes in cats: glucose concentration cut points for impaired fasting glucose and impaired glucose tolerance

Diabetes is typically diagnosed in cats once clinical signs are evident. Diagnostic criteria for prediabetes in cats have not been defined. The objective of the study was to establish methodology and cut points for fasting and 2-h blood glucose concentrations in healthy client-owned senior cats (≥8 yr) using ear/paw samples and a portable glucose meter calibrated for feline blood. Of the 78 cats, 27 were ideal (body condition score [BCS] 4 or 5 of 9), 31 overweight (BCS 6 or 7), and 20 obese (BCS 8 or 9); 19 were Burmese and 59 non-Burmese. After an 18–24-h fast and an ear/paw blood glucose measurement using a portable glucose meter, glucose (0.5 g/kg bodyweight) was administered intravenous and blood glucose measured at 2 min and 2 h. Cut points for fasting and 2-h glucose concentrations were defined as the upper limits of 95% reference intervals using cats with BCS 4 or 5. The upper cut point for fasting glucose was 6.5 mmol/L. Of the overweight and obese cats, 1 (BCS 7) was above this cut point indicating evidence of impaired fasting glucose. The cut point for 2-h glucose was 9.8 mmol/L. A total of 7 cats (4 with BCS 8 or 9 including 1 Burmese; 3 with BCS 6 or 7, non-Burmese) were above this cut point and thus had evidence of impaired glucose tolerance. In conclusion, the methodology and cutpoints for diagnosis of prediabetes are defined for use in healthy cats 8 yr and older with a range of BCSs.

Glucose encapsulating liposome for signal amplification for quantitative detection of biomarkers with glucometer readout.

A new technology was developed to quantitatively detect a broad range of disease biomarkers and proven to be portable, economical, and conveniently accessible. Measurements were performed based on releasing encapsulated glucose from antibody-tagged liposomes and subsequently detecting the released glucose using a commercial personal glucose meter (GM). The innovative aspect of this approach lies in the quantification of target biomarkers through the detection of glucose, thus expanding the applicability of the GM by broadening the range of target biomarkers instead of detecting only one analyte, glucose. Because of the bilayer membrane of liposomes, which can accommodate tens of thousands of glucose molecules, the sensitivity was greatly enhanced by using glucose encapsulating liposomes as a signal output and an amplifier. Here, the model analyte, protein 53 phosphorylated on Serine 15 (phospho-p53(15)), was captured by primary antibodies bound on magnetic Fe3O4 nanoparticles and then recognized by reporting antibodies conjugated to glucose encapsulating liposomes. Finally, the target phospho-p53(15) was detected by lysing the bound liposomes to release the encapsulated glucose (4 × 10(5) glucose molecules per liposome), which is detected with the GM. This approach was demonstrated to be a universal technology that can be easily produced to quantify a wide variety of biomarkers in medical diagnostics, food safety, public health, and environmental monitoring. In the near future, it is expected that these sensors, in combination with a portable GM, can be used in many fields such as physicians' laboratories, hospitals and the common household.

Hypoglycemia in type 2 diabetes patients treated with insulin: the advantages of continuous glucose monitoring

Aims. To determine the incidence and risk factors for hypoglycemia in elderly insulin-treated type 2 diabetes mellitus (T2DM) patients by means of continuous glucose monitoring (CGM). Materials and Methods. We observed seventy-six hospitalized patients with T2DM, aged 65 to 79 years. Treatment with basal insulin (n=36), premixed insulin (n=12) or basal-bolus insulin regimen (n=28) was followed by metformin (n=44), glimepiride (n=14) and dipeptidyl peptidase-4 inhibitors (n=14). 2-days CGM with retrospective data analysis was performed in all patients. During CGM, three fasting and three 2-h postprandial finger-prick glucose values were obtained daily with portable glucose meter. Results. Hypoglycemia (identified as blood glucose

Nanoparticle-based pseudo hapten for target-responsive cargo release from a magnetic mesoporous silica nanocontainer.

A novel homogeneous immunoassay method is developed for sensitive monitoring of small molecular biotoxin by using a portable personal glucose meter (PGM) based on the target-responsive release of cargo (glucose) from a polystyrene microsphere-gated magnetic mesoporous nanocontainer.

Clinical value of blood glucose measurement in pet rabbits

Blood glucose was measured with a portable glucose meter in 907 rabbits, including 238 clinically healthy ones. Blood glucose concentrations ranged from 1.2 to 30.1 mmol/l. Diabetes mellitus was not...

Accuracy of a portable glucose meter and of a Continuous Glucose Monitoring device used at home by patients with type 1 diabetes

BackgroundPatients with diabetes are recommended to self-monitor their blood glucose levels also at home. Accuracy of a hand-held glucometer and a Continuous Glucose Monitoring (CGM) device were comparatively evaluated. MethodsVenous blood samples (for reference laboratory determinations; n=428) were collected from 18 type 1 patients (35–65years old), immediately followed by capillary measurement (Bayer ContourLink meter) and CGM readings (Medtronic Paradigm). ResultsLaboratory values did not differ statistically from ContourLink and CGM readings, mean difference (±SD) being −0.05±1.06mmol/L and 0.10±1.84mmol/L glucose, respectively. A bias ((value−reference)/reference×100) ≥15% was observed in 27.7% and 54.9% of cases, respectively. Notably, below 3.9mmol/L glucose (hypoglycemic threshold), an absolute error>0.8mmol/L was found in 78.9% and 94.1% of cases. The absolute errors of the CGM device were inversely related to the rate of glucose change (r=0.598, p<0.001). ConclusionsA very large error was observed at the extreme glycemic values, which may lead to erroneous therapy. Consequently, performance of future portable glucometers should be focused in particular under hypo- and hyper-glycemia. Moreover, integrated CGM devices should not disregard the effect of the rate of blood glucose change on the sensor readings.

Evaluation of a portable glucose meter for use in cattle and sheep

In farm animal practice, determination of blood glucose concentration under field conditions is often necessary. As there is no portable glucose meter device developed for use in farm animals, the analytical accuracy of a portable glucometer designed for people was evaluated for its use in cattle and sheep. Blood samples from 90 cattle and 101 sheep were used in the study. Glucose concentration was determined in whole blood immediately after blood collection from the jugular vein with the One Touch Vita portable glucometer and in serum with an enzymatic colorimetric method. The agreement between methods was assessed by Passing and Bablok regression analysis. The precision and the accuracy of the measurements were determined using the concordance correlation coefficient. There was a strong linear relationship between the glucose values obtained using the portable glucometer and those obtained by the bench method in both cattle and sheep. Precision was 95% for cattle and 88% for sheep, whereas accuracy was 92% and 99%, respectively. The mean glucose values obtained using the portable glucometer were significantly lower by 8.3% in cattle and 3.2% in sheep than those determined by the bench method. The One Touch Vita portable glucometer can be used in clinical practice to determine blood glucose concentrations in cattle and sheep, but reference intervals (RI) must be corrected to allow for negative bias. Based on these equations the RI for blood glucose in cattle and sheep using the portable glucometer were corrected to 1.84-4.17 and 2.41-4.35 mmol/L, respectively.

Evaluation of hematocrit bias on blood glucose measurement with six different portable glucose meters

Measurement and monitoring of blood glucose levels in hospitalized patients with portable glucose meters (PGMs) is performed widely and is an essential part of diabetes monitoring, despite the increasing evidence of several interferences which can negatively bias the accuracy of measurements. The purpose of this study was to evaluate the effect of the hematocrit on the analytical performances of different PGMs as compared with a reference laboratory assay. The effect of various hematocrit values (approximiately 0.20, approximiately 0.45 and approximiately 0.63 L/L) were assessed in three whole blood specimens with different glucose concentration (approximiately 1.1, approximiately 13.3, and approximiately 25 mmol/L) by using six different commercial PGMs. The identical samples were also tested with the laboratory reference assay (i.e., hexokinase). The percentage difference from the laboratory assay (%Diff) was calculated as follows: % Diff = average PGM value - value from laboratory assay x 100 / value from laboratory assay. The %Diff of the six different PGMs were rather broad, and comprised between 56.5% and -34.8% in the sample with low glucose concentration (approximiately 1.1 mmol/L), between 40% and -32% in the sample with high glucose concentration (approximiately 13.3 mmol/L), and between -50% and 15% in the sample with very high glucose concentration (approximiately 25 mmol/L), respectively. It is also noteworthy that a very high hematocrit value (up to 0.63 L/L) generated a remarkable negative bias in blood glucose (-35%) as measured with the laboratory assay, when compared with the reference sample (hematocrit 0.45 L/L). The results of this analytical evaluation clearly confirm that hematocrit produces a strong and almost unpredictable bias on PGMs performances, which is mainly dependent on the different type of devices. As such, the healthcare staff and the patients must be aware of this limitation, especially in the presence of extreme hematocrit levels, when plasma glucose assessment with the reference laboratory technique might be advisable.

Reducing patient identification errors related to glucose point-of-care testing

Background: Patient identification (ID) errors in point-of-care testing (POCT) can cause test results to be transferred to the wrong patient’s chart or prevent results from being transmitted and reported. Despite the implementation of patient barcoding and ongoing operator training at our institution, patient ID errors still occur with glucose POCT. The aim of this study was to develop a solution to reduce identification errors with POCT. Materials and Methods: Glucose POCT was performed by approximately 2,400 clinical operators throughout our health system. Patients are identified by scanning in wristband barcodes or by manual data entry using portable glucose meters. Meters are docked to upload data to a database server which then transmits data to any medical record matching the financial number of the test result. With a new model, meters connect to an interface manager where the patient ID (a nine-digit account number) is checked against patient registration data from admission, discharge, and transfer (ADT) feeds and only matched results are transferred to the patient’s electronic medical record. With the new process, the patient ID is checked prior to testing, and testing is prevented until ID errors are resolved. Results: When averaged over a period of a month, ID errors were reduced to 3 errors/month (0.015%) in comparison with 61.5 errors/month (0.319%) before implementing the new meters. Conclusion: Patient ID errors may occur with glucose POCT despite patient barcoding. The verification of patient identification should ideally take place at the bedside before testing occurs so that the errors can be addressed in real time. The introduction of an ADT feed directly to glucose meters reduced patient ID errors in POCT.

Evaluation of a new portable glucose meter designed for the use in cats

Portable blood glucose meters (PBGMs) are useful in the management of diabetes mellitus in cats. In the present study we compared the performance of two PBGMs: the AlphaTRAK (Abbott Animal Health, Maidenhead, England) specifically developed for dogs and cats, and the Ascensia ELITE (Bayer HealthCare, Zurich, Switzerland) developed for humans. Quality parameters, including precision and accuracy, were better for the AlphaTRAK meter compared to Ascensia ELITE. While the AlphaTRAK meter results did not differ from the reference method, results from the Ascensia ELITE were significantly (P<0.001) lower. The superior performance of the AlphaTRAK meter supports its use to monitor blood glucose levels in cats.

Tight Glucose Control in Critically Ill Patients: Should Glucose Meters Be Used?

Measurement of blood glucose concentrations using portable, hand-held meters is used widely in patients with diabetes. Clinical settings include self-monitoring of blood glucose by patients, in doctors’ offices, in chronic care facilities, and in hospitals. More recently, evidence has emerged suggesting that tight glycemic control of nondiabetic patients in hospital intensive care units (ICUs)1 improves clinical outcomes. Based on this evidence, lowering blood glucose concentrations with insulin has become the standard of care in many ICUs and other hospital settings. In the vast majority of these patients, frequent measurements of blood glucose are performed with portable glucose meters, and the values are used to determine the dose of insulin. In this Q&A article, 5 experts in the field are asked to comment on the use of glucose meters in tight glycemic control. Greet Van den Berghe2 : This depends on the definition of “tight” and what is meant by “hospitalized.” Although there are numerous studies showing a strong association of both hyperglycemia and hypoglycemia with mortality in hospitalized patients (the nadir of the risk being associated with the “normal for age” fasting blood glucose range), the evidence from randomized controlled studies currently comes from those performed in ICU patients. The 3 studies that we performed in Leuven compared a “normal (fasting) for age” target for blood glucose [80–110 mg/dL (4.4–6.1 mmol/L) for adults, 70–100 mg/dL (3.9–5.6 mmol/L) for children, and 50–80 mg/dL (2.8–4.4 mmol/L) for infants] with a control group in which we assumed hyperglycemia to be a potentially beneficial adaptation. In the control group, we therefore used a “do not touch” approach unless glucose exceeded the renal threshold of 215 mg/dL (11.9 mmol/L). Blood glucose was measured with only 1 device, namely an ABL blood gas analyzer in the surgical and pediatric ICU studies and the HemoCue …

Post-analytical errors with portable glucose meters in the hospital setting

Point-of-care testing (POCT) for blood glucose is widely used in different clinical settings and, thanks to its rapid turnaround time (TAT), it is commonly recommended in patients with critical conditions calling for urgent monitoring. However data in the literature on its reliability and safety are scarce. The aim of the present study was therefore to investigate the type, frequency and clinical risks associated with POCT using portable glucose meters in the hospital setting by evaluating the post-analytical phase when the data are manually transcribed in patients' record. We checked all registrations performed by nurses of 2 selected wards of the hospital during a period of 30 consecutive days, identifying 1966 blood glucose determinations. We found that data obtained were often not reported in patients' files (12.1% of results are missed), the time of blood sampling was recorded in imprecise manner in 7.2% of cases and the glucose concentration was incorrectly reported in 3.2% of results. Although in the post-analytical phase the frequency of incomplete or incorrect data was high, no adverse events were found to be related to this type of error.

Using Portable Lactate and Glucose Meters for Catfish Research: Acceptable Alternatives to Established Laboratory Methods?

AbstractSimple and portable methods for assessing the physiological state of channel catfish Ictalurus punctatus would be valuable tools in field situations where problems with blood storage and transportation occur. This study compared the use of handheld lactate and glucose meters with established laboratory methods in stressed (fatigued) and unstressed (control) channel catfish fingerlings. The results obtained from the Accutrend (Roche Diagnostics Corp.) lactate meter and the Accu‐Chek Advantage (Roche Diagnostics) glucose meter were consistently lower (P &lt; 0.05) than those obtained with the laboratory reference method. However, significant differences (P &lt; 0.0001) were found between the control and fatigued fish for both lactate and glucose, regardless of the method of analysis. Both handheld meters were found to be reliable and suitable for use in field or laboratory situations where relative measurements are acceptable. The costs associated with using the handheld meters were higher than those associated with accepted laboratory methods; however, the initial capital investment was lower for the handheld meters. Ease of use, portability, and rapidity of sample analysis make the handheld meters attractive alternatives to traditional laboratory methods.

Evaluation of four portable self-monitoring blood glucose meters

Self-monitoring of blood glucose (SMBG) is a cornerstone of diabetes care. However, the effectiveness of any glucose-monitoring programme depends on the ability to integrate SMBG into a program of self-care and therapeutic decision-making. Because the accuracy of SMBG is instrument dependent, we analysed 45 heparinized whole blood specimens using four marketed portable glucose meters to evaluate whether their precision and accuracy would be efficient and safe for clinical use. All measurements were standardized and performed by a single expert health-care professional at the same clinical chemistry laboratory. Results were compared with those obtained on the same plasma samples by the hexokinase method on a secondary reference analyser and further analysed according to the error tolerance criteria and the current American Diabetes Association (ADA), Clinical Laboratory Improvement Amendments (CLIA), and National Committee for Clinical Laboratory Standards (NCCLS) guidelines. The within-run imprecision ranged from 2.2% to 3.2%. Passing and Bablok regression analysis yielded slope values from 0.93 to 1.07 and correlation coefficients between 0.994 and 0.998. When compared with the secondary reference analyser, mean variations were between -4.9% and 14.1%, fulfilling in three out of four cases the 5.5% current desirable analytical quality specifications for total error. Nevertheless, when considering the two standard deviations level of this bias, several results exceeded this limit. Although three out of four devices tested achieved or came closer to the NCCLS C30-A2, CLIA and error tolerance targets, none of them met the current analytical ADA thresholds. Despite the acceptable analytical performances, we demonstrated that standardization and harmonization of results in SMBG have not been fully achieved.

Improving Training in Laboratory Medicine

In this issue of Clinical Chemistry , we publish a proposal for curriculum content of residency training in laboratory medicine and for evaluation of resident competency (1). The proposal was developed by the Academy of Clinical Laboratory Physicians and Scientists (ACLPS) and covers residency training in all areas of laboratory medicine. Why have we chosen to publish this curriculum? Why did we publish the entire document, rather than just the portion related to clinical chemistry? Why is the curriculum important to the readers of Clinical Chemistry —particularly PhD and MD laboratory directors? In a broad sense, the first reason for publishing the document is that it represents a comprehensive, well-written template for curriculum content for training of residents in laboratory medicine. Because Clinical Chemistry is a leading journal in laboratory medicine, we know that many of those individuals who are responsible for training pathology residents are among our readers and are members of AACC, which publishes the journal. Now is an important time to address the curriculum of residency programs. As the authors of the curriculum document clearly state in their introduction, the field of laboratory medicine and training in pathology have changed dramatically since the last consensus recommendations were published in 1995 (2). At that time, routine molecular diagnostics was just beginning, the clinical use of pharmacogenomics was only being hinted at, “proteomics” consisted of 2-dimensional gels and serum protein electrophoresis, point-of-care testing was primarily portable glucose meters, and electronic medical records existed only in the VA system. Simultaneous to this explosion of knowledge and technology, the length of residency training in pathology was decreased by 1 year for both combined anatomic pathology/clinical …

New “plasma referenced” POCT glucose monitoring systems—are they suitable for glucose monitoring and diagnosis of diabetes?

Background Results from portable glucose meters should be reported as plasma values as recommended by IFCC. Three new “plasma calibrated” blood glucose meters (Abbott Precision Xcceed, Bayer Ascensia Contour and Roche Accu-Chek Aviva) were compared against laboratory venous plasma glucose measurements to determine their suitability for patient monitoring and diabetes diagnosis. Methods 115 capillary blood samples were analyzed on each of the three meters and compared to venous plasma measurements on the Dade Behring RXL analyzer (Hexokinase method). Results We found a significant positive bias of all meters compared to the laboratory reference method. Deviations of more than 10% were seen in more than a third of all glucose values in all three devices. 13%, 8.7% and 10.4%, respectively, of the values from the Abbott, Bayer and Roche devices fell in zone B or C of the Parkes' error grid. Conclusions Neither glucose meter met the ADA or the NACB goals and should therefore not be used as screening tests to diagnose diabetes but are well suitable for patient monitoring.

A Crucial Role of MafA as a Novel Therapeutic Target for Diabetes*♦

MafA, a recently isolated pancreatic beta-cell-specific transcription factor, is a potent activator of insulin gene transcription. In this study, we show that MafA overexpression, together with PDX-1 (pancreatic and duodenal homeobox factor-1) and NeuroD, markedly increases insulin gene expression in the liver. Consequently, substantial amounts of insulin protein were induced by such combination. Furthermore, in streptozotocin-induced diabetic mice, MafA overexpression in the liver, together with PDX-1 and NeuroD, dramatically ameliorated glucose tolerance, while combination of PDX-1 and NeuroD was much less effective. These results suggest a crucial role of MafA as a novel therapeutic target for diabetes.

Educational intervention together with an on-line quality control program achieve recommended analytical goals for bedside blood glucose monitoring in a 1200-bed university hospital

Portable meters for blood glucose concentrations are used at the patients bedside, as well as by patients for self-monitoring of blood glucose. Even though most devices have important technological advances that decrease operator error, the analytical goals proposed for the performance of glucose meters have been recently changed by the American Diabetes Association (ADA) to reach <5% analytical error and <7.9% total error. We studied 80 meters throughout the Virgen Macarena Hospital and we found most devices with performance error higher than 10%. The aim of the present study was to establish a new system to control portable glucose meters together with an educational program for nurses in a 1200-bed University Hospital to achieve recommended analytical goals, so that we could improve the quality of diabetes care. We used portable glucose meters connected on-line to the laboratory after an educational program for nurses with responsibilities in point-of-care testing. We evaluated the system by assessing total error of the glucometers using high- and low-level glucose control solutions. In a period of 6 months, we collected data from 5642 control samples obtained by 14 devices (Precision PCx) directly from the control program (QC manager). The average total error for the low-level glucose control (2.77 mmol/l) was 6.3% (range 5.5-7.6%), and even lower for the high-level glucose control (16.66 mmol/l), at 4.8% (range 4.1-6.5%). In conclusion, the performance of glucose meters used in our University Hospital with more than 1000 beds not only improved after the intervention, but the meters achieved the analytical goals of the suggested ADA/National Academy of Clinical Biochemistry criteria for total error (<7.9% in the range 2.77-16.66 mmol/l glucose) and optimal total error for high glucose concentrations of <5%, which will improve the quality of care of our patients.

Home monitoring of blood glucose concentrations by owners of diabetic dogs and cats

Generation of blood glucose curves is essential to monitor glycemic control in dogs and cats with diabetes mellitus. Up till now blood collection and blood glucose measurements could only be performed in a hospital. However, glucose concentrations measured in a hospital environment can markedly differ from concentrations measured at home, due to reduced appetite, different activity level and stressful handling. At the Clinic of Small Animal Internal Medicine, University of Zurich, a new method to collect capillary blood from the ear and to measure blood glucose by means of a portable glucose meter has been developed. This method enables owners of diabetic dogs or cats to determine blood glucose concentrations and generate blood glucose curves at home. Three cases demonstrate, how much blood glucose concentrations at home may differ from those in the hospital and how home monitoring can help to establish diabetic control in dogs and cats.