Evaluating the influence of hematocrit: comparison of three POCT devices pursuant to ISO 15197 guidelines. (Preprint)

2021 ◽  
Author(s):  
Matthes Kenning ◽  
Anselm Puchert ◽  
Eckhard Salzsieder
Keyword(s):  
Blood Glucose ◽  
Health Care Professionals ◽  
Glucose Monitoring ◽  
Clinical Importance ◽  
Blood Glucose Monitoring ◽  
Glucose Levels ◽  
Continuous Quality ◽  
Blood Glucose Levels ◽  
Reference Device ◽  
Personal Use

BACKGROUND Maintaining normal blood glucose levels in diabetes therapy is fundamentally linked to precise and accurate blood glucose measurements. In the light of interfering quantities like various substances or hematocrit, these aspects are of utmost clinical importance within a standardized validation of blood glucose monitors for personal use as well as a continuous quality assessment. OBJECTIVE Continuous and independent quality assurance of aspects affecting a blood glucose monitoring system’s performance. METHODS The influence of the hematocrit on the performance of three blood glucose monitors was assessed in accordance with ISO 15197 and sponsor’s requirements. RESULTS Only one device showed acceptable deviations of ≤ 10 mg/dL / 10 % to the reference device across the entire range. The other devices showed minor to clinically relevant interferences, particularly in response to higher hematocrit values. CONCLUSIONS Suitable BGM systems should be selected carefully by health care professionals and patients, especially with medical conditions known to interfere with blood glucose measurements.

scholarly journals A Review of Non-Invasive Optical Systems for Continuous Blood Glucose Monitoring

Sensors ◽  
2021 ◽  
Vol 21 (20) ◽  
pp. 6820
Author(s):  
Bushra Alsunaidi ◽  
Murad Althobaiti ◽  
Mahbubunnabi Tamal ◽  
Waleed Albaker ◽  
Ibraheem Al-Naib
Keyword(s):  
Blood Glucose ◽  
Glucose Monitoring ◽  
Daily Basis ◽  
Glucose Sensing ◽  
Blood Glucose Monitoring ◽  
Optical Systems ◽  
Glucose Levels ◽  
Non Invasive ◽  
Blood Glucose Levels ◽  
Continuous Blood Glucose Monitoring

The prevalence of diabetes is increasing globally. More than 690 million cases of diabetes are expected worldwide by 2045. Continuous blood glucose monitoring is essential to control the disease and avoid long-term complications. Diabetics suffer on a daily basis with the traditional glucose monitors currently in use, which are invasive, painful, and cost-intensive. Therefore, the demand for non-invasive, painless, economical, and reliable approaches to monitor glucose levels is increasing. Since the last decades, many glucose sensing technologies have been developed. Researchers and scientists have been working on the enhancement of these technologies to achieve better results. This paper provides an updated review of some of the pioneering non-invasive optical techniques for monitoring blood glucose levels that have been proposed in the last six years, including a summary of state-of-the-art error analysis and validation techniques.

scholarly journals The dynamics of invasive and noninvasive blood glucose monitoring methods: Recent trends

2016 ◽  
Vol 19 (5) ◽  
pp. 397-405 ◽  
Author(s):  
Alina Yur'evna Babenko ◽  
Yulia Alexeevna Kononova ◽  
Alexandr Ivanovich Tsiberkin ◽  
Michail Konstantinovich Khodzitsky ◽  
Elena Nilkolaevna Grineva
Keyword(s):  
Blood Glucose ◽  
Blood Glucose Control ◽  
Glucose Monitoring ◽  
Cost Effective ◽  
Disease Status ◽  
Accurate Method ◽  
Blood Glucose Monitoring ◽  
Monitoring Methods ◽  
Glucose Levels ◽  
Blood Glucose Levels

Improved prognoses of patients with type 2 diabetes are primarily determined by the extent of blood glucose control (correction of both hyper- and hypoglycemia and normalization of blood glucose levels). The proper identification and timely correction of abnormal blood glucose levels require frequent blood glucose monitoring by the patient. Currently used methods for the self-monitoring of blood glucose have significant drawbacks that limit their use. The most significant problems with these methods include insufficient accuracy, invasiveness and high cost, leading to noncompliance and difficult assessment of disease status. Such factors underscore the need for a noninvasive, cost-effective and highly accurate method to measure blood glucose levels. There are several different approaches for the noninvasive measurement of blood glucose levels, including optical analysis, ultrasound and bioimpedance. The concept of a noninvasive glucometer was launched more than 30 years ago. Nevertheless, most noninvasive technologies are still in early stages of development and are not used in clinical practice. This review describers the most promising developments in this area.

Performance of Seven Blood Glucose Testing Systems at High Altitude

1989 ◽  
Vol 15 (5) ◽  
pp. 444-448 ◽  
Author(s):  
Beverlyp. Giordano ◽  
Wayne Thrash ◽  
Laura Hollenbaugh ◽  
William P. Dube ◽  
Carol Hodges ◽  
...  
Keyword(s):  
Blood Glucose ◽  
High Altitude ◽  
Health Care Professionals ◽  
System Performance ◽  
Glucose Monitoring ◽  
Blood Glucose Monitoring ◽  
Monitoring Systems ◽  
Glucose Levels ◽  
Glucose Testing ◽  
Blood Glucose Testing

Consumers and health care professionals expect blood glucose monitoring systems to consistently generate results that are close to actual blood glucose levels. Numerous environmental, physiologic, and operational factors can affect system performance, yielding results that are inaccurate or unpredictable. This study examined the effect of one factor—high altitude—on the performance of seven blood glucose monitoring systems. One of the systems overestimated blood glucose results; the other six systems underestimated blood glucose values (more than the expected variance). The findings of this study support previous reports of altered blood glucose monitoring system performance at high altitude. Diabetes educators can use this information when counseling consumers who reside or who plan to visit locations at high altitude.

scholarly journals Glycemic deviation index: a novel method of integrating glycemic numerical value and variability

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yizhou Zou ◽  
Wanli Wang ◽  
Dongmei Zheng ◽  
Xu Hou
Keyword(s):  
Blood Glucose ◽  
Glucose Monitoring ◽  
Glycemic Variability ◽  
Blood Glucose Monitoring ◽  
Diabetic Patients ◽  
Glucose Levels ◽  
Blood Glucose Levels ◽  
Deviation Index ◽  
Multiple Characteristics ◽  
Novel Method

Abstract Background There are many continuous blood glucose monitoring (CGM) data-based indicators, and most of these focus on a single characteristic of abnormal blood glucose. An ideal index that integrates and evaluates multiple characteristics of blood glucose has not yet been established. Methods In this study, we proposed the glycemic deviation index (GDI) as a novel integrating characteristic, which mainly incorporates the assessment of the glycemic numerical value and variability. To verify its effectiveness, GDI was applied to the simulated 24 h glycemic profiles and the CGM data of type 2 diabetes (T2D) patients (n = 30). Results Evaluation of the GDI of the 24 h simulated glycemic profiles showed that the occurrence of hypoglycemia was numerically the same as hyperglycemia in increasing GDI. Meanwhile, glycemic variability was added as an independent factor. One-way ANOVA results showed that the application of GDI showed statistically significant differences in clinical glycemic parameters, average glycemic parameters, and glycemic variability parameters among the T2D groups with different glycemic levels. Conclusions In conclusion, GDI integrates the characteristics of the numerical value and the variability in blood glucose levels and may be beneficial for the glycemic management of diabetic patients undergoing CGM treatment.

Evaluation of Nursing Work Effort and Perceptions About Blood Glucose Testing in Tight Glycemic Control

2006 ◽  
Vol 15 (4) ◽  
pp. 370-377 ◽  
Author(s):  
Daleen Aragon
Keyword(s):  
Blood Glucose ◽  
Glycemic Control ◽  
Glucose Monitoring ◽  
Tight Glycemic Control ◽  
Blood Glucose Monitoring ◽  
Glucose Levels ◽  
Glucose Testing ◽  
Intravenous Insulin ◽  
Blood Glucose Levels ◽  
Blood Glucose Testing

• Background Tight glycemic control is important in critically ill patients and involves insulin infusions and monitoring of blood glucose levels. Hourly measurements of blood glucose levels and adjustments of intravenous insulin doses require additional work by nurses. • Objectives To evaluate the nursing work incurred with and nursing perceptions about tight glycemic control and blood glucose monitoring. • Methods A variety of intensive care units were studied. Surveys were used to gain information about nurses’ perceptions. Time-in-motion observations were used to determine the time taken to measure blood glucose levels and adjust insulin doses. • Results Nurses thought that tight glycemic control was important and that the work associated with it was substantial. Nurses thought that easier and automated forms of blood glucose monitoring are needed. They preferred using an arterial catheter to obtain blood samples to avoid excessive finger sticks. The total number of blood glucose measurements was 77 954. The mean time taken for hourly blood glucose monitoring and adjustment of insulin doses was 4.72 minutes. The estimated costs of time spent on glycemic control during a 1-year period were $182 488 for nurses’ salaries and $58 500 for supplies. • Conclusions Although most nurses endorse tight glycemic control, the work associated with it is burdensome and costly. Because up to 2 hours might be required for tight glycemic control for a single patient in a 24-hour period, the costs in time and money are high. Easier clinical methods for monitoring blood glucose levels are needed.

scholarly journals Phantoms for Development of Microwave Sensors for Noninvasive Blood Glucose Monitoring

2015 ◽  
Vol 2015 ◽  
pp. 1-5 ◽  
Author(s):  
Jan Vrba ◽  
Jakub Karch ◽  
David Vrba
Keyword(s):  
Blood Glucose ◽  
Microstrip Antenna ◽  
Glucose Monitoring ◽  
Physiological Saline ◽  
Blood Glucose Monitoring ◽  
Glucose Levels ◽  
Blood Glucose Levels ◽  
Microwave Sensor ◽  
Microwave Sensors

A suitability of two different liquid phantoms of blood-glucose solutions as phantoms for development of microwave sensors for noninvasive blood glucose monitoring is compared. The two phantoms are physiological saline-glucose and pig blood-glucose solutions. For this purpose a simple microwave sensor is developed for in vitro monitoring of blood glucose levels. The sensor consists of a microstrip antenna and of a small rectangular container on the top of the antenna. The container is filled with one of the liquid phantoms. Both phantoms with different glucose concentrations ranging from 0 to 500 mg/dL are considered. Dependence of sensor’s resonant frequency on glucose concentration of LUTs is both estimated by aid of numerical simulations and measured. The results are discussed and compared with some results reported in the literature.

Fluid and Glucose

2021 ◽  
pp. 227-256
Keyword(s):  
At Risk ◽  
Blood Glucose ◽  
Glucose Monitoring ◽  
Oral Feeding ◽  
Blood Glucose Monitoring ◽  
Dextrose Solution ◽  
Glucose Levels ◽  
Blood Glucose Levels ◽  
Oral Doses ◽  
Intravenous Dextrose

The fluid and glucose chapter focuses primarily on unwell newborns who need early blood glucose monitoring for hypoglycemia and immediate stabilization with intravenous dextrose solution. But infants can be at risk for low blood glucose for many reasons, and they too need specific attention and care, even when they are not symptomatic. Oral doses of dextrose gel may help to raise blood glucose levels, which also depend on whether an infant cannot feed or should not be fed (for any reason) and response to supplementation or managed oral feeding. Guidance includes glucose thresholds to aim for, determined by postnatal age, and testing intervals to expedite the normalization of blood glucose values. How to assess, measure, and anticipate fluid requirements in at-risk infants is explained in detail, and risks for hypoglycaemia, dehydration, and overhydration are considered. Two case scenarios examine different hypoglycaemia risks.

scholarly journals An IoT-Based Non-Invasive Glucose Level Monitoring System Using Raspberry Pi

2019 ◽  
Vol 9 (15) ◽  
pp. 3046 ◽  
Author(s):  
Antonio Alarcón-Paredes ◽  
Victor Francisco-García ◽  
Iris P. Guzmán-Guzmán ◽  
Jessica Cantillo-Negrete ◽  
René E. Cuevas-Valencia ◽  
...  
Keyword(s):  
Blood Glucose ◽  
Glucose Monitoring ◽  
Absolute Error ◽  
Blood Glucose Monitoring ◽  
Raspberry Pi ◽  
Glucose Levels ◽  
Non Invasive ◽  
Blood Glucose Levels ◽  
Artificial Neural Network Ann

Patients diagnosed with diabetes mellitus must monitor their blood glucose levels in order to control the glycaemia. Consequently, they must perform a capillary test at least three times per day and, besides that, a laboratory test once or twice per month. These standard methods pose difficulty for patients since they need to prick their finger in order to determine the glucose concentration, yielding discomfort and distress. In this paper, an Internet of Things (IoT)-based framework for non-invasive blood glucose monitoring is described. The system is based on Raspberry Pi Zero (RPi) energised with a power bank, using a visible laser beam and a Raspberry Pi Camera, all implemented in a glove. Data for the non-invasive monitoring is acquired by the RPi Zero taking a set of pictures of the user fingertip and computing their histograms. Generated data is processed by an artificial neural network (ANN) implemented on a Flask microservice using the Tensorflow libraries. In this paper, all measurements were performed in vivo and the obtained data was validated against laboratory blood tests by means of the mean absolute error (10.37%) and Clarke grid error (90.32% in zone A). Estimated glucose values can be harvested by an end device such as a smartphone for monitoring purposes.

scholarly journals Development of a graphic blood glucose monitoring chart for glycaemic control in diabetes mellitus: a modified Delphi method study

2019 ◽  
Vol 25 (4) ◽  
pp. 323-344
Author(s):  
Miriam Carole Atieno Wagoro ◽  
William Sudi Galo ◽  
Chris Podo Rakuom ◽  
Joseph Oderah Mirereh ◽  
Christine Musee
Keyword(s):  
Blood Glucose ◽  
Glycaemic Control ◽  
Delphi Method ◽  
Glucose Monitoring ◽  
Blood Glucose Monitoring ◽  
Monitoring Tool ◽  
Modified Delphi Method ◽  
Glucose Levels ◽  
Modified Delphi ◽  
Blood Glucose Levels

Background In Kenya 30% of patients admitted with ketoacidosis due to hyperglycaemia die within 48 hours of hospitalisation. Effective monitoring of blood glucose levels is critical for glycaemic control and prevention of mortality. Kenya public hospitals lack a graphic blood glucose monitoring tool. Aims To develop a graphic blood glucose monitoring tool. Methods Modified Delphi technique was used for consensus-building among nurses on the features of an appropriate blood glucose monitoring tool. A total of 150 nurses selected by purposive sampling participated in the study. Data were collected for 24 months through sequential interactive rounds and workshops using a questionnaire. At every round, consensus was reached if ≥75% of the nurses agreed or disagreed on a feature. Results A graphic blood glucose monitoring chart was developed with the following features: time on the x-axis, blood glucose values on the y-axis, colour codes corresponding to blood glucose levels, existing conditions during blood glucose measurement. Significance The chart may improve glycaemic control while stimulating further research on its effectiveness. Conclusion Modified Delphi method is useful for successive collation of judgments of nurse experts in the development of a graphic blood glucose monitoring chart.

A Comparative Evaluation of Bedside Capillary Blood Glucose Monitoring Devices Designed for Hospital Use

1995 ◽  
Vol 21 (5) ◽  
pp. 420-425 ◽  
Author(s):  
Patricia L. Johnson ◽  
Robyn J. Luther ◽  
Shelia Hipp ◽  
Michael Stegeman ◽  
Andrew J. Green
Keyword(s):  
Blood Glucose ◽  
Entire Range ◽  
Glucose Monitoring ◽  
Capillary Blood ◽  
Blood Glucose Monitoring ◽  
Reference Standard ◽  
Glucose Levels ◽  
Blood Glucose Levels ◽  
Accuracy And Precision ◽  
Monitoring Devices

Capillary blood glucose monitoring devices (CBGMs) that incorporate "wipeless" technology recently have been designed and marketed for hospital use. Our objective was to evaluate three such devices for accuracy and precision, comparing them to a popular device that utilizes older technology and to a reference standard. Blood glucose level was simultaneously determined on the CBGMs and a reference standard. Results were analyzed for precision by performing repeated measurements of a single sample and for accuracy across the entire range of determinations. Clinically relevant subsets of the entire range also were detemnined and arbitrarily defined as low (<60 mg/dL), normal (60 to 140 mg/dL), high (141 to 300 mg/dL), and very high (>300 mg/dL). We found that accuracy and precision of these devices varied considerably. Lack of accuracy was particularly evident upon analysis of the clinically relevant subset ranges of blood glucose levels. Consequently, routine evaluation of CBGMs should include analysis of clinically relevant subset ranges of blood glucose levels. The marked differences in accuracy and precision between CBGMs that are currently

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