scholarly journals Meeting the New FDA Standard for Accuracy of Self-Monitoring Blood Glucose Test Systems Intended for Home Use by Lay Users

2020 ◽  
Vol 14 (5) ◽  
pp. 912-916
Author(s):  
Laurence B. Katz ◽  
Lorna Stewart ◽  
Danielle King ◽  
Hilary Cameron
Keyword(s):  
Blood Glucose ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Over The Counter ◽  
Self Monitoring ◽  
Fda Guidance ◽  
Test Systems ◽  
Blood Glucose Test ◽  
Glucose Test ◽  
Blood Glucose Monitor

The OneTouch Verio Reflect blood glucose monitor (BGM) has market clearance in several countries based in part on fulfilling the lay user and system accuracy criteria described in ISO15197:2015. However, the Food and Drug Administration (FDA) does not recognize the accuracy criteria in ISO15197 as a basis for gaining regulatory clearance for these devices. The current study evaluates the BGM using the accuracy guidelines issued by the agency for self-monitoring blood glucose test systems for over-the-counter use. Glucose results were accurate vs comparator over a wide glucose range and met lay user and glucose accuracy criteria at extreme glucose values as described in the FDA guidance. Clinicaltrials.gov NCT03851549

scholarly journals Is it beneficial to the state to provide insulin-treated diabetic patients with public funds for self-monitoring blood glucose?

10.14341/7077 ◽  
2017 ◽  
Vol 20 (2) ◽  
pp. 108-118
Author(s):  
Larisa Dmitrievna Popovich ◽  
Marina Vladimirovna Shestakova ◽  
Elena Georgievna Potapchik ◽  
Alexander Yur'evich Mayorov ◽  
Olga Konstantinovna Vikulova
Keyword(s):  
Blood Glucose ◽  
Economic Burden ◽  
Economic Benefits ◽  
Diabetic Patients ◽  
Public Funds ◽  
Self Monitoring ◽  
Blood Glucose Test ◽  
Number Of Patients ◽  
Glucose Test ◽  
Two Measures

Background.In Russia, the prevalence of diabetes continues to increase with the growing diabetes epidemic. In recent years, the paradigm of diabetes treatment has been changing, with patients increasingly becoming equal participants in the treatment process, through the introduction of self-monitoring blood glucose (SMBG). Several clinical studies have demonstrated a positive relationship between SMBG and the decline of the epidemiological and economic burden of diabetes. At present, the procurement of public funds for SMBG is below the specified level in Russia. Aims.To investigate the potential macroeconomic benefits of public health resource allocation and the use of planned state investments to fund SMBG in insulin-treated diabetic patients. Materials and methods.This study was conducted with data from insulin-treated diabetic patients. The epidemiological burden of this cohort was determined by the following indicators: the number of patients and the incidence of complications resulting from diabetes, disability, mortality, age and sex. The economic benefits were evaluated by the implementation of two measures: (1) procurement of public funds for the purchase of means for SMBG in patients with insulin-treated diabetes and (2) the use of highly accurate blood glucose metres. To evaluate economic burden, the epidemiological burden was translated into monetary terms using cost-of-illness. Economic benefits were defined as reductions in economic burden. Results.The economic benefits of public-funded blood glucose test strips for insulin-treated diabetic patients exceeded the required additional investments for their purchase by 1.5 fold. A significant reduction in the inaccuracy of blood glucose metres from 20% to 10% may reduce the economic burden by 9.36 billion RUB. The combined state benefits from the implementation of both measures would significantly decrease the economic burden of diabetes to 29.2 billion RUB. Conclusions. Increased procurement of public funds for SMBG in insulin-treated diabetic patients would bring economic benefits that far exceed the required investments.

Evaluation of the performance of the OneTouch Select®Plus blood glucose test system against ISO 15197:2013

2015 ◽  
Vol 12 (6) ◽  
pp. 771-781 ◽  
Author(s):  
Steven Setford ◽  
Antony Smith ◽  
David McColl ◽  
Mike Grady ◽  
Krisna Koria ◽  
...  
Keyword(s):  
Blood Glucose ◽  
Test System ◽  
Blood Glucose Test ◽  
Glucose Test

scholarly journals Comparison between the QRMA Measurement with the Anamnesis and the Capillary Blood Glucose Test

Jurnal NERS ◽  
2020 ◽  
Vol 14 (2) ◽  
pp. 224
Author(s):  
Muflih Muflih ◽  
Suwarsi Suwarsi ◽  
Fajarina Lathu Asmarani
Keyword(s):  
Blood Glucose ◽  
Blood Glucose Level ◽  
Blood Sugar ◽  
Glucose Level ◽  
Blood Sugar Level ◽  
Capillary Blood ◽  
Capillary Blood Glucose ◽  
Blood Glucose Test ◽  
Significant Difference ◽  
Glucose Test

ABSTRACTIntroduction: The examination of patients with diabetes mellitus (DM) can be done by reviewing their complaints and through a capillary blood glucose level test to determine the value of their Random Blood Glucose Level. QRMA (Quantum Resonance Magnetic Analyzer) is claimed to be able to check the patient’s bodily condition (including blood glucose) with an accuracy of 85%. The purpose of this study was to verify the validity of the QRMA tool and its accuracy by comparing the results of the anamnesis and the examination conducted using the capillary blood glucose test method.Methods: The research method used was a cross-sectional design. The total sample consisted of 44 respondents in the working area of the Community Health Centers in Yogyakarta with the risk factor being blood sugar level instability. The sampling technique used was purposive sampling. The main variable in this study was the value of the blood sugar level measured based on the coefficient value of the QRMA tool and the value of Random Blood Glucose obtained through the capillary blood glucose test.Results: The blood glucose value was not correlated significantly with the coefficient value of QRMA. The value of blood glucose when examined alongside the result of the respondent's anamnesis showed there to be a significant difference. The value of the QRMA coefficient when examined against the results from the history of the respondents showed no significant difference. Linear regression showed that the variables of height, body weight, and IMT had a correlation with the QRMA coefficient value.Conclusion: The QRMA tool was not able to provide a picture of the actual condition of the blood glucose level of the respondents when compared with the results of the anamnesis and the blood glucose value from the capillary blood glucose test. Non-invasive health measurement devices such as QRMA are not used by nurses as a standard for determining the health status of DM patients.

scholarly journals Factors Associated with Adherence to Blood Glucose Test among Diabetes Mellitus Patients at Prof. Dr. W. Z. Johannes Hospital, Kupang

2016 ◽  
Vol 01 (01) ◽  
pp. 12-19
Author(s):  
Dessy Nelciani Timuneno ◽  
◽  
Deviarbi Sakke Tira ◽  
Imelda F. E Manurung ◽  
Keyword(s):  
Diabetes Mellitus ◽  
Blood Glucose ◽  
Factors Associated ◽  
Blood Glucose Test ◽  
Glucose Test

Evaluation of a Continuous Blood Glucose Monitor: A Novel and Non-Invasive Wearable Using Bioimpedance Technology

2021 ◽  
pp. 193229682110541
Author(s):  
Farid Sanai ◽  
Arshman S. Sahid ◽  
Jacqueline Huvanandana ◽  
Sandra Spoa ◽  
Lachlan H. Boyle ◽  
...  
Keyword(s):  
Mathematical Model ◽  
Blood Glucose ◽  
Real World ◽  
Diabetes Management ◽  
Glucose Monitoring ◽  
Relative Difference ◽  
Self Monitoring ◽  
Non Invasive ◽  
Adult Participants ◽  
Blood Glucose Monitor

Background: Frequent blood glucose level (BGL) monitoring is essential for effective diabetes management. Poor compliance is common due to the painful finger pricking or subcutaneous lancet implantation required from existing technologies. There are currently no commercially available non-invasive devices that can effectively measure BGL. In this real-world study, a prototype non-invasive continuous glucose monitoring system (NI-CGM) developed as a wearable ring was used to collect bioimpedance data. The aim was to develop a mathematical model that could use these bioimpedance data to estimate BGL in real time. Methods: The prototype NI-CGM was worn by 14 adult participants with type 2 diabetes for 14 days in an observational clinical study. Bioimpedance data were collected alongside paired BGL measurements taken with a Food and Drug Administration (FDA)-approved self-monitoring blood glucose (SMBG) meter and an FDA-approved CGM. The SMBG meter data were used to improve CGM accuracy, and CGM data to develop the mathematical model. Results: A gradient boosted model was developed using a randomized 80-20 training-test split of data. The estimated BGL from the model had a Mean Absolute Relative Difference (MARD) of 17.9%, with the Parkes error grid (PEG) analysis showing 99% of values in clinically acceptable zones A and B. Conclusions: This study demonstrated the reliability of the prototype NI-CGM at collecting bioimpedance data in a real-world scenario. These data were used to train a model that could successfully estimate BGL with a promising MARD and clinically relevant PEG result. These results will enable continued development of the prototype NI-CGM as a wearable ring.

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