Evaluation of the Accuracy and Safety of a Portable Metabolic Heat Conformation-Based Non-invasive Glucose Meter: A Multicentre Clinical Study. (Preprint)

2021 ◽  
Author(s):  
Yuanmeng Xu ◽  
Ang Li ◽  
Chenyang Wu ◽  
Zhanxiao Geng ◽  
Junqing Zhang ◽  
...  

BACKGROUND Non-invasive blood glucose measurement is expected to be an ideal way for glucose monitoring, although most of the methods are under study and yet to be verified in large-scale clinical trials. OBJECTIVE We intend to evaluate the stability, accuracy of the metabolic heat conformation (MHC)-based non-invasive glucometer in a multicentre, self-controlled clinical trial. This device obtained the first medical device registration certificate awarded by the National Medical Products Administration of China (NMPA). METHODS The clinical study was conducted at three sites on 200 subjects who received glucose measurement with a non-invasive glucometer, the Contour Plus blood glucose monitoring system, and venous plasma glucose (VPG) measurements, in a fasted state and at 2 and 4 hours after meals. Trial Registration: ChiCTR1900020523. RESULTS The non-invasive and VPG measurements showed 93.9% (95% CI, 91.7–95.6%) of the values in zone A + B in a Consensus Error Grid. The measurements obtained in a fasted state and at 2 hours after meals are more accurate, with 99.0% and 97.0% of the values in zone A + B, respectively. The proportion of values in zone A + B and the correlation coefficients in subjects who did not receive insulin were 3.1% and 0.0596 higher than in those who received insulin. The accuracy of the non-invasive glucometer was influenced by the level of islet cell function and insulin resistance, which had a correlation coefficient with the MARD of -0.0961 (p=0.020) and -0.1577 (p=0.00012), respectively. CONCLUSIONS The MHC-based non-invasive glucometer demonstrates generally high stability and accuracy in the glucose monitoring of diabetic patients. The calculation model needs to be further explored and optimised for patients with different diabetes subtypes, levels of insulin resistance and insulin secretion capacity. CLINICALTRIAL the name of the trial registry : A multi-center study for evaluating the accuracy and safety of noninvasive glucose meter in people with diabetes or impaired glucose regulation (impaired fasting glucose and impaired glucose tolerance), using an experimental test system as a reference. registration number : ChiCTR1900020523 URL : https://www.chictr.org.cn/showproj.aspx?proj=33857

Author(s):  
Herbert Fink ◽  
Tim Maihöfer ◽  
Jeffrey Bender ◽  
Jochen Schulat

Abstract Blood glucose monitoring (BGM) is the most important part of diabetes management. In classical BGM, glucose measurement by test strips involves invasive finger pricking. We present results of a clinical study that focused on a non-invasive approach based on volatile organic compounds (VOCs) in exhaled breath. Main objective was the discovery of markers for prediction of blood glucose levels (BGL) in diabetic patients. Exhaled breath was measured repeatedly in 60 diabetic patients (30 type 1, 30 type 2) in fasting state and after a standardized meal. Proton Transfer Reaction Time of Flight Mass Spectrometry (PTR-ToF-MS) was used to sample breath every 15 minutes for a total of six hours. BGLs were tested in parallel via BGM test strips. VOC signals were plotted against glucose trends for each subject to identify correlations. Exhaled indole (a bacterial metabolite of tryptophan) showed significant mean correlation to BGL (with negative trend) and significant individual correlation in 36 patients. The type of diabetes did not affect this result. Additional experiments of one healthy male subject by ingestion of lactulose and 13C-labeled glucose (n=3) revealed that exhaled indole does not directly originate from food digestion by intestinal microbiota. As indole has been linked to human glucose metabolism, it might be a tentative marker in breath for non-invasive BGM. Clinical studies with greater diversity are required for confirmation of such results and further investigation of metabolic pathways.


Author(s):  
Saina Sunny ◽  
S. Swapna Kumar

Analysis and measurement of Diabetes Mellitus (DM) became one of the critical challenges of the coming future. Since by 2030, diabetes effected are increased to 360 million all over the world by the World Health Organization (WHO) analytical study survey results. The main aim of this paper is non invasive and continuous glucose monitoring with the IoT technology involvement. Traditional finger pricking methods pros and cons are notified and tried to rectify its demerits. The designed device consist of an infrared led having a wavelength of 900 to 1100nm for the optical blood glucose measurement. NIR photodiodes used to collect light collected from body parts and regressive analysis is carried out. The signal processing, data algorithm is based on Beer-Lambert’s law. In assistance with internet of things (IoT) in WiFi range push alerts are reached to the patients and their concerns on real time. Therefore, it helps in emergency, continuous real time blood glucose monitoring. An IOT based noninvasive glucose monitoring will be a milestone for emerging and smart generation.


1997 ◽  
Vol 20 (5) ◽  
pp. 285-290 ◽  
Author(s):  
U.A. Müller ◽  
B. Mertes ◽  
C. Fischbacher ◽  
K.U. Jageman ◽  
K. Danzer

The feasibility of using near infrared reflection spectroscopy for non-invasive blood glucose monitoring is discussed. Spectra were obtained using a diode-array spectrometer with a fiberoptic measuring head with a wavelength ranging from 800 nm to 1350 nm. Calibration was performed using partial least-squares regression and radial basis function networks. The results of different methods used to evaluate the quality of the recorded spectra in order to improve the reliability of the calibration models, are presented.


Sensors ◽  
2021 ◽  
Vol 21 (20) ◽  
pp. 6820
Author(s):  
Bushra Alsunaidi ◽  
Murad Althobaiti ◽  
Mahbubunnabi Tamal ◽  
Waleed Albaker ◽  
Ibraheem Al-Naib

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.


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