Products for Monitoring Glucose Levels in the Human Body With Noninvasive Optical, Noninvasive Fluid Sampling, or Minimally Invasive Technologies

Abstract

Background: Conventional home blood glucose measurements require a sample of blood that is obtained by puncturing the skin at the fingertip. To avoid the pain associated with this procedure, there is high demand for medical products that allow glucose monitoring without blood sampling. In this review article, all such products are presented. Methods: In order to identify such products, four different sources were used: (1) PubMed, (2) Google Patents, (3) Diabetes Technology Meeting Startup Showcase participants, and (4) experts in the field of glucose monitoring. The information obtained were filtered by using two inclusion criteria: (1) regulatory clearance, and/or (2) significant coverage in Google News starting in the year 2016, unless the article indicated that the product had been discontinued. The identified bloodless monitoring products were classified into three categories: (1) noninvasive optical, (2) noninvasive fluid sampling, and (3) minimally invasive devices. Results: In total, 28 noninvasive optical, 6 noninvasive fluid sampling, and 31 minimally invasive glucose monitoring products were identified. Subsequently, these products were characterized according to their regulatory, technological, and consumer features. Products with regulatory clearance are described in greater detail according to their advantages and disadvantages, and with design images. Conclusions: Based on favorable technological features, consumer features, and other advantages, several bloodless products are commercially available and promise to enhance diabetes management. Paths for future products are discussed with an emphasis on understanding existing barriers related to both technical and non-technical issues.

Correlations of Salivary and Blood Glucose Levels among Six Saliva Collection Methods

“…Unfortunately, traditional blood glucose monitoring methods usually require blood sampling operations. Blood extraction is painful, inconvenient and presents the risk of infection and mental pains to patients, especially for those patients who need to check their blood glucose levels several times a day [ 9 ].…”

Commercial and Scientific Solutions for Blood Glucose Monitoring—A Review

“…In addition, the success of a commercial device is not only about the technology but also about the cost. In consequence, various approaches using different sensor principles are proposed by different companies, e.g., the TensorTip Combo Glucometer by Cnoga Medical Ltd (NI-optical, CE Mark, not cleared by FDA), the sugarBEAT by Nemaura Medical (NI-fluid-based, CE Mark, not cleared by FDA), and Eversense by Senseonics (minimal invasive, CE Mark and FDA cleared) [123]. A detailed review was published by Shang et al [123] (2021).…”

“…In consequence, various approaches using different sensor principles are proposed by different companies, e.g., the TensorTip Combo Glucometer by Cnoga Medical Ltd (NI-optical, CE Mark, not cleared by FDA), the sugarBEAT by Nemaura Medical (NI-fluid-based, CE Mark, not cleared by FDA), and Eversense by Senseonics (minimal invasive, CE Mark and FDA cleared) [123]. A detailed review was published by Shang et al [123] (2021). They investigated in total 65 different blood glucose monitoring products with different statuses of development regarding their advantages and disadvantages.…”

“…Few of the sensor systems have received the CE Mark and/or have been cleared by the FDA yet. Some of them were discontinued, such as the GlucoWatch Biographer from Cygnus Inc. and the Pendra Device from Pendragon Medical because of issues about burning sensation and inaccuracy, respectively, or did not enter the market, such as the NBM-200G from OrSense [26,77,108,123]. Although there are many failed commercial devices, others are successful, such as the two popular commercial systems, FreeStyle Libre and Dexcom.…”

Diabetes Technology Meeting 2021

“…A recent survey by DTS revealed that, despite the many challenges, there are a surprisingly large number of current NIGM projects in progress, but they are unlikely to meet fully the above requirements, such as glucose specificity, a large signal-to-noise ratio (SNR), and clinical robustness. 1 In the future, nanotechnologies may offer some advantages for NIGM, including improved sensitivity and good SNR.…”