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Review
. 2022 Jan;16(1):168-214.
doi: 10.1177/19322968211007212. Epub 2021 Jun 13.

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

Trisha Shang  1 , Jennifer Y Zhang  1 , Andreas Thomas  2 , Mark A Arnold  3 , Beatrice N Vetter  4 , Lutz Heinemann  5 , David C Klonoff  6
Affiliations
Review

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

Trisha Shang et al. J Diabetes Sci Technol. 2022 Jan.

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.

Keywords: fluid sampling; glucose; invasive; minimally invasive; noninvasive; optical.

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Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: TS, JYZ, and BNV have nothing to disclose. AT was Scientific Manager at Medtronic until April 2020. Currently he has nothing to disclose. MAA discloses a consulting arrangement with LifePlus, Inc. LH is a partner of Profil Institut für Stoffwechselforschung in Neuss, Germany. He is a member of advisory boards for Roche Diagnostics, Zense, and Medtronic. He is also on the Board of Directors for Lifecare. DCK is a consultant for EOFlow, Fractyl, Lifecare, Novo, Roche Diagnostics, Samsung, and Thirdwayv.

Figures

Figure 1.
Figure 1.
How NIFS-GM technologies have been classified. (A) Previously classified by some experts as a noninvasive technology; (B) Previously classified by other experts as a minimally invasive technology; (C) Classified per our definition in this article as a distinct technology separate from NIO-GM and MI-GM.
Figure 2.
Figure 2.
The total quarterly sales for MI-GMs produced by the world’s four largest manufacturers as of the fourth quarter of 2020. Figure adapted from Cai et al.
Figure 3.
Figure 3.
A PRISMA diagram of how we performed our database reviews to create a list of identified NIO-GM, NIFS-GM, and MI-GM products. Abbreviations: CE, Conformité Européenne; FDA, Food and Drug Administration; NIFS-GM, noninvasive fluid sampling glucose monitor; MI-GM, minimally invasive glucose monitor; NI-GM, noninvasive glucose monitor; NIO-GM, noninvasive optical glucose monitor; PRISMA, Preferred Reporting Items for Systematic Review and Meta-Analyses.
See this image and copyright information in PMC

References

    1. American Diabetes Association. 7. Diabetes technology: standards of medical care in diabetes—2021. Diabetes Care. 2021;44(suppl 1):S85-S99. https://care.diabetesjournals.org/content/44/Supplement_1/S85 - PubMed
    1. Fullerton B, Jeitler K, Seitz M, Horvath K, Berghold A, Siebenhofer A. Intensive glucose control versus conventional glucose control for type 1 diabetes mellitus. Cochrane Database Syst Rev. 2014;(2):CD009122. doi:10.1002/14651858.CD009122.pub2 - DOI - PMC - PubMed
    1. Rodriguez-Gutierrez R, Gonzalez-Gonzalez JG, Zuñiga-Hernandez JA, McCoy RG. Benefits and harms of intensive glycemic control in patients with type 2 diabetes. BMJ. 2019;367:l5887. doi:10.1136/bmj.l5887 - DOI - PubMed
    1. Cousins S, Blencowe NS, Blazeby JM. What is an invasive procedure? A definition to inform study design, evidence synthesis and research tracking. BMJ Open. 2019;9(7):e028576. doi:10.1136/bmjopen-2018-028576 - DOI - PMC - PubMed
    1. Villena Gonzales W, Mobashsher AT, Abbosh A. The progress of glucose monitoring—a review of invasive to minimally and non-invasive techniques, devices and sensors. Sensors. 2019;19(4):800. doi:10.3390/s19040800 - DOI - PMC - PubMed

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