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

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          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.

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          Most cited references177

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          2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes—2021

          (2020)
          The American Diabetes Association (ADA) "Standards of Medical Care in Diabetes" includes the ADA's current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, a multidisciplinary expert committee (https://doi.org/10.2337/dc21-SPPC), are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA's clinical practice recommendations, please refer to the Standards of Care Introduction (https://doi.org/10.2337/dc21-SINT). Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC.
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            Photoplethysmography and its application in clinical physiological measurement

            John Allen (2007)
            Physiological Measurement, 28(3), R1-R39
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              Flash Glucose-Sensing Technology as a Replacement for Blood Glucose Monitoring for the Management of Insulin-Treated Type 2 Diabetes: a Multicenter, Open-Label Randomized Controlled Trial

              Introduction Glycemic control in participants with insulin-treated diabetes remains challenging. We assessed safety and efficacy of new flash glucose-sensing technology to replace self-monitoring of blood glucose (SMBG). Methods This open-label randomized controlled study (ClinicalTrials.gov, NCT02082184) enrolled adults with type 2 diabetes on intensive insulin therapy from 26 European diabetes centers. Following 2 weeks of blinded sensor wear, 2:1 (intervention/control) randomization (centrally, using biased-coin minimization dependant on study center and insulin administration) was to control (SMBG) or intervention (glucose-sensing technology). Participants and investigators were not masked to group allocation. Primary outcome was difference in HbA1c at 6 months in the full analysis set. Prespecified secondary outcomes included time in hypoglycemia, effect of age, and patient satisfaction. Results Participants (n = 224) were randomized (149 intervention, 75 controls). At 6 months, there was no difference in the change in HbA1c between intervention and controls: −3.1 ± 0.75 mmol/mol, [−0.29 ± 0.07% (mean ± SE)] and −3.4 ± 1.04 mmol/mol (−0.31 ± 0.09%) respectively; p = 0.8222. A difference was detected in participants aged <65 years [−5.7 ± 0.96 mmol/mol (−0.53 ± 0.09%) and −2.2 ± 1.31 mmol/mol (−0.20 ± 0.12%), respectively; p = 0.0301]. Time in hypoglycemia <3.9 mmol/L (70 mg/dL) reduced by 0.47 ± 0.13 h/day [mean ± SE (p = 0.0006)], and <3.1 mmol/L (55 mg/dL) reduced by 0.22 ± 0.07 h/day (p = 0.0014) for intervention participants compared with controls; reductions of 43% and 53%, respectively. SMBG frequency, similar at baseline, decreased in intervention participants from 3.8 ± 1.4 tests/day (mean ± SD) to 0.3 ± 0.7, remaining unchanged in controls. Treatment satisfaction was higher in intervention compared with controls (DTSQ 13.1 ± 0.50 (mean ± SE) and 9.0 ± 0.72, respectively; p < 0.0001). No serious adverse events or severe hypoglycemic events were reported related to sensor data use. Forty-two serious events [16 (10.7%) intervention participants, 12 (16.0%) controls] were not device-related. Six intervention participants reported nine adverse events for sensor-wear reactions (two severe, six moderate, one mild). Conclusion Flash glucose-sensing technology use in type 2 diabetes with intensive insulin therapy results in no difference in HbA1c change and reduced hypoglycemia, thus offering a safe, effective replacement for SMBG. Trial registration ClinicalTrials.gov identifier: NCT02082184. Funding Abbott Diabetes Care. Electronic supplementary material The online version of this article (doi:10.1007/s13300-016-0223-6) contains supplementary material, which is available to authorized users.
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                Author and article information

                Journal
                J Diabetes Sci Technol
                J Diabetes Sci Technol
                DST
                spdst
                Journal of Diabetes Science and Technology
                SAGE Publications (Sage CA: Los Angeles, CA )
                1932-2968
                13 June 2021
                January 2021
                : 16
                : 1
                : 168-214
                Affiliations
                [1 ]Diabetes Technology Society, Burlingame, California, USA
                [2 ]AGDT (Working group of Diabetes Technology), Germany, Ulm, Germany
                [3 ]University of Iowa, Department of Chemistry, Iowa City, Iowa, USA
                [4 ]Foundation for Innovative New Diagnostics, Geneva, Switzerland
                [5 ]Science Consulting in Diabetes GmbH, Neuss, Germany
                [6 ]Mills-Peninsula Medical Center, San Mateo, California, USA
                Author notes
                [*]David C. Klonoff, MD, FACP, FRCP (Edin), Fellow AIMBE, Mills-Peninsula Medical Center, 100 South San Mateo Drive, Room 5147, San Mateo, California 94401, USA. Email: dklonoff@ 123456diabetestechnology.org
                [*]

                Authors contributed equally to the manuscript.

                Author information
                https://orcid.org/0000-0001-9687-9336
                https://orcid.org/0000-0002-3374-9777
                https://orcid.org/0000-0002-6549-2793
                https://orcid.org/0000-0001-9375-1863
                https://orcid.org/0000-0002-7898-472X
                https://orcid.org/0000-0003-2493-1304
                https://orcid.org/0000-0001-6394-6862
                Article
                10.1177_19322968211007212
                10.1177/19322968211007212
                8721558
                34120487
                8966ae95-9918-4a8b-8758-f1a5623cb33a
                © 2021 Diabetes Technology Society

                This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License ( https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages ( https://us.sagepub.com/en-us/nam/open-access-at-sage).

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                Categories
                Review Article
                Custom metadata
                ts1

                invasive,noninvasive,glucose,fluid sampling,minimally invasive,optical

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