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      Clinical Practice Recommendations on the Routine Use of Eversense, the First Long-Term Implantable Continuous Glucose Monitoring System

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          Abstract

          Background: The use of real-time continuous glucose monitoring (rtCGM) systems has proved to positively impact the management of type 1 diabetes with the potential to lower HbA1c, reduce frequency and time spent in hypoglycemia, and lower glycemic variability. Nevertheless, the acceptance of rtCGM remains below expectations and the dropout rate within the first year has been reported to be 27%. Besides financial reasons due to limited reimbursement, reasons include the need for frequent sensor replacement, the discomfort of wearing a sensor, the presence of adverse skin reactions, or privacy. Thus, novel approaches to rtCGM are desired to overcome these barriers. The first long-term implantable rtCGM system diversifies the field of glucose monitoring further. However, due to its novelty, there are no published clinical practice guidelines available.

          Aims: The aim of this article is to set the foundation for a best clinical practice for the everyday clinical care using a long-term implantable CGM system.

          Methods: An international expert panel for the long-term implantable CGM system developed this best practice guidance. All participants were certified and experienced in the use of the Eversense ® long-term implantable CGM system. The workflows from the respective clinics were presented, discussed and are summarized in an ideal care workflow outlined in these practice recommendations.

          Results: The participants agreed on the following aspects: definition of the patient population that will benefit from a long-term implantable CGM device; real-world experience on safety and accuracy of a long-term CGM; definition of the ideal sensor position; description of the optimal process for sensor insertion, removal, and replacement.

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          Most cited references29

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          Current state of type 1 diabetes treatment in the U.S.: updated data from the T1D Exchange clinic registry.

          To examine the overall state of metabolic control and current use of advanced diabetes technologies in the U.S., we report recent data collected on individuals with type 1 diabetes participating in the T1D Exchange clinic registry. Data from 16,061 participants updated between 1 September 2013 and 1 December 2014 were compared with registry enrollment data collected from 1 September 2010 to 1 August 2012. Mean hemoglobin A1c (HbA1c) was assessed by year of age from 75 years. The overall average HbA1c was 8.2% (66 mmol/mol) at enrollment and 8.4% (68 mmol/mol) at the most recent update. During childhood, mean HbA1c decreased from 8.3% (67 mmol/mol) in 2-4-year-olds to 8.1% (65 mmol/mol) at 7 years of age, followed by an increase to 9.2% (77 mmol/mol) in 19-year-olds. Subsequently, mean HbA1c values decline gradually until ∼30 years of age, plateauing at 7.5-7.8% (58-62 mmol/mol) beyond age 30 until a modest drop in HbA1c below 7.5% (58 mmol/mol) in those 65 years of age. Severe hypoglycemia (SH) and diabetic ketoacidosis (DKA) remain all too common complications of treatment, especially in older (SH) and younger patients (DKA). Insulin pump use increased slightly from enrollment (58-62%), and use of continuous glucose monitoring (CGM) did not change (7%). Although the T1D Exchange registry findings are not population based and could be biased, it is clear that there remains considerable room for improving outcomes of treatment of type 1 diabetes across all age-groups. Barriers to more effective use of current treatments need to be addressed and new therapies are needed to achieve optimal metabolic control in people with type 1 diabetes.
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            Continuous Glucose Monitoring: A Review of Successes, Challenges, and Opportunities.

            Continuous glucose monitoring (CGM) provides information unattainable by intermittent capillary blood glucose, including instantaneous real-time display of glucose level and rate of change of glucose, alerts and alarms for actual or impending hypo- and hyperglycemia, "24/7" coverage, and the ability to characterize glycemic variability. Progressively more accurate and precise, reasonably unobtrusive, small, comfortable, user-friendly devices connect to the Internet to share information and are sine qua non for a closed-loop artificial pancreas. CGM can inform, educate, motivate, and alert people with diabetes. CGM is medically indicated for patients with frequent, severe, or nocturnal hypoglycemia, especially in the presence of hypoglycemia unawareness. Surprisingly, despite tremendous advances, utilization of CGM has remained fairly limited to date. Barriers to use have included the following: (1) lack of Food and Drug Administration approval, to date, for insulin dosing ("nonadjuvant use") in the United States and for use in hospital and intensive care unit settings; (2) cost and variable reimbursement; (3) need for recalibrations; (4) periodic replacement of sensors; (5) day-to-day variability in glycemic patterns, which can limit the predictability of findings based on retrospective, masked "professional" use; (6) time, implicit costs, and inconvenience for uploading of data for retrospective analysis; (7) lack of fair and reasonable reimbursement for physician time; (8) inexperience and lack of training of physicians and other healthcare professionals regarding interpretation of CGM results; (9) lack of standardization of software methods for analysis of CGM data; and (10) need for professional medical organizations to develop and disseminate additional clinical practice guidelines regarding the role of CGM. Ongoing advances in technology and clinical research have addressed several of these barriers. Use of CGM in conjunction with an insulin pump with automated suspension of insulin infusion in response to actual observed or predicted hypoglycemia, as well as progressive refinement of closed-loop systems, is expected to dramatically enhance the clinical utility and utilization of CGM.
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              Real-time continuous glucose monitoring in adults with type 1 diabetes and impaired hypoglycaemia awareness or severe hypoglycaemia treated with multiple daily insulin injections (HypoDE): a multicentre, randomised controlled trial

              The effectiveness of real-time continuous glucose monitoring (rtCGM) in avoidance of hypoglycaemia among high-risk individuals with type 1 diabetes treated with multiple daily insulin injections (MDI) is unknown. We aimed to ascertain whether the incidence and severity of hypoglycaemia can be reduced through use of rtCGM in these individuals.
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                Author and article information

                Journal
                Diabetes Technol Ther
                Diabetes Technol. Ther
                dia
                Diabetes Technology & Therapeutics
                Mary Ann Liebert, Inc., publishers (140 Huguenot Street, 3rd FloorNew Rochelle, NY 10801USA )
                1520-9156
                1557-8593
                01 May 2019
                07 May 2019
                07 May 2019
                : 21
                : 5
                : 254-264
                Affiliations
                [ 1 ]Center for Endocrinology and Diabetology, Medicover Berlin-Mitte, Berlin, Germany.
                [ 2 ]Department of Pediatrics, Diabetology, Endocrinology and Nephrology, Medical University of Lodz, Łódź, Poland.
                [ 3 ]Center for Diabetes and Endocrinology, Johannesburg, South Africa.
                [ 4 ]Donald Gordon Medical Centre, WITS (University of the Witwatersrand), Johannesburg, South Africa.
                [ 5 ]Hywel Dda University Health Board, Llanelli, United Kingdom.
                [ 6 ]Division of Endocrinology, Third Department for Internal Medicine, City-Hospital Hietzing Vienna, Vienna, Austria.
                [ 7 ]Department of Endocrinology and Nutrition, CIBER of Diabetes and Associated Metabolic Diseases, Health Sciences Research Institute and University Hospital Germans Trias i Pujol, Badalona, Spain.
                [ 8 ]Universimed Holding GmbH, Medical Writing, Vienna, Austria.
                [ 9 ]Department of Endocrinology, Diabetology and Metabolism, Antwerp University Hospital, University of Antwerp, Antwerp, Belgium.
                [ 10 ]Department of Health Science, University Magna Græcia, Catanzaro, Italy.
                Author notes
                [*]

                These two authors share the joint senior authorship for this article.

                [*]Address correspondence to: Dorothee Deiss, Center for Endocrinology and Diabetology, Medicover Berlin-Mitte, Hausvogteiplatz 3-4, 10117 Berlin, Germany dorothee.deiss@ 123456medicover.de
                Article
                10.1089/dia.2018.0397
                10.1089/dia.2018.0397
                6532544
                31021180
                ea52867f-4dcb-401f-a0e7-1ea1306b3860
                © Dorothee Deiss, et al., 2019; Published by Mary Ann Liebert, Inc.

                This Open Access article is distributed under the terms of the Creative Commons License ( http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited.

                History
                Page count
                Figures: 3, References: 48, Pages: 11
                Categories
                Original Articles

                clinical practice guide,long-term implantable glucose monitoring,long-term continuous glucose monitoring system,real-time continuous glucose monitoring system

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