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      First assessment of the performance of an implantable continuous glucose monitoring system through 180 days in a primarily adolescent population with type 1 diabetes

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          Abstract

          Aim

          To investigate the performance of the Eversense XL implantable continuous glucose monitoring (CGM) system through 180 days in a primarily adolescent population with type 1 diabetes (T1D).

          Materials and methods

          This prospective, single‐centre, single‐arm, 180‐day study evaluated the effectiveness and safety of the implantable CGM system in Canadian adolescent and adult subjects with T1D. Accuracy measures included mean absolute relative difference (MARD), 15/15% agreement between CGM glucose and blood glucose measured by Yellow Springs Instruments and surveillance error grid analysis. Adolescent subjects received one sensor in the upper arm and adult subjects received one sensor in each upper arm. In‐clinic CGM system accuracy studies were performed every 30 days. The safety assessment included the incidence of adverse events related to either device or the insertion/removal procedure through 180 days.

          Results

          Thirty‐six subjects (30 adolescent/6 adult, 13 female/23 male, mean age 17 ± 9.2 years, mean body mass index 22 ± 4 kg/m 2) received the CGM system. Overall MARD was 9.4% (95% CI: 8.6%‐10.5%). CGM system agreement at 15/15% (N = 7163) through 60, 120 and 180 days was 82.9% (95% CI: 78.4%‐86.1%), 83.6% (95% CI: 80.4%‐85.7%) and 83.4% (95% CI: 79.7%‐85.5%), respectively. Surveillance error grid analysis showed 98.4% of paired values in clinically acceptable error zones A and B. No insertion/removal or device‐related serious adverse events were reported.

          Conclusion

          The Eversense XL CGM system is safe and accurate through 180 days in a primarily adolescent population of subjects with T1D.

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          Most cited references11

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          Diabetes Device Use in Adults With Type 1 Diabetes: Barriers to Uptake and Potential Intervention Targets

          OBJECTIVE Diabetes devices (insulin pumps, continuous glucose monitors [CGMs]) are associated with benefits for glycemic control, yet uptake of these devices continues to be low. Some barriers to device uptake may be modifiable through psychosocial intervention, but little is known about which barriers and which patients to target. RESEARCH DESIGN AND METHODS We surveyed 1,503 adult T1D Exchange participants (mean age 35.3 [SD 14.8] years, mean diagnosis duration 20.4 [SD 12.5] years) to investigate barriers to device uptake, understand profiles of device users versus nonusers, and explore differences by age and sex. Scales used were the Diabetes Distress Scale, Technology Use Attitudes (General and Diabetes-Specific), and Barriers to Device Use and Reasons for Discontinuing Devices. RESULTS Most commonly endorsed modifiable barriers were related to the hassle of wearing devices (47%) and disliking devices on one’s body (35%). CGM users (37%) were older than nonusers (mean 38.3 vs. 33.5 years), had diabetes for longer (22.9 vs. 18.8 years), had more positive technology attitudes (22.6–26.0 vs. 21.4–24.8), and reported fewer barriers to using diabetes technology than nonusers (3.3 vs. 4.3). The youngest age-group (18–25 years) had the lowest CGM (26% vs. 40–48%) and insulin pump (64% vs. 69–77%) uptake, highest diabetes distress (2.2 vs. 1.8–2.1), and highest HbA1c levels (8.3% [67 mmol/mol] vs. 7.2–7.4% [55–57 mmol/mol]). CONCLUSIONS Efforts to increase device use need to target physical barriers to wearing devices. Because young adults had the lowest device uptake rates, highest distress, and highest HbA1c compared with older age-groups, they should be the focus of future interventions to increase device use.
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            Accuracy and Longevity of an Implantable Continuous Glucose Sensor in the PRECISE Study: A 180-Day, Prospective, Multicenter, Pivotal Trial.

            It is known that continuous glucose monitoring (CGM) systems can lower mean glucose compared with episodic self-monitoring of blood glucose. Implantable CGM systems may provide additional benefits.
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              A Prospective Multicenter Evaluation of the Accuracy of a Novel Implanted Continuous Glucose Sensor: PRECISE II

              Abstract Background: Persistent use of real-time continuous glucose monitoring (CGM) improves diabetes control in individuals with type 1 diabetes (T1D) and type 2 diabetes (T2D). Methods: PRECISE II was a nonrandomized, blinded, prospective, single-arm, multicenter study that evaluated the accuracy and safety of the implantable Eversense CGM system among adult participants with T1D and T2D (NCT02647905). The primary endpoint was the mean absolute relative difference (MARD) between paired Eversense and Yellow Springs Instrument (YSI) reference measurements through 90 days postinsertion for reference glucose values from 40 to 400 mg/dL. Additional endpoints included Clarke Error Grid analysis and sensor longevity. The primary safety endpoint was the incidence of device-related or sensor insertion/removal procedure-related serious adverse events (SAEs) through 90 days postinsertion. Results: Ninety participants received the CGM system. The overall MARD value against reference glucose values was 8.8% (95% confidence interval: 8.1%–9.3%), which was significantly lower than the prespecified 20% performance goal for accuracy (P < 0.0001). Ninety-three percent of CGM values were within 20/20% of reference values over the total glucose range of 40–400 mg/dL. Clarke Error Grid analysis showed 99.3% of samples in the clinically acceptable error zones A (92.8%) and B (6.5%). Ninety-one percent of sensors were functional through day 90. One related SAE (1.1%) occurred during the study for removal of a sensor. Conclusions: The PRECISE II trial demonstrated that the Eversense CGM system provided accurate glucose readings through the intended 90-day sensor life with a favorable safety profile.
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                Author and article information

                Contributors
                ronnie.aronson@lmc.ca
                Journal
                Diabetes Obes Metab
                Diabetes Obes Metab
                10.1111/(ISSN)1463-1326
                DOM
                Diabetes, Obesity & Metabolism
                Blackwell Publishing Ltd (Oxford, UK )
                1462-8902
                1463-1326
                23 April 2019
                July 2019
                : 21
                : 7 ( doiID: 10.1111/dom.2019.21.issue-7 )
                : 1689-1694
                Affiliations
                [ 1 ] LMC Diabetes and Endocrinology Toronto Ontario Canada
                [ 2 ] Senseonics, Incorporated Germantown Maryland USA
                Author notes
                [*] [* ] Correspondence

                Ronnie Aronson MD, LMC Diabetes & Endocrinology, 107 ‐ 1929 Bayview Avenue, Toronto, ON, Canada, M4G 3E8.

                Email: ronnie.aronson@ 123456lmc.ca

                Author information
                https://orcid.org/0000-0002-8976-2321
                Article
                DOM13726
                10.1111/dom.13726
                6618327
                30938036
                67a0788e-f8c6-42e8-aa5c-4a8f6397b512
                © 2019 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

                This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

                History
                : 19 January 2019
                : 18 March 2019
                : 26 March 2019
                Page count
                Figures: 1, Tables: 3, Pages: 6, Words: 4536
                Funding
                Funded by: Senseonics, Inc.
                Funded by: American Diabetes Association
                Categories
                Original Article
                Original Articles
                Custom metadata
                2.0
                dom13726
                July 2019
                Converter:WILEY_ML3GV2_TO_NLMPMC version:5.6.5 mode:remove_FC converted:10.07.2019

                Endocrinology & Diabetes
                clinical trial,continuous glucose monitoring,type 1 diabetes
                Endocrinology & Diabetes
                clinical trial, continuous glucose monitoring, type 1 diabetes

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