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JOURNAL ARTICLE

First Assessment of the Performance of an Implantable CGM System Through 180 Days in a Primarily Adolescent Population with Type I Diabetes

Ronnie Aronson, Alexander Abitbol, Katherine S Tweden
Diabetes, Obesity & Metabolism 2019 April 1
30938036

AIMS: The Eversense® XL (Senseonics, Maryland USA) is an implantable continuous glucose monitoring (CGM) system. This study is the first investigation of its performance through 180 days in a primarily adolescent population with type 1 diabetes (T1D).

MATERIALS AND METHODS: This prospective, single-center, 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 (BG) measured by Yellow Springs Instrument (YSI), 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 BMI 22±4 kg/m2 ) 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 SAEs were reported.

CONCLUSIONS: The Eversense XL CGM system is safe and accurate through 180 days in a primarily adolescent population of subjects with T1D. This article is protected by copyright. All rights reserved.

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