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(7) HYPOGLYCEMIC PERFORMANCE EVALUATION OF A NEW IMPLANTABLE CGM SYSTEM


Authors:

Francine Kaufman

Katherine S Tweden, PhD – Vice President, Clinical Science, Senseonics, Incorporated

Leslie Klaff, M.D., Ph. D., F.R.C.P., F.A.C.E. – Medical Director, Rainier Clinical Research Center

Ron Brazg, M.D., F.A.C.E. – Director and Principle Investigator, Rainier Clinical Research Center

Timothy Bailey, FACE, FACP – Clinical Assistant Professor, UCSD School of Medicine, 2AMCR Institute Inc.

Mark Christiansen, MD, National Board of Medical Examiners, the American Board of Internal Medicine, the American Board of Diabetes, Endocrinology and Metabolism, Certified Clinical Densitometrist – Co-Medical Director, Endocrinologist, Diablo Clinical Research Inc.,

Abstract:

Objective :

A strong accuracy and safety profile of the new implantable Eversense CGM system in participants with type 1 or type 2 diabetes (T1D, T2D) was demonstrated in a prior multi-center, prospective, blinded study (PRECISE II).  The objective of the study was to conduct a subsequent prospective, multi-center study (PRECISION) was conducted to assess overall performance and safety with an unblinded device with specific focus in the hypoglycemic range.

Methods :

Effectiveness parameters of MARD between paired Eversense and Yellow Springs Instrument (YSI) reference glucose measurements and percent of CGM system agreement within 15 mg/dL or 15% (15/15% metric) of YSI reference measurements through 90 days for reference glucose values from 40 to 400 mg/dL were evaluated. The incidence of device-related or sensor insertion/removal procedure-related serious adverse events (SAEs) through 90 days post-insertion was the primary safety endpoint.

Results :

Thirty-five adults with T1D or T2D were inserted with the CGM system. CGM system agreement within 15/15% of reference values through 90 days was 85% over the glucose range of 40–400 mg/dL. 92% and 87% of CGM values were within 15 mg/dL of reference with corresponding mean absolute differences of 7.2 mg/dL and 7.6 mg/dL, respectively, in the hypoglycemic ranges of 40-60 and 61-80 mg/dL. The MARD against reference glucose values through 90 days was 9.6% (95% CI: 8.9, 10.4).  No early sensor failures and no device- or procedure- related SAEs were observed.

Discussion :

The accuracy and safety of the implantable Eversense CGM system over the 90-day sensor life was confirmed with an MARD of 9.6% over the glucose range of 40–400 mg/dL and 85% of CGM values within 15/15% of reference values. Accuracy was particularly strong in the hypoglycemic range with 92% of readings within 15/15% of reference values in the glucose range of 40 to 60 mg/dL. The favorable safety profile demonstrated in PRECISE II was corroborated in this study with no device- or procedure-related SAEs.

Conclusion :

The robust performance and favorable safety profile of the Eversense CGM system was verified in the PRECISION study which evaluated an unblinded system through 90 days. Of note, strong accuracy performance was attained in the hypoglycemic ranges.

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