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Multicenter Study
. 2018 Mar;20(3):197-206.
doi: 10.1089/dia.2017.0142. Epub 2018 Jan 30.

A Prospective Multicenter Evaluation of the Accuracy of a Novel Implanted Continuous Glucose Sensor: PRECISE II

Mark P Christiansen  1 , Leslie J Klaff  2 , Ronald Brazg  2 , Anna R Chang  3 , Carol J Levy  4 , David Lam  4 , Douglas S Denham  5 , George Atiee  6 , Bruce W Bode  7 , Steven J Walters  8 , Lynne Kelley  8 , Timothy S Bailey  9
Affiliations
Multicenter Study

A Prospective Multicenter Evaluation of the Accuracy of a Novel Implanted Continuous Glucose Sensor: PRECISE II

Mark P Christiansen et al. Diabetes Technol Ther. 2018 Mar.

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.

Keywords: Accuracy; Continuous glucose monitoring; Implantable; Longevity; Type 1 diabetes; Type 2 diabetes.

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Conflict of interest statement

M.P.C., A.R.C., D.L., D.S.D., and G.A. report no disclosures. L.J.K. has received research grants from Medtronic, Abbott, and Dexcom. R.B. has received research funding from Senseonics, Medtronic, Dexcom, Abbott, Roche Diabetes Care, Sanofi, Lilly, Novo, Viromed, Diasome, and Novartis. C.J.L. has received research support from Senseonics and Lexicon Pharmaceuticals, both paid directly to the institution. B.W.B. has received speaker and consultant fees from Astra Zeneca, BI/Lilly, Janssen, Medtronic, Novo Nordisk, and Sanofi; his employer (Atlanta Diabetes Associates) has received research and grant support from Abbott, Dexcom, Medtronic, and Senseonics. T.S.B. reports the following disclosures: research support from Abbott, Ambra, Ascensia, BD, Boehringer Ingelheim, Calibra, Companion Medical, Dexcom, Elcelyx, Glysens, Janssen, Lexicon, Lilly, Medtronic, Novo Nordisk, Sanofi, Senseonics, Versartis, and Xeris; consulting honoraria from Astra Zeneca, Bayer, BD, Calibra, Lilly, Medtronic, Novo Nordisk, and Sanofi; and speaking honoraria from Abbott, Insulet, Medtronic, Lilly, Novo Nordisk, and Sanofi.

Figures

<b>FIG. 1.</b>
FIG. 1.
Eversense sensor. CM, centimeter; DXA, dexamethasone acetate; PMMA, polymethyl methacrylate.
<b>FIG. 2.</b>
FIG. 2.
Eversense sensor insertion procedure.
<b>FIG. 3.</b>
FIG. 3.
Cumulative frequency of transmitter use per day of all participants through 90 days or sensor retirement. Dotted red line shows that median wear time for the participants was 23.4 hours per day.
<b>FIG. 4.</b>
FIG. 4.
Example of an in-clinic session occurring on day 55 with YSI reference points illustrating the meal challenge excursions along with the continuous measurements from the sensor system. CGM, continuous glucose monitoring; YSI, Yellow Springs Instruments.
<b>FIG. 5.</b>
FIG. 5.
Clarke Error Grid analysis of CGM and YSI glucose measurements through 90 days.
<b>FIG. 6.</b>
FIG. 6.
Kaplan–Meier analysis of sensor survival probability through 90 days.
See this image and copyright information in PMC

References

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