Eversense CGM
Device Name:
CGM
Manufacturer:
Senseonics Inc. (Eversense), 20451 Seneca Meadows Parkway, Germantown, MD 20876-7005, UNITED STATES.
Measuring functions:
Blood glucose
Primary Client Use:
Intended for professional use
Measurement Site:
Finger
Measurement Occurrence:
Continuous measurement
Availability:
Available Currently
Description:
The Eversense CGM is an automatic blood glucose meter. Although its blood glucose measurement technology has been evaluated, it is not possible to base a determination on its accuracy from this research. Blood glucose measurements are taken from the finger. It is intended for professional use.
Assessment:
The technology used in the Eversense CGM, to measure blood glucose, has been assessed, in a general population, according to a non-standard protocol.
Recommendations:
Accuracy AssessmentRecommendationBasis
BG Medaval None When an evaluation is carried out using a non-standard protocol, no inference can be made on accuracy based on a standard protocol.
Validation Publications:

Kropff J, Choudhary P, Neupane S, Barnard K, Bain SC, Kapitza C, Forst T, Link M, Dehennis A, DeVries JH. Accuracy and Longevity of an Implantable Continuous Glucose Sensor in the PRECISE Study: A 180-Day, Prospective, Multicenter, Pivotal Trial. Diabetes Care. 2017 Jan;40(1):63-68. Epub: 2016 Nov 4. doi: 10.2337/dc16-1525. PMID: 27815290.

Ad Hoc protocol General population

Results indicate the safety and accuracy of this new type of implantable CGM system and support it as an alternative for transcutaneous CGM.

Christiansen MP, Klaff LJ, Brazg R, Chang AR, Levy CJ, Lam D, Denham DS, Atiee G, Bode BW, Walters SJ, Kelley L, Bailey TS. A Prospective Multicenter Evaluation of the Accuracy of a Novel Implanted Continuous Glucose Sensor: PRECISE II. Diabetes Technol Ther. 2018 Mar;20(3):197-206. Epub: 2018 Jan 30. doi: 10.1089/dia20170142. PMID: 29381090. Available from: PMC5867508.

Ad Hoc protocol General population

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.

Christiansen MP, Klaff LJ, Bailey TS, Brazg R, Carlson G, Tweden KS. A Prospective Multicenter Evaluation of the Accuracy and Safety of an Implanted Continuous Glucose Sensor: The PRECISION Study. Diabetes Technol Ther. 2019 May;21(5):231-237. Epub: 2019 Mar 29. doi: 10.1089/dia.2019.0020. PMID: 30925083. Available from: PMC6532543.

Ad Hoc protocol General population

PRECISION corroborated prior accuracy and safety findings of the Eversense CGM System through the 90-day sensor life. The updated algorithm improved accuracy of measurements in PRECISE II.

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