Anyone hear about senceonics CGM?
It’s available in Europe - waiting for FDA approval here, pricey.
Anyone hear about senceonics CGM?
Senseonics is still waiting on FDA approval for the implantable device (Eversense) with a (presumed) 90 day lifespan.
It was (previously) expected for a late 2017 approval however it sounded like the company dropped the ball on something related to the application with the FDA. Approval is still expected however early 2018 is now the anticipated target.
PDF attached of study from 2016. It has a bunch of interesting information for anybody interested in the Senseonics Eversense CGM system.
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.
Senseonics-Eversense.pdf (632.1 KB)
Man this would be wonderful for people like me who deal with seemingly unsolvable skin irritation from everything. I’m sure there is some ridiculous FDA reason why it isn’t approved here yet (like why is it that it, as well as everything else, is safe enough for Europe, but requires extra expensive and time consuming approval in the US?).
I watched the video. Gross. No way would I agree to be sliced open to have that thing installed–especially so frequently. Total non-starter for me and I know others have expressed the same sentiment.
That is why choices are great. More products and more competitors in the cgm market benefit everybody.
I found this statement to be quite interesting in its numerous implications:
First author Mark Christiansen, MD, Leslie Klaff, MD, and colleagues added: "The results from this study demonstrate that the use of a long-term, 90-day, implantable continuous glucose sensor is accurate and safe with high rates of adherence to use.
“Additional clinical studies will be required to evaluate the accuracy and usability of the Eversense CGM system among pediatrics, with reduced calibration frequency, and for extended durations through 180 days.”
FDA granted label change via PMA supplement for non-adjunctive use of the 90-day Eversense cgm system.
The system is indicated for use to replace fingerstick blood glucose measurements for diabetes treatment decisions.
Not sure I understand. Did they do the post approval study? Makes it sound like they have to do the 12 month study and THEN they can go without finger stick?