Thank you for the opportunity to speak today. I am Dr. Danielle Shapiro, I am a physician and senior fellow at the National Center for Health Research. Our research center scrutinizes scientific and medical data and provides objective health information to patients, providers and policy makers. Those are the perspectives I bring with me today. We do not accept funding from device companies and therefore I have no conflicts of interest.
Patients with insulin-dependent diabetes need better options to monitor their glucose. Ideally, this information can be used to make decisions about therapy and disease management. The market for CGMs is growing. Although the Eversense device has more longevity and unique design features compared to other CGMs on the market, the sponsor has not provided sufficient data to demonstrate that proposed benefits outweigh the potential risks.
We have several concerns:
#1. We are concerned about this device’s unclear benefits. Exactly what are the benefit since the indication is in addition to rather than instead of self-monitoring of blood glucose (SMBG)? Would any patients or providers want this device if they understood that 1) this device requires minor surgery 2) patients may require more extensive procedures to remove the device; and 3) patients should not rely on the readings to make insulin dosing adjustments? .
#2. We are concerned that the changes made to the device hardware and software have not been tested in real time on actual patients. Of particular note, the new algorithm was developed on the European data set and tested on the U.S. data post-hoc. It was not validated in real time. Compared to real-time clinical testing, post-hoc data processing does not provide sufficient evidence that the device sensor accurately measures glucose levels. Therefore it can’t be considered to provide valid readings. For those reasons, the sponsor has not proved that this device would be beneficial for real-world patients.
#3. In addition to concerns about accuracy, we are concerned about the potential risks during device implantation and removal. We commend the sponsor for recognizing potential device failures and procedural complications. However, the sponsor has not demonstrated that these post-trial design modifications reduce or eliminate the risks. While it is reassuring that most providers were able to use the new instruments in the simulated scenario, this does not provide sufficient evidence that the device will be safe and effective when implanted with these new tools.
There is no urgent need for this device, even if it is safe and effective. Since the sponsor has not proven that it is safe or effective, we urge you to recommend that clinical data be provided before FDA makes a decision about whether to approve it.
In conclusion, patients with insulin dependent diabetes need better solutions to monitor and manage their disease. There is currently no proof that the benefits of Eversense outweigh the risks. We need additional clinical evidence before the FDA should decide whether or not to approve it.
Thank you for the opportunity to share our perspective.