New continuous glucose monitoring (CGM) technologies are exciting. We are seeing achieve regulatory approval those that are due to come out and are currently under review.
As we all know, sensor therapy vastly improves glycemia for persons living with diabetes, and we’ve seen that they flatten the curve of A1c achieved across a large age spectrum. How do we best allow this technology to penetrate clinical care? I think the advancements we’re seeing from all the companies will help improve that.
We recently had the approval for the Libre 3. The Libre 3 builds on the technology that device already has by now making it a real-time GCM. That means that you no longer need to scan and you’re automatically getting the data streamed. In addition to that, the size of the device has vastly decreased. When you think about it, it’s roughly the size of two pennies that are stacked.
We have a smaller, more discreet device may make it more feasible. In addition, the insertion device is easier to use because it’s one step and very quick to place. Right now, it’s not currently interoperable with other systems, but we look forward to the potential of that in the not too distant future.
The next sensor to hear about is the Dexcom G7, which is currently under US Food and Drug Administration (FDA) review. What’s interesting about this device is that it’s cutting back on the size of the device by about 60% from the current Dexcom G6 that we all know. It has an integrated transmitter. What does that mean? I no longer need to continually use my transmitter over 3 months’ time, and that may allow for better sensor signal because you’re getting a fresh transmitter with every single wear.
The warmup period going from 2 hours down to 30 minutes is meaningful. They know that they’re going to get the data faster. Because the Dexcom G7 is integrated with various pumps and other automated insulin delivery systems, the idea that we can continue automation more seamlessly with shorter duration of warm up has been very important. We don’t know when it will be commercially available and approved by the FDA, but we’re eager to see that reach our persons with diabetes that we treat.
Next, we have the Medtronic sensors, and this has been a huge step forward in terms of the technology that they offer. We have the Guardian 4, which is currently under review by the FDA.
We finally get into the area of no longer requiring fingerstick calibrations. The Guardian 4 has the same form factor as the Guardian 3, but you’re able to use the device without needing that constant calibration. The duration of wear will continue to be 7 days. That is currently under FDA review and has achieved CE mark, and so it is used in Europe in collaboration with a 780G system that also is currently under review by the FDA in the US.
What’s even more exciting is the Medtronic Simplera sensor, which was previously known as the Synergy. What’s different about this sensor is that now we change the form factor. It’s going to be an integrated sensor with a transmitter, so you’re using a new sensor with every single wear. Persons with diabetes no longer need to worry about charging the sensor, there is no need to calibrate the sensor, and it’s much reduced in terms of size. The pivotal trials of that sensor have been completed. An interim analysis was presented at American Diabetes Association (ADA) this year, and the plan, from what I understand, is that Medtronic hopes to submit for CE mark and FDA review this fall.
Finally, the Senseonics Eversense E3, which is different than the other sensors that we’ve talked about because it’s an implantable sensor. A small piece is inserted in the upper arm and that sensor remains in place now for 180 days with the Eversense E3. This allows persons with diabetes to use an on-body transmitter that detects the sensor signal through Bluetooth signals and allows them to view their data. The on-body transmitter allows for on-body vibratory alerts.
In addition, we’ve seen improvements in terms of the survival of the device with some modifications they’ve made in manufacturing. Previously, if you’re looking out to 180 days, roughly 65% of the sensors would survive out to that time point. Now, 90% of the sensors are surviving to that 180-day wear. With this sensor, there is still a requirement for calibrations; two calibrations are required daily for the first 21 days, and after that, it’s one calibration daily.
For all these different devices that are either approved in terms of commercialization or currently under review in USA, the main takeaways are that they’re very accurate, the devices are decreasing in size, and the insertion is getting easier. This translates into increased penetration of sensor technology for all persons with diabetes
From www.medscape.com
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