Medtronic (NYSE:MDT) named its next-generation “Simplera” continuous glucose monitor (CGM) as a nod to its simplicity.
The company, which just initiated the system’s launch in Europe following CE mark approval, is exceedingly optimistic about the technology.
Medtronic’s all-in-one, disposable CGM features a simple, two-step insertion process for people with diabetes using multiple daily injections (MDI). Its newest no-fingerstick sensor eliminates the need for overtape, too. It seamlessly integrates with the InPen smart insulin pen for real-time, personalized dosing guidance to simplify diabetes management.
The company coordinated its European launch with the European Association for the Study of Diabetes (EASD) 59th Annual Meeting in Hamburg, Germany earlier this month. Ali Dianaty, Medtronic VP of product innovation, and Dr. Robert Vigersky, chief medical officer, spoke to Drug Delivery Business News during the conference to outline the latest step forward for the Diabetes unit at the medtech giant.
“It’s really a brand new form factor for us,” Dianaty said. “It’s a brand new CGM that offers a lot more simplicity. That’s why we call it Simplera. No more overtape, no more charging, smaller form factors, very easy to put onto the body. And it’s almost invisible.”
On top of that, the InPen integration adds another dimension to Simplera that Dianaty feels can bring it beyond standard CGM technology.
“We feel that as though CGM has done a good job of giving people the information they need, but it’s still a diagnostic,” Dianaty said. “It’s now a complete system where they can dose their insulin and do what they need to do. It gives them the information they need in order to improve their outcomes. This system, especially for those people that are on multiple daily injections, allows for that. It helps them with that.
“Of course, an automated insulin dosing device could do an even better job of it. But for those people that aren’t interested in being on a pump, this clearly will have many more advantages than just being on standalone CGM by itself.”
The features of the new Simplera CGM system in tandem with InPen
Dianaty explained the enhancements for Simplera that set it apart from the previous-generation Guardian 4 sensor.
He highlighted the quick insertion process — uncapping the sensor, placing it on the back of the arm, pushing and it’s done. Everything connects to an app, both on iOS and Android operating systems.
From there, patients get alerts, alarms and more that they expect with a standalone CGM. But, the InPen integration addresses a major problem Medtronic identified for CGM users: alarm fatigue.
“We’ve added in these features where, instead of someone getting alert that [their glucose levels are] too high, we’re actually looking at CGM data and whether or not they’ve dosed their insulin,” Dianaty explained. “We’re helping to remind them that they missed this meal and should take a dose of insulin. It stops alarming them so they’re not constantly reminded but they take the actionable step.
“Once they’ve dosed themselves, we won’t remind them anymore and let them live their life alarm-free.”
Like Medtronic’s latest MiniMed 780G automated insulin delivery system, Simplera and InPen work to offer mealtime insulin corrections. Again, it requires no more alarms, but it offers actionable numbers for users to correct their doses.
“There’s a lot of room for improvement [in automated insulin delivery],” Dianaty said. “In the interim, that’s where this system will shine. It basically would account for the majority of people taking insulin today. … We think this system would add a lot of value to those folks.”
Vigersky added that the correction only acts as part of the solution. The bigger picture comes in terms of providing the safe correction dose.
If a user has to give a correction dose, having already taken a big dose of insulin, the technology calculates whether it’s safe to provide a correction dose, Vigersky explained. It may even advise the user to give a smaller correction dose. That feature ensures that users don’t fail to correct within a few hours, causing their time in range to decrease.
“The pairing of InPen with Simplera makes it a smart CGM system,” Vigersky said. “In this case, they really work hand-in-hand together.”
Medtronic presents positive data for its automated system, too
In addition to the buzz around Simplera, Medtronic provided further positives for those interested in using its automated system.
The MiniMed 780G received FDA approval in April of this year. It cleared another major hurdle with Medicare coverage announced in July. The system features glucose target settings as low as 100 mg/dL — the lowest in any automated insulin pump on the market. It closely mirrors the average glucose of someone not living with diabetes.
At EASD, Medtronic shared data demonstrating the global consistency of MiniMed 780G.
People with diabetes are encouraged to achieve greater than 70% time in range. Time in tight range, once considered an aggressive target for diabetes management, lowers the threshold. This recently introduced metric sits between 70-140 mg/dL.
Medtronic presented data demonstrating that users of MiniMed 780G, on average, reach a time in tight range of 48.9%. Some even reached up to 56.1% when using recommended settings. Vigersky said this could help “up the ante” in terms of establishing higher parameters for time in range.
The data showed that using the system allows people with diabetes to meet or exceed internationally recommended targets regardless of location. The medtech giant says a barrier to automated insulin delivery (AID) adoption and reimbursement in developing and middle-income countries has been a lack of data supporting its performance and cost-effectiveness in those regions. This comes as a result of large disparities in ethnic, cultural and regional representation in clinical and real-world studies.
Vigersky cited a study of hundreds of patients on MiniMed 780G during Ramadan. Those who observe Ramadan fast — refraining from food and drink — between sunrise and sunset for a month. This could have a significant impact on glycemic control.
What Medtronic observed, though, was stark — glycemic control data during the month before Ramadan, the month during Ramadan and the month after Ramadan were “indistinguishable,” Vigersky said.
“That just goes to emphasize the universality of this device between people in various circumstances, based on religion in this case and based on their meal and exercise habits,” Vigersky said.
Inverting the pyramid
While the Simplera and InPen news remains positive, Medtronic’s Diabetes unit retains its high hopes for the automated system. Dianaty’s point that “automated insulin dosing device could do an even better job” reflects that, in addition to even more positive data for MiniMed 780G.
One of the main features, Meal Detection Technology, provides automatic adjustments and corrections to sugar levels every five minutes. This occurs for both basal (background) and bolus (mealtime) insulin needs. Que Dallara, Medtronic Diabetes EVP and president, told Drug Delivery Business News that this feature is “a big deal.”
Vigersky said the MiniMed 780G opportunity is an example of how far diabetes management has come. He said being prescribed an insulin pump used to be a rare event for which the discussion often led to asking “did this person deserve an insulin pump?” He said the pumps were reserved for what was considered “the ideal patient.”
“Certain patients just couldn’t handle the technology and there were a whole bunch of barriers,” Vigersky said. “Now there’s a body of evidence, evidence that you don’t need to know anything about technology to come right from MDI and [blood glucose] monitoring to 780G and get great results.”
Studies now show that people who actually need automated systems are the ones who should receive it, “not this ‘ideal’ group.” That “ideal” group only makes up a small minority of people with type 1 diabetes, Vigersky explained.
He likens the situation to an inverted pyramid. The tip, a small minority of “ideal” patients sits on top of the bulk of the pyramid that represents those who wouldn’t have received a pump in previous times.
Turn the pyramid upside-down and the tip is now people who don’t want a pump or don’t have insurance that will pay for it or can’t afford it out of pocket. But, Vigersky said, the vast majority — the bulk of the pyramid — would benefit from automated insulin delivery.
“I think the paradigm that used to be the case is changing,” Vigersky said. “I think the sentiment is changing. It’s clear to me. I think we’ll see this trend expanding as time progresses because this data is very compelling.”