[Image courtesy of Walmart]
After a banner year for diabetes technology in 2022, there’s still plenty to look forward to in 2023.
Throughout 2022, we saw a wide range of advancements in diabetes technology. We saw launches for next-generation technologies, exciting clinical trial results, and rumored spinouts and acquisitions.
You can read all about the biggest diabetes stories of 2022 here.
There’s plenty to look forward to in the diabetes space in the months ahead. Here are a few things worth keeping an eye on.
CMS decision could benefit CGMs
In October, The Centers for Medicare and Medicaid Services (CMS) published a new local coverage determination (LCD). That LCD modified coverage criteria for continuous glucose monitors (CGMs). The modification includes people with diabetes who receive insulin treatment or have a history of problematic hypoglycemia.
Analysts suggested at the time that the decision was a win for CGM makers, including Abbott and Dexcom.
“The comment period on the proposed LCD will run through Nov. 19, after which a final determination will be made,” BTIG analyst Marie Thibault wrote. “We expect potential inclusion in the final determination will catalyze increased CGM adoption in this patient population, benefiting both [Abbott] and [Dexcom].”
Thibault said the decision could benefit an estimated 3 million U.S. basal-only patients.
Dexcom CTO Jake Leach said in a recent interview with MDO sister site Drug Delivery Business News that Dexcom is “really excited” by the potential expanded coverage.
“We see that as just another validation of how CGM can really benefit people with diabetes,” Leach said. “This is a whole new group of folks that haven’t had access to it before. I think we’re going to really see some great outcomes as that population starts to use CGM more regularly. We’re really excited about G7 servicing that population when it becomes available.”
He expects to see that coverage come through in the second half of 2023. However, “we’ll be ready” if it comes earlier, Leach said.
Expanded diabetes technologies
In 2022, a slew of next-generation technologies cleared major regulatory hurdles. That includes the Dexcom G7, Abbott FreeStyle Libre 3, Insulet Omnipod 5 and the Senseonics Eversense E3.
Given the general timelines for these technologies, it’s unlikely we’ll see the coming generations this year or even for a few years. That doesn’t mean these companies will stop innovating in the meantime.
Insulet continues to expand its insulin delivery platform, developing a basal-only pod for individuals with type 2 diabetes. The company said in November that it intends to submit for FDA 510(k) clearance “soon.” Expect updates on that timeline in 2023, with potential clearance on the horizon.
Senseonics’ Eversense E3 offers a 180-day wear time, and the company already has plans to double that. It said in November that it completed enrollment of a pivotal trial for a 365-day sensor configuration. The company also submitted an IDE for enrollment of a pediatric cohort. While analysts expect a regulatory nod to come in 2024, we could see data for the 365-day CGM in the interim sometime in 2023.
Dexcom CEO Kevin Sayer recently told Drug Delivery Business News that the company has major technology expansion plans. That includes moving beyond diabetes to expand CGM use across a number of areas in health. The company plans to move to monitoring during pregnancy and in the hospital setting, among other spaces. Sayer also said Dexcom wants to extend the life of its sensor. It currently has a 10-day wear time, but Sayer wants to increase that to 15 days.
Where does Medtronic stand?
In 2022, Medtronic CEO Geoff Martha cited uncertainty over approval timing for the company’s next-generation platforms. That includes the MiniMed 780G insulin pump and Guardian 4 CGM sensor.
A December 2021 FDA warning letter highlighted inadequacies in specific medical device quality system requirements at its Diabetes business’ Northridge, California, facility. Martha said on the company’s third-quarter (2022) earnings call that it achieved 90% of the FDA’s action items related to the warning.
In September, the law firm of Kessler Topaz Meltzer & Check announced a lawsuit filed in the U.S. District Court for Minnesota. It claimed securities fraud over how Medtronic disclosed its insulin pump problems.
That same month, Medtronic identified a potential cybersecurity issue through internal testing with its MiniMed 600 series insulin pumps (MiniMed 630G and 670G). Affected devices also include the Guardian Link 3 transmitter, Contour Next Link 2.4 blood glucose monitor and the CareLink USB.
Still, what 2023 holds for Medtronic remains a mystery. Data for the next-generation MiniMed 780G with Guardian 4 has been positive. The company also launched a 7-day extended infusion set for insulin delivery in 2022.
New diabetes technologies coming to the fore
Some of the big hitters in diabetes launched new products in 2022. Look for other companies to rise to the challenge in 2023.
In December, Korea-based EOFlow submitted a 510(k) application to the FDA for its EOPatch wearable, disposable insulin pump. Shortly after, EOFlow partnered with Diabeloop to commercialize EOPatch in Europe.
Tandem Diabetes Care had a busy 2022 that could result in a prosperous 2023. The company dipped into the M&A market, acquiring infusion set developer Capillary Biomedical in July. Just before the end of the year, Tandem made another move, acquiring AMF Medical, maker of the Sigi patch pump for insulin delivery. That deal closed on Jan. 23.
Beta Bionics’ timeline for the iLet bionic pancreas system remains unclear, but the company is preparing for a launch. It recently hired Dr. Steven Russell as its new CMO with an eye on the commercial release of iLet.
Watch for further developments from Eli Lilly and Ypsomed on the insulin pump front. Lilly broke off a partnership in pursuit of its own development program for pump technology. However, Ypsomed still aims to find partners for potential U.S. commercialization. It already has an automated insulin delivery system available in Europe through a collaboration with Abbott and CamDiab.
Embecta, the BD diabetes spinoff, also has a product under development. Analysts were hopeful to learn more at the end of the year about the company’s insulin patch pump, but Embecta has remained tight-lipped. More updates may come this year.
What about diabetes drugs?
Diabetes patients are scrambling to find Ozempic due to its rise in popularity as an off-label weight loss drug. Novo Nordisk’s Ozempic is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus. It first received FDA clearance in 2017.
The drug has been on the FDA’s shortage list since August. The shortage will persist barring an increase in production, curtailing of demand or the rise of an Ozempic alternative.
Could Oramed’s oral insulin be that alternative? Not for those with type 2 diabetes — for now, at least. Oramed recently said its Phase 3 trial missed its endpoints, leading the drugmaker to consider discontinuing development of the therapeutic for type 2 patients.
Hope remains for the drug in other diabetes indications. The ORMD-0801 oral insulin capsule is currently under evaluation in a second pivotal Phase 3 trial. The company recently inked a deal to commercialize the oral insulin treatment in the Republic of Korea. It also picked up a new patent for its oral diabetes treatment earlier this month.