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Medtronic to submit MiniMed 780G to FDA for type 2 diabetes in 2025, updates on patch pump

November 19, 2024 By Sean Whooley

Medtronic MiniMed 780G with Guardian 4 sensor
The MiniMed 780G with the Guardian 4 sensor. [Image courtesy of Medtronic]
Medtronic (NYSE:MDT) has plans to submit its MiniMed 780G for an expanded indication from the FDA for type 2 diabetes in the near future.

On the company’s second-quarter earnings call, Que Dallara, EVP and president of Medtronic Diabetes outlined the progress on that front.

“We’ve finished enrollment [in a study of MiniMed 780G for type 2 diabetes],” Dallara said. “We expect to submit to the FDA for expanded indication in the first half of the next calendar year. So, that’s progressing very well.”

Automated insulin delivery (AID) has historically catered to the type 1 diabetes population, but a number of companies are pursuing expanded indications for their technology, like Medtronic.

Insulet won the race, so to speak, earning FDA clearance for its Omnipod 5 system for type 2 diabetes in August. Clearance made Omnipod 5, the company’s latest-generation AID system, the first and only such system cleared for type 1 and type 2 diabetes. Tandem Diabetes Care said earlier this month that it recently completed a clinical study in support of a regulatory filing to expand the indication for its Control-IQ automated insulin dosing technology to include people with type 2 diabetes.

“We’re still largely a type 1 business,” Dallara noted. “We do see type 2 as being quite a large opportunity. The clinical data that we’ve generated for type 2 is extremely good, so we are quite optimistic about the type 2 opportunity.”

Medtronic also updates on patch pump progress

The medtech giant was set to enter the patch pump space currently led by Insulet late last year with a $738 million acquisition of EOFlow. However, about six months after striking that deal, the company called it off, citing multiple breaches of their acquisition agreement.

Reports surfaced in Korea not long after the deal fell through saying that mutual interest remained between companies. However, Medtronic also said at the time that it has its own differentiated patch pump under development.

On the earnings call, Martha said the company’s patch pump programs “remain dynamic.”

“We’ve got a couple of shots on goal, there,” he said. “I don’t believe we’ve given any timing on that, other than that we’ve been investing heavily in diabetes across the entire [ecosystem]. One of our strengths is that we have the entire ecosystem, and a patch needs to be a part of that. We’ve got a couple shots on goal here, but we’re not giving timing on that.”

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Regulatory/Compliance, Technology Tagged With: Medtronic

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at swhooley@wtwhmedia.com.

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