2022 represented a landmark year for next-generation diabetes tech. Here are the biggest stories from the past year.
Some companies picked up major regulatory nods. Others experienced major regulatory setbacks.
Partnerships were formed and ended, while mergers and acquisitions came and went. There were many stories to choose from in the world of diabetes tech, but here are 10 big ones that stood out:
Dexcom G7 receives FDA clearance
The long-awaited regulatory nod for Dexcom’s next-generation continuous glucose monitor (CGM) finally came in December.
Some suggested that San Diego-based Dexcom may pick up clearance as soon as summer 2022. However, a software change recommended by the FDA, plus COVID-19-related backlog, delayed proceedings.
Dexcom COO Jake Leach told Drug Delivery Business News that G7 represents a “huge leap” forward for the company — and the treatment of diabetes.
Other Dexcom news in 2022:
- How Dexcom uses wearables to deliver differentiated diabetes management
- Dexcom launches Dexcom One offering overseas
- Dexcom launches NIL program for college athletes with diabetes
Senseonics wins regulatory nods for 180-day CGM
Near the start of the year in February, Senseonics picked up a major regulatory win with FDA clearance for its next-generation CGM.
The 180-day Eversense E3 CGM includes proprietary sacrificial boronic acid (SBA) technology. This helps to extend its longevity to six months for users with diabetes. Senseonics previously offered the system with a 90-day wear time. Senseonics CMO Dr. Fran Kaufman told DDBN that even more innovation could be on its way from Senseonics, including a 365-day CGM.
Eversense E3 also later picked up CE mark approval in June.
Other Senseonics news in 2022:
- Senseonics, Ascensia partner with Nurse Practitioner Group on CGMs
- Eversense integrates with Apple Health
- Senseonics hits milestone on 365-day CGM
FDA clears next-gen Omnipod 5 from Insulet
Many major diabetes players registered regulatory wins in 2022. The first big one came in January when the FDA cleared the next-generation Insulet Omnipod 5.
The wearable insulin delivery pump system initially received clearance for individuals aged six years and older with type 1 diabetes. The platform provides easier glucose management, with no multiple daily injections, no tubes and zero fingersticks.
In August, the FDA cleared Omnipod 5 for users aged two years old and up. The system also garnered CE mark in 2022, with coverage for the same age range also coming in September.
Other Insulet news in 2022:
- Insulet CEO Shacey Petrovic steps down for personal reasons
- Some troubles with the Insulet Omnipod 5 controller
- Insulet breaks ground on $200M manufacturing facility in Malaysia
Medtronic’s Diabetes business feels effects of FDA warning letter
At the end of last year, Medtronic received a warning letter from the FDA. The agency uncovered inadequacies at the company’s Northridge, California Diabetes headquarters. As a result, CEO Geoff Martha suggested that the company’s next-generation diabetes technologies may see delays in regulatory timelines. That could include its Guardian 4 sensor and MiniMed 780G insulin pump, both of which have shown promise in clinical studies.
In earnings reports, the Medtronic Diabetes business suffered, too. Analysts even suggested that it was a spinoff candidate, although that seems less likely now after other divestments by the company. More trouble came in September when investors sued Medtronic, claiming securities fraud over how it disclosed insulin pump problems.
On a more positive note, Medtronic announced in November that it has addressed 100% of the concerns outlined int he FDA warning letter. It’s seeking a reinspection. “We remain focused on restoring strong growth for this important franchise in the coming years,” Martha said.
Other Medtronic news in 2022:
- Medtronic launches diabetes insights program for MiniMed users
- Medtronic launches 7-day infusion set for insulin pumps in U.S.
- How Medtronic aims to address health inequities in diabetes
Next-gen FreeStyle Libre 3 from Abbott garners FDA nod
Add one more to the list of next-generation diabetes technologies receiving FDA clearance this year. In May, Abbott received the nod for its FreeStyle Libre 3 CGM.
Abbott’s FreeStyle Libre 3 represents the smallest and thinnest CGM sensor in the world. Its size compares to two pennies stacked on top of one another. Clearance covers use by people 4 years of age and older living with diabetes.
FreeStyle Libre 3 CGM demonstrated a 7.9% mean absolute relative difference (MARD). That measure of accuracy makes FreeStyle Libre 3 the most accurate 14-day CGM on the market. It also offers readings sent directly to a smartphone every minute.
Clinical trial data continues to back FreeStyle Libre 3. Abbott also revealed plans for a $450 million investment to increase FreeStyle Libre production in Ireland.
Other Abbott news in 2022:
- Abbott among the companies standing to benefit from new CMS decision on CGMs
- Galien Foundation names FreeStyle Libre the ‘best medical technology’ in the last 50 years
- FreeStyle Libre pairs with Novo Nordisk insulin pens in the UK
Rumors of a Dexcom-Insulet merger quickly quashed
A report in May cited people familiar with the matter suggesting a major diabetes merger on the cards. Those sources claimed Dexcom entered talks to acquire Insulet. The two companies know each other well, given that Insulet’s Omnipod insulin pumps use Dexcom CGMs.
They partnered in early 2020 to use Dexcom’s CGM with Insulet’s wearable pump. Dexcom and Insulet have since worked together on next-generation technologies.
However, within about a week, those rumors died down. Dexcom issued a statement “in response to recent media and market speculation.” The company said it regularly reviews opportunities to enhance stockholder value and create benefits for customers. That process includes looking at mergers and acquisitions. Dexcom then definitively said it was not in discussions over an acquisition or merger at that time.
How Embecta is poised to penetrate the diabetes space
In April, BD successfully completed the spinoff of its diabetes business. Embecta then became a standalone company. Its focus centers around the production of diabetes injection devices. It expects investment to come in organic and inorganic growth opportunities to improve the lives of those with diabetes.
CEO Devdatt Kurdikar told DDBN shortly after that Embecta can build upon its history within BD. That includes 98 years in the diabetes space. He said the company’s plans include developing an insulin patch pump system designed for people with type 2 diabetes.
Little is known about the system under development at Embecta. Analysts suggested in September that a transition to growth for the company could take multiple years. They also said earlier this month that questions will remain until the company reveals more about its patch pump efforts.
Sernova’s Cell Pouch System could ‘cure’ insulin-dependent diabetes
A lot of focus in the diabetes space hovers around CGMs and insulin pumps. One company aims to treat diabetes in a completely different way.
Sernova develops its proprietary Cell Pouch System. The implantable and scalable medical device forms a natural environment in the body. This facilitates the long-term survival and function of therapeutic cells. Those cells release necessary proteins or factors missing from the body to treat chronic diseases, including insulin-dependent diabetes. The company has reported positive clinical trial data for its Cell Pouch System, too.
CEO Dr. Philip Toleikis told DDBN that the company is expecting a “very exciting” coming year for its technology.
Are Ypsomed, CamDiab and Abbott creating the next big automated insulin delivery system?
In November, Ypsomed announced that its mylife Loop received authorization to work with the Abbott FreeStyle Libre 3 sensor in Germany.
The Ypsomed mylife YpsoPump combines with the CamDiab mylife CamAPS FX algorithm and FreeStyle Libre 3. Together, they form an intelligent and automated insulin delivery (AID) system for people with type 1 diabetes. Users can better control glucose levels and alleviate the burden of daily diabetes management. The three companies partnered to develop an AID earlier this year.
Abbott later noted that the trio intends to offer this AID system in additional European countries in 2023.
Meanwhile, in the U.S., Ypsomed remains an interesting company to watch. It recently announced that Eli Lilly elected to stop a joint project to enter the U.S. insulin pump market. Ypsomed still plans to continue its development program for the U.S. pump. The company said it intends to deepen discussions with other interested parties.
Tandem Diabetes Care makes a pair of acquisitions
While other companies reportedly flirted with M&A, Tandem Diabetes Care made two deals in 2022.
In July, the company acquired extended-wear infusion set developer Capillary Biomedical. Capillary’s technology is currently in development and not commercially available. The company designed its SteadiFlow seven-day-wear infusion set technology to significantly extend patient wear time to a week and maintain insulin stability.
Earlier this month, Tandem acquired AMF Medical, the maker of the Sigi patch pump for insulin delivery. Sigi, an ergonomic, rechargeable patch pump, reduces the burden of diabetes management. It uses pre-filled insulin cartridges and offers compatibility with automated insulin delivery technology.
Tandem already develops the t:slim X2 automated insulin delivery system. It will be interesting to see what they aim to pursue with the technology acquired from both companies.
Other Tandem news in 2022:
- Tandem Diabetes Care wins FDA clearance for insulin dosing via smartphone app
- Tandem Diabetes Care delivers 1 million insulin boluses using t:connect mobile app
- Study supports Tandem t:slim X2 insulin pump for type 2 diabetes