October 19, 2026
In the space of three days this October, the US diabetes device market moved decisively towards a patient population it has spent years circling. On October 14, The New England Journal of Medicine published the Dexcom-funded CONNECT trial, the first fully powered randomised study of continuous glucose monitoring (CGM) in adults with Type 2 diabetes who do not take insulin. Two days later, on October 16, the FDA cleared Sequel Med Tech's twiist automated insulin delivery (AID) system for adults aged 18 and over with insulin-treated Type 2 diabetes, a group the company estimates at around 5.5 million people in the US.
Hanging over both announcements is a decision the whole category is waiting on: whether the Centers for Medicare & Medicaid Services (CMS) will extend Medicare CGM coverage to people with Type 2 diabetes who are not on insulin. Dexcom expects a decision before the end of the year, with implementation in mid-2027, according to Leerink Partners.
Taken together, these developments point to a structural shift in where diabetes devices are sold. For two decades, the commercial engine of this category has been built around endocrinology. The next phase of growth sits with the patients endocrinologists rarely see, and that means primary care practices, pharmacy benefit channels and payers are becoming the centre of gravity. For commercial leaders, that is not a marketing adjustment. It is a rebuild of the field organisation.
The most commercially significant detail of CONNECT is not the headline result but the setting. The study screened 440 people across 22 primary care practices in the US, randomising 145 participants to Dexcom's G7 CGM and 138 to routine care with fingerstick monitoring.
After 26 weeks, HbA1c in the CGM group fell on average from a baseline of 8.8% to 7.2%, compared with a fall from 8.7% to 8.0% in the control group, a 0.9 percentage point greater reduction. CGM users also spent roughly five additional hours per day in the 70 to 180 mg/dL target range, and 97% were still using the device at the end of the study, most of them daily. Dexcom reported that the benefit held across age, income, insurance type and medication regimen, including among participants already taking GLP-1 therapies, where CGM delivered an additional 0.9% HbA1c reduction versus routine care.
That GLP-1 finding matters commercially. The primary care offices now prescribing GLP-1 medications at scale are the same offices device companies need to reach, and CONNECT gives sales teams a data point that positions CGM as complementary to the drugs those clinicians are already using, rather than competing for their attention.
It also matters that the evidence came from primary care rather than specialist clinics. Family physicians, nurse practitioners and physician assistants are far more likely to act on data generated in practices that look like theirs, and the American Academy of Family Physicians is already carrying Dexcom-sponsored material on the trial aimed at its members.
Today, Medicare covers CGM for people with diabetes who are insulin-treated or who have a history of problematic hypoglycaemia. The non-insulin Type 2 population sits outside that criteria, and it is enormous. Dexcom estimates that roughly 25 million people in the US have Type 2 diabetes and do not take insulin, and that around half of them are of Medicare age. Abbott told investors in July that the expansion would make about 10 million more Medicare beneficiaries eligible for CGM, while Leerink estimates it would double Dexcom's covered lives from about 15 million to 30 million.
Timing remains uncertain, and nothing is final until CMS acts. But analysts at William Blair described the NEJM publication as a likely catalyst for the decision, and Dexcom is clearly preparing the payer market in parallel. On October 16, the American Journal of Managed Care published a Dexcom-sponsored clinical brief written specifically for payers, pharmacy benefit managers and health system leaders weighing CGM coverage for non-insulin Type 2 patients. Commercial insurers have already been moving; Dexcom's CEO said earlier this year that private payer coverage for this group had begun to open up.
The twiist clearance is the third AID system to secure a Type 2 indication in the US, after Insulet's Omnipod 5 in 2024 and Tandem Diabetes Care's Control-IQ+ in February 2025. The clearance was supported by a 13-week, 307-participant trial that showed an HbA1c improvement of 0.7 percentage points, published in Diabetes Care. Sequel says twiist is available through pharmacies with a prescription, and it works with Abbott's FreeStyle Libre 3 Plus and Senseonics' Eversense 365 sensors.
Insulet offers the clearest picture of what a primary care and pharmacy-led diabetes device business looks like at scale. By the end of 2025, Omnipod 5 was available through approximately 48,000 US pharmacies, its prescriber base had grown about 28% year on year to more than 30,000 healthcare professionals, and the company described its sales force as the largest in the industry, built to reach high-prescribing offices treating both Type 1 and Type 2 patients. Insulet has also said it is investing in simplifying prior authorisation for primary care prescribers, and that a fully closed-loop system planned for 2028 is intended to reach the broader primary care population. Tandem, for its part, has made pharmacy channel expansion a central priority alongside its Type 2 launch.
The direction of travel is consistent across CGM and insulin delivery alike: smaller, simpler devices, prescribed by generalists, dispensed through pharmacies and reimbursed under pharmacy benefit designs.
Endocrinology is a concentrated, technology-literate specialty. A diabetes device representative can build a territory around a manageable number of high-volume clinics where clinicians already understand sensor data, insulin titration and pump onboarding. Primary care is the opposite. It is fragmented across tens of thousands of practices, clinicians are managing dozens of conditions in short appointments, device experience is limited, and the administrative burden of prior authorisations and supplier paperwork can kill a prescription before it is written.
That changes almost every assumption behind a commercial model, from territory size and call frequency to who in the practice the representative actually needs to influence. In many primary care offices, nurse practitioners, physician assistants, care coordinators and practice managers carry as much weight in device adoption as the physician. Pharmacy channels add another layer, because access depends on benefit design, PBM contracts and formulary placement rather than the durable medical equipment supplier relationships that have traditionally underpinned diabetes devices.
The first and most visible demand is for primary care sales representatives who can sell a device into a generalist setting. The profile looks different from a traditional endocrinology rep. It rewards high-volume territory management, the ability to deliver a clear clinical story in a few minutes, and comfort working with entire care teams rather than single key opinion leaders. Representatives who have sold GLP-1s, SGLT2 inhibitors or other cardiometabolic products into primary care already know these offices, and pharma-to-device crossover is likely to become a meaningful talent route.
Alongside them, payer and market access teams are moving from a supporting function to a frontline one. If CMS expands coverage, companies will need people who can translate a national Medicare decision into practical access across Medicare Advantage plans, commercial insurers and PBMs, and who can build the health economic and real-world evidence case that payers increasingly expect. Market access professionals with both device and pharmacy benefit experience are rare, and competition for them is likely to intensify as several companies prepare for the same coverage event.
Pharmacy channel managers are becoming critical in a category that was not built around retail pharmacy. Managing relationships with retail and specialty pharmacies, wholesalers and PBMs, ensuring stock availability, and removing friction at the pharmacy counter is specialist commercial work, and much of the experience sits in pharmaceutical trade relations rather than in MedTech.
Finally, clinical educators become the bridge between a prescription and a patient who keeps using the device. Primary care practices generally do not have diabetes technology specialists on staff, and many Type 2 patients now becoming eligible for CGM or AID have never used either. Sequel has specifically pointed to twiist's results in patients without prior pump experience. Certified diabetes care and education specialists, nurse educators and field-based trainers who can onboard patients, train practice staff and support pharmacists will determine whether early prescriptions turn into durable adoption, and they are already in short supply.
If CMS issues its decision before the end of the year and coverage takes effect in mid-2027, companies that wait for the announcement to start building primary care, access and channel teams will be hiring into a market where every competitor is doing the same thing at once. Commercial leaders planning for 2027 are effectively planning for a coverage event that could double their addressable population, and the teams required to capture it take months to recruit, train and ramp.
The companies best positioned for this next phase will be those that treat Type 2 diabetes not as a line extension of their endocrinology business, but as a new market with its own customers, channels and economics, and staff accordingly.
At 44 International, we work with US MedTech companies building the commercial teams that new markets demand, from primary care field sales and market access to pharmacy channel and clinical education talent. If you are planning your 2027 diabetes commercial organisation, we would welcome the conversation.
© All rights reserved