Welcome back. Three signals this month: one on a technology that just earned the evidence it was waiting for, one on a market that grew to ten billion dollars with the evidence lagging behind, and one on a measure that costs nothing and takes eight years to show its worth.
— Nadège
In this Issue
The CONNECT trial, published in the *New England Journal of Medicine* on 14 October 2026 (Oser et al.), is the first large multicentre randomised trial of continuous glucose monitoring in adults with type 2 diabetes who are not on insulin — a population that has largely been left out of CGM research, and one that is managed overwhelmingly in primary care. The trial ran across 22 primary care sites in the United States. Mean HbA1c fell from 8.8% to 7.2% in the CGM group, against 8.7% to 8.0% in the control group, and participants using CGM spent roughly five additional hours per day within the target range of 70–180 mg/dL. The benefit held across age, sex, race and ethnicity, body mass index, diabetes duration, income, education, insurance status and concurrent glucose-lowering therapy. Nearly all participants were still wearing the sensor at 26 weeks. The trial was funded by Dexcom, and the device studied is its own — a fact worth holding alongside the result rather than instead of it. It is also the first time in close to two decades that the NEJM has published clinical data on standalone real-time CGM, and it lands as the Centers for Medicare & Medicaid Services weigh expanding coverage to people with type 2 diabetes who do not use insulin. Evidence and reimbursement rarely arrive in that order.
Medicare Part B spending on skin substitutes — the cellular, acellular and matrix-like products used on chronic wounds — rose from roughly $252 million in 2019 to over $10 billion in 2024, close to a fortyfold increase. The CMS CY2026 Physician Fee Schedule Final Rule, issued in October 2025, responded by ending payment for most of these products as biologicals and reclassifying them as incident-to supplies, folded into the application procedure at a flat rate of about $127 per cm², effective 1 January 2026, with no payment for discarded material. CMS expects the change to cut spending on these products by close to 90%. What made that intervention possible was an evidence base thin enough that the payer could act on price alone. Randomised trials in this category have been scarce relative to its size — which is what makes the one published on 5 October 2026 in the *International Wound Journal* worth reading. Armstrong and colleagues report a prospective multicentre randomised controlled trial of a composite ovine forestomach matrix and hyaluronic acid graft in diabetes-related foot wounds: complete closure at 12 weeks reached 55% with the graft added to standard care, against 35% for standard care alone, with mean healing time shortened by 7.8 days. The trial is funded by the manufacturer, as most in this field are, and it was designed and running well before the CMS rule was written. None of this is settled — manufacturers are lobbying and litigating, a reform bill sits in Congress, and CMS has signalled it may differentiate future rates by FDA regulatory category. Wound care clinicians are not of one mind about any of it. But the sequence is worth sitting with, and not only in wound care: when a field's therapies grow faster than its trials, someone other than the field eventually decides what they are worth.
Read the trial →
A nationwide retrospective cohort study in *JAMA Network Open* (Shin et al., 2 October 2026) followed people with type 2 diabetes in the Korean national health screening system, classifying smoking status through repeated national checkups and tracking microvascular outcomes through December 2023. Compared with those who kept smoking, people who had stopped for eight years or more had a 19% lower risk of any diabetic microvascular complication (adjusted HR 0.81, 95% CI 0.70–0.95), with a 41% lower risk of diabetic eye disease, a 21% lower risk of diabetic kidney disease, and a 20% lower risk of diabetic nerve damage. The detail worth carrying into clinic is in the early years. Among those who had stopped for less than two years, the risk of diabetic kidney disease was 12% *higher* than among continuous smokers — most plausibly reflecting weight gain after cessation, reverse causation in people who quit because they were already unwell, or both. This is observational work and cannot settle the mechanism. But it reframes what we tell patients: the benefit is real, it is substantial, and it is measured in years rather than months. A patient who quits and sees nothing at eighteen months has not failed.
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— Nadège Sheehan, PhD
President, OneGuild Institute
New York, October 2026
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