Wait until you need insulin
A randomized trial found a glucose sensor lowered blood sugar in adults with type 2 diabetes who take no insulin. Medicare's rule still turns mainly on the insulin rather than the evidence.
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read by an AI voiceMedicare will pay for a glucose sensor once a patient has started insulin. Seen from the patient's side of the desk, the rule asks a person with type 2 diabetes to get sicker first.
A trial published on Oct. 14 in the New England Journal of Medicine suggests that is backward. It assigned 283 adults at 22 primary care practices at random to a continuous glucose monitor, or CGM, which reads sugar through the day and sends it to a phone, or to routine care with a finger-stick meter. None was using insulin when the trial began. After 26 weeks, hemoglobin A1c, the test that reflects average sugar over about three months, had fallen 0.9 percentage points further in the sensor group. Dexcom, which makes the sensor, sponsored the trial and announced the results.
Medicare's rule runs the other way. The coverage document its contractors use pays for a sensor only if the patient “is insulin-treated” or has “a history of problematic hypoglycemia.” The trial excluded anyone who had used insulin in the previous year, apart from short-term use in the hospital, and anyone planning to start. So its participants fail the first condition outright. They qualify, if at all, only through the second.
Dexcom has not waited for the contractors. It told investors in July that it had sent the data to the Centers for Medicare and Medicaid Services and expected a decision before the end of the year. On Oct. 29 it said it still did, with any expanded coverage taking effect in the middle of 2027. So the question is no longer whether anyone will read the evidence. It is whether the answer turns on the evidence or on the insulin, and whether the agency shows its reasoning.
The trial itself holds up better than most things a manufacturer announces. It was randomized rather than a trawl through records, and it ran in primary care practices, though several sites were research networks. Patients knew which group they were in. The comparison group wore a blinded sensor at intervals so glucose could be measured in both. Time in the target range was 21 percentage points higher, about five hours more a day. No severe low-sugar events were reported. Dexcom paid for the work and five of its employees are among the authors. The senior author is not one of them and works at the Jaeb Center for Health Research, a trial collaborator. In the company's announcement he called the trial “the first and only level A evidence demonstrating strong benefit of CGM” in this group, the highest grade the American Diabetes Association gives.
Treat one number in that announcement carefully. Dexcom's announcement singles out the patients furthest from target. Its own account says participants starting above 10 percent A1c averaged a 3.1 point drop, 2.1 points more than the comparison group. That is a subgroup of a 283-patient trial, reported by the manufacturer from a conference presentation. It is the least durable part of the result. A reason to look again at the rule, not a basis for writing one.
The guidelines have already moved. The association's 2026 standards of care, issued in December 2025, recommend the sensor “at diabetes onset and anytime thereafter” for anyone who could benefit, not only insulin users. Medicare's rule has widened before, in public. In April 2023 the contractors dropped a requirement of three or more daily insulin doses or a pump. What is moving now is not in public. One contractor's tracking list, updated on Oct. 15, shows four open reconsiderations and not one of them is on glucose monitors. The policy was untouched in the Oct. 1 revisions. No proposed policy, no comment period.
Payers have a real answer, and the numbers are on their side. Medicare's payments for sensors and supplies rose from $109 million in 2018 to $1.3 billion in 2023, and in one year exceeded what suppliers paid for the equipment by 69 percent, the inspector general found. The trial measured a blood test at six months. Not heart attacks, not kidney failure, not lost sight. Its participants averaged 60 years of age, younger than most people on Medicare. All fair. But price and coverage are different questions, and Medicare is already working on price. Coverage asks whether the thing works, and the contractors' own test for that is published peer-reviewed evidence.
There is a route, and it does not belong to the manufacturer. Any interested party doing business in a contractor's jurisdiction, a practicing clinician included, may ask for a reconsideration. The request is invalid unless it proposes the exact language and encloses published, full-text, peer-reviewed evidence indexed in PubMed. The contractor answers within 60 days. A proposed policy carries at least 45 days of comment. A proposal is finalized or retired within a rolling year. The request letter, the proposed policy and the answers to comments are published. The diabetes and primary care societies should file it, with this trial attached and the wording written out: coverage for adults with type 2 diabetes who use no insulin and whose A1c stays above a stated level.
Others need not wait for the agency. Commercial insurers and state Medicaid programs write their own rules, and an estimated 20 million American adults have type 2 diabetes and take no insulin, the trial's first author said. Patients who can pay are already past all of this. In 2024 the Food and Drug Administration cleared a different, over-the-counter sensor, not the prescription device the trial used, for adults 18 and older who are not on insulin. And Dexcom should publish the trial's second half, in which both groups wore sensors, whether or not the numbers favor the device.
So the sensor is covered once the insulin starts. The trial found its clearest benefit earlier, in the primary care offices where most of these patients are actually seen, and by the company's own account the agency already has that evidence. A rule that waits for the insulin is reading it backward.
- The CONNECT trial as publishedOser, Martens, Ruedy and colleagues, "Continuous Glucose Monitoring in Non-Insulin-Treated Type 2 Diabetes," New England Journal of Medicine, Oct. 14, 2026 (DOI 10.1056/NEJMoa2608571; PubMed 42878622). A 26-week trial at 22 primary care practices in the United States randomly assigned adults with type 2 diabetes not using insulin to CGM (145 participants) or routine care (138), 283 in all, ages 21 to 84. Primary outcome: glycated hemoglobin at 26 weeks. Mean A1c fell from 8.8+/-1.3% to 7.2+/-1.1% with CGM and from 8.7+/-1.2% to 8.0+/-1.4% with routine care (adjusted mean difference -0.9 percentage points; 95% CI, -1.1 to -0.6; P<0.001). CGM-measured time in 70 to 180 mg/dL was 21 percentage points higher (95% CI, 16 to 26). Time below 54 mg/dL differed by -0.17 percentage points and time below 70 mg/dL by -0.20, both tested for non-inferiority. No severe hypoglycemia events were reported. Funded by Dexcom; five authors list Dexcom, San Diego, as their affiliation. The journal's own page refused automated access; the abstract was read in the PubMed record.
- What the trial registration saysClinicalTrials.gov NCT06601166, "CONtiNuous glucosE Monitoring (CGM) in People wiTh Type 2 Diabetes Not on Insulin: The CONNECT Study." Sponsor: DexCom, Inc. Collaborators: Jaeb Center for Health Research, Scripps Research Digital Trial Center, Precision Data Health, Inc. Interventional; enrollment 283; start Aug. 15, 2024; primary completion May 13, 2026; status active, not recruiting. Adults over 18 with type 2 diabetes managed in primary care and a screening HbA1c of 7.5% or higher were randomized 1:1 to real-time CGM or routine care plus interval blinded CGM wear. Use of insulin in the 12 months before screening, or a plan to start it within 12 months, was exclusionary, as was prior personal CGM use within 6 months; short-term inpatient insulin use was not exclusionary, and previous wear of a professional CGM was not either. A 26-week extension follows in which both groups use CGM. The registry lists 21 sites, including Parkersburg, West Virginia; Odessa and Lubbock, Texas; Raleigh, North Carolina; and Aurora, Colorado; the published paper reports 22 primary care practices.Source: ClinicalTrials.gov
- Dexcom's own announcement of the resultsDexcom's news release of June 6, 2026 (Business Wire), "Dexcom CONNECT Study: The Most Significant Clinical Study Demonstrating CGM Benefits for People with Type 2 Diabetes Not Using Insulin," reports an oral presentation at the American Diabetes Association's 2026 Scientific Sessions: 440 screened at 22 primary care practices, 283 randomized to Dexcom G7 or routine care, 265 completing the 26-week study. It states an average 1.6% A1c reduction with G7 from a mean baseline of 8.8%, 0.9% greater than control; that participants with an initial A1c above 10% had on average a 3.1% reduction, 2.1% greater than control; time in range of 62% against 41%, about five hours a day more; and median G7 use of 97%. The release calls the trial "Dexcom sponsored" and quotes Roy Beck, medical director of the Jaeb Center for Health Research and the senior author, and Jake Leach, the company's president and chief executive: "We anticipate these results will help establish a new standard of care in the US and around the world."
- Medicare's coverage rule for glucose monitorsLCD L33822, "Glucose Monitors," is the local coverage determination used by the four durable medical equipment contractors: CGS Administrators (Jurisdictions B and C) and Noridian Healthcare Solutions (Jurisdictions A and D). Original effective date Oct. 1, 2015; revision effective for services performed on or after Oct. 1, 2024. Initial CGM coverage requires five criteria, among them that the beneficiary "is insulin-treated; or," "has a history of problematic hypoglycemia" documented as recurrent (more than one) level 2 events (glucose below 54 mg/dL) persisting despite changes in treatment, or one level 3 event (glucose below 54 mg/dL) requiring third-party assistance; a practitioner visit within six months before the order; and a visit every six months for continued coverage. The appendices state that "Insulin does not exist in an oral form." Revision R12, effective April 16, 2023, removed the earlier requirement of "multiple (three or more) daily administrations of insulin or a continuous subcutaneous insulin infusion (CSII) pump."Source: CMS Medicare Coverage Database
- No contractor reconsideration is openCGS Administrators' DME LCD tracking page for Jurisdiction C, updated Oct. 15, 2026, lists four requests with development status open: power mobility devices, wheelchair options and accessories, oxygen and oxygen equipment, and external breast prostheses. No glucose monitor request appears as open. Two completed entries are reconsideration requests to modify the coverage criteria for continuous glucose monitors, with finals announced in June 2021 and March 2023. Noridian's summary of LCD and policy article revisions effective Oct. 1, 2026 lists eight policies and does not include glucose monitors. Neither page covers CMS itself. Dexcom told investors on July 30, 2026 that it had submitted the CONNECT data to CMS and expected a decision before the end of 2026, with implementation modeled around the middle of 2027; trade reporting of Aug. 27, 2026 said the same. On its third-quarter call on Oct. 29, 2026, the company said it still expected CMS to announce a coverage decision in 2026 for people with type 2 diabetes who do not use insulin, with any expanded coverage taking effect in the middle of 2027, and that it had given the published trial to the medical directors reviewing its submission. No proposed policy or comment period for it appears on either contractor's list.
- How a coverage rule gets reopenedNoridian's LCD reconsideration page states who may request a change to a final local coverage determination: "Beneficiaries residing or receiving care in a contractor's jurisdiction," "Health care professionals doing business in a contractor's jurisdiction" and "Any interested party doing business in a contractor's jurisdiction." A request must include "the specific language that the requestor proposes added to or deleted from the LCD," and "Submitted literature and references should be limited to published, full-text, peer-reviewed evidence"; the page also requires that the literature be indexed in PubMed, and states that "The failure to include specific literature with the request will render the LCD request invalid." Noridian "will respond to the request within 60 calendar days upon receipt"; a proposed LCD carries a comment period of at least 45 days, notice is given at least 45 days before the effective date, and "Proposed LCDs will be finalized or retired within a rolling calendar year of publication date."Source: Noridian Healthcare Solutions
- What Medicare already pays for sensorsHHS Office of Inspector General report OEI-04-23-00430, November 2025, "Medicare Payments for Continuous Glucose Monitors and Supplies Exceeded Supplier Costs and Retail Market Prices." Part B payments for CGMs and supplies rose from $109 million in 2018 to $1.3 billion in 2023. For July 2022 through June 2023, payments exceeded supplier acquisition costs by $377 million (69 percent) and suppliers' estimated total costs by $70 million (8 percent); payments for supplies exceeded retail market prices by $290 million. CMS concurred with both recommendations. CMS's CY 2026 DMEPOS competitive bidding final rule, published Dec. 2, 2025 and effective Jan. 1, 2026, revives competitive bidding; a CMS fact sheet updated Dec. 8, 2025 lists Class II continuous glucose monitors and insulin pumps among the next round's categories, with contracts taking effect in 2028, and CGMs reclassified to monthly rental payment. The final rule itself does not list the categories, and CMS may change them.
- Guidelines, and a sensor sold without a prescriptionThe American Diabetes Association's news release of Dec. 8, 2025 announcing its 2026 Standards of Care in Diabetes lists among the changes "Recommended use of continuous glucose monitoring at diabetes onset and anytime thereafter" "to improve outcomes for anyone who could benefit from its use in diabetes management." A report on the new standards states that the recommendation is "not limited to insulin users or those at high risk for hypoglycemia." Separately, the Food and Drug Administration cleared Dexcom's Stelo in March 2024 as the first over-the-counter continuous glucose monitor in the United States, "for use by people 18 years and older who are not on insulin therapy", and it is sold without a prescription. The CONNECT trial used the prescription G7 sensor, not the over-the-counter device. The trial's first author has said that an estimated 20 million adults in the United States have type 2 diabetes and do not take insulin.