The Final Countdown for New CMS Glycemic Measures: Glytec Prepares Hospitals and Health Systems with Proven, FDA-Cleared Technology Platform
BOSTON, July 17, 2025 /PRNewswire/ -- Glytec is the leading provider of an AI-powered technology platform for diabetes and related conditions, including its FDA-cleared Glucommander® EHR-integrated solution for inpatient glycemic management. Today, Glytec reinforced its commitment to supporting U.S. hospitals in preparation for the upcoming Centers for Medicare & Medicaid Services (CMS) mandate on inpatient glycemic control reporting.
With the measurement period set to begin on January 1, 2026, and just 167 days remaining, now is an important time for hospitals to begin preparing. Equipping teams with the right tools, workflows, and data systems can help ensure readiness for these critical requirements—and avoid potential reductions in Medicare reimbursement starting in fiscal year 2028. Under the new mandate, CMS will require reporting of both severe hypoglycemia (blood glucose <40 mg/dL) and severe hyperglycemia (blood glucose >300 mg/dL) as electronic clinical quality measures (eCQMs). These measures apply to nearly 40% of hospitalized patients who experience dysglycemia during their stay.
"CMS is creating focus and awareness around inpatient diabetes care," said Patrick Cua, CEO of Glytec. "This will help drive improved patient care and patient safety, but hospitals also have revenue to gain via reduced length of stay and cost avoidance through reduced hypoglycemia, lower testing costs, and improved workflows. Glytec's platform is purpose-built to lead hospitals through this transition safely and to continue to innovate around diabetes workflows to drive better patient care and overall economics for healthcare stakeholders."
The new CMS reporting mandate is driven in part by the increasing prevalence of diabetes and its associated complications, which place a significant burden on healthcare systems, payors, and individual lives. More than one-third of hospitalized patients require insulin therapy to manage elevated blood glucose levels during their stay [1]. Each year, more than 2 million patients experience adverse events in the hospital related to hypoglycemia—events that, according to the Agency for Healthcare Research and Quality (AHRQ), contribute to over $8 billion in costs and are associated with increased length of stay and higher readmission rates. Despite the widespread impact of glycemic events, nearly one-third of hospitals do not track glucose management metrics, and 59% lack automated methods to collect data on rates of hyperglycemia and hypoglycemia [2]. In response, some institutions have developed internal solutions, which, while well-intentioned, may introduce challenges related to clinical oversight, regulatory alignment, and the safe management of a high-risk therapy like insulin.
Technology Built for Clinical Excellence and Return on Investment
The Glytec Technology Platform, leveraged by over 400 hospitals, manages complex, high-impact workflows—from hospital to home—with proven results and AI-driven intelligence. It is built on over 100 patents, 100 clinical publications, 16 years of experience, and 50+ billion data points.
As an FDA-cleared platform, Glytec provides:
Industry superior insulin dosing algorithms with ongoing clinical validation, monitoring, and venture-backed investment
Real-time dashboards aligned with CMS reporting requirements
Turn-key EHR integration, enhanced cybersecurity, and reducing IT burden and overhead
Freedom to operate across the breadth of Glytec's 100+ patented algorithms, workflows, and other intellectual property.
In-House Insulin Tools Fall Short
Some hospitals have explored building their own in-house insulin calculators to manage glycemia, but studies and real-world feedback reveal that these solutions:
Lack clinical validation, scalability, and rigor of FDA-cleared solutions
Can introduce user interface challenges and omit clinical guardrails that contribute to dosing errors and patient harm
Require ongoing maintenance and investment that cannot keep pace with dedicated venture-backed technology companies, and
Divert critical IT staff from broader strategic hospital technology objectives
167 Days and Counting to Get It Right
The countdown is on. As the CMS mandate nears, hospitals must choose partners to deliver speed, safety, and scale, and avoid the cost, delay, and proven lower outcomes of risky non-regulated approaches.
About Glytec
Glytec's industry-leading technology platform, trusted by over 400 hospitals, empowers collaborative diabetes management and insulin dosing, improving patient outcomes, reducing hospital length of stay, and optimizing clinical workflows. Its flagship product, Glucommander®—the first-ever FDA-cleared cloud-based insulin management software—integrates seamlessly with EMRs, providing advanced clinical decision support, workflow alerts, patient monitoring, and AI-driven analytics. Supported by over 100 patents and 100 peer-reviewed publications, Glytec is dedicated to improving care from hospital to home. For more information, visit www.glytec.com or follow Glytec on LinkedIn.
Media Contact:
Public RelationsGlytecPR@glytec.com
References:
Umpierrez GE, et al. Journal of Clinical Endocrinology & Metabolism, 87(3), 978–982. (March 2002). https://doi.org/10.1210/jcem.87.3.8341
Cook CB, et al. Endocrine Practice, 16(2), 219–230. (March 2010). https://doi.org/10.4158/EP09234.OR
View original content to download multimedia:https://www.prnewswire.com/news-releases/the-final-countdown-for-new-cms-glycemic-measures-glytec-prepares-hospitals-and-health-systems-with-proven-fda-cleared-technology-platform-302508181.html
SOURCE Glytec, LLC
Hashtags

Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles


Bloomberg
18 minutes ago
- Bloomberg
Sarepta Announces Voluntary Pause of Elevidys Shipments in US
Sarepta Therapeutics Inc. announced that the company plans to temporarily pause all shipments of its gene therapy to treat Duchenne muscular dystrophy, Elevidys, in a reversal of its prior stance. The Food and Drug Administration asked Sarepta to pause shipments of the drug on Friday following news reports of a patient death in a clinical trial for another Sarepta therapy that works in a similar way. The company initially refused, which drew backlash.


Business Wire
an hour ago
- Business Wire
Sarepta Therapeutics Announces Voluntary Pause of ELEVIDYS Shipments in the U.S.
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today issued the following statement: Today, Sarepta Therapeutics notified the U.S. Food and Drug Administration (FDA) of its decision to voluntarily and temporarily pause all shipments of ELEVIDYS (delandistrogene moxeparvovec) for Duchenne muscular dystrophy in the United States, effective close of business Tuesday, July 22, 2025. This proactive step will allow Sarepta the necessary time to respond to any requests for information and allow Sarepta and FDA to complete the ELEVIDYS safety labeling supplement process. The Company looks forward to a collaborative, science-driven review process and dialogue with the FDA. 'As a patient-centric organization, the decision to voluntarily and temporarily pause shipments of ELEVIDYS was a painful one, as individuals with Duchenne are losing muscle daily and in need of disease-modifying options,' said Doug Ingram, chief executive officer, Sarepta. 'It is important for the patients we serve that Sarepta maintains a productive and positive working relationship with FDA, and it became obvious that maintaining that productive working relationship required this temporary suspension while we address any questions that FDA may have and complete the ELEVIDYS label supplement process.' Sarepta remains committed to transparency and patient safety and will continue to provide timely updates to patients, families, healthcare providers, and the broader Duchenne community as additional information becomes available. About ELEVIDYS (delandistrogene moxeparvovec-rokl) ELEVIDYS (delandistrogene moxeparvovec-rokl) is a single-dose, adeno-associated virus (AAV)-based gene transfer therapy for intravenous infusion designed to address the underlying genetic cause of Duchenne muscular dystrophy – mutations or changes in the DMD gene that result in the lack of dystrophin protein – through the delivery of a transgene that codes for the targeted production of ELEVIDYS micro-dystrophin in skeletal muscle. ELEVIDYS is indicated for the treatment of Duchenne muscular dystrophy (DMD) in individuals at least 4 years of age. For patients who are ambulatory and have a confirmed mutation in the DMD gene For patients who are non-ambulatory and have a confirmed mutation in the DMD gene. The DMD indication in non-ambulatory patients is approved under accelerated approval based on expression of ELEVIDYS micro-dystrophin in skeletal muscle. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). IMPORTANT SAFETY INFORMATION CONTRAINDICATION: ELEVIDYS is contraindicated in patients with any deletion in exon 8 and/or exon 9 in the DMD gene. WARNINGS AND PRECAUTIONS: Infusion-related Reactions: Infusion-related reactions, including hypersensitivity reactions and anaphylaxis, have occurred during or up to several hours following ELEVIDYS administration. Closely monitor patients during administration and for at least 3 hours after the end of infusion. If symptoms of infusion-related reactions occur, slow, or stop the infusion and give appropriate treatment. Once symptoms resolve, the infusion may be restarted at a lower rate. ELEVIDYS should be administered in a setting where treatment for infusion-related reactions is immediately available. Discontinue infusion for anaphylaxis. Acute Serious Liver Injury: Acute serious liver injury has been observed with ELEVIDYS, and administration may result in elevations of liver enzymes (such as GGT, GLDH, ALT, AST) or total bilirubin, typically seen within 8 weeks. Patients with preexisting liver impairment, chronic hepatic condition, or acute liver disease (e.g., acute hepatic viral infection) may be at higher risk of acute serious liver injury. Postpone ELEVIDYS administration in patients with acute liver disease until resolved or controlled. Prior to ELEVIDYS administration, perform liver enzyme test and monitor liver function (clinical exam, GGT, and total bilirubin) weekly for the first 3 months following ELEVIDYS infusion. Continue monitoring if clinically indicated, until results are unremarkable (normal clinical exam, GGT, and total bilirubin levels return to near baseline levels). Systemic corticosteroid treatment is recommended for patients before and after ELEVIDYS infusion. Adjust corticosteroid regimen when indicated. If acute serious liver injury is suspected, consultation with a specialist is recommended. Immune-mediated Myositis: In clinical trials, immune-mediated myositis has been observed approximately 1 month following ELEVIDYS infusion in patients with deletion mutations involving exon 8 and/or exon 9 in the DMD gene. Symptoms of severe muscle weakness, including dysphagia, dyspnea, and hypophonia, were observed. Limited data are available for ELEVIDYS treatment in patients with mutations in the DMD gene in exons 1 to 17 and/or exons 59 to 71. Patients with deletions in these regions may be at risk for a severe immune-mediated myositis reaction. Advise patients to contact a physician immediately if they experience any unexplained increased muscle pain, tenderness, or weakness, including dysphagia, dyspnea, or hypophonia, as these may be symptoms of myositis. Consider additional immunomodulatory treatment (immunosuppressants [e.g., calcineurin-inhibitor] in addition to corticosteroids) based on patient's clinical presentation and medical history if these symptoms occur. Myocarditis: Acute serious myocarditis and troponin-I elevations have been observed following ELEVIDYS infusion in clinical trials. If a patient experiences myocarditis, those with pre-existing left ventricle ejection fraction (LVEF) impairment may be at higher risk of adverse outcomes. Monitor troponin-I before ELEVIDYS infusion and weekly for the first month following infusion and continue monitoring if clinically indicated. More frequent monitoring may be warranted in the presence of cardiac symptoms, such as chest pain or shortness of breath. Advise patients to contact a physician immediately if they experience cardiac symptoms. Preexisting Immunity against AAVrh74: In AAV-vector based gene therapies, preexisting anti-AAV antibodies may impede transgene expression at desired therapeutic levels. Following treatment with ELEVIDYS, all patients developed anti-AAVrh74 antibodies. Perform baseline testing for presence of anti-AAVrh74 total binding antibodies prior to ELEVIDYS administration. ELEVIDYS administration is not recommended in patients with elevated anti-AAVrh74 total binding antibody titers greater than or equal to 1:400. Adverse Reactions: The most common adverse reactions (incidence ≥5%) reported in clinical studies were vomiting, nausea, liver injury, pyrexia, and thrombocytopenia. Report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. You may also report side effects to Sarepta Therapeutics at 1-888-SAREPTA (1-888-727-3782). For further information, please see the full Prescribing Information. About Sarepta Therapeutics Sarepta is on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. For more information, please visit or follow us on LinkedIn, X, Instagram and Facebook. Forward-Looking Statements This statement contains 'forward-looking statements.' Any statements that are not statements of historical fact may be deemed to be forward-looking statements. Words such as 'believe,' 'anticipate,' 'plan,' 'expect,' 'will,' 'may,' 'intend,' 'prepare,' 'look,' 'potential,' 'possible' and similar expressions are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements relating to our future operations, ELEVIDYS, ongoing interactions with FDA related to ELEVIDYS, and our decision to voluntarily and temporarily pause shipments of ELEVIDYS in the United States. Actual results could materially differ from those stated or implied by these forward-looking statements as a result of such risks and uncertainties. Known risk factors include the following: our products or product candidates may be perceived as insufficiently effective, unsafe or may result in unforeseen adverse events; our products or product candidates may cause undesirable side effects that result in significant negative consequences following any marketing approval; different methodologies, assumptions and applications we use to assess particular safety or efficacy parameters may yield different statistical results, and even if we believe the data collected from clinical trials are positive, the results of future research may not be consistent with past positive results, or may fail to meet regulatory approval requirements for the safety and efficacy of product candidates; we may not be able to comply with all FDA requests in a timely manner or at all; the possible impact of regulations and regulatory decisions by the FDA and other regulatory agencies on our business; and those risks identified under the heading 'Risk Factors' in our most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) as well as other SEC filings made by the Company, which you are encouraged to review. Any of the foregoing risks could materially and adversely affect the Company's business, results of operations and the trading price of Sarepta's common stock. For a detailed description of risks and uncertainties Sarepta faces, you are encouraged to review the SEC filings made by Sarepta. We caution investors not to place considerable reliance on the forward-looking statements contained herein. Sarepta does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof, except as required by law. Internet Posting of Information We routinely post information that may be important to investors in the 'For Investors' section of our website at We encourage investors and potential investors to consult our website regularly for important information about us.


Newsweek
an hour ago
- Newsweek
Ice Cream Recall In 23 States After Possible Listeria Contamination
Based on facts, either observed and verified firsthand by the reporter, or reported and verified from knowledgeable sources. Newsweek AI is in beta. Translations may contain inaccuracies—please refer to the original content. Millions of ice cream bars distributed in schools and businesses across 23 states have been recalled amid possible listeria contamination, with the U.S. Food and Drug Administration (FDA) warning of "adverse health consequences" should someone consume the affected product. Why It Matters Rich's Ice Cream products are available in schools and businesses in 23 states. On its website, the Florida-based ice cream company says it only ships "to large wholesale ice cream distributors all over the US." "These distributors then sell our ice cream to schools and businesses in their local market," the website said. Newsweek reached out to Rich's Ice Cream by email for comment outside of normal business hours on Monday. What to Know Numerous flavors of Rich's Ice Cream have been pulled from store shelves amid possible listeria contamination. In total, 110,292 cases of ice cream were recalled, with 96 units in each case resulting in more than 10 million bars of ice cream impacted. Lot numbers 24351 through 25156 were included in the recall. A stock photo of an ice cream bar. A stock photo of an ice cream bar. bombermoon/Getty The ice cream was distributed to 23 states, including California, Pennsylvania, Ohio, Georgia, New York, New Jersey, Florida, Texas, Virginia, Arizona, Alabama, Illinois, Missouri, Massachusetts, Tennessee, Iowa, South Carolina, Oregon, Oklahoma, Nevada, Louisiana, Wisconsin, and Nebraska, as well as Nassau and the Bahamas. Listeriosis is a bacterial infection that can occur after consuming food contaminated by the Listeria monocytogenes bacteria. Symptoms can range from mild to life-threatening, according to a report by the Cleveland Clinic, and are particularly dangerous for those who are pregnant or who have a weakened immune system. Foods that can be contaminated by Listeria include hot dogs, deli meats, and soft cheese. Symptoms can include fever, headache, chills, fatigue, vomiting and diarrhea. It can take as long as two weeks for symptoms to appear after consuming a contaminated product, the Cleveland Clinic reported. When was the recall issued? Rich's Ice Cream voluntarily issued the recall on June 27, according to the FDA report. On July 17, the FDA classified the recall as a Class II, meaning that exposure to the product could cause "adverse health consequences." Which products were recalled? Full List Products affected by the recall include the following varieties: Chocolate Crunch Cake Bar Strawberry Shortcake Bar Rich Bar Crumbled Cookie Bar Orange Cream Bar Fudge Frenzy Bar Cotton Candy Twirl Bar Savagely Sour BlueRaspberry Bar Savagely Sour Cherry Bar Cool Watermelon Bar What People Are Saying The FDA, in an online definition, about Class II recalls: "A situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote." Rich's Ice Cream on its webpage: "Our products are available in schools and on street vending trucks (a.k.a. "the ice cream man") all across the country." What Happens Next The recall is listed as ongoing, according to the FDA. Instructions on how to contact the company or if refunds would be offered were not included in the recall.