Latest news with #hypoglycemia
Medscape
17 hours ago
- Health
- Medscape
Implantable Device Shows Promise for Preventing Hypoglycemia
A new minimally invasive device, while still in development, could become a lifesaver for individuals with diabetes who experience hypoglycemia, according to researchers at the Massachusetts Institute of Technology (MIT) in Cambridge, Massachusetts. In a paper published in Nature Biomedical Engineering , Siddharth R. Krishnan, PhD, now an assistant professor of electrical engineering at Stanford University in Stanford, California, and colleagues at MIT described a wireless device implanted into diabetic mice that prevented hypoglycemia. The implant weighs < 2 g and is only 3 cm3 in size; it remains under the skin and releases a powdered version of glucagon automatically when a sensor detects low blood sugar. The researchers simulated hypoglycemia in the mice, and the release of the dry glucagon was triggered wirelessly. Measurements showed a rapid rise in blood glucose soon after the release, with a peak of 30 mg/dL after no more than 15 minutes. A second set of studies replicated conditions that often drive hypoglycemia, such as missed meals and automated infusions from insulin pumps. Similarly, the use of the wireless release of dry glucagon resulted in blood glucose concentrations above the threshold for hypoglycemia (average concentration of 80 mg/dL) within the first hour after the release. An area under the curve analysis over 30 minutes after release showed significant changes in the glucose group compared with the control group who received lactose. 'A Pathway to Emergency Rescue' 'Glucagon is widely administered as an emergency rescue drug for patients suffering acute hypoglycemia, particularly in the context of type 1 diabetes,' corresponding author Daniel Anderson, PhD, a professor at the Koch Institute for Integrative Cancer Research at MIT, told Medscape Medical News . Glucagon's short half-life and low stability in solution has made development of pump systems a challenge, he said. By contrast, 'Dry powder versions of glucagon offer long-term stability but are difficult to deliver,' he said. 'An implantable device that can respond to hypoglycemia and release dry powder glucagon potentially offers a pathway to emergency rescue from hypoglycemia events without the need for patient intervention,' Anderson said. The early impact of the dry power was unexpected, Anderson said. 'The glucagon in our system is a dry powder that we designed to dissolve directly in biofluid, and the timeline for this dissolution and subsequent availability of the drug in circulation was an open question when we started this project,' he noted. 'The fact that we saw biological activity within 5 minutes of drug release was an important result in this context, and not one that we predicted.' Although the device is not ready for human use, the size and longevity are key questions for adoption in clinical practice, Anderson told Medscape Medical News . 'We are working on miniaturizing the device, so it is compatible with minimally invasive insertion techniques, and with a sufficient number of doses to provide protection from acute hypoglycemia for multiple years,' he said. 'So far, we have validated the device in preclinical small animal models.' Simultaneously miniaturizing the system and optimizing the dose and longevity in large animal models are the next steps for research, he added. Unmet Need for Glycemic Control 'Hypoglycemia and fear of hypoglycemia remains major barriers to optimal glycemic control for those with diabetes,' said Andrew Kraftson, MD, a specialist in endocrinology and internal medicine at the University of Michigan, Ann Arbor, Michigan, in an interview. 'Glucagon emergency delivery devices have advanced and become more user friendly but will not work if not available or expired. Liquid glucagon presents numerous challenges and is not yet commercially available for dual hormone insulin pump use,' said Kraftson, who was not involved in the research. 'Dual hormone pumps that are being studied or have been approved in Europe are large/bulky, may require two CGM [continuous glucose monitoring] sensors, and may require glucagon to be refilled more frequently than insulin, so a nonliquid, implantable device could avoid some of the obstacles posed by liquid glucagon,' Kraftson noted. However, more research is needed on the logistics of human implementation of the glucagon delivery device tested in the current study, Kraftson told Medscape Medical News . Questions include how the device would be implanted; how many doses the reservoir would hold; and how often, on average, it would need to be changed, he said. Other factors include how cumbersome this device might be for humans, potential risks for irritation or infection, and options for manual delivery in the event of a malfunctioning CGM or signal challenges in device communication, he said. 'Ideally, glucagon use for patients with diabetes would expand beyond emergency rescue,' Kraftson added. 'Reducing or even holding insulin is sometimes insufficient to avoid hypoglycemia, particularly rapid onset.' 'Additionally, eating carbohydrates to prevent or treat hypoglycemia is not ideal given the risk of subsequent overcorrection/hyperglycemia and weight gain; therefore, more frequent, sensor/algorithm-based use of glucagon can more effectively achieve stable glucose levels and help avoid the 'rollercoaster,'' he said. The small size of the device in the current study may limit its ability to participate in the larger mission of glucose management but could certainly still play an important role in hypoglycemia reduction, he noted. This study was funded by the Leona M. and Harry B. Helmsley Charitable Trust, the National Institutes of Health, a JDRF postdoctoral fellowship, and the National Institute of Biomedical Imaging and Bioengineering. Anderson and several coauthors reported being inventors on a patent application relevant to the technology described in this study but had no other financial conflicts of interest.
Associated Press
14-07-2025
- Health
- Associated Press
Amylyx Pharmaceuticals Presents New Exploratory Analyses from Phase 2 and Phase 2b Clinical Trials of Avexitide in Post-Bariatric Hypoglycemia at ENDO 2025
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jul 13, 2025-- Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) ('Amylyx' or the 'Company') today announced the presentation of new exploratory analyses from the Phase 2 PREVENT and Phase 2b clinical trials of avexitide, an investigational, first-in-class glucagon-like peptide-1 (GLP-1) receptor antagonist for the treatment of post-bariatric hypoglycemia (PBH) at the Endocrine Society's annual meeting (ENDO 2025). In the Phase 2b trial, avexitide 90 mg once daily, the dose being evaluated in the pivotal Phase 3 LUCIDITY trial, led to a 64% least-squares (LS) mean reduction (p=0.0031) vs. baseline in the composite rate of Level 2 and Level 3 hypoglycemic events in PBH, with more than half of the participants experiencing no events during the treatment period. LUCIDITY is a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating the efficacy and safety of avexitide in approximately 75 participants with PBH following Roux-en-Y gastric bypass surgery. The FDA-agreed-upon primary endpoint of LUCIDITY is reduction in the composite of Level 2 and Level 3 hypoglycemic events. Consistent reductions in composite rate of Level 2 and Level 3 hypoglycemic events also were seen with avexitide 45 mg twice daily studied in the Phase 2b trial and avexitide 30 mg twice daily and 60 mg once daily studied in the Phase 2 PREVENT trial. New pharmacokinetic (PK) and pharmacodynamic (PD) data were also presented demonstrating continuous pharmacologic activity of the 90 mg once daily dose regimen for a 24-hour period. 'Post-bariatric hypoglycemia can profoundly disrupt daily life, requiring individuals to carefully manage meals, social interactions, and routines, often while living in fear of their next hypoglycemic event. The new analysis presented at ENDO 2025 continues to support that avexitide may significantly reduce the frequency of these events,' said Marilyn Tan, MD, FACE, Principal Investigator of the LUCIDITY trial and Clinical Associate Professor at Stanford University. Camille L. Bedrosian, MD, Chief Medical Officer of Amylyx, added, 'Post-bariatric hypoglycemia is a serious and underrecognized condition with no FDA-approved treatments. The data presented show that, in an exploratory analysis from the Phase 2 PREVENT and Phase 2b clinical trials, avexitide significantly reduced the composite rate of Level 2 and 3 hypoglycemic events, including at the 90 mg once daily dose that is being studied in our pivotal Phase 3 LUCIDITY trial. We are particularly encouraged that over half of participants did not experience Level 2 or Level 3 hypoglycemic events during the treatment period. In addition, the pharmacokinetic and pharmacodynamic data demonstrated continuous pharmacologic activity of avexitide 90 mg once daily dose over 24 hours. We continue to be encouraged by avexitide's potential to deliver consistent, meaningful benefit to people living with PBH.' The population PK and PD analyses presented at ENDO 2025 demonstrated that avexitide 90 mg once daily maintained consistent GLP-1 receptor inhibition from morning to midnight and between doses. In vitro potency studies showed an IC₅₀ of approximately 20-30 nM (70-100 ng/mL), indicating robust target inhibition even in the presence of significant levels of GLP-1. PK modeling demonstrated that avexitide plasma levels exceeded IC₅₀ for a full 24-hour period. LUCIDITY was informed by data from five PBH clinical trials of avexitide showing consistent, dose-dependent effects, including statistically significant and clinically meaningful reductions in hypoglycemic events. Avexitide was generally well-tolerated, with a favorable safety profile replicated across clinical trials. Completion of recruitment for LUCIDITY is expected in 2025, with a data readout anticipated in the first half of 2026 and, if approved, commercial launch anticipated in 2027. The presentation and posters are available on the ' Presentations ' tab of the Amylyx website. Webcast Information Amylyx will host an investor event today, July 13, 2025, at 6:00 p.m. PT / 9:00 p.m. ET in San Francisco to discuss post-bariatric hypoglycemia and avexitide. A live webcast of the presentation and Q&A portion of the event can be accessed under 'Events and Presentations' in the Investor section of the Company's website, The webcast will be archived and available for replay for 90 days following the event. About Avexitide Avexitide is an investigational, first-in-class glucagon-like peptide-1 (GLP-1) receptor antagonist that has been evaluated in five Phase 1 and Phase 2 clinical trials for post-bariatric hypoglycemia (PBH) and has also been studied in congenital hyperinsulinism (HI). The U.S. Food and Drug Administration (FDA) has granted avexitide Breakthrough Therapy Designation for both indications, Rare Pediatric Disease Designation in congenital HI, and Orphan Drug Designation for the treatment of hyperinsulinemic hypoglycemia (which includes PBH and congenital HI). Avexitide is designed to bind to the GLP-1 receptor on pancreatic islet beta cells and inhibit the effect of GLP-1 to mitigate hypoglycemia by decreasing insulin secretion and stabilizing blood glucose levels. In PBH, excessive GLP-1 can lead to the hypersecretion of insulin and subsequent debilitating hypoglycemic events. In two Phase 2 PBH clinical trials, avexitide demonstrated highly statistically significant reductions in hypoglycemic events. These events can lead to autonomic and neuroglycopenic symptoms that can have a devastating impact on daily living. About Post-Bariatric Hypoglycemia (PBH) Post-bariatric hypoglycemia (PBH) is a condition that is estimated to affect approximately 8% of people in the U.S. who have undergone the two most common types of bariatric surgery, sleeve gastrectomy and Roux-en-Y gastric bypass (approximately 160,000 people in the U.S.). PBH is thought to be caused by an excessive glucagon-like peptide-1 (GLP-1) response leading to hypoglycemia and impaired quality of life. PBH can cause debilitating hypoglycemic events associated with inadequate supply of glucose to the brain, known as neuroglycopenia. Clinical manifestations can include impaired cognition, loss of consciousness, and seizures. PBH is also associated with a high degree of disability that can result in major disruptions to independent living. There are no approved therapies for PBH. About the LUCIDITY Trial LUCIDITY ( NCT06747468 ) is an approximately 75-participant, multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating the efficacy and safety of avexitide in participants with PBH following Roux-en-Y gastric bypass (RYGB) surgery. The Phase 3 trial will be conducted at approximately 20 sites in the U.S. Participants will be randomized 3:2 to receive either 90 mg of avexitide subcutaneously once daily or placebo. The trial includes an up to six-week screening period, including a three-week run-in period, and a 16-week double-blind treatment period. Participants who complete the double-blind period will be eligible to enter an open-label extension (OLE) period with a duration of 32 weeks. The primary efficacy objective of LUCIDITY will evaluate the FDA-agreed upon primary outcome of reduction in the composite of Level 2 and Level 3 hypoglycemic events through Week 16. Safety and tolerability will also be evaluated. About Amylyx Pharmaceuticals At Amylyx, our mission is to usher in a new era of treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are currently focused on three investigational therapies across several neurodegenerative and endocrine diseases in which we believe they can make the greatest impact. For more information, visit and follow us on LinkedIn and X. For investors, please visit Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, Amylyx' expectations regarding: the potential of avexitide as a treatment for PBH; expectations regarding the timing for recruitment completion and topline data readout of the Phase 3 LUCIDITY trial of avexitide in PBH; and expectations regarding timing for potential commercialization of avexitide. Any forward-looking statements in this press release and related comments in the Company's earnings conference call are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost, and timing of Amylyx' program development activities; Amylyx' ability to execute on its regulatory development plans and expectations regarding the timing of results from its planned data announcements and initiation of clinical studies; the risk that early-stage results may not reflect later-stage results; Amylyx' ability to fund operations, and the impact that global macroeconomic uncertainty, geopolitical instability, and public health events will have on Amylyx' operations, as well as the risks and uncertainties set forth in Amylyx' United States Securities and Exchange Commission (SEC) filings, including Amylyx' Annual Report on Form 10-K for the year ended December 31, 2024, and subsequent filings with the SEC. All forward-looking statements contained in this press release and related comments in our earnings conference call speak only as of the date on which they were made. Amylyx undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. View source version on CONTACT: Media Amylyx Media Team (857) 320-6191 [email protected] Lindsey Allen (857) 320-6244 [email protected] KEYWORD: UNITED STATES NORTH AMERICA MASSACHUSETTS INDUSTRY KEYWORD: HEALTH CLINICAL TRIALS RESEARCH PHARMACEUTICAL SCIENCE BIOTECHNOLOGY SOURCE: Amylyx Pharmaceuticals, Inc. Copyright Business Wire 2025. PUB: 07/13/2025 05:00 PM/DISC: 07/13/2025 05:00 PM
Health Line
01-07-2025
- Health
- Health Line
How to Dispose of Used Diabetes Supplies
To dispose of used diabetes supplies, use an FDA-cleared container for sharp medical supplies. This can help prevent injury from exposed needles when they're disposed of properly. Diabetes medical supplies play an important role in managing blood sugar and living a healthy life. But once you've used them up, figuring out how to dispose of the waste can be a chore. That can mean finding a place to discard used syringes and sharp needles, bloody test strips, old infusion sets, empty glass vials, or many other disposable parts that come with diabetes devices. Some of this may end up in the trash or recycle bin, heading to a disposal site along with Amazon boxes, empty water bottles, and trash going to a landfill. But for the rest, including sharp medical supplies, you may have to take more care in disposing of used diabetes items. Handling medical sharps The Food and Drug Administration (FDA) refers to these as 'sharps,' the medical term for supplies and devices with sharp points or edges that can puncture or cut your skin. For people with diabetes, this may include: lancets used to poke their fingers syringes or pen needle tips for injecting insulin insulin pump infusion sets and continuous glucose monitor (CGM) sensors that have tiny built-in needles to puncture the skin needles for certain forms of fast-acting glucagon used for severe hypoglycemia Generally, the public health risk tied to sharps disposal has been well-documented and monitored by the FDA along with healthcare professionals. This older study noted that people with diabetes are most likely to dispose of medical sharps in the 'most convenient manner,' which is often household trash. According to this 2023 research review, people who've lived with the condition longer are the least likely to dispose of medical sharps correctly. Those who have newly received the diagnosis tend to be more cautious when handling needles and medical sharps and disposing of used supplies. These findings echo an earlier 2018 study, in which researchers found those who'd lived with diabetes for 30 or more years were the least likely to dispose of medical sharps correctly. According to researchers, many people with diabetes didn't learn about proper disposal practices from healthcare professionals, but those who did had the highest rates of correctly disposing of diabetes supply waste. This Indonesia-based research, published in 2023, found that only healthcare professional training helped people improve their practices in disposing of diabetes supplies, particularly medical sharps like insulin syringes and pen needle caps. Yet, this 2024 research shows that people in Egypt with 'fair' knowledge of how to dispose of diabetes supplies may not always dispose of them correctly. How to dispose of used diabetes sharps You can dispose of and sometimes recycle sharps in special sharps containers, according to state and local rules. The FDA offers this website along with a Be Smart With Sharps campaign focused on safe sharps disposal. Some basics of that campaign are as follows: Used sharps should be immediately placed in a sharps disposal container. FDA-cleared sharps containers are generally available through pharmacies, medical supply companies, healthcare professionals, and online. These containers are made of puncture-resistant plastic with leak-resistant sides and bottoms. They also have a tight-fitting, puncture-resistant lid. Sharps containers come in many sizes, which can be important for certain supplies such as disposable insulin pens that are longer than some standard sharps containers can hold. If an FDA-cleared container is not available, a heavy-duty plastic household container, such as a laundry detergent container, can be used as an alternative. DO NOT USE milk jugs, soda cans, glass containers, or water bottles because they can break or puncture easily. Donation options A few national programs, such as the nonprofit Afya, accept donations of used medical supplies. Check with local used medical supply collection programs that may accept these types of used products. Each state and even local communities have different rules in place, so here's a guide to sharps disposal in each state. Insulin pump supplies and infusion sets The leftover parts from insulin pump use include the infusion sets (the piece inserted under your skin with a needle to enable insulin delivery) and the cartridges or reservoirs that hold the insulin inside the pump. You can include most of these pieces with sharps in those waste containers. Note that the 90-degree infusion sets (said to be more comfortable for people with smaller bodies) are compatible with all tubed pump brands. They come in plastic 'pods' with the infusion needle built in. While you can also dispose of those in sharps containers, they are a bit bulkier and take up more space. Some insulin pump brands create more waste than others. Medtronic and some other older, discontinued tubed pump brands have a cylinder reservoir that holds the insulin, with the infusion needle housed in a small part on top. You can dispose of both with other medical waste, but the needle part is sharp. Tandem's t:slim X2 is the only tubed pump that doesn't use a cylinder but a slim plastic cartridge with an insulin-containing bag inside. The t:slim supplies include a syringe and needle cap to fill the bag, the plastic cartridge, and a separate infusion set with tubing. None of the insulin pump companies in the United States have an official recycling program specific to their products. Insulet had a recycling program for Omnipod, but it was discontinued in 2018. Do-it-yourself diabetes supply disposal ideas Within the Diabetes Online Community, many people offer tips and tricks on what they do about recycling and disposing of old diabetes supplies. Do not put these directly into the trash or recycling bin as-is, because of the used needles inside. While some supplies are self-contained, they can still come apart. This can be dangerous for people picking up the recycling or coming into contact with it later on. Collect these supplies over time and then drop them off in bulk at a local sharps container facility that can process them accordingly. Disassemble the auto-inserters using a screwdriver and pliers to separate the parts and remove the sharp needle inside. Then, put the sharper metal items into a sharps container and recycle the rest of the plastic. Some people use thick containers, such as food containers or clear or colored jugs, once they're empty. This isn't recommended because some containers may be thinner than others — such as milk jugs or boxes — and sharps may poke through them and be dangerous. Those using glass or thicker plastic containers should label them to indicate 'hazardous medical sharps' inside. Try turning them into creative, crafty ideas. In #WeAreNotWaiting diabetes DIY groups online, you can regularly find instances where people have donated old transmitters and sensors to fellow experimenters to reuse for testing and building purposes. The takeaway You can dispose of used diabetes supplies in several ways, especially sharp medical supplies. These may include empty glass insulin vials or cartridges, insulin syringes, pen cap needles, glucose meter lancets, insulin pump infusion sets, or CGM supplies with built-in needles for inserting them into the skin. Medical sharps containers are the preferred disposal method. They can be found at certain doctors' offices, clinics, health facilities, or other locations. You can also buy them online or at medical supply stores. After filling those containers, check your local ordinances and state rules, which may provide more details on how and where you can properly dispose of these sharps containers.
Telegraph
06-05-2025
- Health
- Telegraph
Fresh evidence may prove ‘male Lucy Letby' conviction is unsafe
The conviction of a former nurse who has been compared to Lucy Letby could be unsafe based on new evidence, the Court of Appeal has heard. Colin Campbell, formerly known as Colin Norris, was found guilty in 2008 of killing four women and attempting to kill a fifth by injecting them with insulin. All were elderly inpatients on orthopaedic wards where Campbell worked in 2002 and each developed severe, unexplained hypoglycemia. But the Criminal Cases Review Commission (CCRC), which referred the convictions to the Court of Appeal in London four years ago, said the case against Campbell was 'wholly circumstantial'. Campbell was alleged to have been present when or shortly before each of the patients suffered hypoglycemia and, because of the rarity of such a cluster of cases happening within a short space of time, prosecutors said the nurse must have been responsible. A total of 20 experts gave evidence during a five-month trial at Newcastle Crown Court, after which Campbell was sentenced to life imprisonment with a minimum term of 30 years. But now, medical developments meant there was more evidence to support the argument that the patients may have died from natural causes, Campbell's lawyer has argued. Campbell has always denied any wrongdoing and said he did nothing to cause hypoglycemia in any of the patients. On Tuesday, Michael Mansfield KC, for Campbell, told a Court of Appeal hearing: 'The nature of the prosecution case was that this appellant, Colin Campbell, was a nurse, recently qualified, who was at two teaching hospitals in Leeds – the General Infirmary and St James's. 'The prosecution case was that he injected the five individuals with insulin and, as a result of that injection, they all suffered a sudden and severe episode of hypoglycemia, namely, low blood sugar.' He said there was a consensus among the experts at trial that a sudden and severe onset of hypoglycemia was extremely rare. He told the court: 'The approach of the witnesses we intend to call on behalf of the appellant indicates an evolution of understanding, of knowledge, about hypoglycemia and about glucose generally. 'So we say there is now a range of possibilities relating to natural causes.' 'Remarkably similar ages' He also said that, towards the end of Campbell's trial, the jury had asked whether there were other cases of patients suffering from 'sudden and profound' hypoglycemia in any of the Leeds teaching hospitals after Campbell stopped working. Four such cases have since been identified, Mr Mansfield told the court, with the deaths recorded between January 2003 and August 2005, before adding that 'no-one is suggesting that these cases were anything other than natural causes'. The barrister also noted the 'remarkably similar' ages in all nine cases, with the patients being between 78 and 93 years old, but this 'was not discussed' at the trial. Campbell unsuccessfully appealed against his conviction in 2009 and applied to the CCRC in 2011. In referring the case, the CCRC said new expert evidence suggests the women may have died from natural causes, meaning there was a real possibility the Court of Appeal could find the conviction to be unsafe. There have also been other developments in the understanding of hypoglycemia that cast doubt on the expert evidence given at trial, the CCRC said. The appeal, before Lady Justice Macur, Sir Stephen Irwin and Mr Justice Picken, is expected to last three weeks.
