Latest news with #CGMs
Atlantic
2 days ago
- Health
- Atlantic
How the Glucose Monitor Became a MAHA Fixation
To hear some of them tell it, the companies selling continuous glucose monitors have stumbled upon a heretofore unknown quirk of human biology. Seemingly healthy people, many of these companies argue, have 'glucose imbalances' that need to be monitored and, with dietary vigilance, eradicated. Millions of people are going through life eating bananas, not knowing that their blood sugar is rising with every bite. This must be stopped. To this end, the companies market the continuous glucose monitor, or CGM, a quarter-size sensor that takes a near-constant measure of the glucose in the fluid between a person's cells. Once inserted into an arm, the sensor allows the wearer to monitor their blood-sugar levels on a phone app for $80 to $184 a month. Doing so allows you to 'see the impact of what you eat' (according to the start-up Lingo), to 'motivate behavior change and encourage healthier choices' (according to another called Levels), and to 'personalize your approach' to weight loss, because 'everyone's journey is different' (according to Nutrisense). The gadgets have been revolutionary for many people with diabetes—previously the main available device for measuring blood sugar required users to prick their fingers multiple times a day. Many insurers cover CGM prescriptions for diabetics; they can pick up the devices at the pharmacy just as they would blood-test strips. But when I asked a half dozen experts whether people who don't have diabetes should wear CGMs, I got a resounding 'Meh.' 'It's a free country. People can pay money for whatever they feel like doing,' David Nathan, a diabetes expert at Harvard, told me. 'But from a medical point of view, I am personally unconvinced that they lead to any health benefit.' Relying on a Harvard diabetes expert to give you diabetes advice, however, goes against the general ethos of the 'Make America Healthy Again' movement, many of whose members have been heavily promoting CGMs in recent months, including to people who don't have diabetes. Robert F. Kennedy Jr., the secretary of Health and Human Services, talked them up in an April CBS interview as 'extraordinarily effective in helping people lose weight and avoid diabetes.' At his Senate confirmation hearing, before becoming Food and Drug Administration commissioner, Marty Makary said glucose monitors help people 'learn about what they're eating.' Casey Means, the wellness influencer whom President Donald Trump nominated for surgeon general, has said that more Americans should use CGMs too. (As it happens, she is a co-founder of Levels.) 'I believe CGM is the most powerful technology for generating the data and awareness to rectify our Bad Energy crisis in the Western world,' Means wrote in her best-selling book, Good Energy. (Bad Energy is her term for the metabolic dysfunction that she believes to be at the root of many chronic health problems.) The devices are emblematic of the self-reliance that characterizes the MAHA movement. 'The Casey Means's of the world,' Alan Levinovitz, a James Madison University religion professor who has studied alternative health, told me in an email, 'are using the rhetoric of naturalness as a way of telling people they can have complete control and expertise over their own health—which is the natural way to be healthy, rather than outsourcing that wisdom to top-down elites.' Indeed, one of the chapters of Good Energy is titled 'Trust Yourself, Not Your Doctor.' (Means did not respond to a request for comment.) CGMs appear to have trickled into MAHA world from the Joe Roganosphere, helped along by the fact that the devices, which in the past had been prescribed mainly to diabetics, were made available last year for purchase over the counter—that is, by anyone. Five years ago, Paul Saladino, a doctor who promotes an ' animal-based diet,' said on Rogan's podcast, 'This is the kind of stuff that really tells you about your metabolic health. There's no way to lie with a continuous glucose monitor.' Since then, CGMs have been endorsed on popular wellness podcasts such as Andrew Huberman's Huberman Lab and Dave Asprey's The Human Upgrade, and by pop-health doctors such as Peter Attia and Mark Hyman, the latter of whom called the CGM 'a gadget that has completely changed my life.' A wellness influencer known as the Glucose Goddess said that although they may not be for everyone, CGMs can be 'a pretty incredible tool to start to connect what you're eating with what's actually happening inside of your body,' and offers a guide to them on her website. Gwyneth Paltrow, the empress of Goop, was recently spotted wearing one. Sun Kim, a Stanford endocrinologist, told me that a few years ago, 'I was literally contacted by a start-up almost every month who wanted to incorporate a CGM' into their products. Of course, some CGM companies do specialize in people who have diabetes and need around-the-clock monitoring. But Kim and others I spoke with told me they suspect that, to boost sales, CGM manufacturers are trying to expand their potential-customer base beyond people living with diabetes to the merely sugar-curious. Jake Leach, the president of Dexcom, maker of the over-the-counter CGM Stelo, told me via email, 'Stelo was originally designed for people who have Type 2 diabetes not using insulin and those with prediabetes, however, given the broad accessibility of this device, we are encouraged to see people without diabetes interested in learning more about their glucose and metabolic health.' A spokesperson for Dexcom pointed out to me that most people with prediabetes are undiagnosed. Fred St. Goar, a cardiologist and clinical adviser for Lingo, told me in a statement that CGMs can be beneficial for nondiabetics because 'understanding your body's glucose is key to managing your metabolism, so you can live healthier and better.' Scant research exists on how many nondiabetic people are buying CGMs, but anecdotally, some providers told me that they are seeing an uptick. Nicola Guess, a University of Oxford dietician and researcher, said that '10 years ago, no, I never saw anyone without diabetes with a CGM. And now I see lots.' Mostly, she said, they're people who are already pretty healthy. In this sense, CGMs are an extension of the wearables craze: Once you have an Oura Ring and a fitness tracker, measuring your blood sugar can feel like the next logical step of the 'journey.' Should people who aren't diabetic wear one of these? Health fanatics who have $80 a month to burn and want to see how various foods affect their blood sugar are probably fine to wear a CGM, at least for a little while. Spoiler: The readout is probably just going to show that eating refined carbs—such as white bread, pasta, and sweets—at least temporarily raises blood sugar to some degree. Normal glucose patterns for nondiabetic people tend to vary quite a bit from meal to meal and day to day. Most nondiabetics' blood-sugar readings will typically fall within the 'normal' range of 70 to 140 milligrams per deciliter. But many healthy people will occasionally see spikes above 140, and scientists don't really know if that's a cause for concern. ('Great question' is a response I heard a lot when I asked.) In the studies he's worked on, Kevin D. Hall, a former National Institutes of Health nutrition scientist, has found that even in tightly controlled settings, people's blood-sugar levels respond very differently to the same meal when eaten on different occasions. Given all these natural deviations, a CGM may not be able to tell you anything especially useful about your health. And CGMs can be less accurate than other types of blood-sugar tests. In another study, Hall and his co-authors stuck two different brands of CGM on the same person, and at times, they provided two different blood-sugar readings. The conclusion, to Hall, was that more research is needed before CGMs can be recommended to nondiabetics. What's more, blood sugar depends on sleep, stress, and exercise levels, and whether any given meal includes protein or fat. If you notice a spike after eating a banana, the banana might not be the reason. It might be the four hours of sleep you got the previous night, because sleep deprivation can affect the hormones that influence blood sugar. As a result, Guess said, 'a CGM cannot tell you whether a single food is right for you'—though some CGM enthusiasts make this promise. (A CGM can help you 'learn your reaction to individual foods and meals,' Means has written.) For some people, tracking data does help nudge them toward healthier behaviors. If you get a clear readout from a CGM that your blood sugar has risen after you've eaten refined carbs, and it moves you to eat fewer refined carbs, that's not necessarily a bad thing. But researchers haven't found evidence yet that nondiabetic people eat better after wearing a CGM. And if you know how to read a CGM, you probably already know what a healthy diet looks like. You could just eat it. Anne Peters, a diabetes researcher at the University of Southern California, told me, 'You could just not wear it at all and tell yourself to eat more vegetables and a more plant-based diet and eat healthy, lean protein.' Many of the biohackers who talk up CGMs also promote a low-carb, protein-heavy diet that would include a T-bone more readily than a Triscuit. (Asprey, the man behind The Human Upgrade, recommends putting butter in coffee.) The potential downside of glucose monitoring is that people who are (perhaps needlessly) alarmed by their CGM data will swap out healthy carbs such as fruit and whole grains for foods that are less healthy—butter, for example, or bacon and red meat. Those foods don't make an impact on blood sugar, but they can affect other markers of health, such as cholesterol and body fat. Eat a stick of butter, and your CGM will probably show a flat, pleasant line. But your arteries may protest. I noticed these perverse incentives myself during my pregnancy, when I had gestational diabetes and wore a CGM to manage my blood sugar. A bowl of heart-healthy oatmeal would cause my blood-sugar reading to soar to an unacceptable 157, but a piece of cheesecake—with loads of fat balancing out the sugar—would keep it safely under my goal level of 135. At the time, I wanted to eat whatever kept my blood sugar low, for the sake of my baby. But few dieticians would advise healthy people to eat cheesecake instead of oatmeal every morning. Glucose, after all, is just a small part of the picture of human health. 'Waist circumference, blood pressure, LDL cholesterol, resting heart rate—they are much better measures of how healthy someone is than glucose,' Guess said. And watching a real-time readout of your blood glucose can become an obsession of sorts—not an entirely harmless one. 'Something being a waste of time is a net harm,' Guess told me. 'There is something unethical to me about filling people's heads with worries that never come to pass.' Many of the researchers I spoke with said that if you are concerned you might have diabetes or prediabetes, you could just get an A1c blood test at your annual physical. Like a CGM, it, too, measures blood sugar, but much more cheaply and without requiring you to wear a device all the time. And if it shows that you're at risk of developing type 2 diabetes, you could do what doctors have suggested doing for decades now: Eat a diet rich in vegetables and lean proteins, and get some exercise most days. ('Duh,' Nathan said.) One way for Kennedy and others in the Trump administration to find out if CGMs do all they say they do would be to fund studies on whether CGMs are helpful, and for whom. Quite the opposite is happening. Hall recently left Trump's NIH because he believed he was being censored when speaking about the results of studies that conflicted with Kennedy's views, and Nathan's diabetes-prevention study was recently frozen by the Trump administration. So far, the administration has ended or delayed nearly 2,500 NIH grants, including some related to researching blood glucose. If the Kennedy-led HHS department truly would like to make America healthy again, it could stop defunding the people studying Americans' health.
Indian Express
07-06-2025
- Health
- Indian Express
Onboard Shubhanshu Shukla's mission: Study to enable diabetes patients travel to space
AMONG the studies and experiments that will keep India's Shubhanshu Shukla and other astronauts on Axiom-4 mission busy during their two-week stay in space expected to launch June 10, is one aimed at enabling diabetic people to travel into space. As of now, insulin-dependent diabetic patients are not selected to become astronauts. That is because the space environment, particularly micro-gravity conditions, makes it difficult to control and maintain blood sugar levels. But scientists around the world have been working for the last several years to make this possible. A diabetes-related research project on Axiom-4 mission marks an important step in that effort. One or more astronauts on the mission — it is not disclosed who they may be — will wear Continuous Glucose Meters (CGMs) throughout their stay in space, and their real-time blood sugar measurements will be monitored by the research team on Earth. They will also collect blood samples during their flight which can be tested later to validate the readings of the CGM. The mission will also carry two varieties of insulin pens: one refrigerated, the other in ambient air conditions. These will check whether their integrity remains intact in micro-gravity conditions. 'One of the primary objectives of the study is collect data that is relevant for enabling space travel possible for diabetic people. But it is not just that. The research can be helpful for the management of diabetes on Earth as well,' Mohammad Fityan, the Dubai-based clinical lead for this research project called Suite Ride, told The Indian Express in an interview. Fityan is the chief medical officer at the Burjeel Medical City, a hospital in Dubai which is collaborating with Axiom Space for this research project. Diabetes research in space is not new. Studies on this has been going on for several years. Even CGMs have been worn by astronauts before. The astronauts on the Polaris Dawn mission, a private mission that remained in space for five days in September last year, wore CGMs. But this was limited to collecting blood sugar data while in space. Last year, the Galactic 07 mission, a sub-orbital flight operated by Virgin Galactic, demonstrated for the first time that commercially available insulin pens can be used to effectively deliver the hormone in space. Fityan said the study on Axiom-4 mission is a more 'well-rounded attempt' on diabetes research in space. 'Real-time measurement of blood sugar, the validation of CGMs, and an assessment whether insulin maintains its viability and integrity in space… these are the things that have never been done before,' Fityan said. 'The study will continue for the two weeks of the mission. This is still a short-term study. We would not be able to monitor the blood glucose levels over a longer period. But even this data is very critical for understanding the effect of zero-gravity on diabetes. Microgravity removes many of the physical and gravitational forces acting on the body, allowing us to observe metabolic processes in a fundamentally different context,' he said. Fityan said the research was relevant for diabetic people on Earth as well. 'Previous studies on the International Space Station for example have shown that the effect of microgravity causes fluid shifts in the astronauts. This kind of situation is similar to long-term bed-ridden patients, whose movement is severely restricted. The data that we are hoping to get from the Axiom-4 mission might be very helpful in improving the management of diabetes on Earth as well,' he said. 'Then there is this possibility of the data throwing up some unexpected insights which can lead to secondary outcomes. This kind of thing happens all the time in scientific research,' he said. Anonna Dutt is a Principal Correspondent who writes primarily on health at the Indian Express. She reports on myriad topics ranging from the growing burden of non-communicable diseases such as diabetes and hypertension to the problems with pervasive infectious conditions. She reported on the government's management of the Covid-19 pandemic and closely followed the vaccination programme. Her stories have resulted in the city government investing in high-end tests for the poor and acknowledging errors in their official reports. Dutt also takes a keen interest in the country's space programme and has written on key missions like Chandrayaan 2 and 3, Aditya L1, and Gaganyaan. She was among the first batch of eleven media fellows with RBM Partnership to End Malaria. She was also selected to participate in the short-term programme on early childhood reporting at Columbia University's Dart Centre. Dutt has a Bachelor's Degree from the Symbiosis Institute of Media and Communication, Pune and a PG Diploma from the Asian College of Journalism, Chennai. She started her reporting career with the Hindustan Times. When not at work, she tries to appease the Duolingo owl with her French skills and sometimes takes to the dance floor. ... Read More
Yahoo
17-05-2025
- Business
- Yahoo
Dexcom CEO says CGMs fit MAHA agenda ‘very nicely'; Tandem preps for new products
This story was originally published on MedTech Dive. To receive daily news and insights, subscribe to our free daily MedTech Dive newsletter. Dexcom CEO Kevin Sayer touted the company's recent efforts to expand coverage of CGMs for people with Type 2 diabetes. On a May 1 earnings call, the CEO told investors that all three major U.S. pharmacy benefit managers now cover the company's G7 glucose monitor for anyone with diabetes. Dexcom expects to have coverage for nearly 6 million people with Type 2 diabetes who don't take insulin by the end of the year. 'While this still represents only a portion of this 25 million-person population in the U.S., we often see smaller and customized plans quickly follow suit of the larger PBM formularies,' Sayer said. Dexcom will seek coverage from Medicare for people with diabetes who don't take insulin. The company is working to gather evidence from a randomized controlled trial to submit a request to the Centers for Medicare and Medicaid Services, Sayer said. Wolfe Research analyst Mike Polark on the earnings call noted comments by Health and Human Services Secretary Robert F. Kennedy Jr. supporting CGMs. Food and Drug Administration Commissioner Martin Makary has also suggested making the devices more widely available. 'We're very pleased with the comments of the administration,' Sayer said, adding that the company thinks its devices 'fit the Make America Healthy agenda very nicely.' Dexcom reported revenue of $1.04 billion in the first quarter, a 12% increase year over year. Tandem is seeking Europe's CE mark for its newer, smaller Mobi insulin pump, CEO John Sheridan said in an April 30 earnings call. Tandem received FDA clearance for the device in 2023. The company plans to launch Mobi outside of the U.S. with multiple sensor integrations by the year's end, Sheridan said. In February, Tandem received an expanded FDA indication for its Control-IQ+ algorithm for Type 2 diabetes. The algorithm pairs data from glucose monitors with the company's insulin pumps for automated dosing. Tandem hopes to launch the newer version of that algorithm internationally by the end of the year, pending regulatory approval, Sheridan said. The CEO also provided an update on Tandem's efforts to develop an insulin patch pump. The company is working on a tubeless feature for its Mobi pump that is now in verification testing and manufacturing buildout, Sheridan said. Meanwhile, the company has moved development of the Sigi patch pump that it acquired in 2022 to San Diego. Insulet, which received an expanded indication last year for its Omnipod 5 patch pump, said people with Type 2 diabetes represent a growing portion of new patients. Eric Benjamin, chief product and customer experience officer, told investors on May 8 that people with Type 2 diabetes made up more than 30% of new starts in the first quarter, an increase from 25% in the fourth quarter. The company grew revenue by nearly 29% to $569 million in the first quarter, compared to the year-ago period, and named longtime medtech executive Ashley McEvoy as CEO. Insulet estimated in February that the Type 2 indication expands the total addressable market for its patch pumps in the U.S. to more than 5.5 million people with Type 2 diabetes who take insulin. About 2.5 million of those people take multiple daily injections of insulin. Insulet estimated the market is less than 5% penetrated. Benjamin expects the company could double or triple that number, telling investors, 'Right now, we're making that market.' Recommended Reading New Insulet CEO Ashley McEvoy sets priorities Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Indianapolis Star
12-05-2025
- Business
- Indianapolis Star
Roche will put $550 million facility for glucose monitors in Indianapolis, adding 650 jobs
Roche Diagnostics will invest $550 million in its Indianapolis base to construct a new manufacturing facility for glucose monitoring devices, which will add several hundred jobs and further solidify the company's footprint and presence in Indiana. Swiss-based Roche will refurbish an existing building at its North American Headquarters located along I-69 on the border of Fishers and Marion County. The building will be completed in phases by 2030 and house technology to manufacture continuous glucose monitoring devices, the company announced May 12. If the company decides it needs more space for the operations, it could construct additional buildings. Some 650 high-skill jobs are expected to be added in Indianapolis because of the investment. Roche employs nearly 5,000 people in the Indianapolis area, where the company has had strong roots since the 1960s when Roche established its diagnostics arm. "Indianapolis was a natural choice when we sought a location for this newest investment," said Richeal Cline, Roche head of global operations. "This location has strong manufacturing capabilities and a longstanding history of producing diabetes care products for Roche." The investment is part of a larger $50 billion investment in U.S. manufacturing that Roche announced last month to strengthen the biotech behemoth's production capacity. Eventually Roche plans to export more medicines from the United States than it imports into the country. Roche is the latest pharmaceutical company to take steps to increase drug and medical device production in the United States amid President Donald Trump's ongoing tariff war. On May 12, Roche also announced a $700 million facility in North Carolina to build the next generation of weight-loss medications. Roche executives believe the company is better off than other drugmakers as it has been increasing production in the United States for years. Roche can significantly increase U.S. manufacturing output "overnight," CEO Thomas Schinecker said in an April earnings call. Roche's Indianapolis campus has established itself as a hub for glucose monitors and diabetes research. The site produces approximately 5.2 billion Accu-Chek diabetes test strips each year and serves as one of Roche's two global distribution hubs, helping make Indiana the largest state for advanced manufacturing in the country. Continuous glucose monitors, or CGMs, are wearable devices that record sugar levels just under the skin for 24 hours a day. More than 38 million Americans live with diabetes, a hard disease to manage given its unpredictability, Roche officials said. The investment will help with rising global demand for CGMs and improve diabetes management for millions, President and CEO of Roche Diagnostics Brad Moore said. In choosing to build the facility in Indianapolis, Roche will receive a 10-year tax abatement from the city worth $40 million in addition to a state tax incentive package worth $20 million. Roche will also spend $2 million on community investments. State Secretary of Commerce David Adams said the creation of several hundred in-demand jobs resulted in a generous tax credit package for Roche. When offering incentive packages, the state wants to help companies keep talented employees in Indiana while attracting others to the state who want to work in a strong biotech hub. "We also want to be able to track down talent from around the country as they see the life sciences ecosystem here as a destination location," Adams said. Roche responds to tariffs: As potential tariffs loom, Roche in 'much better' position than competitors, CEO says Since 2012, Roche has poured $450 million into the Indianapolis campus and increased operational space and warehouse capacity by 37%. Roche's $50 billion investment includes several other facilities across the country, including:
Reuters
02-05-2025
- Business
- Reuters
Dexcom beats quarterly sales estimates, reiterates annual forecast
Companies May 1 (Reuters) - Medical device maker Dexcom (DXCM.O), opens new tab beat first-quarter sales estimates helped by strong demand for its continuous glucose monitors (CGMs) used by patients with diabetes. Shares of the company rose 3.26% to $72.55 in after market trading. Keep up with the latest medical breakthroughs and healthcare trends with the Reuters Health Rounds newsletter. Sign up here. Increasing diabetes care awareness, wider insurance coverage, and preference for devices that do not need finger pricks have benefited CGM devices such as Dexcom's Stelo and G7. The San Diego, California-based company reiterated its annual revenue forecast of $4.60 billion. Analysts on average expect 2025 revenue of $4.61 billion, according to data compiled by LSEG. It expects annual gross profit margin of about 62%, compared to between 64% and 65% expected previously. This is due to incremental costs related to short-term supply factors, which were previously announced, as the company rebuilds its finished goods inventory to ideal levels, Dexcom said. Last year, Dexcom's shares were hit after the company slashed its annual revenue forecast, citing a restructuring of its sales team, fewer customers and lower revenue. The device maker is pinning its hopes on Stelo, which was launched for adults aged 18 and older who do not use insulin, making it the first CGM available for over-the-counter sales. Earlier this month, the FDA cleared Dexcom's updated G7 15-day CGM. Dexcom's first-quarter revenue increased 12% to $1.04 billion, beating analysts' estimates of $1.02 billion. On an adjusted basis, the company earned a profit of 32 cents per share, compared to estimates of 33 cents per share.
