Continuous glucose monitors are on the rise after FDA approval

By Holly Honderich, bbc news

Getty Images Young diabetic patient monitoring glucose level with a remote sensor at home;  She has a glucose monitor on her arm.fake images

Continuous glucose monitors have become powerful tools for those living with diabetes.

Blood sugar monitoring devices could soon be in the arms of millions of Americans after regulators cleared two new devices for use without a prescription. Is it a way to improve our health? Or is data just another distraction?

In the middle of the night last June, Cindy Bekkedam woke up to the sound of an unknown alarm. It was loud, like an emergency alert, and it came from her phone. More specifically, it came from a newly installed app linked to a glucose sensor embedded in her arm.

According to this app, his blood sugar level had dropped to a worrying level while he was sleeping, which had set off the alarm.

“So I got up in the middle of the night and ate a granola bar,” he said.

Millions of diabetics have used continuous glucose monitors (CGMs), which monitor glucose levels in real time, for years. As a dietitian in Ontario, Canada, Ms. Bekkedam installed hers to better understand the technology for her diabetes patients.

But his two-week trial became something of a warning.

“I was going crazy,” she said. “I actually asked myself, Oh my God, do I have diabetes?”

She did not do it. And, after some additional investigation, she discovered that her glucose levels were completely normal. But receiving constant updates about his high and low blood sugar levels, without having a medical condition that required it, incited unnecessary fear.

“That’s where I think people could go down a rabbit hole,” he said.

But these devices may be in the hands — or arms — of many more people soon, thanks to two recent approvals from the Food and Drug Administration (FDA) for more widespread use. This week, Abbott Laboratories announced that it had received federal authorization for two over-the-counter CGMs, including one for people without diabetes.

CGM use is already increasing, and the telltale arm patches are easily spotted during morning commutes in major American cities. But experts say that even if there is no proven harm, there is little evidence to justify spending the hefty fees – up to $300 (£240) a month – if you are not diabetic.

Abbott’s Lingo, which is a CGM for people without diabetes, is marketed to consumers “who want to better understand and improve their health and well-being.” It was one of two devices approved by the FDA. on sale and is now available in the UK. The FDA’s 510(k) regulatory process evaluates the safety and effectiveness of medical devices, but marketing claims are not part of the review.

“Understanding your body’s glucose is key to controlling your metabolism so you can live better and healthier lives,” an Abbott spokesperson told the BBC.

Getty Images Athlete using a CGMfake images

Many experts say there is little evidence that CGMs are beneficial for those without diabetes.

Abbott said flattening glucose curves could help improve energy, mood and sleep and pointed to studies showing the impact of glucose spikes on overall health and the role of CGMs in tracking them.

There is skepticism about such claims in the medical community, but one thing experts agree on is that CGMs have significantly improved care for some people living with diabetes.

Type 1 diabetes occurs when a person’s pancreas stops producing insulin, so regular injections are needed. Type 2 diabetes is more common and occurs when the body’s cells become resistant to insulin and therefore more is needed to keep blood glucose levels within a normal range. It can usually be controlled through medication, diet, exercise, and close monitoring, although some take insulin. Traditionally, diabetics checked their blood sugar with finger-prick tests, but CGMs can alert people with diabetes when their blood sugar levels are getting dangerously high or low, and if they need to inject insulin .

But many experts say the evidence that CGMs improve the health of non-diabetics is effectively non-existent. They insist that the devices are, at best, a distraction and, at worst, could lead to dangerous fixations.

A growing trend

CGMs are big business. Market leaders have estimated that sales will reach $20 billion globally over the next four years.

Earlier this year, the FDA cleared the sale of an over-the-counter CGM made by Dexcom, intended for type 2 diabetics who don’t use insulin but want to avoid regular finger-prick tests. And some CGM startups, such as Signos, Nutrisense, and Levels Health, now market off-label prescription devices as energy, mood, and metabolism tools.

The devices are becoming popular with some people in the health, wellness and sports industries.

Dutch marathoner Abdi Nageeye, who will compete in the Paris Olympics, told Reuters earlier this week that he wears an CGM to try to better track your body’s available energy.

Getty Dutch marathoner Abdi Nageeye wins the Rotterdam marathon in 2022getty

Dutch marathoner Abdi Nageeye used a CGM during the Rotterdam marathon in 2022, according to Reuters

Others, including some members of the scientific community, have also expressed interest in the effects of glucose on metabolic health.

Nick Norwitz, 28, who graduated from Oxford University with a doctorate in nutrition and is currently in his fourth year of medical school at Harvard, said he believes CGMs can be powerful tools because glucose is “a indicator of what is happening hormonally in the body. .

He studied its use while at Harvard and said he welcomes more research in the field.

Norwitz said he believed that in the long term, hormonal changes associated with frequent glucose spikes could cause negative effects, including through fat gain.

But, he added, glucose is just one metric and shouldn’t drive all health decisions.

“To be clear, I don’t think that means that if you eat a mango and your blood sugar goes up, it’s ‘worse’ for you than eating a plate of bacon,” he said.

Interest in how CGMs can help you change your diet has also flourished in some corners of the Internet. Depending on your algorithm, a search for glucose monitors on TikTok or Instagram could lead you to dozens of testimonials from health and wellness influencers espousing the benefits of the technology.

One of those influencers, Brittney Bouchard, who promoted a new CGM company on her TikTok and offered her followers a discount code, said that using a CGM helped her adjust her diet to reduce glucose spikes. She received an affiliate commission when people purchased the device through her link.

“I could tell the difference immediately, in my energy, my sleep and my brain fog,” said Bouchard, a 41-year-old health coach from Los Angeles.

Brittney Bouchard Wellness coach Brittney Bouchard poses with her CGMBrittney Bouchard

Brittney Bouchard, a wellness influencer, said she adjusted her diet after using a CGM.

In her opinion, the CGM showed her that her body “was unfortunately very, very sensitive to carbohydrates… even fruits,” she said, recalling that eating a pineapple had made her feel “nervous” and sick.

“If I eat oatmeal I’ll be tired in an hour.”

A solution in search of a problem

But while some researchers and companies say CGMs can have great benefits for the average person, many in the scientific community are skeptical, pointing to a lack of evidence.

Glucose spikes are a symptom, not a cause, of diabetes. said Oxford researcher and dietician Dr Nicola Guess.. He said CGMs “have no benefit” for non-diabetics.

“Normally you would identify a problem and invent a solution to fix it,” he told the BBC. “This is the other way around. It’s like if we have this technology, now we just have to find groups of people who we can convince that they need this technology.”

One key issue experts point out is that it’s surprisingly difficult to find much data on what blood sugar patterns look like in people without diabetes. This makes it difficult to interpret an individual’s results in a meaningful way.

And most people’s sugar levels rise with fruit, a food group rich in vitamins and nutrients, but that’s no reason to stop eating it.

Dr. Ethan Weiss, a clinical cardiologist at the University of California, San Francisco, agreed that there is little evidence that monitoring glucose levels in people without diabetes can measurably improve their health.

“I know of studies that show that you can change your diet and reduce glucose spikes. “I don’t know of any studies that show that (glucose monitoring) is actually doing anything beneficial, in any significant way, like reducing the risk of disease,” he said. “I think it’s mainly the devotees who believe it.”

But, Dr. Weiss added, he was also not aware of any studies showing that CGMs caused harm.

Others, including Dr. Guess, said the potential for harm was very real. Instead of focusing on the fundamental elements of health (things like regular exercise and a nutrient-dense diet), trackers like CGMs encourage us to focus on the minutiae of imperfect metrics. And, at worst, they can foster new problems, such as eating disorders.

“I’m concerned that instead of doing simple things to improve our health, we’re turning mealtimes into scientific experiments,” she said.

“I feel like, in a way, people have forgotten the meaning of living.”

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