Continuous glucose monitors on the rise following FDA approval

Image source, Getty Images

Image caption, Continuous glucose monitors have become powerful tools for people with diabetes

  • Author, Holly Honderich
  • Role, BBC news
  • Reporting from Washington, DC

Blood sugar monitoring devices could soon be in the arms of millions of Americans after regulators approved two new devices for use without a prescription. Is it a way to improve our health? Or is the 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, her blood sugar levels had dropped to worryingly low levels during her sleep, which had triggered the alarm.

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

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

But her two-week trial became a bit of a cautionary tale.

“I panicked,” she said. “I was actually wondering, oh my gosh, do I have diabetes?”

She didn’t. And after some additional testing, she discovered that her glucose levels were completely normal. But constantly monitoring the highs and lows of her blood sugar levels, without having a medical condition that required it, created unnecessary anxiety.

“I think people can go down a rabbit hole there,” she said.

But these devices could soon end up in the hands (or on the arms) of many more people, thanks to two recent Food and Drug Administration (FDA) approvals for broader use. This week, Abbott Laboratories announced it had received federal approval for two over-the-counter CGMs, including one for people without diabetes.

The use of CGMs is already increasing, with the telltale arm patches easily spotted during morning traffic in major US cities. But experts say that even if there is no proven harm, there is little evidence to justify spending the high costs – up to $300 a month – if you are not a diabetic.

Abbott’s Lingo, 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 for sale by the FDA and is already available in the UK. The FDA’s 510(k) regulatory process evaluates medical devices for safety and efficacy, but marketing claims are not part of the review.

“Understanding the glucose in your body is key to managing your metabolism so you can live a healthier, better life,” an Abbott spokesperson told the BBC.

Image source, Getty Images

Image caption, Many experts say there is little evidence that CGMs are beneficial for people 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 monitoring them.

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

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

But many experts say there is actually no evidence that CGMs improve the health of non-diabetics. They claim that the devices are at best a distraction and at worst can lead to dangerous fixations.

A growing trend

CGMs are big business. Industry leaders estimate that sales will reach $20 billion worldwide over the next four years.

Earlier this year, the FDA approved sales of an over-the-counter CGM, made by Dexcom, intended for type 2 diabetics who don’t use insulin but want to avoid regular fingerstick tests. And some new CGM startups, such as Signos, Nutrisense and Levels Health, are now marketing off-label devices as energy, mood and metabolism aids.

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

Image caption, Dutch marathon runner Abdi Nageeye wore a CGM during the 2022 Rotterdam marathon, according to Reuters

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

Nick Norwitz, 28, a graduate of Oxford University with a doctorate in nutrition who is currently in his fourth year of medical school at Harvard, said he believes CGMs can be powerful tools because glucose is “a gauge of what’s going on hormonally in your body.” happens”.

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

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

But, he added, glucose is just one measure and should not drive all health decisions.

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

Interest in how CGMs can help you change your diet has also blossomed in some corners of the internet. Depending on your algorithm, a search for glucose meters on TikTok or Instagram can lead you to dozens of testimonials from health and wellness influencers who embrace the benefits of the technology.

One such influencer, Brittney Bouchard, who promoted a particular CGM start-up on her TikTok and offered her followers a discount code, said wearing 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 immediately see a difference, in my energy, my sleep and my brain fog,” says Ms. Bouchard, a 41-year-old health coach from Los Angeles.

Image source, Brittney Bouchard

Image caption, Brittney Bouchard, a wellness influencer, said she changed her diet after using a CGM

According to her, the CGM showed her that her body was “unfortunately very sensitive to carbohydrates… even fruit,” she said, recalling that eating a pineapple had made her feel “jittery” and nauseous.

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

A solution in search of a problem

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

“Normally you identify a problem and come up with a solution to solve it,” she told the BBC. “This is backwards. It’s like we have this technology, now we just need to find groups of people that we can convince that they need this technology.”

One of the key issues 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 sugars will rise with fruit—a food group rich in vitamins and nutrients—but that’s no reason to stop eating them.

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 am aware of studies showing that you can change your diet and reduce your glucose spikes. “I’m not aware of any studies showing that (glucose tracking) actually does anything useful, in a meaningful 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 unaware of any studies showing that the CGMs caused harm.

Others, including Dr. Guess, said the potential for harm was very real. Instead of focusing on the basic building blocks 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 in the worst cases, they can cause new problems, such as eating disorders.

“I worry that instead of doing simple things to improve our health, we are turning meals into science experiments,” she said.

“I just feel like in some ways people have forgotten the meaning of life.”