Continuous glucose monitors are on the rise following FDA approval

Blood sugar monitoring devices could soon be in the hands of millions of Americans after regulators approved two new devices for over-the-counter use. Is this a way to improve our health? Or is data just another distraction?

Last June, in the middle of the night, Cindy Bekkedam woke up to the sound of an unknown alarm. It was loud, like an alarm, and it was coming from her phone. More specifically, the signal came from a newly installed app connected to the glucose sensor built into her arm.

According to the app, her blood sugar dropped to an alarming level while she was sleeping, which 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 installed her device to better understand this technology for her diabetic patients.

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

“I was afraid,” she said. “I was actually thinking, oh my God, do I have diabetes?”

She didn’t do it. After additional tests, she found that her glucose levels were completely normal. However, constantly receiving updates on her high and low blood sugar levels, even though the disease did not require it, created unnecessary fear.

“I think people could fall down the rabbit hole,” she said.

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

CGM use is already on the rise, and the distinctive shoulder patches can be easily spotted on morning commutes in major U.S. cities. But experts say that even if no harm has been proven, there is little evidence to justify shelling out the hefty fees – as much as $300 (£240) a month – if you are not diabetic.

Abbott’s Lingo, or CGM for people without diabetes, is aimed at 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 now available in the UK. The FDA’s 510(k) regulatory process evaluates medical devices for safety and effectiveness, but marketing claims are not part of the review.

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

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

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

Type 1 diabetes occurs when the pancreas stops producing insulin, so regular injections are necessary. Type 2 diabetes is more common and occurs when the body’s cells become resistant to insulin, so more insulin is needed to keep blood glucose levels within the normal range. It can usually be controlled with medication, diet, exercise and close monitoring, although some people take insulin. Traditionally, diabetics monitored blood sugar levels using finger prick tests, but CGMs can alert people with diabetes when blood sugar levels rise dangerously or when an insulin injection is needed.

However, many experts say there is actually no evidence that CGMs improve the health of people without diabetes. They argue that these devices are distracting at best and can lead to dangerous fixations at worst.

CGM is big business. Market leaders estimate global sales will reach $20 billion over the next four years.

Earlier this year, the FDA approved the sale of Dexcom’s over-the-counter CGM, intended for type 2 diabetics who don’t use insulin but want to avoid regular finger prick tests. Some new CGM startups, such as Signos, Nutrisense, and Levels Health, now sell prescription devices off-label as tools to improve energy, mood, and metabolism.

These devices are becoming popular among certain health, wellness and sports industries.

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

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

He researched their use at Harvard and said he welcomed further research in this area.

Norwitz stated that in the long term, hormonal changes associated with frequent spikes in glucose levels may have negative effects, including an increase in fat tissue.

However, he added that glucose is only one indicator and should not influence all health decisions.

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

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

One such influencer, Brittney Bouchard, who promoted a particular CGM startup on her TikTok and offered her followers a discount code, found that wearing a CGM helped her adjust her diet to limit glucose spikes. She received an affiliate commission when people purchased a device through her link.

“I felt a difference right away in terms of energy, sleep and brain fog,” said Ms. Bouchard, a 41-year-old health coach from Los Angeles.

She said the CGM showed her that her body “was unfortunately very, very sensitive to carbohydrates… even fruit,” she said, recalling that she felt “jittery” and sick after eating pineapple.

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

While some researchers and companies claim that CGMs can provide enormous benefits to the average person, many in the scientific community are skeptical, pointing to a lack of evidence.

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

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

Most people’s sugar levels will increase 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 tracking glucose levels in people without diabetes can measurably improve their health.

“I know research that shows that you can change your diet and reduce glucose spikes. “I don’t know of any research showing that (glucose monitoring) actually does anything beneficial in a meaningful way, such as reducing the risk of disease,” he said. “I think it’s mostly the devotees who believe it.”

However, Dr. Weiss added that he was not aware of any studies showing that CGMs cause harm.

Others, including Dr. Guess, said the potential harm was very real. Instead of focusing on the basic building blocks of health – such as regular exercise and a nutrient-rich diet – monitoring devices like CGM encourage us to focus on the details of imperfect indicators. In 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 people have kind of forgotten the meaning of life.”