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 allowed two new devices to be used without a prescription. Is it a way to improve our health? Or is data just another distraction?

At midnight last June, Cindy Bekkedam woke up to a strange 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 the glucose sensor attached to her arm.

According to the app, her blood sugar dropped to worryingly low levels while she slept, which triggered the alarm.

“So I woke 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 many years. As a dietitian in Ontario, Canada, Ms. Bekkedam installed her software to better understand technology for patients with diabetes.

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

“I was so scared,” she said. “I actually questioned, oh my God, do I have diabetes?”

She didn’t. And after some further research, she discovered that her blood sugar levels were completely normal. But constantly receiving updates about the highs and lows of her blood sugar, without having a medical condition that would require it, caused some unnecessary fear.

“I think that’s where people can go down the rabbit hole,” she said.

But these devices may soon be in the hands — or arms — of even 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.

CGM use is on the rise, with arm patches easily visible on the morning commute in major US cities. But experts say that even if no harm is proven, there is little evidence that warrants paying the hefty fees – up to $300 (£240) a month – if you don’t have the disease diabetes.

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 wellness.” This is one of two FDA-cleared devices for sale and is 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 process.

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

Flattening the glucose curve can help improve energy, mood and sleep, Abbott said, pointing to studies showing the impact of glucose spikes on overall health and the role of CGM in tracking them.

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

Type 1 diabetes is when a person’s pancreas stops producing insulin, so regular insulin injections are needed. Type 2 diabetes is more common and occurs when cells in the body become resistant to insulin and therefore need more of it to keep blood sugar levels at normal levels. It can usually be controlled through medication, diet, exercise and close monitoring, although some require insulin. Traditionally, diabetics monitor their blood sugar levels with a finger prick test, but CGMs can alert people with diabetes when their blood sugar levels are dangerously high and low. and whether insulin injections are needed.

But many experts say that evidence that CGM improves the health of people without diabetes is non-existent. They emphasize that these devices are distracting at best and can lead to dangerous fixation at worst.

CGM is a big business. Market leaders have estimated sales will reach $20 billion globally in the next four years.

Earlier this year, the FDA authorized the sale of an over-the-counter CGM, made by Dexcom, for Type 2 diabetics who don’t use insulin but want to avoid frequent finger-prick testing. And several new CGM startups, like Signos, Nutrisense and Levels Health, now market off-label prescription devices as energy, mood and metabolism tools.

These devices are becoming popular in several medical, healthcare, and sports industries.

Dutch marathoner Abdi Nageeye, who will compete at the Paris Olympics, told Reuters earlier this week that he was wearing a CGM to try to better monitor his body’s available energy.

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

Nick Norwitz, 28, who graduated with a PhD in nutrition from Oxford University and is now in his fourth year at Harvard Medical School, said he believes CGM can be a powerful tool because glucose is “an indicator of signals what’s going on hormonally in your body.” .

He researched their uses while at Harvard and said he welcomed more research in the field.

Mr. Norwitz said he believes that in the long term, the hormonal changes associated with frequent spikes in sugar levels in the body could have negative effects, including fat gain.

However, he added, glucose is just one measure and should not influence every health decision.

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

Interest in how CGM can help you change your diet has also grown strongly in some places on the Internet. Depending on your algorithm, searching for glucose trackers in TikTok or Instagram could lead you to dozens of testimonials from health and fitness influencers espousing the benefits of the technology.

One such influencer, Brittney Bouchard, who promoted a particular CGM startup on her TikTok and offered her followers discount codes, said wearing a CGM has Help her adjust her diet to reduce glucose spikes. She receives an affiliate commission when someone purchases equipment through her link.

“I could see an immediate difference in my energy, sleep, and brain fog,” says Ms. Bouchard, a 41-year-old health coach from Los Angeles.

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

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

But while some researchers and businesses claim that CGM can bring huge benefits to 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, says Oxford researcher and nutritionist Dr Nicola Guess. She said CGM has “no benefit” for people without diabetes.

“Usually you will identify the problem and find a solution to fix it,” she told the BBC. “This is the opposite. Like we already have this technology, now we just need to find groups of people that we can convince that they need this technology.”

One key issue experts point out is that it’s hard to find much data on blood sugar levels in people without diabetes. This makes it difficult to meaningfully interpret an individual’s results.

And most people’s sugar levels will spike when eating 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, agrees that there is little evidence that monitoring glucose levels in people without diabetes can improve their health. them significantly.

“I know studies show you can change your diet and possibly reduce sugar spikes. I don’t know of any studies showing that [tracking glucose] really doing anything that is beneficial, in a meaningful way, like reducing the risk of disease,” he said. “I think it’s mostly religious people who believe in it.”

However, Dr. Weiss added, he also isn’t aware of any studies showing that CGM causes damage.

Others, including Dr. Guess, say the potential for harm is very real. Instead of focusing on the fundamentals of health — things like regular exercise and a nutrient-rich diet — tracking tools like CGM encourage us to focus on the minutiae of imperfect data. And in the worst cases, they can cause new problems, such as disordered eating.

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

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