Continuous glucose monitors on the rise after FDA approval

Blood glucose monitoring devices may soon be on the arms of millions of Americans, after regulators approved two new devices for over-the-counter use. Is this the way to improve our health? Or is the data just a distraction?

In the middle of the night last June, Cindy Bekkedam woke up to an unfamiliar alarm sound: it was a loud emergency alert and it was coming from her phone. More precisely, it was coming from a newly installed app that was linked to a blood glucose sensor implanted in her arm.

According to the app, her blood sugar had dropped dangerously low while she was sleeping, triggering an alarm.

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

Continuous glucose monitors (CGMs), which monitor blood glucose levels in real time, have been used by millions of people with diabetes for years, and Bekkedam, a registered dietitian in Ontario, Canada, wore one to better understand the technology for people with diabetes.

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

“I panicked,” she said. “I actually wondered, 'Oh my God, do I have diabetes?'”

She didn't, and further investigation revealed that her blood sugar levels were completely normal. But receiving constant updates about high and low blood sugar levels without any medical condition that required it stirred up unnecessary fear.

“I think that's where people can get lost,” she said.

But recent approval for broader use by the US Food and Drug Administration (FDA) could soon put these devices within the reach of many more people: This week, Abbott Laboratories announced it had received federal approval for two over-the-counter CGMs, including one for people who don't have diabetes.

CGM use is already on the rise – arm patches are easily seen on the morning commute in major US cities – but experts say there is little evidence to justify paying the steep cost, up to $300 (£240) a month for non-diabetics, even if there is no proven harm.

Abbott's Ringo is a CGM for people without diabetes, marketed to consumers who “want to better understand and improve their health and wellness.” This was one of two devices approved by the FDA. It is being marketed and is already available in the U.K. The FDA's 510(k) regulatory process evaluates the safety and effectiveness of medical devices, but does not review marketing claims.

“Understanding glucose in your body is key to managing your metabolism and living a healthier, better life,” an Abbott spokesman told the BBC.

Flattening the blood sugar curve could help improve energy, mood and sleep, Abbott said, pointing to research that shows the impact of blood sugar spikes on overall health and the role of CGMs in monitoring it.

While some in the medical community are skeptical of these claims, experts agree that CGMs have significantly improved the care of people with diabetes.

Type 1 diabetes requires regular injections because the pancreas no longer produces insulin. Type 2 diabetes is more common, and cells in the body become resistant to insulin, so more insulin is needed to keep blood sugar levels within normal range. It can usually be controlled with medication, diet, exercise and close monitoring, but some people use insulin. Traditionally, people with diabetes monitored their blood sugar levels by pricking their finger, but CGMs can alert people with diabetes when their blood sugar levels are dangerously high or low and when insulin injections are needed.

But many experts say there's virtually no evidence that CGMs improve the health of non-diabetic people, and they argue the devices are at best a distraction and at worst could lead to a dangerous obsession.

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

Earlier this year, the FDA approved over-the-counter sales of a CGM made by Dexcom Inc. for people with type 2 diabetes who don't use insulin but want to avoid regular finger-prick testing, and several new CGM startups, including Signos, NutriSense and Levels Health, are marketing their medical devices as energy, mood and metabolism tools without a prescription.

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

Abdi Nageai, a Dutch marathon runner who will compete in the Paris Olympics, He told Reuters earlier this week that he was wearing a CGM. This is to help you more accurately track the available energy in your body.

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

Nick Nowitz, 28, who has a PhD in nutrition from Oxford University and is now a fourth-year student at Harvard Medical School, said he believes CGM can be a powerful tool because blood sugar levels are “an indicator of the hormonal state of the body.”

He studied its use while at Harvard University and said he would welcome further research in the area.

Nowitz said he believes that in the long term, hormonal changes that accompany frequent blood sugar spikes could have negative effects, including through fat gain.

But he added that blood sugar levels are just one indicator and shouldn't be the basis for all health decisions.

“To be clear, just because eating a mango raises your blood sugar doesn't mean it's 'worse' than eating bacon,” he said.

Interest in how CGMs can help people change their eating habits has also grown in some parts of the internet: Depending on the algorithm, a search for blood glucose monitors on TikTok or Instagram could turn up a slew of testimonials from health and wellness influencers touting the benefits of the technology.

One such influencer, Britney Bouchard, promoted a particular CGM startup on TikTok and offered her followers a discount code. She said wearing a CGM helped her adjust her diet and limit blood sugar spikes. She received an affiliate commission when people purchased the device through her link.

“I noticed an immediate difference in my energy, sleep and brain fog,” said Bouchard, 41, a health coach from Los Angeles.

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

“Oatmeal makes me tired within an hour.”

But while some researchers and companies claim CGM could offer significant benefits to the general public, much of the scientific community remains skeptical, citing a lack of evidence.

Blood sugar spikes are a symptom of diabetes, not the cause. Dr Nicola Guess, a researcher and nutritionist at the University of Oxford, said:She said there is “no benefit” to CGM for people who don't have diabetes.

“Usually you identify a problem and then come up with a solution to solve it,” she told the BBC. “This is the other way around. The technology is here, you just need to find a group of people you can convince that they need it.”

One key problem experts say is that there is a surprising lack of data showing what blood sugar patterns look like in people without diabetes, making it difficult to meaningfully interpret individual results.

And while most people's blood sugar levels spike when they eat fruit, a food group rich in vitamins and nutrients, that's no reason to stop eating fruit.

Dr. Ethan Weiss, a clinical cardiologist at the University of California, San Francisco, agreed that there is little evidence that tracking blood sugar levels in people without diabetes measurably improves their health.

“We know from research that changing your diet can help prevent blood sugar spikes. [tracking glucose] “It's doing something that actually benefits you in meaningful ways, like reducing your risk of disease,” he said. “I think it's mainly believers who believe that.”

But Weiss added that he is not aware of any studies that show CGM causes damage.

Others, including Dr. Guess, said the potential for harm is very real: Instead of focusing on the basic building blocks of health, like regular exercise and a nutritious diet, trackers like CGMs encourage people to focus on the minutiae of imperfect metrics — and, at worst, could create new problems, like eating disorders.

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

“In a way, it feels like people have forgotten the meaning of life.”