Continuous glucose monitors on the rise following FDA approval

Blood glucose monitoring devices may soon be on the arms of millions of Americans after regulators approved two new devices for use without a prescription. Is this a way to improve our health? Or is data just another distraction?

In the middle of the night last June, Cindy Bekdam was woken up by an unfamiliar alarm clock. The sound was loud, like an emergency alert, coming from her phone. More specifically, it came from a newly installed app connected to a glucose sensor embedded in her arm.

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

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

Continuous glucose monitors (CGM) provide instant monitoring of blood glucose levels and have been used by millions of diabetics over the years. As a dietitian in Ontario, Canada, Ms. Bekkedam installed a dietitian to better understand the technology available to her diabetic patients.

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

“I was terrified,” she said. “I actually asked, Oh my gosh, do I have diabetes?”

She didn’t. And, after some additional research, she discovered that her blood sugar levels were completely normal. But having constant updates on her blood sugar levels, without a medical condition that warranted it, sparked some unnecessary fear.

“I think people can fall down rabbit holes,” she said.

But the devices may soon be in the hands or arms of more people, thanks to two recent approvals from the U.S. Food and Drug Administration (FDA) for wider use. This week, Abbott Laboratories announced that it has received federal clearance for two of its over-the-counter continuous glucose monitors, including one for use in non-diabetic patients.

CGM use is already increasing, with patches easily spotted on arms during the morning commute in major U.S. cities. But experts say even if there are no proven harms, there’s no evidence it would cost you too much – up to $300 (£240) a month – if you’re not diabetic.

Abbott’s Lingo is a continuous glucose monitoring (CGM) for non-diabetics, targeting consumers who “want to better understand and improve their health.” This is one of two devices approved by the FDA For sale and already 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.

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

A flat blood sugar curve can help improve energy, mood and sleep, Abbott said, pointing to research showing the impact of blood sugar spikes on overall health and the role of continuous glucose monitoring in monitoring blood sugar.

The medical community is skeptical of such claims, but one thing experts agree on is that continuous glucose monitoring has significantly improved the care of some people with diabetes.

Type 1 diabetes is when an individual’s pancreas stops producing insulin, requiring regular injections. Type 2 diabetes is more common and occurs when cells in the body become resistant to insulin, requiring more insulin to maintain blood sugar levels within a normal range. Although some people need to take insulin, it can usually be managed with medication, diet, exercise, and close monitoring. Traditionally, people with diabetes monitor their blood sugar through finger-prick blood tests, but continuous glucose monitoring can alert people with diabetes when their blood sugar is dangerously high or low and if an insulin injection is needed.

But many experts say the evidence that continuous glucose monitoring improves the health of people without diabetes does not exist. They insist the devices are distracting at best and can lead to dangerous addictions 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 an over-the-counter CGM made by Dexcom for people with type 2 diabetes who don’t take insulin but want to avoid regular finger-prick blood tests. Several new CGM startups, such as Signos, Nutrisense and Levels Health, now market off-label prescription devices as energy, mood and metabolism tools.

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

Dutch marathon runner Abdi Nageeye will compete in the Paris Olympics, told Reuters earlier this week that he was wearing a CGM Trying to better track the energy available to his body.

Others, including some in 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 PhD in nutrition and is now in his fourth year at Harvard Medical School, said he believes continuous glucose monitoring (CGM) can be a powerful tool. Because glucose is “the vane of hormonal changes in the body.”

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

Mr Nowitz said he believed the hormonal changes associated with frequent blood sugar spikes could lead to negative effects in the long term, including through fat gain.

But, he added, blood sugar is just one indicator and shouldn’t drive all health decisions.

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

There’s also growing interest in some corners of the internet about how continuous glucose monitoring can help you change your diet. Depending on your algorithm, a search for a blood glucose monitor on TikTok or Instagram might bring you dozens of recommendations from health and wellness influencers who espouse the benefits of the technology.

One such influencer is Brittney Bouchard, who promoted a specific CGM startup on TikTok and offered discount codes to her followers, saying wearing a CGM helped her adjust her diet to reduce blood sugar spikes . When people purchase the device through her links, she receives an affiliate commission.

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

She believed that continuous glucose monitoring showed that her body was “unfortunately, very, very sensitive to carbohydrates…even fruit,” recalling that eating pineapple made her feel “jittery” and nauseous.

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

While some researchers and companies claim that continuous glucose monitoring could bring huge benefits to the average person, many in the scientific community are skeptical, pointing to a lack of evidence.

Elevated blood sugar is a symptom of diabetes, not its cause. Dr Nicola Guess, researcher and nutritionist at the University of Oxford, says. Continuous glucose monitoring “doesn’t do any good” for people without diabetes, she said.

“Normally you identify a problem and invent a solution to solve it,” she told the BBC. “It’s a step backwards. It’s like we already have the technology, now we just need to find the people who can convince them they need it.

A key problem noted by experts is the difficulty of finding large amounts of data on blood sugar patterns in non-diabetics. This makes it difficult to interpret individual results in a meaningful way.

Most people get a sugar spike from fruits (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, agrees that there’s not much evidence that tracking blood sugar levels in people without diabetes can significantly improve their health.

“I know there are studies that show you can change your diet and you can lower your blood sugar spikes. I’m not aware of any studies that show [tracking glucose] It’s really about doing anything beneficial in a meaningful way, such as reducing the risk of disease,” he said. “I think it’s mostly believers who believe it.”

However, Dr. Weiss added that he was not aware of any studies showing that continuous glucose monitoring causes harm.

Others, including Dr. Gass, say the potential harm is very real. Trackers like CGM encourage us to focus on the details of imperfect metrics rather than focusing on the basic building blocks of health (like regular exercise and a nutrient-dense diet). 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’re turning mealtimes into a science experiment,” she said.

“I just feel like in some ways people have forgotten what life is about.”