27 minutes ago
By Holly Honderich, BBC News
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Continuous glucose monitors have become powerful tools for those living with diabetes
Blood-sugar monitoring devices could soon be on the arms of millions of Americans after regulators cleared 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 unfamiliar alarm. It was loud, like an emergency alert, and it was coming from her phone. More specifically, it was coming from a newly installed app linked to a glucose sensor embedded in her arm.
According to this app, her blood sugar had dropped to a concerning low while she slept, 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 somewhat of a cautionary tale.
“I was freaking out,” she said. “I actually questioned, oh my goodness, do I have diabetes?”
She didn’t. And, after some extra research, she found that her glucose levels were entirely normal. But constantly getting updates on her blood sugar highs and lows, without having a medical condition that required it, incited some unnecessary fear.
“That’s where I think people could go down a rabbit hole,” she said.
But these devices may be in the hands – or on the arms – of many more people very soon, thanks to two recent Food and Drug Administration (FDA) approvals for more widespread use. This week, Abbott Laboratories announced it had received federal clearance for two over-the-counter CGMs, including one for those without diabetes.
Use of CGMs is already rising, with the tell-tale arm patches easily spotted during morning commutes in major American cities. But experts say that even if there is no proven harm, there is little evidence to warrant spending the hefty fees – as much as $300 (£240) a month – if you’re not a diabetic.
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”. It was one of two devices cleared by the FDA for sale, 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 your body’s glucose is key to managing your metabolism so you can live healthier and better,” an Abbott spokesperson told the BBC.
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Many experts say evidence is scant that CGMs are beneficial to those without diabetes
Abbott said that 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 scepticism about such claims in the medical community, but one thing experts agree on is that CGMs have significantly improved the care of some people living with diabetes.
Type 1 diabetes is when an individual’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 and so more is needed to keep blood glucose levels within a normal range. It can usually be controlled through medication, diet, exercise and close monitoring, although some take insulin. Traditionally, diabetics monitored their blood sugar with finger-prick tests, but CGMs can alert people with diabetes when their blood sugars are running dangerously high and low, and if insulin needs to be injected.
But many experts say that the evidence for CGMs improving the health of non-diabetics is effectively non-existent. They insist the devices are, at best, a distraction and at worse could lead to dangerous fixations.
A growing trend
CGMs are big business. Market leaders have estimated sales will reach $20bn globally over the next four years.
Earlier this year, the FDA cleared the sale of an over-the-counter CGM made by Dexcom, meant for Type 2 diabetics who don’t use insulin but want to avoid regular finger-prick tests. And some new CGM startups, like Signos, Nutrisense and Levels Health, now market prescription devices off-label as tools for energy, mood and metabolism.
The devices are becoming popular among some in health, wellness and sports industries.
Dutch marathoner Abdi Nageeye, who will compete in the Paris Olympics, told Reuters earlier this week he is wearing a CGM to try to better track his body’s available energy.
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Dutch marathoner Abdi Nageeye wore a CGM during the Rotterdam marathon in 2022, 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, who graduated from Oxford University with a PhD in nutrition and is currently in his fourth year of medical school at Harvard, said he believes CGMs can be powerful tools because glucose is “a bellwether for what’s happening hormonally in your body”.
He has studied their use while at Harvard, and said he welcomes more research in the field.
Mr Norwitz said he believed that over the long term, the hormonal changes associated with frequent glucose spikes could cause negative effects, including through fat gain.
But, he added, glucose is just one metric, and shouldn’t drive all health decisions.
“To be clear, I don’t think that means if you eat a mango and have your blood sugar go up that it’s ‘worse’ for you than were you to have a plate of bacon,” he said.
Interest in how CGMs can help you change your diet has flourished in some corners of the internet too. Dependiendo de tu algoritmo, una búsqueda de monitores de glucosa en TikTok o Instagram podría llevarte a docenas de testimonios de influyentes de salud y bienestar que ensalzan los beneficios de la tecnología. Una de estas influyentes, Brittney Bouchard, quien promocionó una start-up de CGM en particular en su TikTok y ofreció a sus seguidores un código de descuento, dijo que usar un CGM le ayudó a ajustar su dieta para reducir los picos de glucosa. Recibió una comisión de afiliación cuando la gente compraba el dispositivo a través de su enlace. “Pude notar una diferencia inmediatamente, en mi energía, mi sueño y mi niebla cerebral”, dijo la Sra. Bouchard, una entrenadora de salud de 41 años de Los Ángeles. Brittney Bouchard, una influyente de bienestar, dijo que ha ajustado su dieta después de usar un CGM. En su opinión, el CGM le mostró que su cuerpo “era lamentablemente muy, muy sensible a los carbohidratos… incluso a la fruta”, dijo, recordando que comer piña la había hecho sentir “nerviosa” y enferma. “Si como avena, estaré cansada en una hora”. Una solución en busca de un problema. Mientras algunos investigadores y empresas afirman que los CGM pueden tener grandes beneficios para la persona promedio, muchos en la comunidad científica son escépticos, señalando la falta de evidencia. Los picos de glucosa son un síntoma, no una causa, de la diabetes, dijo la investigadora de Oxford y dietista Dra. Nicola Guess. Dijo que no hay “ningún beneficio” en los CGM para aquellos que no son diabéticos. “Normalmente se identificaría un problema e inventaría una solución para arreglarlo”, dijo a la BBC. “Esto es al revés. Es como si tuviéramos esta tecnología, ahora solo tenemos que encontrar grupos de personas a quienes podamos convencer de que necesitan esta tecnología”. Un problema clave al que señalan los expertos es que es sorprendentemente difícil encontrar muchos datos sobre cómo son los patrones de azúcar en la sangre en personas sin diabetes. Esto hace que sea difícil interpretar los resultados de un individuo de manera significativa. Y los azúcares de la mayoría de las personas aumentarán con la fruta, un grupo alimenticio rico en vitaminas y nutrientes, pero eso no es motivo para dejar de comerla. El Dr. Ethan Weiss, cardiólogo clínico de la Universidad de California, San Francisco, coincidió en que hay escasa evidencia de que el seguimiento de los niveles de glucosa en personas sin diabetes pueda mejorar mediblemente su salud. “Estoy al tanto de estudios que muestran que puedes cambiar tu dieta y puedes disminuir los picos de glucosa. No estoy al tanto de ningún estudio que muestre que [seguir la glucosa] realmente esté haciendo algo beneficioso, de manera significativa, como reducir tu riesgo de enfermedad”, dijo. “Creo que principalmente son los devotos quienes lo creen”. Pero, el Dr. Weiss agregó, tampoco estaba al tanto de ningún estudio que mostrara que los CGM causaran daño. Otros, incluida la Dra. Guess, dijeron que el potencial de daño era muy real. En lugar de centrarse en los fundamentos de la salud, como el ejercicio regular y una dieta rica en nutrientes, los rastreadores como los CGM nos animan a enfocarnos en los detalles de métricas imperfectas. Y, en los peores escenarios, pueden fomentar nuevos problemas, como los trastornos alimenticios. “Me preocupa que en lugar de hacer cosas simples para mejorar nuestra salud, estemos convirtiendo las comidas en experimentos científicos”, dijo. “Siento que de alguna manera la gente ha olvidado el punto de vivir”.