England’s National Health Service (NHS) said on Tuesday that “tens of thousands of children and adults” with type 1 diabetes will receive an “artificial pancreas” to help manage their insulin levels. The hybrid closed loop system — a sensor under the skin that sends wireless readings to an externally worn pump, which delivers insulin as needed — can help patients avoid the risks of type 1 diabetes without worrying about finger sticks or injections.

This isn’t the first device of its kind. Tandem makes similar insulin pumps in the US after it received FDA authorization in 2019. Gizmodo notes that another company called iLet got FDA approval for a similar device last year. Although the NHS hasn’t said which specific device(s) its program will use, what’s different here is the nation’s publicly funded health care system providing them for free rather than as an exclusive privilege for the well-to-do. (Sigh.)

The hybrid closed loop system starts with a sensor implanted beneath the skin, which continually monitors glucose levels at regular intervals. The sensor sends that data wirelessly to a pump, worn externally, which delivers the proper insulin dosage. The “hybrid” part of its name comes from the fact that some user input, including entering carb intake, is still required in the otherwise self-regulating system.

The government agency gave an ultra-precise figure of 269,095 people in England living with type 1 diabetes, highlighting how many folks could potentially benefit from the rollout. The NHS says local branches will begin identifying patients for the program starting on Tuesday.

“Diabetes is a tough and relentless condition, but these systems make a significant, life-changing difference — improving both the overall health and quality of life for people with diabetes,” Colette Marshall, chief executive of Diabetes UK, wrote in the NHS’s press release announcing the rollout. “This really is a landmark moment and we’ll be working with the NHS and others to ensure a fair rollout that reaches people as quickly as possible.”

The US Food and Drug Administration has approved the first continuous glucose monitor (CGM) people can buy without a prescription. Dexcom's Stelo Glucose Biosensor System has a sensor users are meant to insert into their upper arm, similar to the company's other CGMs that need a doctor's prescription for purchase. It pairs with a smartphone application that can show the user's blood glucose measurements and trends every 15 minutes. 

The company designed the device specifically for adults 18 and up who are not using insulin, such as those managing their diabetes with oral medications and non-diabetics making a conscious effort to control their sugar intake. It could be a great tool for people with insulin resistance, including individuals with PCOS and other metabolic issues that heighten their probability of developing diabetes in the future. In general, it could give users the insight to be able to better understand how the food they eat and the movements they make impact their overall health. 

While CGMs aren't anything new, they've become a wellness trend on social media last year, and even non-diabetics started using them. By clearing Stelo, the FDA is making the monitors more accessible than before. "CGMs can be a powerful tool to help monitor blood glucose," said Jeff Shuren, MD, director of the FDA's Center for Devices and Radiological Health. "Today's clearance expands access to these devices by allowing individuals to purchase a CGM without the involvement of a health care provide. Giving more individuals valuable information about their health, regardless of their access to a doctor or health insurance, is an important step forward in advancing health equity for U.S. patients."

Stelo will be available starting this summer. Each patch is meant to last for 15 days before users will need to replace it. Dexcom has yet to reveal how much it would cost, but it said Stelo will "provide an option for those who do not have insurance coverage for CGM."

Dexcom

“Let’s see what a Snickers bar does to my blood sugar,” Justin Richard, a 52-year-old Toronto-based TikToker says just before eating the candy bar on camera. After an edited time skip, Richard says, “It’s been several hours since I’ve had the chocolate bar, let’s have a look at the glucose monitor and see what actually happened.” He slightly lifts his arm flashing the device, an inconspicuous blue circular patch that almost looks like a Band-Aid. Above his head flashes a screenshot of his blood glucose reading, which appears to have spiked, dipped, and spiked again. “I had a spike in my blood sugar,” he says. “That's not a shock because this is loaded with sugar.” A red ‘X’ graphic appears over some b-roll of the Snickers bar. “I did this test because I’m trying to establish a benchmark.”

This is a typical 60-second TikTok from Richard, whose handle is @insulinresistant1 on the platform. In the following clip, Richard eats a cup of broccoli before eating another full Snickers bar, then goes on to share the results of his blood glucose levels from his personal continuous glucose monitor. He eats this oddball combination to show how variations in his food intake can impact or even prevent a blood glucose spike.

Continuous glucose monitors (or CGMs) have long been used as a tool to track blood sugar levels for people with Type 1 and Type 2 diabetes. Here’s the thing, though: Richard does not have diabetes.

While monitoring sugar intake is standard practice for people on tight blood sugar control treatment plans and those with persistently low blood glucose levels, modern CGM devices – non-invasive wearables that can attach to the back of an arm for weeks at a time – have become a popular wellness trend on social media. Users like Richard that have integrated a CGM into their daily life have stormed platforms like TikTok and Instagram. Some internet health coaches and dieticians have trumpeted their praise. On TikTok, the hashtags #insulinresistance has 1.2 billion views, while #continuousglucosemonitor has over 32.7 million views. Richard, who has over 800,000 TikTok followers, is just one influencer who helped fuel this trend. On his page, which he started during the pandemic, showcases him eating a wide range of foods and drinks, from sodas to chocolate bars, reacting to readings emitting from his Signos-sponsored CGM device.

Richard says he got into continuous glucose monitoring to “optimize his health” and prevent chronic illness, which was especially important to him considering his extensive family history of Type 2 diabetes. “It's like having a coach,” he said in an interview. “But the coach is telling you to do something.” That something was to make some pretty dramatic dietary changes. “'I'm not a healthcare professional and I don't pretend to be. All of my tests are about my blood sugar, and what I read online and how it affects me,” he said, adding that his disclaimer that “individual results will vary” is a key part of his messaging.

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Blood glucose monitoring devices are not new. In the late 1990s, medical companies like Medtronic, Dexcom and Abbott revolutionized the way diabetes could be managed. The importance of continuous glucose monitoring for patients is well established as a means of improving glycemic control, especially in the case of Type 1 diabetes.

CGMs are a vital tool for preventing diabetic ketoacidosis, a life-threatening complication seen in Type 1 diabetic patients. When sugar levels are too high and the body begins to break down fat as fuel, it can lead to a high amount of acid circulation in the bloodstream. For non-diabetics, however, complications stemming from extremely high or low blood sugar levels isn’t a concern. There is little to no research to back that monitoring blood glucose levels in generally healthy adults equates to an overall improvement in health. 

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Dr. Idz, another TikToker with over 1.7 million followers, calls the use of CGM devices for adults without any prescribed medical need a “feature of disordered eating.” Dr. Idz, short for Idrees Mughal, is a board-certified UK-trained medical doctor with expertise in nutritional research. He became a prominent figure when he started rebuking the “nonsense health information” circulating on TikTok that “prey[s] on people's vulnerabilities.” He says CGMs aren’t really intended for non-diabetics because “our body is designed to regulate the spike.” Dr. Idz says people need to understand that spiking blood glucose is not a problem. In fact, that is supposed to happen when you eat food. “Even protein can spike your blood glucose, and no one is really hyped about that, right?”

Although there may not be an inherent physical risk for people who wear a CGM device to monitor and track sugar levels, there is a real possibility that access to “too much data” can lead to information overload, false alarms, unnecessary anxiety, confusion or misinterpretation. Slight fluctuations in blood sugar levels are normal in people who don’t have diabetes. Dr. Robert Shmerling, a senior faculty editor for Harvard Health Publishing and author of “Is blood sugar monitoring without diabetes worthwhile?” writes that, “we're at the very beginning of the learning curve for home monitoring of blood sugar in people without diabetes. Before buying into what may be the next fad in health monitoring, I think we need to learn a lot more.”

Still, it’s no surprise that more people are interested in experimenting with CGM devices. Not only are TikTokers promoting blood glucose monitoring as an indicator of health and wellness, but ads for CGM devices from up-and-coming brands like Nutrisense, Veri and Signos have been flooding social media.

The companies use language designed to sell the average person on the importance of regularly tracking blood sugar levels as a way to lose weight or as a “metabolism hack.” The idea is that eating refined carbs and sugary foods can spike blood glucose levels and, over time, the cells that are supposed to take up insulin and regulate glucose production in the liver become resistant to the hormone due to habitual bad dieting. Heather Davis, a registered and licensed dietitian and nutritionist at Nutrisense denies that the company promises weight loss through glucose monitoring. “A CGM is not a weight loss device per se,” she said. “The CGM is simply one tool among many that may support insights into how different dietary and lifestyle approaches influence metabolic health, including weight factors.”

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Dr. Idz would disagree with Nutrisense on that. He argues that the vast majority of people won't even know how to interpret CGM results. “Even me as a medical doctor, I would probably need to look at some reference values for each individual, you know, perhaps have to do some calculations. And that's me who's actually a medical doctor. Imagine the average person who's just going, ‘oh, my gosh, I've had a spike. That must mean it's bad, right?’ You don't even know how to interpret it. So it's going to be completely useless.”

Nutrisense’s Davis concedes that there is limited research currently looking at CGM use in non-diabetic populations, but she argues that “once upon a time, there was also limited research looking at CGM use in diabetic populations” and that the “risks of wearing a CGM are extremely minimal for most people.” Still, the FDA has never recommended continuous glucose monitoring for healthy individuals. It has only even approved a handful of devices for people who do suffer from diabetes. Although it may be useful for predicting a risk for pre-diabetes and diabetes, there is a consensus that more scientific studies are needed to observe CGM use among healthy populations.

Companies marketing their wearables to healthy people are entering a crowded, but growing market that’s ripe for exploitation. There is arguably an enormous opportunity for companies advertising to healthy individuals to reap financial benefits from the latest health fad.

Signos

TikToker Richard says he thinks continuous glucose monitoring is only going to grow from here. “I don't think this trend is going to end anytime soon,” he said. “Anybody and every country that's adopted this fast food, highly processed diet is having this same increase in Type 2 diabetes and you really can't ignore it. So I think this trend is gonna continue as long as this fast food is so prevalent.” Dr. Idz, on the other hand, would argue that if you want to prevent diabetes, “that's fine but you're not going to do it by wearing a CGM because you know, as long as you're not insulin resistant, you'll find that you don't need you don't need a CGM.”

To make matters worse, not only are CGMs questionably useful for healthy individuals, but they can be expensive, too. The devices must be replaced every seven to 14 days depending on the manufacturer. Nutrisense does not accept insurance coverage on the grounds it is a “wellness program,” with monthly subscriptions starting at $225 and no-commitment plans reaching $399 a month. Competitors like Signos, which accepts insurance with a diabetes diagnosis, offers a monthly plan for its wearable and monitoring app, and that costs upwards of $449 a month. Veri may accept insurance, depending on the provider. And even though it’s able to dramatically undercut its competitors, the monthly fee of between $40 to $109 is hardly cheap. Richard, who has historically paid out of pocket for his CGM devices, believes the high cost is going to “save him money in the long run.”

Unfortunately, these lofty prices don’t just affect health-conscious TikTokers. Access to CGM devices for diabetic populations can be spotty. Individuals covered by Medicaid are less likely to have one covered, especially people of color, according to the American Diabetes Association (ADA).

Aside from the technology’s often inaccessible price points, some experts argue that there simply isn't enough guidance from the scientific community on CGM applications for healthy individuals. The ADA does not recommend CGM device use by healthy people, only clearly stating that the technology should be considered “from the outset of the diagnosis of diabetes that requires insulin management.”

Dr. Idz takes this a step further, stating flatly that “there is no evidence whatsoever that blunting blood sugar spikes does anything for our health.” He backs up his argument with research from a retrospective and randomized trial that focused on the impact of blood glucose monitoring in diabetic and non-diabetic populations. Dr. Idz says, if anything, research suggests that a low average blood glucose level is bad for you and might increase mortality risk over time due to diminished consumption of healthy nutrients and decreased liver function.

Harvard’s Dr. Shmerling reports he could not find a published study suggesting that monitoring blood glucose levels directly translated into improved health. “Unfortunately, some makers of CGM systems aren't waiting for solid research results to market these devices to healthy people. So, consumers and marketing professionals — not researchers or doctors — may wind up driving demand for the product,” Dr. Shmerling writes. Despite the lacking body of evidence to support blood glucose monitoring among healthy populations, the inflated price points for direct to consumer products, and the technological handicaps still present in the burgeoning industry, the growing popularity of CGMs among health and fitness enthusiasts does not seem to be slowing down.

Apple's long-running quest to bring blood glucose monitoring to the Apple Watch appears to be moving forward. Bloombergsources claim the company's no-prick monitoring is now at a "proof-of-concept stage" and good enough that it could come to market once it's smaller. The technology, which uses lasers to gauge glucose concentration under the skin, was previously tabletop sized but has reportedly advanced to the point where an iPhone-sized wearable prototype is in the works.

The system would not only help people with diabetes monitor their conditions, but would ideally alert people who are prediabetic, the insiders say. They could then make changes that prevent Type 2 (adult onset) diabetes.

Apple declined to comment. The project has supposedly been in development for a long time. It began in 2010, when an ailing Steve Jobs had his company buy blood glucose monitoring startup RareLight. Apple is said to have kept the effort secret by operating it as a seemingly isolated firm, Avolonte Health, but folded it into a previously unknown Exploratory Design Group (XDG). CEO Tim Cook, Apple Watch hardware lead Eugene Kim and other top leaders have been involved.

Any real-world product is likely years away, according to Bloomberg. The industry also doesn't have a great track record of bringing no-prick monitors to market. In 2018, Alphabet's health subsidiary Verily scrapped plans for a smart contact lens that would have tracked glucose using tears. Even major brands with vast resources aren't guaranteed success, in other words, and it's not clear how accurate Apple's solution would be.

There are strong incentives to bring this tech to wearables. The Apple Watch is frequently marketed as a health device and can spot signs of atrial fibrillation, low blood oxygen levels and (as of Series 8) ovulation cycles. Non-intrusive glucose monitoring could make it an indispensable tool for those with diabetes — you wouldn't need a dedicated device that invades your skin, such as a continuous glucose sensor that sends info from an electrode-equipped thin needle to an external receiver. That painless approach could give the Apple Watch an edge over competing smartwatches.

Tandem Diabetes Care says the Food and Drug Administration (FDA) has cleared its smartphone app to program and cancel insulin doses from the t:slim X2 insulin pump. The company claims it's the first time the FDA has cleared a phone app for such a purpose.

The t:connect mobile app on iOS and Android will enable users to program and cancel bolus insulin doses from the pump, according to Tandem Diabetes Care. When connected to the pump, the app can display information about the last 24 hours of a user's glucose trends, changes in status (including alerts and alarms) and insulin therapy data.

Pumps typically require users to dial in insulin doses manually. Given that they are often able to view glucose readings on their handset, patients will be able to use their phone to determine how much insulin they need and then program their dose.

The FDA clearance could be a step toward a more convenient way for diabetes patients to administer insulin doses. Tandem Diabetes Care plans to offer the feature at no extra cost to new and in-warranty t:slim X2 insulin pump customers via a software update. The plan is to grant access to a limited number of users in the spring ahead of a broader rollout this summer.

People with diabetes have more than a few hassles, particularly at meals. They not only have to measure their blood glucose levels and inject the right amount of insulin, but carry all the relevant equipment with them. MIT and Brigham and Women's Hospital researchers might soon eliminate many of the headaches, though. They're developing all-in-one devices (not pictured) that measure glucose, calculate the necessary insulin dose and inject you accordingly.

The first device includes the blood-drawing lancet, glucose test strips and an insulin needle. Users would first take a photo of their meal using a smartphone app to estimate the food volume and carbohydrate levels. After that, they'd start the automated process of collecting blood, calculating glucose (again through the app) and delivering the appropriate amount of insulin.

The second gadget would only need one needle jab — it would build the glucose sensor into the insulin needle and inject the appropriate amount of insulin. You'd have to wait five to ten seconds, but you wouldn't have to stick yourself twice.

The technology is still some ways off. While the first device would use parts that were already FDA-approved, it hasn't been tested in humans. The second, meanwhile, uses a new sensor type that will likely require more work to be testable with humans. Scientists have filed patents for both devices and are hoping to work with companies on further development.

There's a strong motivation to bring these devices to market, at least. People with diabetes would only need to use one device at meals, and with the hybrid sensor/needle might suffer less pain. That, in turn, could encourage consistent treatment that improves your overall wellbeing.

Blood glucose monitors are pretty ubiquitous today. For most people with diabetes, these cheap and reliable sensors are their primary means of managing their blood sugar. But what is the enterprising diabetic hacker to do if he wakes up and realizes, with horror, that a primary aspect of his daily routine doesn’t involve an Arduino?

Rather than succumb to an Arduino-less reality, he can hopefully use the shield [M. Bindhammer] is working on to take his glucose measurement into his own hands.

[Bindhammer]’s initial work is based around the popular one-touch brand of strips. These are the cheapest, use very little blood, and the included needle is not as bad as it could be. His first challenge was just getting the connector for the strips. Naturally he could cannibalize a monitor from the pharmacy, but for someone making a shield that needs a supply line, this isn’t the best option. Surprisingly, the connectors used aren’t patented, so the companies are instead just more rigorous about who they sell them to. After a bit of work, he managed to find a source.

The next challenge is reverse engineering the actual algorithm used by the commercial sensor. It’s challenging. A simple mixture of water and glucose, for example, made the sensor throw an error. He’ll get it eventually, though, making this a great entry for the Hackaday Prize.