Where Does Diabetes Technology Stand In 2022?

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Author: berci.mesko

Diabetes management went through a radical transformation in the last years due to technology: the diabetes patient community found a strong voice online, continuous glucose monitors are taking the place of finger pricks, digital patches and insulin pumps make the dosage of insulin more predictable, and connected devices promise the era of artificial pancreas real soon. We looked around where diabetes technology stands today and what could we expect in the next 5-10 years.

The diabetes community and digital health tech companies pushing for change

Diabetes continues to affect the lives of millions around the globe. According to the latest estimates of the International Diabetes Federation, 537 million adults suffer from diabetes worldwide – and the number is growing steadily. It means that hundreds of millions need to manage a chronic condition on a daily basis, which might lead to stroke, blindness, heart attack, kidney failure or amputation. In an even more disquieting manner, the number is expected to rise to 783 million by 2045.

Luckily, more and more diabetes tech companies are working on providing solutions to ease the everyday struggle with the condition – from big tech companies, such as Google, Amazon, or Apple to small start-ups in incubators. And the diabetes community, one of the most active groups of people online, is also pushing for making disease management simpler, easier, and more efficient.

The best example of the persistence of the community is the #wearenotwaiting Twitter movement. The initiator of the community, Dana Lewis, and her husband built a so-called artificial pancreas at home and spread the blueprints and know-how on Twitter to other diabetes patients – without waiting for the approval of the FDA or any other agency. Why? Because they got tired and angry at Medtech companies for failing to solve their problems.

What is an artificial pancreas?

An artificial pancreas creates a closed-loop system constantly measuring the glucose level while communicating with an insulin pump to administer insulin and glucagon in the right amount at the right time automatically. This prevents serious complications like the dead-in-bed syndrome, where patients die in their sleep due to low blood glucose levels while asleep and their inability to correct it in time.

The blatant failure of medical hardware companies and regulatory bodies forced diabetic patients to take matters into their own hands. After all, theirs is a daily struggle where the stakes are life and death.

Dana had been using her own device for almost two years by the time the US Food and Drug Administration finally approved it in 2016. The openAPS system is currently used by almost 3 thousand patients.

Nevertheless, times are a-changing. In the past years, medical companies recognized the potential in connected health devices and started to go after building the artificial pancreas, while digital health start-ups introduced products for patients so that they can use digital patches and their smartphones instead of having to prick their finger for blood glucose monitoring, with a steadily growing user base. So, let’s see where diabetes tech stands at the moment and what we can expect in the next 5-10 years.

Continuous Glucose Monitoring takes the place of
finger pricks

Diabetes patients – no matter whether Type 1 (the body fails to produce insulin) or Type 2 (the organism cannot use insulin effectively) – need to check their blood glucose levels regularly, which may result in having to use a blood glucose meter up to 10 times a day. That means testing a drop of blood released through a needle prick of the finger up to 10 times a day. Does that sound like a troublesome, limiting necessity to you? Well, it definitely is that’s why so many have been making efforts to replace it.

The San Diego-based diabetes management superpower, DexCom, has been building continuous glucose sensing technologies since 1999. Its G6 system does not require finger pricks or a blood draw, and it was approved by the FDA in March 2018. Similarly to other continuous glucose monitoring systems, it allows diabetics to see their blood sugar throughout the day and night with a sensor inserted under the skin. The device can be connected with Apple Health, Garmin watches and Google Fit allowing users easier monitoring of their metrics.

The company also upgraded the Dexcom G7 as a result of collaboration with Alphabet’s Verily, the G7 system received the CE Mark in March 2022.

At first, Google tried and failed at building its own non-invasive technology for glucose monitoring: the smart contact lens. It seems that big tech companies learned their lessons: they need health industry players who have expertise in building safe devices and know how to work together with regulators.

Other companies lined up next to DexCom in manufacturing CGM devices, too. Abbott released a FreeStyle Libre wireless monitor, a new class of glucose monitoring devices that use “flash” technology. The user has to wear a sensor on the upper arm, which measures glucose in the body water known as “interstitial fluid”. In October 2018, Abbott received CE Mark clearance for the Freestyle Libre 2 device with Bluetooth and customisable alarms.

By now we can find studies proving how much artificial pancreas devices improve type-1 diabetes management in both kids and adults.

Are we close to non-diabetics wearing glucose monitoring sensors too?

Although “official” devices for continuous glucose monitoring may have come late to the party, they soon became a soaring business opportunity, their market size was valued at USD 5.25 billion in 2021, and is projected to reach USD 14.92 billion by 2030.

There is a budding debate on how much non-diabetic individuals would/could/should benefit from these CGM sensors. After all, temporary, but significant drops and peaks in blood sugar levels can have adverse effects in non-diabetic individuals as well. People have very different metabolisms, and their bodies can react in varied ways to the same nutrients.

While some medical professionals argue that healthy individuals could also benefit from continuously monitoring their blood sugar levels, others suggest that instead of paying monthly fees for such devices and services, people should rather learn about how their bodies react to certain foods and develop more balanced eating/snacking habits with the support of their general practitioners.

However, for diabetics, these achievements in available technology are life-changing. Tim Street, Founder of the Diabettech blog said that one of the most significant changes for him as a Type 1 diabetes patient in the last years was lower cost, continuous glucose recording, as it has provided an insight into living with the condition that isn’t achievable through blood testing – even very frequent blood testing – and drove him to change insulin delivery from MDI to a pump and then the adoption of the artificial pancreas. Now, we need to slow down a bit here and look around at what insulin pumps, artificial pancreas, or non-invasive products for blood glucose monitoring, such as digital skin patches can do.

Invasive or non-invasive: digital skin patches &
co.

A longer-term version of CGMs can already be put under the skin. The Eversense sensor continues to monitor your blood sugar every 5 minutes for 6 months after being implanted. The sensor works by generating a light signal in response to the amount of glucose in your interstitial fluid.

However, some people have aversions towards sensors practically implanted into their body – almost like an RFID chip, so many prefer non-invasive solutions. The FDA has cleared the POPS! one System for glucose testing on the go. The device is stuck to the back of a smartphone and includes a lancet, a sensor port that measures blood glucose and everything else you need to get results within about 30 seconds. Once testing is complete, the numbers are available for review on the accompanying smartphone app.

The UK-based company, Nemaura, offers a non-invasive solution with its SugarBEAT CGM. With favorable costs, it might be an attractive alternative for patients. In its early days, it wasn’t quite as accurate as CGM systems from Dexcom and other companies, but Nemura improved the device significantly in recent years and it was submitted to FDA for preliminary approval in January 2022.

Another skin patch developed at the University of Bath in England is able to suck glucose from the interstitial fluid in the skin and measure it without having to actually measure blood itself. And now, before we move on to the artificial pancreas front, we have to look around the latest innovations in insulin dosage management – as there won’t be any artificial pancreas without these technologies.

Insulin
pumps versus SmartPens

Insulin pumps are sophisticated devices that can be programmed to deliver predetermined rates of insulin over a full day and store data about usage patterns. These sometimes bulky, not exactly patient-friendly instruments have to be attached to the body. On the other hand, pens are affordable, lightweight and non-invasive. That’s why many diabetes patients go for insulin pens, although their downside is that traditionally they weren’t programmable and do not capture data.

That seems to be changing with the latest innovations. Smart pens like InPen and NovoPen connect via Bluetooth to a smartphone app that keeps track of insulin doses and timing. InPen by Companion Medical has been available in the U.S. for iOS users since December 2017. The device works exactly like a traditional insulin pen but has Bluetooth technology that connects to an easy-to-use smartphone app. It tracks each dose and delivers every piece of data to a smartphone app.

The NovoPens are also reusable connected insulin pens, able to store and download the last 800 shots (about 3 months’ worth) to another device, and their data connects with several diabetes monitoring systems to help better manage diabetes.

When
will the artificial pancreas appear in its full glory?

Finally, we arrived at the issue around the artificial pancreas. For building such a synthetic “organ”, we needed to get to know the latest innovations in continuous glucose monitoring as well as insulin pumps – as both are necessary to create a so-called “closed-loop”, automated system. In this scheme, a CGM constantly checks blood sugar levels, while the pump would use an algorithm to determine how much insulin the diabetes patient needs to lower the blood sugar to a target range or deliver glucagon (a hormone that releases sugar from the liver) to raise blood sugar. It would automatically deliver the correct dose to keep blood sugar steady day and night.

Manufacturers haven’t achieved a true closed-loop system yet, but they’re working at full speed on its completion and they are pretty close. The concept and realisation of the artificial pancreas are gaining momentum: its market is anticipated to reach $390.4 million by 2024, according to a new report by Grand View Research, Inc.

So far, the closest anyone could get beyond biohacking and the DIY pancreas is Medtronic with its MiniMed 670G system, the first hybrid closed-loop system. It continuously monitors blood sugar levels and automatically delivers insulin, but you still have to input the bolus insulin dose (the insulin type usually taken during meals) based on what you eat.

Beta Bionics is developing an iLet Bionic Pancreas System with insulin/glucagon, the feasibility study is about to end these days. Pivotal trial results are promising.

Thus, looking at the trends we expect a “real” artificial pancreas to hit the market within the next 5-10 years.

What
will the future bring? Can we cure diabetes?

As a truly forward-looking innovation, already on the path toward the “real” artificial pancreas, researchers at MIT developed a device that can keep pancreatic islets alive after being implanted into the body. In addition, collaborators from Cornell University, Novo Nordisk, and the University of Michigan Medical School developed their own implant that contains living pancreatic cells. These experiments may bring an organic replacement of failing organs in the future – either with gene therapies or new organs developed from stem cells.

From his part, Tim Street believes that “the future in this space is not only mechanical/technological. It is also biological, with the idea that glucose-responsive insulin that could be taken once a week could react to variation in the blood glucose levels and not require the use of CGM or a pump, but I’d suggest that’s ten years off. In the meantime, potentially better insulins may help enable technological systems to operate more effectively.” And what if we dream big and look to the far future? He also believes in the power of gene therapies: “in an ideal world, there would be no diabetes management, as there would no longer be type 1 diabetes. This will be driven by suppressing the immune response and gene therapies that allow those with the disease to be cured.” Well, we can only support this vision and hope that one day we arrive in a world without the everyday struggles of diabetes.

The post Where Does Diabetes Technology Stand In 2022? appeared first on The Medical Futurist.

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