Hype or Hope: Will the 3Cs of Diabetes Tech Revolutionize Care?

December 18, 2017

Diabetes technology is the new kid on the block when it comes to the management of type 1 and type 2 diabetes, but for most doctors and patients it's still an enigma, and only a small minority of people with diabetes in developed countries know anything about it or are actually using it.

In an attempt to demystify the topic, Adam Brown, head of diabetes technology and digital health at Close Concerns (a diabetes news and education website) and a type 1 diabetes patient himself, with 50,000+ hours of experience using a continuous glucose monitor (CGM), gave a fascinating and highly informative talk at the International Diabetes Federation (IDF) Congress 2017 recently, entitled: "Diabetes tools and apps: What's new, what works, and what do patients really want?"

Brown broke down existing technology into three categories that he believes are starting to show real promise, which he christened "the 3Cs" — CGM, coaching/remote care, and clever insulin delivery.

What people with diabetes really want, he said, is "better outcomes — time in range and HbA1c. They want to sleep better and have a happier life and mind-set."

Brown has written a book, Bright Spots & Landmines: The Diabetes Guide I Wish Someone Had Handed Me, which is available from diaTribe.org/BrightSpots as a free PDF or online for $6, which shares the food, mind-set, exercise, and sleep strategies he has personally learned over the many years of dealing with his diabetes.

"Many endocrinologists have told us they are giving the book to…patients in their clinic with diabetes," he told Medscape.

Patients also want diabetes to be much less of a burden, he stressed. And this is where technology can really help.

"Does the technology in question reduce this burden, in terms of time spent, hassle, and frustrating conversations? Great devices, apps, and tools will do all of this," he said.

For doctors, Brown has this message: "Technology is going to give you better data to make decisions, it's going to scale your impact because you'll be able to do more, and it's going to make your patients happier because they won't have to do things like take finger sticks."

"Technology is going to transform the lives of patients and providers and diabetes care. It has to, because there are not enough doctors and way too many patients for them and not enough time."

One Problem in Adopting Technology Has Been Lack of Data

In another talk at the IDF meeting, discussing "E-health solutions for diabetes: Hype or hope?" Cornelius J Tack, MD, PhD, of Radboud University Nijmegen, the Netherlands, said that approximately 250,000 medical apps exist, about 2500 of which are currently targeted at diabetes, as well as a myriad of other technologies.

But right now, "there is a remarkable lack of scientific evidence for effectiveness, which is mainly due to lack of research," he stressed.

Some advocates of technology argue that the field is changing so rapidly that research isn't feasible and that good products will be "self-selected" and will automatically make it to the market.

But Dr Tack said he believes that at least minimal demonstration of effectiveness of a product and in whom is urgently needed.

Brown acknowledged this, and in his talk showed examples of products from the three categories that are now starting to generate "published data that show they improve outcomes, so there is less burden."

"As a result, more payers are getting interested," he explained. "I think we are going to see more and more [products available] in each of those categories in the next few years."

CGM: Getting Better and Will Make Patients' and MDs' Lives Easier

Brown started off discussing CGM, which he said is "a fairly new technology, but it's really gotten better recently and has seen a lot of adoption in the past couple of years as the systems have improved."

The aim of the technology is to give patients more time in the correct blood glucose range, 24/7 glucose data, and fewer (or no) finger-stick tests.

CGM can be used by patients using insulin pumps or multiple daily injections.

"The value of CGM is that you have a value every 5 minutes, and you get these beautiful charts and graphs that say, 'Hey, you tend to be low overnight,' or 'You tend to be high after lunch,' and with that data, you can actually do something: change someone's insulin, change their oral medication dose, etc," he explained.

Doctors do well when they have data on how their patients are doing "because then they can make really informed decisions," he stressed.

"So CGM should make doctors lives' easier…especially once algorithms are layered on top…to tell the doctor exactly how to change the given therapy. It's really powerful to see the glucose data in real time and then make changes based on that."

For people on insulin using conventional blood glucose testing (finger-stick monitoring), they may be taking three or four finger sticks a day, "but how do you titrate this challenging and dangerous drug based on three data points, when every day is different?"

He added: "A lot of people say taking finger sticks is like taking pictures and CGM is like seeing diabetes in a movie, and I think that's a really good analogy."

However, penetration of CGM is currently miniscule: Brown estimates that less than 0.5% of the global population with type 1 or type 2 diabetes is actually using a CGM currently, meaning only approximately 0.7 to 1 million of 212 million people diagnosed with diabetes worldwide.

The main reasons, he says, are that CGM is "still expensive, it is getting reimbursement...but it simply takes a lot of time to change practice. And a lot of providers and patients just don't know about it."

And then there is the question of evidence to support its use.

Data on CGM Are Emerging, Getting Published

Brown said data showing good health and cost benefits for use of CGMs is now starting to emerge, for example in poster presentations at diabetes meetings.

Outcomes such as hospitalization for hypoglycemia/diabetic ketoacidosis and work absenteeism are being cut by up to 50% with use of CGM.

And "We're starting to see a mix of randomized clinical trials that take time to do but are published (DIAMOND and GOLD, showing benefit of CGM in those with type 1 diabetes injecting insulin; IMPACT; and REPLACE), and real-world data," he explained.

There are also some data on CGMs in type 2 diabetes.

He showed graphs indicating strong uptake of two newer CGM systems, the Dexcom G5 CGM (which now has $700 million worth of sales) and the Abbott FreeStyle Libre "flash" glucose monitoring system (sometimes called "intermittent" rather than "continuous" glucose monitoring), which now has more than 400,000 users worldwide.

And type 1 diabetes patients, at least, are raving about these specific devices on social media.

Source: Diatribe

Source: Diatribe

Dr Tack cautioned that this is a very small sample size, however.

"My impression is that this is a quite selected, North American, highly educated, group of people with type 1 diabetes, and a few in Europe," he told Medscape Medical News.

"I run a university clinic [in the Netherlands], so we have about 800 people with type 1 that we care for, and they are relatively highly educated. But hardly any one of them participates in this [talking about technology on social media] — it's a real niche."

Clever Insulin Dosing: The Next Big Thing?

Next Brown went on to discuss advances in insulin dosing, giving examples of some products currently helping with insulin-dose titration include Voluntis Insulia, Sanofi My Dose Coach, and Amalgam isage Rx.

Another very important category is new "smart" pens and needles, a number of which are in development. These will capture injection data and send this information to a cellphone, the cloud, or a healthcare-provider "dashboard."

Source: Diatribe

This field is currently led by the Companion Medical InPen, which has just been launched in the US.

And although most of these smart injection devices aren't currently widely available, they are likely to be much more widely used in the long run than the so-called "artificial pancreas" — a closed loop system with insulin pump and CGM — Brown told attendees.  

This is because many, many more diabetes patients worldwide use insulin pens rather than pumps.

But for some, automated insulin delivery is the holy grail. The only such product so far available is the Medtronic MiniMed 670G, launched in the US last year with over 20,000 users; it is slated for introduction in other countries next year.

Other tech and pharma companies have similar closed-loop, or so-called artificial pancreas, systems in development, including Tandem, Bigfoot, Insulet, Lilly, Diabeloop, Roche/Senseonics, and Beta Bionics.

Brown said what would really be informative is a head-to-head study of these new smart injection devices vs closed loop systems, once more of these are available. This is a possibility, as two companies, at least — Bigfoot/Abbott and Lilly/Dexcom — both plan to have a system in each category, he explained.

Coaching Apps and Remote Care: Can It Scale Up?

Finally, Brown discussed "coaching" apps such as Livongo, mySugr, and One Drop and programs incorporating remote or "virtual" care, such as the Virta Health "online clinic."

Although published data are starting to emerge for these products, as recently reported by Medscape Medical News, there are limitations, he says, such as the fact much of it is observational and often as not there is no control group.

Better studies, including randomized clinical trials, will help. But critical questions remain on many of these products — will they get reimbursed, for example?

There is some hope on the horizon on this score, Brown said — citing one example — a pilot trial of CGM and coaching planned in 10,000 type 2 diabetes patients, recently announced by Dexcom and UnitedHealth Group, which he called "unprecedented."

But many questions remain. Will these payer-based coaching setups have a better chance of reaching more people? How will the companies support the needs of the patients? And how does a Dexcom/UnitedHealth coach interact with the healthcare provider that a patient has traditionally seen? Brown wondered.

He also acknowledged there is "a big question on liability I don't know the answer to.

"What about when a company takes care of a patient through one of these remote care models? Who's accountable in that system, and who do I listen to — the company or my own healthcare provider? I don't know." 

Tack reports receipt of unrestricted grants from AZ, honoraria for lectures from Novo Nordisk, and participation in advisory boards for Novo Nordisk and Merck. Brown reports no relevant financial relationships.  

International Diabetes Federation (IDF) Congress 2017. December 5, 6, 2017; Abu Dhabi, United Arab Emirates. Abstract 213, Abstract 265

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