The conclusion of this debate will be that it comes down to personal choice, but Dr. Edelman will be battling it out with Dr. Irl, his type 1 brother. Expect a lively exchange of information on the pros and cons for each form of therapy. It is important to know this is a real debate that will make you think about your choices for how to control your type 1.
If you are new to a pump or want to hear about new pump options, this is where you need to be. We will talk about the advantages of pump therapy and most importantly how to get the right pump for you. We will also touch on how much (if anything) can a pump be expected to lower your A1c and what a pump can do in regards to helping you with hypos.
By David Ahn, MD
In late August, the FDA approved Tandem Diabetes’ long-awaited first software update for their X2 Insulin Pump that enables Dexcom G5 integration. With a FREE simple software update performed in the comfort of their own home, thousands of X2 users can now display CGM data (from the Dexcom G5 Mobile System) directly on their Tandem pump screen.
In the world of smartphone apps and hybrid closed loops, viewing CGM data on a pump screen might not appear at first glance to be groundbreaking, but Tandem’s software update will provide meaningful benefits not only for Tandem customers, but for the entire industry of people affected by diabetes.
First time a software update has added a new feature to an insulin pump
“The pump that gets updated, not outdated” is appropriately Tandem’s marketing slogan for their X2 Insulin Pump. A longstanding frustration for pump owners has been that insurance companies will not replace or upgrade most insulin pump hardware until the 4 year warranty period expires.
Therefore, while you might be buying the latest and greatest pump on the market right now, it will likely be outdated within 18 months. By the time your 4 year warranty period expires, you might be two or three generations behind. And as we draw nearer to a fully closed-loop artificial pancreas, those two or three generations might make a huge difference.
However, Tandem’s X2 platform has been built with the future in mind. People who received the very first X2 pumps nearly one year ago now have the same new Dexcom G5 integration available in the latest version shipping today with a simple convenient software update. Adding completely new features via software update has never been done in an insulin pump before.
Tandem X2 is now the only pump that integrates with Dexcom G5
Dexcom integration with Tandem pumps might seem like old news because their T:Slim G4 pump (released in September 2015) similarly displayed CGM data from the Dexcom G4. However, the T:Slim G4 did not include the advanced software 505 algorithm, leading to less accurate readings than on a later Dexcom G4 or G5 model. Second, the T:Slim G4’s lack of bluetooth functionality prevented integration with the Dexcom G5 and its popular ability to transmit CGM data directly to smartphones.
Therefore, prior to this G5 software update, Tandem and Dexcom customers were stuck with a dilemma: purchase the older T:Slim G4 and forego the amazing smartphone feature OR go with an X2 and forego the ability to view CGM data on the pump. With the new G5 software update, this dilemma is solved and the X2 is the only pump that directly integrates with the Dexcom G5. (The Animas OneTouch Vibe Plus was planning to integrate with the G5 but Johnson and Johnson decided to exit the pump market).
Dexcom G5 integration is a godsend for many Android users
While G5 owners with iPhones have long enjoyed the luxury of viewing their CGM data on their phone or Apple Watch, Android users have only been recently granted access. And only Android users that use certain models. For example, owners of the highly-rated Google Pixel smartphone or other non-Samsung Android phones will not find the Dexcom app in their App Store. (Workarounds do exist, but are at your own risk).
Therefore, insulin pump users that own Android phones not supported by Dexcom would previously have to resort to carrying around their insulin pump controller AND their Dexcom receiver. Not fun.
With the latest software update, X2 owners can leave their Dexcom receiver at home AND take advantage of the advanced software algorithm and smartphone-sharing capabilities of the G5 Mobile.
The update points toward even better upgrades in the future
Tandem has already begun the pivotal study for their next significant software update, PLGS (predictive low glucose suspend). PLGS will allow the X2 pump to automatically suspend insulin delivery when its advanced software algorithm predicts that the blood sugar will sink below <80 mg/dL in the next 30 minutes, significantly reducing dangerous hypoglycemia. This feature also aims to reduce hyperglycemia as users will be less fearful of low blood sugars limiting proper bolusing.
Tandem Diabetes has indicated that the PLGS software update will apply to the current X2 pump, so all existing X2 owners will be able to add that feature when the company hopes it will be released in Summer of 2018. (Unlike the free G5 software update, the PLGS software update might require a one-time cost).
Conclusion: Pump competition is good for consumers
Unfortunately, the pump market is currently getting smaller with the exits of Asante, Roche, and Animas in the past several years. No matter which remaining pump company you find yourself rooting for, having options when it comes to insulin pumps is important for several reasons.
First, competition breeds innovation. In the smartphone market, if it weren’t for Google and Samsung, Apple would have very little reason to continue adding new features to the iPhone year after year. In fact, many features such as the “Plus” form factor and the rapid evolution of voice assistants such as “Ok Google,” Alexa, and Siri are likely a direct result of competition in the market.
In the insulin pump market, Medtronic pumps looked largely the same and only added minimal new features until other players in the market came along.
Second, competition brings down costs. The cost of living with Diabetes is already ridiculous as it is, the last thing we need is for a single company to monopolize the pump market. In fact, Tandem Diabetes is offering all owners of their previous T:Slim pump an upgrade pathway, costing $399-$799, which is dramatically lower than Medtronic’s upgrade cost of either $599 or $3100.
Lastly and most importantly, competition brings choice. People with diabetes aren’t all alike and their needs might change over time. When starting a new patient on a pump, I like to present the wide variety of pumps on the market, each with their own strengths and weaknesses. Medtronic has the only hybrid closed loop on the market; Insulet’s Omnipod is the only tubeless patch pump available; Tandem’s X2 has the only touchscreen pump.
With Tandem’s X2 ability to add new features via software update, patients have an option that will remain up-to-date over the next few years.
The pain of insulin injections is well-documented, and the diabetes community is always searching for better alternatives. One such promising technology is the long-awaited OneTouch Via, an insulin patch pump from Johnson & Johnson subsidiary Calibra Medical.
Designed for both Type 1 and Type 2 diabetes, the OneTouch Via is a very small (2 x 1 x 0.25 inches) patch pump that stores up to 200 units of prandial (aka fast-acting) insulin, which can be delivered by discretely pressing two mechanical buttons on both sides of the pump. It can be worn for up to 3 days, and would be used in combination with basal (or long-acting) insulin.
A replacement for Multiple Daily Injections
Both doctors and patients dread starting multiple daily insulin injections (aka MDI). It means more painful pokes, more potential for public embarrassment, and more opportunities to forget a dose of insulin. Thanks to new classes of non-insulin therapies (eg Victoza, Trulicity, Invokana, etc), starting mealtime insulin can often be prevented or delayed, but millions of people with Type 2 diabetes (and all with Type 1) will still require MDI.
Mealtime insulin usually requires carrying around insulin injection supplies (insulin pens and needles or vials and syringes) and injecting before meals, which can be embarrassing and/or cumbersome. Traditional insulin pumps present their own challenges, as most have long tubing and complicated electronic interfaces that are not user-friendly.
Similar to the V-Go from Valeritas, the OneTouch Via is an entirely mechanical, tubeless, and disposable patch pump. There is no screen or complicated electronics, which keeps costs down, and makes for an easy-to-use interface. The user just presses two buttons down at the same time to deliver mealtime insulin, in 2 unit increments. This can be done through clothing, so a user could easily and discretely take 12 units (as an example) with six button presses done through their fabric.
Another advantage for both types of diabetes is that the OneTouch Via allows users to easily take additional boluses, for small snacks or hyperglycemic episodes that would otherwise require a new injection.
In study data shared at the 2016 American Diabetes Association Meeting, users wearing the OneTouch Via reported injecting mealtime insulin 50% more often than they had previously done with pen or vial, and 88% of them reported that they worried less about forgetting insulin injections.
Unlike the V-Go, the Via can be worn for 3 days and stores up to 200 units (the V-Go stores only 36units and must be changed every day). Also unlike the V-Go, the Via only replaces mealtime insulin and should be used in conjunction with basal (long-acting) insulin.
The Rocky Road Ahead
As the marketing efforts for inhaled insulin and the Valeritas V-Go have shown, replacing mealtime insulin injections in market and mindshare isn’t as easy as one would expect.
While 75% and 100% of providers in the previously mentioned study preferred the Via over insulin pens and insulin syringes respectively, providers in the community can be slower to adopt and more wary of newer technologies.
Also, adhesive patches and wearable devices are not the ideal solutions for all people. Patients can develop skin reactions to the adhesive or feel burdened when a device is stuck to their body, no matter how small.
Perhaps in light of these concerns, the OneTouch Via had been previously slated for release in early 2017, but now might face delays in light of JnJ’s recent intentions to explore the sale of their diabetes division.
The diabetes community has been set ablaze after UnitedHealthcare announced an agreement for Medtronic devices to be the “preferred” in-network, durable medical equipment (DME) provider of insulin pumps. Starting July 1, 2016, UnitedHealthcare patients will be funneled toward using a Medtronic insulin pump instead of offerings from manufacturers like Tandem and Animas.
Many diabetes advocates have eloquently voiced their outrage and have been rallying under the hashtags #MyPumpMyChoice and #AccessMatters, and I strongly echo their sentiment that this policy puts “profits before patients”. It’s unacceptable, and both UnitedHealthcare and Medtronic deserve any negative publicity that results from such a short-sighted decision.
To add another layer to the discussion, though, what I find particularly insightful about the controversy is that it highlights the distinction between medication and medical technology. I rarely blink an eye when my patient has to switch brands of insulin, so why is it such a big deal when they have to switch brands of insulin pumps?
Technology is Intensely Personal
Whether it’s Apple vs Samsung, Xbox vs Playstation, Nikon vs Canon, or BMW vs Mercedes, fierce loyalties are found among their users. Beautiful photos of phones and smartwatches adorn billboards across the city, evoking emotions such as envy and desire in a way that no medication can.
When buying a new device, there’s a curious sense of satisfaction when finally choosing a model after poring over reviews and comparing individual specifications. Making that choice creates a personal connection before it even arrives in your hands.
On a personal level, many of my most touching diabetes patient interactions are due to technology. A recently-emigrated woman came to my office and was overjoyed to find that she could obtain an Omnipod pump, as it hadn’t been allowed by her previous nationalized health system. Additionally, I love watching the eyes light up in patients and their family members when they first learn about continuous glucose monitoring (CGM) and the ability to view their blood sugars on their phone.
In diabetes, harnessing technology to manage a chronic condition brings a sense of empowerment that medications alone can never do. Removing the ability to choose medical devices only adds to the sense of helplessness that underlies too many other aspects of diabetes.
Technology is Defined by Interaction
For medications, pharmaceutical companies create chemical compounds that elicit a desired physiologic effect. Their competition will create a slightly different chemical compound with a similar mechanism of action, and these medications are grouped into the same class (eg Humalog and Novolog insulin). For the most part, they are interchangeable to patients and providers, and insurances frequently prefer one over the other. No big deal — just swap out one pill (or pen/vial) for another.
But for devices, focusing on the desired outcome only tells a portion of the picture. For reference, choosing a smartphone is about more than making phone calls and browsing the web. As Apple’s success has shown, the overall user experience of gadgets often matters more than functionality. The iPhone was not the first smartphone (remember Blackberry?), but its intuitive and simple user experience expanded the smartphone audience from working professionals to college students, children, the elderly, and everybody in between.
When using an unfamiliar smartphone or computer operating system, even a simple task like sharing a photo can seem Herculean. With health technology, the stakes are exponentially higher as potentially lethal medications must be managed by complex user interactions with software dashboards and calculators. Being forced to switch between differing interfaces of insulin pumps and other diabetes technology creates confusion/frustration at best, and gaps in diabetes management at worst.
Put simply, there are no “class-equivalents” in the world of devices because they encompass a complex interplay between software and hardware. A Medtronic Pump is as similar to a Tandem Pump as a Blackberry (they still exist!) is to an iPhone.
Competition breeds innovation
To be clear, the outrage isn’t regarding the quality of Medtronic’s insulin pumps, or whether they are inferior or superior to the competition. Rather, the issue is that eliminating competition and choice in the insulin pump market stifles creativity and innovation.
We live in such an exciting time for diabetes technology. For insulin pumps alone, there are touch-screen pumps (Tandem), tubeless patch pumps (Omnipod), color screens (Tandem, Omnipod, and Animas), and cartridge-based pumps (Asante). Each of these features are appealing to different types of users. It’s not one size fits all.
Evidenced by Tandem’s 20% decline in stock after the UnitedHealthcare announcement, it’s hard to believe that such product diversity would exist in a world where insurance companies anoint a winner. Would Android and iPhones have come as far as they have if wireless carriers “preferred” Apple and required a prior authorization for any Android phone?
In the above timeline, notice that Medtronic Insulin Pumps did not noticeably upgrade their user interface for over 10 years… until after the 2012 release of the Tandem T: Slim. Now, the upcoming Medtronic 640G incorporates a dramatic redesign that seems to take some design cues from its competition. Had the Tandem never come to market, I suspect that the next Medtronic would look similar to the previous generations.
Deeper implications beyond diabetes
The digital health revolution is underway, and the future of health technology includes fascinating devices like wearable (or even implantable!) sensors and novel drug-delivery mechanisms, affecting specialties from psychiatry to pain management.
I’ve often beaten the drum that diabetes technology has been a harbinger of the future of health technology (continuous glucose monitors preceded the current infatuation with wearable sensors by about 10 years), and this week’s news suggests a bleak future where established, larger device manufacturers can outmaneuver innovative disruption by strategically partnering with insurance companies.
Free markets and capitalism have been serving the best interests of technology consumers for decades, and such interference by insurers would negatively impact health devices in all areas of medicine.
Call to Action
So what should we do? Make your voice heard, and raise awareness of the issue by sharing posts like this on Facebook and Twitter. Reach out to the pump manufacturers, tell your doctor, and vocalize your displeasure to the insurance companies. DiabetesMine has compiled a helpful list of action points here and will continue to cover the issue as it develops along with other advocacy sites like Diatribe.
As the world of glucose meters have shown, it might be a UnitedHealthcare-Medtronic partnership now, but what’s to prevent UnitedHealthcare from switching to a different pump manufacturer when their current agreement expires?
That’s why we must act now and make it clear that we will not take it lightly when insurance companies try to dictate which medical devices we use and prescribe.