With so many choices for insulin delivery out there these days, how do you know which one is right for you? Type 1 Coach Carla Cox (PhD, CDE, RD, FAAD, CPT) shares insights on some of the top options.
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“The pump that gets updated, not outdated” is appropriately Tandem’s marketing slogan for their X2 Insulin Pump.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Therefore, while you might be buying the latest and greatest pump on the market right now, it will likely be outdated within 18 months.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.
Fall has come with a flurry of new products, FDA approvals, and announcements from the major players in diabetes technology. Don’t miss out by checking out a quick recap of what matters:
1. Tandem Diabetes begins shipping the forward-thinking T:Slim X2
Thanks to an all-new bluetooth transmitter and its FDA-approved ability to add new features with software updates, the T:Slim X2 unifies and replaces Tandem Diabetes’ outgoing models, the T:Slim and T:Slim G4. (The T:Flex will remain as the primary option for users requiring higher doses of insulin).
While it currently closely resembles the outgoing T:Slim in form and function the T:Slim X2 will soon introduce (via free software update) the long-overdue ability to display data directly from the Dexcom G5 continuous glucose monitor (CGM). In addition to wirelessly receiving information from other devices like the G5, the T:Slim X2 can transmit data to other devices such as the iPhone. This two-way communication opens up the very likely possibility of smartphone apps to display information from (and possibly even control) insulin pumps and CGM’s.
Years down the road, the future-proof X2 platform will be able to incorporate “artificial pancreas” features such as predictive low glucose suspend and eventually fully autonomous closed loop systems.
Current owners of Tandem products can learn about upgrade options here.
2. FDA approves Medtronic 570G, the next step toward the Artificial Pancreas
The same month that the (underwhelming) 630G systems began shipping, the FDA surprised the diabetes community by approving the eagerly anticipated Medtronic 670G Hybrid Closed Loop system, including their next-generation CGM sensor.
The Medtronic 670G’s landmark feature is its SmartGuard HCL (Hybrid Closed Loop) technology, which automatically adjusts the pump’s insulin rate to target a blood sugar of 120. Much like a car with adaptive cruise control, the 670G will increase or decrease the basal rate of insulin delivery but will still require user intervention for notable events such as mealtime boluses. (We explore why this matters in a separate article.)
The 670G also comes with the updated design introduced in the 630G, and includes the new Guardian 3 sensor, featuring better accuracy and a 7 day wear period (up from 6 days).
Although Medtronic won’t ship the 670G until April 2016, the 670G’s FDA approval represents a pivotal step forward toward achieving the goal of a true Artificial Pancreas.
3. FDA Approves Abbott Freestyle Libre Pro System for Short-Term CGM Usage
Although the Abbott Freestyle Libre has been available for personal use in Europe for years, the hybrid-CGM comes stateside with limited functionality as a professional system (rather than for personal use). That means the Libre Pro System would be purchased by health care providers to be worn by their patients for a 14 day period. (This 14 day period improves upon the Medtronic iPro’s 4 day and Dexcom Professional’s 7 day period)
During that 14 day period, the patient will not have to do any calibrations, BUT they would also not have real-time access to their CGM readings. At the end of the period, the patient would review their CGM data with their provider to identify patterns.
While we’re still hoping that the FDA will eventually approve the version of the Freestyle Libre for long-term, personal use found in Europe, the Libre Pro System can still benefit patients in the USA whose insurance only covers short-term CGM trials. Also, the Freestyle Libre Pro System’s 14 day wear period and freedom from calibrations makes it an obvious upgrade over the Medtronic iPro.
4. Medtronic adds Android compatibility to Connect
The Connect is Medtronic’s answer to Dexcom’s Share, and comes in the form of a small dongle that helps transmit data to nearby smartphones. Also like the Dexcom’s smartphone connectivity, Medtronic had been limited to the Apple iPhone. Until now… With the release of MiniMed Connect in the Android Play Store, the Connect finally allows data from the 530G to be viewed from your smartphone, Apple or Android. (Dexcom plans to release a G5 app into the app store very soon).
Unfortunately, the Medtronic Connect platform is curiously not compatible with the aforementioned upcoming 670G and their current top-of-the-line 630G.
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.