Monday, June 07, 2021

Should I Say Adios to Dexcom G7, Hello Abbott Freestyle Libre 2? Maybe.

Dexcom recently announced new features to be part of its new G7 CGM system which is anticipated to be available by late 2021 for most of the U.S.  Among the new features and supposed improvements will be a reduction in the sensor warm-up time from a lengthy 2 hours (on the G6) to just a half-hour (on the G7), and the company will also be making its sensors and transmitters all-in-one, with the automated inserter device handling regular replacements as the G6 does. Unlike the G6 which requires a separate transmitter,  the new G7 will contain everything. My guess is that will mean a big price increase to the device, and the added value seems less thrilling to me. 

I'd rather have my costs reduced. since I, like more than 55% of all Americans, have a high-deductible insurance plan which means they're forced to pay the bloated higher price for Dexcom's G7 sensors out-of-pocket, at least until mid-year when many usually satisfy the annual deductible. 

An interesting side-note from Dexcom's Q2 2021 Earnings Conference, in which Dexcom company executives revealed the following statement: "We've advanced pharmacy access in the U.S., where more than 70% of our commercial customers have a monthly out-of-pocket cost of less than $60 per month, and nearly 1/3 of our customers have 0 out-of-pocket costs for their G6 sensors. According to IQVIA, this is less than the comparable out-of-pocket cost for our nearest competitor." That said, 30% of customers are part of the other group, and it also excludes everyone covered under Medicare.

Although I won't have to make a decision until Dexcom actually discontinues the G6, I am now seriously considering a different CGM. 

I have been annoyed by repeated "Signal Loss" errors on my Dexcom G6, which is annoying and disruptive and due to no fault of my own. One CGM on my radar is the Abbott Freestyle Libre https://www.freestyle.abbott/us-en/home.html system, which I had not expected. Also, since the latest version of Dexcom G6 software came out, it repeatedly rejects my calibration attempts. I rely upon calibrations to keep the Dexcom readings accurate. The reality is I will always trust a fingerstick reading of actual plasma blood glucose more than a reading from a CGM which isn't a blood glucose reading, but a correlation to blood glucose based on molecules found in interstitial fluid. That's a proven scientific reality. 

Also, while the Dexcom G6 bulky insertion devices are assuredly easier than the old G5 inserters ever were, they add a ton of plastic and other shit into the waste disposal system, which is annoying. The other thing is the accuracy on the Dexcom G6 really sucks. It alerts me to impending lows which I love, but it seemingly never returns to normal readings after treating a low, it keeps alarming and alarming unless I calibrate the Dexcom app to force it to show a reading that accurately reflects a normalized fingerstick reading, effectively forcing it to do so, which sucks. Perhaps the next iteration will also slim the enormous medical waste of the inserter down, but I'm guessing Dexcom isn't even considering that in its decision-making.

I'm sort of in a state of suspension on the matter whether I wish to switch. Right now, I hope to try it soon so I can decide what I want to do headed into 2022.

The reality is with my current healthcare plan, whenever I pick-up my Dexcom G6 Sensors, my cost has steadily been $35 each month, which is well below the actual retail price of $350.00 for a package of three Dexcom G6 sensors sold at CVS. The reason is because apparently, my insurance plan, which was a relatively new plan, actually adopted the new IRS standards for diabetes supplies offering them at discounted prices prior to patients having satisfied the deductible rather than the bloated full cash retail prices. We as American taxpayers are paying the insurance company to do that, so its not insurance benevolence driving that move. 

I still can't believe that part. 

I was originally expecting the cost to be thousands, and thanks to a change by the U.S. Department of the Treasury and the IRS, its been MUCH less. I thank the IRS for reclassifying certain medical care services received and items purchased, including prescription drugs and a few medical devices for certain chronic conditions which are now be re-classified as "preventive care" for people living with chronic conditions. Diabetes (all types), asthma and depression were among the major chronic conditions which were recently added to that list, thereby making many diabetes treatments and supplies eligible for pre-deductible coverage which was announced in 2019. I blogged about that at http://blog.sstrumello.com/2019/09/in-2020-people-with-diabetes-may-wish.html, but I first called on Federal lawmakers to do it in 2018 http://blog.sstrumello.com/2018/11/we-need-get-insulin-added-to-national.html

Of course, no insurance company applied the new U.S. Treasury Department and IRS rule to any existing plans, only to new plans which were to employers sold since the IRS changed the rules. 

That may leave me in an enviable position to switch CGM's by choice rather than by economic necessity.

Right now, Dexcom has been losing in my opinion. The endless "Signal Loss" errors I experience on my Dexcom G6 are an efficacy failure and are endlessly irritating. Maybe the G7 will fix that and maybe it won't. But the software also often rejects my calibration efforts even though the Dexcom readings are  >75 mg/dL off. I cannot help but wonder if I'd be better off with a rival CGM instead. I'm seriously looking at Abbott Freestyle Libre due to my growing dissatisfaction with the accuracy of Dexcom G6.

Technically, although the Abbott Freestyle Libre 2 (and the Libre 14-Day system which works with smartphones) is often referred to as a CGM, it is in fact a "flash glucose monitoring system" as it relies upon the user to scan the sensor in order to receive the glucose readings stored in the sensor. The difference between a "flash glucose monitoring system" and a true CGM are 3 key (but relevant) features which are 'missing' when using the Libre sensor as-is:

  1. Alarms - crucial to many wearers and their caregivers to alert them to lows (and highs) -- many users consider the alarms to be a CGM requirement;
  2. The ability to share patient glucose reading info with another person/caregiver, for similar reasons as the alarms;
  3. Continuity of seeing readings - without a need to scan for them

The absence of these key features enables Abbott to sell a device which is a lot less costly than more traditional CGM devices because there's no transmitter, receiver, or smartphone software application or the costly clinical trials needed to prove their validity. In fact, Abbott's Libre 2 sensors sell for about a third less than Dexcom's (or Medtronic's) sensors do. Abbott claims the Freestyle Libre system is priced at 70% below the list price of other CGM systems. But the company released trial data on its Freestyle Libre 3 sensor, and promises that its new product will offer full-CGM functionality because it will no longer require any sensor scanning to provide real-time glucose readings. The new Libre 3 will generate real-time glucose readings each minute, displaying that result on the compatible mobile app on iPhone or Android. This continuous stream of data allows optional alerts for high and low blood sugars, along with glucose results. This is a big leap forward compared to Libre 2 that still requires a confirmation scan to get a numeric reading, and doesn’t offer any alerts. Like Dexcom, Abbott boasts about the size reduction for the Libre 3 which will smaller and thinner, about the thickness of just two pennies (rather than two stacked quarters in earlier versions). Per Abbott, that is a more than 70% size reduction that uses 41% less plastic. We don't know for certain, but after delays due to COVID-19, it is believed we should expect a launch date for the product sometime later in 2021 or early 2022. This revision will make the Abbott Freestyle Libre a more direct competitor to Dexcom.

Medtronic also has its Guardian Connect CGM system https://www.medtronicdiabetes.com/products/guardian-connect-continuous-glucose-monitoring-system which is primarily used by Medtronic insulin pump users (not all, but many). It has started selling a standalone Guardian Connect System to work with its smart insulin pen known as InPen (see the Medtronic sight at https://www.medtronicdiabetes.com/products/inpen-smart-insulin-pen-system) since the company acquired Companion Medical Systems of San Diego a few years ago.

The other major CGM is Senseonics' https://www.senseonics.com/ Eversense https://www.eversensediabetes.com/ CGM system. However, technologically, the Senseonics CGM sensors require a doctor's insertion into the patients' arms, and are therefore even longer-lasting than all of the self-inserted varieties are. It is therefore more costly because of the doctor-required insertion and it lasts like six months, although loyal patients believe the underlying Eversense sensor technology provides much more accurate CGM readings and they like the freedom of being able to disconnect and reconnect as frequently as they desire. My own endo has never inserted one before, so that makes me less thrilled since it requires me as a patient to get a Senseonics instructor to come to the doctor's office, using ME as the guinea pig teaching her how to do it. Scheduling that is a hassle, and the cost-savings seems sketchy at best.

On the Freestyle Libre 2 model, Abbott (as a company) was able to skip the additional clinical trials and associated equipment and software (along with a host of different operating system versions and the problems associated with all of those) which are an added layer of complexity which requires additional testing and FDA regulatory approval. Instead, its system enables tech firms to do the work on genuine CGM functionality. Its not perfect, but the model has worked well for the company. It means Freestyle Libre sensors are considerably cheaper than those from Medtronic and Dexcom. That, combined with 2-week usage enables a genuine pricing differential. Meanwhile, the Senseonics Eversense sensor is a slightly different variety (technically, some human clinical trials conducted in Europe revealed that the Senseonics Eversense CGM sensors could work reliably for a year or longer, but that's a terrible business model, hence we can expect them to require more frequent sensor changes to pad the company's bottom line). Senseonics had a near-death experience until the glucose monitoring company Ascensia rescued it with a cash infusion last year, so some decisions are now driven by the bottom line.

NFC Enables Abbott Freestyle Libre to Be a True CGM (If It Wants)

It's not that Abbott's Freestyle Libre 2 is incapable of being a true CGM. Specifically, the Freestyle Libre sensors emits what's called NFC (Near Field Communications) signal of readings which enable genuine CGM functionality. The company has said that its next generation system (the Freestyle Libre 3 model) will include transmitters that many American patients have come to expect from a CGM. In the meantime, Abbott is selling its Libre 2 sensors in the U.S. for about $75.00 per sensor. They are sold in packages of two at retail pharmacies across the country (a box of 2 sensors sells for $150.00/box), although patients satisfying deductibles can get GoodRx coupons to buy them for about $65.00/sensor or about $116.00 for a box of 2 sensors. Cost-wise, it is cheaper than rival most other CGM's are.

In fact, Abbott as a company seemed content with its commanding global lead in sensor sales in Europe and elsewhere in the world. The reality is that as a company, Abbott is a LOT bigger than rival Dexcom is in terms of global sensor sales. Its production of those sensors is done on a mass-market scale, further enhancing the company's low-cost differential. Some worry the transmitter model might mess up the company's cost differential in an upwards direction, but its currently just speculation, because Dexcom's new model will be an all-in-one sensor and transmitter, hence making it easier but also even more expensive than that is now. That means Abbott's Freestyle Libre may yet be even less costly given Dexcom's decision which will inevitably bloat the price tag. But I question whether Dexcom is worth the premium price. More on that in a minute.

The Freestyle Libre 2 sensor never required calibration or warm-up so its fast (though some users say their readings on the first and/or last day are suspect, which is a similar issue on other CGM's), while a true CGM may need the user to calibrate it by carrying out a finger stick test, to ensure the levels it gives are 'accurate'. In fact, newer generation CGM are trying to eliminate the calibration requirements (Dexcom G6 often rejects my calibrations, which I used to keep the readings accurate), but the reality is most sensors' accuracy simply isn't good enough to enable that. My personal perspective is that Dexcom's G6 sensors are NOT terribly accurate, often being off by more than 50 mg/dL or more on the very first reading, so I think there's a lot of room for more precision. When it comes to accuracy, Dexcom isn't great. Call me less-than impressed with Dexcom's sensor readings.

Anyway, Abbott's strategic decision to avoid the U.S. market while it was establishing itself as a global sensor leader around the world means in the U.S., its currently an also-ran. The company now uses its lower-cost differential, yet many patients remain unpersuaded. I understand it. But if you're dealing with costs, there are some convenient accessory devices which read the Abbott Freestyle Libre NFC (Near Field Communications) and solve a huge issue many believe to be its biggest deficit, a lack of alarms and share function with caregivers.

Add-On Transmitters Turns Libre 2 into CGM Now. Beware: FDA Approval Not Required. But Bigfoot Unity (and Soon Its Pumps) Has FDA Approval. 

In addition to the Abbott decision to dominate the rest of the world, even today, Abbott's Freestyle Libre 2 DOES in fact have the ability to work right now as a genuine CGM by using add-on devices and software. There are a handful of such add-on transmitter packages on the market. Some operate primarily in Europe, where Abbott's Freestyle Libre 2 dominates the "CGM" market already. Most are from scrappy startups with a handful of smart techies. That enables them to keep their products affordable, although they often lack a customer service infrastructure which sometimes can leave leaves users frustrated that the apps aren't working on whatever operating system iteration the patient is using. That's attributed to technology in general and is less a function of the companies which develop it. Also  Beware of the downside, which is that its products are add-ons and are not required to get FDA approval, so if they do not work, the company has no obligation to help. Abbott plays no role in these add-ons other than its product emits NFC signals which are open to others to work on.

Bigfoot Unity: SmartPen Cap + Freestyle Libre 2 Transmitter All In-One

There are a handful of these add-ons around the world, but since I'm in the U.S., my main concern is the U.S. and Canada. The Libre 2's NFC (Near Field Communications) signal is openly accessible to be read by other devices and software. Bigfoot Biomedical's "smart" insulin pens dubbed Unity https://www.bigfootbiomedical.com/bigfoot-unity will do just that. But Bigfoot is currently not working directly with patients, but with medical practices, which might be a unique model, but means hardly anyone in the U.S. has a Bigfoot Unity pen cap, and that model is largely inaccessible, leaving patients like myself to turn to rival Companion Medical Systems, which is now in Medtronic Diabetes' stable of products. Their insulin pens are attractive and they work pretty well although many insurance companies refuse to cover the insulin pen cartridges leaving it out of reach for many. Bigfoot's Unity pen cap system is much less bulky and has a lot more features, most notably the ability to turn the Freestyle Libre 2 system into a true CGM. In effect, the presence of a Unity smart pen cap to read the Libre's NFC signal turns the Libre 2 into a true CGM. Bigfoot also plans to do the same for its insulin pumps (now in development), but those systems are not yet FDA approved. 

I'm personally very annoyed by Bigfoot's shitty distribution model for Unity. If you're a patient who would like to use Unity, but don't have an endo (such as one part of a large group practice) who's not a subscriber to the Bigfoot Clinic Hub, the product is out-of-reach. It is sold as a subscription to doctor's practices, who are then supposed to charge their patients for it. It means the Unity system is virtually unavailable except for those whose doctors' subscribe and offer it to their patients, and the handful of practices they have teamed up with seem to in the immediate area of the company's Milpitas California headquarters (also in the South Bay area bordering on Silicon Valley, but also bordering on the East Bay near Fremont) right now. As I said, many endos are now part of group practices owned by hospital chains. They cannot simply subscribe to Bigfoot Clinic Hub even if their patients want it because the decision is out of their hands. I likely will not be among Bigfoot's clients unless it changes its marketing model. Its an annoying business model and I kind of question whether they're really serious about selling the product with a business model that leaves many thousands of patients completely out-of-reach. Bigfoot Unity could reach many more with a more traditional model of targeting insurance companies directly, but they will instead merchandise themselves at the ADA Scientific Sessions hoping to sign up doctors at events like that instead of working with insurance companies. Its anyone's guess whether it will be successful, but I suspect it will not be, although it will help the company to establish relationships with endocrinologists and CDE's which it envisions will be necessary to compete in the insulin pump space when its device is finally approved.

MiaoMiao Transmitter and Its Tomato Smartphone Software

Aside from Bigfoot, a lesser-known company also sells add-on Freestyle Libre 2 transmitters. One is from a Toronto-based startup named MiaoMiao https://miaomiao.cool/ (whose app is called Tomato http://tomato.cool/, which is available to download on both the Google Play [Android] store and Apple's iOS App store). I have no experience with the MiaoMiao or its Tomato software, but as I understand it, it is software is liked by users, which means that even though its transmitter add-on appears a not to fit in a way that's more likely to work pretty flawlessly, I believe its design enables it to work better with Bluetooth connectivity compared to other designs if online reviews are to be believed. Other companies' transmitters are also capable of working with the Tomato smartphone software which is a plus. However, another option is to simply use the MiaoMiao transmitter hardware and use software from yet aother firm which calls its software Spike https://spike-app.com/. Because these products (transmitters and software) are legally considered add-ons to the FDA-approved Abbott Freestyle Libre sensor, they are therefore not legally required to get FDA approval, so if they do not work, beware that Abbott has no obligation to help and you can't report it to the FDA. That said, users can use MiaoMiao's Tomato or Spike's software with MiaoMiao's add-on Libre transmitter (another add-on which bypasses FDA). A number of users praise this company's software (though others like Spike better) and it remains a popular option on the global market to turn Freestyle Libre's existing products into genuine CGM's.

Ambrosia Systems BluCon Transmitter

Another of the add-on transmitter devices for Freestyle Libre 2 are the relatively inexpensive (about $150 for a waterproof model, but this one appears to enable the batteries to reportedly be changed by the patient, so I think its often a one-time expense, unless the transmitter dies) which is from a Newark, CA (which is located in the San Francisco Bay Area's East Bay region, although the company was originally based in the Silicon Valley town of Sunnyvale) known as Ambrosia Systems, Inc. https://www.ambrosiasys.com/ whose add-on transmitter and software package is called BluCon. The company offers different varieties of transmitters, including a slightly cheaper non-waterproof model, but I think the difference in price between that and the waterproof model is comparatively small.

BluCon is a BLE (Bluetooth Low Energy) electronic transmitter which also works with smartphone software developed by Ambrosia Systems. Bluetooth can be a bit messy from my perspective and that's a key reason why Bigfoot's Unity product is so impressive in my opinion, because it links so many different pieces together in spite of a limit of a single bluetooth connection to exist. Still, I admire the way the Ambrosia's reader physically attaches to the Abbott Freestyle Libre's sensor as well as it appears to (though some users say the size is quite large), the fact that the company is based in the United States, and its apps appear functional (at least on Apple iOS devices; so many apps fail on the Android side because there are too many operating system iterations which exist and phone hardware makers can choose whichever version they want, making Android devices a much more challenging nut for them to crack effectively). That also bedevils far too many reputable medical device-makers including Dexcom. 

Ambrosia's BluCon offers software which works on different smartphone operating systems software enabling the product to receive and share the Freestyle Libre readings data with another app giving caregivers access to receive Libre readings and they are available right now. Beware of the downside, which is that its products are add-ons and are not required to even seek FDA approval, so if they do not work, the company has no obligation to help. I cannot speak from experience with Ambrosia, but it has several positive things going for it, including most notably it's here and it exists now, it's comparatively inexpensive, and it is from a domestic supplier. The downside is its from a small startup with few employees and similar to MiaoMiao, it bypasses the FDA completely. A biggest downside is that its products are add-ons and are not required to get FDA approval, so if they do not work, the company [nor Abbott which makes the underlying sensors] has no obligation to help and you can't report it to the FDA.

Bubble Smart Reader

A third option for Freestyle Libre 2 is known as the Bubble Smart Reader https://www.bubblesmartreader.com/. I cannot really tell where this firm is even based. It could be in a former Soviet republic for all I know, although some Europeans seem to like it. I am less enamored with a company which I cannot even identify a headquarters location for and whose website has a few obvious English language errors. Remember: Americans are not even the target market for their work, so the company really does not care, but the important thing is for users to know that the company exists and it remains yet another option if they are underwhelmed with the others.

Conclusion

In the end, I'm getting sick of Dexcom and its product and being considered a market tied to Dexcom itself. I feel as if the company's initial focus on patients has declined, and the company now takes its T1D patients for granted as it pushes for events to drive its share price up, targets the T2D universe to generate more sales. While its retail model has made getting the product to consumers vastly easier for patients, but its basic product has really not improved much. The new G7 model will make some modest changes, along with reducing the number of SKU's needed for the company to commercialize the product, which is less of a patient benefit and more about making distribution to retail pharmacies even easier for the company itself. That should theoretically result in lower prices, but because it combines sensor and transmitter functions into a single item, patients can basically count on higher prices. That means Dexcom views patients as little more than a revenue source. Is that really worth a slightly shorter warm-up? That depends on if it fixes the countless problems I've experienced over the past few years with countless "Signal Loss" and calibrations repeatedly being rejected. Sorry, but I trust fingerstick readings much more than I do CGM interstitial fluid correlations. If Dexcom manages to fix those problems, I'll be pleased. 

Still, these things have me seriously considering alternatives to Dexcom. And Abbott's Freestyle Libre 2 is one of them I'm really considering because of its simplicity and add-on functionality (not to mention the fact that its sensors are priced about 30% less than Dexcom's are). Then again, the Libre 3 model could be commercialized before too long. Watch this space.

2 comments:

Unknown said...

You worry here that the G7 will cost more than the G6, and list this as one of the factors leading you to consider switching to Abbot. But a number of articles, going back to 2018 and continuing on to this month, have indicated that Dexcom is signaling that the G7 will be cheaper than the G6, due to a combination of lower manufacturing costs and a simpler, more scalable direct retail model:
https://diatribe.org/whats-coming-dexcom-2020-low-cost-slimmer-fully-disposable-cgm
https://asweetlife.org/the-dexcom-interview-part-2-introducing-the-dexcom-g7/
https://www.medtechdive.com/news/dexcom-shares-clinical-data-on-g7-cgm-ahead-of-next-gen-showdown-with-abbot/601280/

Scott S said...

The only conclusion which can be reached is the product is expected to be approved and commercialized. Even presuming Dexcom drops its price (which is highly suspicious for a public company which is now combining both a sensor AND a transmitter into a single-use item since it will serve two functions previously addressed by products sold separately in the G6 model), Dexcom products still currently command a price premium of at least 30% over Abbott. The pricing differential which is expected to remain with Abbott's newer sensor, which will also have full alarms and transmitters much like Dexcom G6 does today. Only time will tell, but its still looking as if Dexcom will remain the higher-priced product.