Diabetes Tech: Moving into the Future

2020 has brought long-awaited changes to my life with diabetes. I am using my second Dexcom G6 sensor and so far it has been fabulous. Of course there is something quite pitiful that a diabetes device is the coolest thing in my life and I am not bragging about a new Tesla or Coach purse. But that’s life with a chronic disease….

Those of us on Medicare are late to the G6 game and you can find tons of reviews online and don’t need a review from me. But I will quickly say that the insertions have been painless and I am seeing more consistent accuracy with G6 than I ever saw with G5. (And I considered G5 to be very good.) Here is an image from Day 9 of my first sensor.

I am thrilled with not having to calibrate the sensor. One, it is not required for accuracy in most cases. Two, it eliminates the constant calibration notifications on my phone, watch, and pump. I calibrated the first sensor twice. On Day 6 it was reading super low in the 50’s when my BG was 110. A calibration quickly brought it back in line without the delays or rebounds common with G5. But the next day all of a sudden the sensor was reading too high and I had to do a reverse calibration of the previous day. The two calibrations essentially cancelled each other out and I wonder if I shouldn’t have done the first one. To be determined as I gain more experience….

If my first two sensors are a valid test, I can say without doubt that Dexcom G6 is an improvement over G5. But the biggest change in my diabetes tech life is….

Basal IQ.

As described on the Tandem Diabetes provider website: “Basal-IQ technology uses a simple linear regression algorithm that uses Dexcom G6 CGM values to predict glucose levels 30 minutes ahead based on 3 of the last 4 consecutive CGM readings. If the glucose level is predicted to be less than 80 mg/dL, or if a CGM reading falls below 70 mg/dL, insulin delivery is suspended. Insulin delivery resumes as soon as sensor glucose values begin to rise.”

For many years I used temporary basal rates of zero to head off lows. But frankly although it was a helpful technique, it didn’t always work great. The insulin suspension took too long to work and often resulted in highs later on. The difference between my attempts at manipulating insulin and Basal IQ is that the Tandem pump suspends insulin predictively. It is smarter than I am. I am smart, but Basal IQ is smarter.

I have been using Basal IQ for 2 weeks and there is no doubt that I have had fewer lows. I have had a few nights where I had no Dexcom alarms for lows. For me that is monumental. But in typical diabetes fashion I have had a few nights with moderate highs that repeated boluses are slow to bring down. There is some comfort in knowing that I can bolus more aggressively than in the past because Basal IQ will ameliorate (but not necessarily prevent) the inevitable resulting lows.

One thing I like about Basal IQ is that I can chose no notifications when it turns on and off. I am a poster child for alarm fatigue with my diabetes devices. Basal IQ prevents a lot of my lows resulting in few alerts from the Dexcom app. But I still rarely have a night with no diabetes issues and either need to completely stop snacks in the evening or raise my high alarm threshold.

I think it is interesting that Basal IQ can be considered to be a basal test. One might argue that if you repeatedly have a 3-hour period overnight where your basal is suspended for almost the whole time, your basal rates might be too high. Or if you have a period of sustained highs and never have suspended insulin through another period, maybe your rates are too low. I assume that somewhere in between is the “sweet basal spot.” But maybe not — because I have always suspected that there is not a perfect basal profile that works for every day. Remember the Diatribe 42 factors that affect blood sugar. 

In the online community, especially the Seniors with Sensors group on Facebook, there are many seniors doing really well with their diabetes. The definition of “really well” differs from person to person. But at my age if you’re satisfied with your care, your D-numbers, and have a supportive doctor, I think you’re doing really well. Some seniors using the Tandem pump and Dexcom G6 are thrilled with Basal IQ and appreciate help avoiding lows. I am mostly in that group. Others are frustrated with post-insulin-suspension highs or are convinced that a sensor-augmented insulin delivery system can’t match their manual results. A lot of seniors are going to have a hard time giving up manual control of their diabetes and their concerns are valid. In contrast the diabetes world has a whole generation of CGM users growing up not knowing anything other than complete trust in their sensors. And soon that will be the norm, not we old folks who used pee-strips, urine-testing chemistry sets, and 15 BG meter tests a day.

Tandem’s Control IQ has been approved by the FDA and will soon be available via a software update to all of us with in-warranty Tandem X2 pumps. Even those of us on Medicare! My A1c and average BG will rise if I use Control IQ. Will the reduced mental burden be worth it? Statistics and my endo might argue that I would be healthier and living with less risk if my A1c increased. Am I old enough that I should be modifying my targets and treatment? Do current risk studies for seniors with Type 1 diabetes reflect the adoption of CGM technology that protects us from most severe lows? How good does my diabetes control have to be? The questions go on and on.

I know people online who will never adopt new technology that they don’t trust or that might raise their A1c’s out of the low 5’s. I know others who are always open to trying new things and are willing to take some risks on the path to diabetes nirvana. And for sure there are people who have struggled every day of their diabetes lives and are willing to let smart technology take control of their physical and mental health. I am not sure exactly where I stand on these decisions and know that I will be writing more in the future about Control IQ.

At the moment, I am still learning Basal IQ and feel my D-life has been improved with this technology and the Dexcom G6. One roadblock that might prevent me from updating my pump to Control IQ is that I will not have the option to go back to just Basal IQ. They are completely different pump software configurations and algorithms. By going with Control IQ I am limited to the programmed target blood glucose levels for highs and they are higher than I currently target. Basal IQ just addresses lows and leaves highs to me. Does it matter? I don’t know and plan to stay on the sidelines a while before making the commitment to change.

If you are considering Control IQ, I suggest that you listen to this Diabetes-Connections podcast where Stacey Simms interviews Molly McElwey Malloy from Tandem. After listening to the podcast I was comfortable that Control IQ would be good for me. But I know I need to learn more before committing. This coming Wednesday (1/15/20) Tandem will have a live presentation on Facebook explaining Control IQ and answering listener questions. I don’t have a specific link but here is a screenshot of the email i received from Tandem. For sure you’ll hear more from me in the future about Control IQ–my opinions and those of my fellow seniors with diabetes.

 

Medicare and Dexcom G6: Yes!?!

There is a lot of discussion on social media this week about Dexcom G6 finally being available for Medicare recipients. Most of it is personal testimony along with a few links and guesses of what the story is. But some seniors are definitely ordering G6 systems and that is great news. I have heard from two sources that Dexcom will be sending current Medicare G5 users “A LETTER.” But now that the cat’s out of the bag, many of us are not patiently waiting for instructions from Dexcom.

The most information about G6 Medicare availability is on the Dexcom Provider website. This link details the steps a physician should go through to prescribe a G6 for Medicare patients:

https://provider.dexcom.com/support/medicare-coverage-and-prescribing-information

Interestingly Walgreen’s is being mentioned as the go-to supplier. Walgreen’s is licensed to dispense Part B DME for Medicare because that is how they have for many years provided test strips, insulin for pumps, and other DME products. Patients are also allowed to use other approved DME suppliers to get their Dexcom G6 and I have chosen to use Solara Medical which provides my pump supplies. Although I am mostly a satisfied Walgreen’s customer, they do periodically bill my Part B insulin to my Part D prescription plan and I don’t want to give them the chance to do the same with my CGM supplies. Hopefully the Dexcom-Walgreen’s partnership will be successful but I suspect it will take a while to work seamlessly.

Here are a couple more helpful links:

Medicare FAQ’s:  https://provider.dexcom.com/faqs-categories/medicare

DME suppliers other than Walgreens:  https://www.dexcom.com/medicare-coverage

I have no idea what the Dexcom letter will say or if there really is one. I do know that upgrade eligibility will require that it be at least 90 days since since the most recent G5 transmitter was shipped. I was somewhat concerned by the following statement on the provider FAQ’s webpage addressing existing Medicare patients: “New Medicare patients will have access to Dexcom G6 immediately, and we will begin upgrading existing Dexcom G5 Medicare patients soon.”

Since I have lived with Dexcom’s definitions of “soon” and “next quarter” for over a year, I was not willing to wait to see what happens. I called Solara this morning and a sales specialist placed my order. Solara will contact my endocrinologist for a prescription and the required chart notes. My last G5 transmitter shipped on August 6 and my G6 system should be eligible to be shipped on November 5. My G5 receiver is the old style and not able to be updated to G6. Therefore my initial G6 shipment will include a touchscreen receiver. Medicare regulations still require that a receiver be used occasionally to view Dexcom data although there is currently no enforcement of the policy. I think it is a “Don’t ask, Don’t tell” situation and a reflection of the fact that CMS has no interest in diving into the black hole of trying to update Medicare DME policies. Because Dexcom Clarity does reflect what devices I use to collect my CGM data, I try to use the receiver a day or two every couple of months. That seems “occasional” enough to me….

I am mostly happy with my Dexcom G5. But I use a Tandem pump and have been very frustrated at my inability to access Basal IQ because I don’t have a Dexcom G6. I truly believe that Basal IQ will improve my safety and sleep as it shuts off insulin delivery in response to predicted lows. Whether I use Basal IQ all of the time or just at night will be determined in the next couple of months. 

Nothing about this blogpost is official although it shares some legitimate facts through the Dexcom provider links. Other than that, it is what I have learned on Facebook from other Medicare Dex users and by talking with a sales rep at Solara Medical. Until a Dexcom G6 system arrives on my front porch, I will only hope that the road that I have chosen to G6 is a good one. If any of my readers has more information, opinions, or G6 experience, please share in the comments.

But I am smiling today because I was worried that today might never come….

Lots of I Don’t Know’s

Okay. Let’s talk about Basic Medicare** and the Dexcom G6. Then let’s talk about Basic Medicare** and Tandem Basal IQ. And then let’s just admit that we don’t know the answers to our questions and that we’re not going to get answers in the next 5 minutes.

Who, what, when, where, why? 

Yeah, I don’t have a clue.

As someone on Medicare I’ve felt left out in some of my Facebook groups recently. In the Dexcom D5/G6 Users group and the DEXCOM G6 group, the vast majority of topics are about the G6. Do you like it? What is great? What is terrible? Adhesives, accuracy, and sensor longevity. Insurance and supply issues. The Tandem tSlim Pump group is all about Basal IQ with the majority of users stating that it is fabulous. There are questions about how it works and at what point basal insulin is suspended and then resumed. Stories about climbing Mt. Everest and others wondering about how to coordinate the prescription from their doctor, the training, and the software download. I don’t fit in anymore and I have no advice to give. In fact I am a little bored in these groups and mostly not checking in.

You see—I’m on Medicare. I don’t have the Dexcom G6 and my Tandem X2 t:slim pump is not updated to Basal IQ. I am not whining. Okay, maybe I am–just a little. But mostly I am just stating facts.

After weeks of rumors, it was officially announced on October 16 that Medicare will begin covering the Dexcom G6 for Medicare recipients. The nitty-gritty has not been worked out but it is estimated that April 2019 is a reasonable target date.

For those of us who have been involved in advocacy for CGM coverage by Medicare for years and who have been joyously receiving coverage since the second half of 2017, this announcement is welcomed but generates more questions than answers. I think that the more you know, the more questions you have. Addressing customers on the Dexcom G5, the news release states:

“Once G6 is available, Dexcom will be reaching out to current Medicare G5 customers when their transmitter is eligible to be replaced. Dexcom will also discuss the G6 and the Medicare beneficiary’s eligibility during routine monthly contact.”

That sounds very straight forward but I worry that it is not. The elephant in the room for those of us on G5 is The Receiver. In January 2017 after the initial approval of the Dexcom G5 by Medicare, I wrote a post titled “Medicare and CGM Coverage: Love Your Receiver!” and explained how Medicare justified the approval of the G5 as Durable Medical Equipment (DME) because the receiver had an estimated 3-year life. Therefore for those of us on Medicare, the G5 receiver has a 3-year warranty. Although we are now allowed to use our smart devices to read our G5 data, Medicare regulations still state that the smartphone is used “in conjunction with” the receiver. And FDA approval of both the Dexcom G5 and G6 requires a receiver to be provided as part of the initial bundle.

I have an old-style Dexcom G5 receiver that cannot be updated to G6 in contrast with the newer touchscreen G5 receiver that can be updated remotely to G6. Medicare through stupid regulations that I don’t understand does not allow Medicare recipients to participate in manufacturer upgrade programs. Thus Dexcom cannot give me the option of paying $100 or $25 or whatever to exchange my dated receiver for a touchscreen G5 or G6 receiver. 

Technically my G5 receiver is warrantied for 3 years and I can’t upgrade it. Am I going to be able to switch to the Dexcom G6? Interestingly, the Dexcom press release only addresses the transmitter and makes no mention of the receiver. Without knowing the details of Dexcom/Medicare negotiations, I have no way of knowing my status. Is everyone forgetting the FDA requirement of the G6 receiver? Is Dexcom going to provide G6 receivers to current G5 users at no charge? Will I get a G6 transmitter and sensors without a receiver? IMO there is no way in h*ll that Medicare will pay for another receiver. Because the Medicare/Dexcom relationship is on a subscription basis, will all of the previous rules about upgrades be thrown to the wind?

As I said above, the estimate is that Dexcom G6 products will be provided to Medicare recipients starting in April of 2019. I have neither seen nor heard of specifics regarding this rollout. There are lots of discussions and rumors floating around Facebook but no one really knows. I have been on Medicare long enough to live by the mantra: “When I know, I’ll know. Until then, I won’t.”

If I were not using a Tandem X2 pump, I would not care much about using Dexcom G6. I look forward to an easier insertion and no required calibrations with the G6, but neither is a huge deal for me. But I really look forward to updating my Tandem X2 pump to Basal IQ which automatically shuts off basal with predicted lows. And then the future Control IQ which will function as an early generation artificial pancreas. 

But if things are in the dark with Dexcom and Medicare, they are really in the dark with Tandem and Medicare. The last communication I had from Tandem regarding the use of my pump as a receiver for my Dexcom CGM was in November 2017. The webmail stated:

“Dear Customer: As someone who, according to our records, has a t:slim X2™ Pump and also has Medicare for health insurance benefits, you may be aware that Medicare coverage of continuous glucose monitoring (CGM) is limited to viewing CGM data only on a Dexcom receiver and NOT a smart phone or an insulin pump.”

Since then I have heard nothing.

Frankly I think that the current Tandem policy regarding Medicare is: “Live and let live.” Some people are being told by their Tandem reps that it is okay to use their pump with Dexcom. But I do not think that is true because there has been no official announcement allowing the pump as a Dexcom receiver. At the same time there is no enforcement of the policy and Tandem is not sending reminder emails about Medicare. Although one part of me thinks that it is poor customer policy that Tandem is not communicating with Medicare recipients, the other part is okay with just ignoring the problem.

Unfortunately the problem of Tandem and Medicare will come to a head when the Dexcom G6 is distributed to Medicare users. Will we be allowed to download the Basal IQ software update (which requires G6) to our X2 pumps? Tandem has said nothing and unfortunately IMO it would be a total violation of current Medicare policies to allow the update.

Once again we don’t know the answers.

No answers to who, what, when, where, why.

Just a reminder to be patient and go with the flow…

Of no information…

and…

Fingers crossed for the ability of those on Medicare to benefit from the latest and greatest in diabetes technology.

Until then, just remember the Medicare mantra:

“When I know, I’ll know. Until then, I won’t.”

*******

** Please note that although Medicare Advantage plans must cover everything covered by Basic Medicare, they may have more flexible policies than Basic Medicare and provide more benefits. Currently some of these plans are already covering the Dexcom G6, but most are in line with Basic Medicare.

Living on Planet Dexcom

Starting with the Dexcom G4  released in 2012, I have bolused insulin based on my CGM. Although the G4 was not FDA-approved for insulin dosing, I was comfortable doing so “sometimes, in certain circumstances, and within certain guidelines.” That quote comes from a 2013 blogpost titled “To Dose or Not to Dose” and explains that I mostly trusted the Dex but averaged 8 fingersticks per day.

Fast forward 5 years. I regularly dose insulin off my Dexcom CGM and only average 4 meter tests per day. That average reflects sensor day 1 where I might test 8 times and other days where I may only test 2-3 times. The Dexcom G5 is somewhat more accurate than the algorithm of the original G4, but the difference is only a couple MARD points and not a huge statistical variation.

So what has changed that I have eliminated at least 4 meter tests per day?

What has changed is Me. 

I have 10 years of CGM usage under my belt. The early years of Medtronic SofSensors were rocky with a huge improvement when I moved to the Dexcom 7+. The 7+ was reliable for trends but I don’t remember trusting it enough to guide my bolusing decisions. With the mostly reliable G4 numbers, I frankly just became lazy about using my BG meter. I had good insurance with no need to ration test strips and no issue poking holes in my fingers. I was just lazy and welcomed a small reprieve from a few daily diabetes tasks. Before I knew it, the laziness turned into a habit. It was initially a guilty habit but over time CGM reliance became entrenched in my diabetes decision-making. 

And guess what. It didn’t kill me! And now it is FDA-approved.

Lately I have been frustrated with inconsistencies between my meter and my Dexcom numbers. It drives me crazy. I have always had issues with Dex sensors reading low. As I increasingly target normal-ish BG numbers, the Dex low tendency often results in alarms for lows that aren’t lows. Dexcom screams 65; meter says 85. Maybe I calibrate and Dex goes up to 75 before dropping back down to the 60’s. I know that numbers showing up after calibrations are determined by “The Algorithm” but sometimes if I enter 85, I just want the receiver to say 85. 

My perfecto personality overreacts to diabetes numbers. When my meter and CGM feud, I calibrate too often. I over-manage blood sugars. I get lows and highs as I target perfection and my mental health meter explodes. 

What do I do?

Do I start testing 8-12 times a day like in the old days? Do I donate the CGM to Goodwill?

Heck No!

I just move to Planet Dexcom and go with the flow of CGM numbers. I test less.

Although Dr. Bernstein might disagree, I believe that when you are 66 years old with 42 years of diabetes under your belt, 20 or 30 points here and there probably doesn’t matter a lot. Especially if I have a flatter CGM tracing because of fewer peaks and valleys. By not obsessively using my meter, I might miss some large Dexcom/meter discrepancies. At the same time, it hasn’t killed me yet. I am mostly hypo unaware. But because I have had so few catastrophic lows since the introduction of Dexcom G4, I have some confidence that if I pay attention to my body and my diabetes devices, I am somewhat protected from incapacitating lows.

Remember. It hasn’t killed me yet.

Note: Because I am on Medicare, I am using the Dexcom G5 and it will be a while before I have access to the G6. I find it interesting that many of the early-users of the G6 which requires no calibration are celebrating its accuracy. Simultaneously they are claiming that they are not using their BG meter. So actually they don’t know how accurate it is. They are living on Planet Dexcom and finding that it is a relatively safe and happy place to be.

There will come a day when blood glucose meters go away and everyone with diabetes uses some type of continuous glucose meter. We’ll live on

Planet Dexcom or

Planet Libre or

Planet Medtronic or

Planet Eversense or

Some other CGM planet in the diabetes universe.

Relatively safe and happy.

Choosing the Dexcom G5—Again

Laddie_Head SquareIn September I wrote a blogpost about the pros and cons of upgrading from the Dexcom G4 CGM to the Dexcom G5. Since my upgrade was free and I did not have to return the new and still-unused G4 transmitter, the decision to accept the G5 transmitters was a no-brainer.

Two weeks ago my transmitter warranty expired and I was once again faced with the G4/G5 decision. Most of the arguments from my September post are still valid, but probably my biggest concern was whether I liked the positives of the G5 enough to outweigh the increased cost of the transmitters. As most of you know, G4 transmitters are warrantied for 6 months but operate until they die—sometimes as long as a year after initial use. G5 transmitters are sold in pairs with each transmitter programmed to shut-off after 108-112 days (90 days + 18-22 days grace period).

Around the DOC I have seen many CGM users who have chosen to remain with the G4 for various reasons. Read Mike Hoskins’ post at Diabetes Mine for a good description of valid reasons for not changing. Recently on Facebook there have been discussions where some users are considering going back to the G4 as their G5 warranties expire. In most cases the motivation is financial although some users have been dissatisfied with the transmission range and signal reliability of the G5 system.

I have been using the Dexcom G5 since late February. Initially I was quite frustrated by the alert sound options on my iPhone and in typical fashion wrote a rant blogpost. At that point I was too new to the system to evaluate other pros and cons of the G5 platform.

Fast forward a few weeks and when once again faced with the G4/G5 decision, I chose without hesitation to remain with the G5 system. So what changed and why am I totally on board with the G5?

Dexcom G5 Choice

1. Although I never really minded carrying the Dex receiver, I quickly fell in love with not carrying it. I appreciate having one less thing in my pockets and one less expensive device to keep track of. I like how my BG numbers are displayed on the phone and how the G5 app allows me to key in calibration numbers rather than scrolling on the receiver wheel. I like the use of color in the app and the ability to see graphs in landscape mode. I appreciate the new iPhone “complication” that allows me to see my BG number without unlocking my phone.

2. When I use the receiver, I find the screen with the white background easy to read unlike the G4 screen with colored numbers and tracings on a black background. As someone who spends a lot of time hiking in bright sunlight, I found the G4 receiver impossible to read at those times when I needed it the most. (See “Sunlight and the Dex G4: A Bad Mix.”) I will admit that I dislike the glaring spotlight of the G5 screen when checking it in the middle of the night.

3. Although I am still not happy with the sound profiles on the iPhone, it is not bothering me very much. I am experimenting with using the receiver at night and my phone during the day. When I combine the musical Dexcom alerts with my Lantus reminder alarm in the evening, I feel like a digital music box.

4. Because I am a year away from Medicare and no CGM coverage, it is easy to argue that I should be hoarding transmitters and continuing with the extended life of the G4 transmitters. A great idea in theory, but it ignores the probable release of the Dexcom G6 in 2017 or early 2018. The G6 promises improved accuracy and reliability and I suspect it will quickly leave the G4 and G5 platforms in the dust. Because the G5 does not require a receiver, maybe it will be more economical than the G4. Or are you required by the FDA to purchase a new receiver every year?

Right now Medicare is a huge “unknown” in my life and I will soon be writing about my preparations and guesswork as I move closer to April 1, 2017. I hate the idea of hoarding supplies and technology that will become obsolete and possibly unused. But I am not optimistic about a change in Medicare CGM policy and am I crazy not to stock up on G4 transmitters?

5. I have not been bothered by things that could be considered flaws of the G5 system. I have experienced very few dropped data points. I have occasionally lost the signal on my phone, but that also happened periodically with my G4 receiver. The battery of my almost 3-year old iPhone 5 runs down more quickly due to the Dex G5, but not enough to be a real problem. I am still not satisfied with the lack of a robust vibrate alert on my phone, but I’m losing no sleep over it.

Summary:  As I am reminded whenever I write technology blogposts, I am indeed one of the “Diabetes Privileged.” I would of course prefer not to have diabetes and it is certainly not a “privilege” to live with this difficult-nagging-frustrating-serious-chronic health condition. But given that I do, I have many things in my favor. I am educated. I have good health insurance and am able to buy insulin and other required medications/supplies. I have a computer, an iPhone, and a connection to the Internet and the Diabetes Online Community. I have access to good food and a safe environment in which to walk and exercise. I am the beneficiary of the newest diabetes technologies and able to debate whether I want to live with the fabulous Dexcom G4 CGM or the newer and fabulous Dexcom G5 CGM.

And today I choose the Dexcom G5.