New (?) CoaguChek meter

[Protimenow]

Last night, I did some of my semi-regular searching on eBay. I keep an eye on meters, strips and stuff like that.

I saw two listings for the CoaguChek InRange.This meter has been out for a few years, and isn't available in the United States (as far as I know). I did some research to see if this availability issue has changed, and came across some news about a CoaguChek Vantus.

The news was from early 2018 (last year) and the meter was supposed to hits U.S. markets that summer.

This meter seemed slightly different from the XS: it had Bluetooth built in, and reported results in INR only (no prothrombin time reported). The meter also has a USB port. It appeared to be designed to transmit - via phone or computer - to a doctor or anticoagulation clinic. It also appeared to be able to take remarks from the patient when a test is made, and to (perhaps) handle messages from a doctor or clinic. I think that also reminds the patient when it's time to test.

I asked Roche about when, or if, this will hit the market. (My guess is that it may take too much control from the patient - that the patient may be tied in to a clinic or doctor, and wouldn't have the ability to own a meter, run his or her own test, and ignore the handcuffs to the doctor that may be built into the meter).

The meter has a color display, and uses the XS test strips. It apparently stores the code number from code chips for up to five batches of strips.

The Coag-Sense PT2 that I use also has Bluetooth (plus WiFi, plus an NFC reader, USB, and an Ethernet port) and doesn't put the restrictions on the patient that the Vantus might.

It'll be interesting to see what's happening with the Vantus (that was supposed to become avaliable a year ago).

 

[Warrick]

Just looking at pictures of the inr range and the vantus and they look the same with the same graphics apart from the top sticker, I guess they are not?

 

[pellicle]

aren't they all just the same thing with different 'on board' recording capability? I just transfer my readings by my hands to my keyboard which sends that to the spreadsheet file I keep on my computer (backed up onto dropbox automatically)

No need for the tooth of blue and pairing if you have already a pair of hands.

 

[Protimenow]

I looked at the specs for both. They DO look alike. Both meters use the XS strips.

From one news piece, the Vantus doesn't show Prothrombin time, but the InRange does.

I don't know, yet, if the Vantus has finally become available in the United States. People are selling the InRange in the United States, but it appears that the InRange isn't available in the United States, and may not have any support in the United States. (I don't know if there was an FDA approval issue for the InRange, which explains why it's not available in the United States).

I'll see if Roche answers the questions about the Vantus that I asked.

 

[Protimenow]

aren't they all just the same thing with different 'on board' recording capability? I just transfer my readings by my hands to my keyboard which sends that to the spreadsheet file I keep on my computer (backed up onto dropbox automatically)

No need for the tooth of blue and pairing if you have already a pair of hands.

That's how I have recorded my INR for the past 10+ years. The idea behind the bluetooth and INR is that, using software provided by doctor or clinic, you can transfer the results to someone who 'must know a lot more about warfarin dosing than you do', and who charges for receiving the results. HOWEVER, it would be nice to have software transfer the results from meter to computer (a really big jump). Much easier than typing it onto a spreadsheet.

 

[vitdoc]

Usually the reason that the medical device is not available in the US is that the manufacturing company has not gotten the device through the FDA. Even if there are relatively small changes often the FDA still requires a lot of input from the company which may not make business sense given the cost of getting the device through the FDA.

 

[Protimenow]

Yes. And Roche didn't seem to have any reason to bring out the latest, greatest meter (the InRange or the Vantus) when they were already doing so well with the XS. It's not the kind of business where people would by the new model - when the old one does almost the same thing (if this was a car, bells and whistles matter, 'bluetooth' and USB probably make little difference to current self-testers).

 

[Protimenow]

I heard from Roche today.

The InRange, Vantus and XS all use the same strips.

The InRange is not supposed to be available in the United States. I didn't ask if the FDA approved it for sale in the United States. There is at least one seller on eBay who offers the InRange - I don't know about warranty or support in the U.S. for this unauthorized meter.

The Vantus has FDA approval and, according to Roche, is being delivered to some customers in the United States. The Vantus is ONLY being distributed by Roche Coagulation Service - it's sent to subscribers, along with strips. Results are automatically sent through a Bluetooth connection, to the client's phone, and through the phone to Roche. Roche then reports the INR to the doctor.

The Vantus can't be purchased outide the service. If a client discontinues the service, the meter is returned to Roche. (It doesn't seem that any Vantus meters will be available outside of the service - none will probably enter the gray market (like eBay) - and it probably won't go into other clinics or doctor's offices. This seems to be an InRange that has been slightly modified to report only to the Roche service, and to only report INR. Unless you're using the Roche service, you probably won't be able to get your hands on this meter).

For myself, I'll stick with my Coag-Sense PT2 and what I call 'classic.'

 

[Protimenow]

Roche has been in touch with me a few times. They sent a letter via FedEx that I haven't received, and I don't have a clue what's in it (maybe boilerplate product sheets, or something). I spoke to an executive at Roche's U.S. anticoagulation service. This is a service that providers meters, strips, and supplies, and informs the doctor what your meter reports.

I was told that all new subscribers get the Vantus meter. If the user has an Android or Apple phone, the meter can connect via Bluetooth, and transfer the report to the service. The service then informs the patient's doctor.

The doctor does the dose calculations (and probably specifies the frequency of testing and other things that doctors may want to do for their patients).

Roche apparently charges the patient's insurer, or in some cases gets paid directly by subscribers, for the 'service' which, I think, probably involves sending the meter and strips, possibly also sending lancets (and maybe alcohol wipes). The patient takes the test, and if the phone isn't bluetooth enabled, calls the results in to a number for that purpose. The Vantus can send reminders when testing is scheduled (or missed).

A doctor or someone at the office can train the person how to run a test. Alternately, Roche can handle training.

Control of the Vantus appears to be absolute - you only get it if you use the Roche service If you stop using the service, they want it returned (I'm not certain that the person who called me confirmed this). I doubt that there will be a black or gray market for this meter.(For all I know, I wouldn't be surprised if they sent a code to the meter to lock or unlock it - like the satellite radio providers do - but I have no way to check this). The XS does its job without bluetooth, the InRange that is being sold into the United States - but isn't supposed to be - appears to be the same as the Vantus.

I don't know about support for the InRange in the United States - warrantees possibly won't be in force if the device wasn't bought from an authorized dealer (and none of the authorized distributors will sell into the U.S. market).

To make a long story short - The CoaguChek Vantus IS being distributed inside the United States. It is only available from the Roche anticoagulation service. Bluetooth capabilities will enable it to transfer test results and testing reminders.

 

[pellicle]

The idea behind the bluetooth and INR is that, using software provided by doctor or clinic,

well that's part of the idea, the other is to prevent transcription errors especially as the device mentioned is designed to handle multiple patients. So a nurse (for instance) could just stick it beside the computer and upload all the patients data (plural on patient) and then 1) save time 2) reduce errors. Given what I do for a living that part was particularly obvious. But as we here aren't usually representing that group I didn't see it brought much benefit to us.

As to transferring the data to the INR managers for a clinic for the test at home folks it prevents you lying to them (or just not wearing your glasses, or just not doing the reading) and then leaving them with no evidence trail to ensure data integrity ... but as none of us here are representative of that group either I didn't mention them either.

I have NOT developed my INR system into an app because I would totally require that sort of system to prevent dippy users from putting in what ever they wanted into the app (and then blaming my app for any issues). Given that I would anticipate that pairing of a bluetooth device to a phone is problematic (to say the least) and probably beyond most potential home testers I haven't given that a lot of thought. I didn't mention that either because I expected nobody else was interested.

So for me I'll just stick with the pair of hands to type the data into my spreadsheet #lowHangingFruit

 

[Protimenow]

Pellicle - yes, running the results from meter - to bluetooth - then through phone to service is a good idea, but in this case the Vantus is distributed to single users - it's not being distributed for use in clinics or environments where multiple tests are being run, and reporting for many patients through bluetooth will eliminate transcription errors, and easily update patient records.

The Coag-Sense PT2 DOES have those capabilities. It can record 2000 test results, patient information (via an optional OCR scanner), operation identification, and other details related to each test. In addition to Bluetooth, it has WiFi, USB, and an Ethernet port. The PT2 has features that should (or already do) make it a good match to anticoagulation clinics,, doctors' offices, and even for self-testers.

The way Roche appears to distributing the Vantus is as a meter that is dedicated to the person who receives it, and that is able to send results to the Roche anticoagulation service.

 

[pellicle]

...
The way Roche appears to distributing the Vantus is as a meter that is dedicated to the person who receives it,

I wasn't talking about any specific product, only that I wanted to make clear that I already was well aware of why bluetooth data transfer was a handy feature and where (and where it wasn't a big deal)

 

[mecretired]

I have the Coaguchek xs and use the Roche services. Medicare and my supplement fully cover it. I do weekly testing and then log in to the Roche website and record my inr. They get the info to my Coumadin clinic. If inr is out of range I get a call from the Coumadin clinic. It has worked great for me without Bluetooth.

 

[Protimenow]

I wasn't talking about any specific product, only that I wanted to make clear that I already was well aware of why bluetooth data transfer was a handy feature and where (and where it wasn't a big deal)

For a self-tester, there's probably not much advantage to Wi-Fi or Bluetooth on the meter - except for, as you said, reducing transcription errors. Of course, meters with Bluetooth or Wi-Fi store hundreds or thousands of test results, so transcription errors can be caught and corrected. The meters also will probably have some basic charting or graphing capabilities.

One possible advantage is firmware upgrades, delivered over the Internet.

BUT - for clinics that do hundreds or thousands of tests each week, having the ability to store the patient ID numbers, the identifier for the person who ran the test (the 'technician'?), time, strip lot number, and results, being able to track all this information, quickly and automatically, can be very valuable. (The Coag-Sense PT2 has this capability, can store 2000 test results, can store results of high and low control tests, and has an NFC reader that can easily transfer the numbers from a new box of strips to the meter.)

For this self-tester, these extra features add little value. The rechargeable battery is also a nice touch.

 

[Protimenow]

I have the Coaguchek xs and use the Roche services. Medicare and my supplement fully cover it. I do weekly testing and then log in to the Roche website and record my inr. They get the info to my Coumadin clinic. If inr is out of range I get a call from the Coumadin clinic. It has worked great for me without Bluetooth.

It's great to see that you're testing weekly, and the system working for you.

I'm a bit curious -- do you know how much Medicare and your supplemental coverage are paying to Roche for this service?

 

[mecretired]

It's great to see that you're testing weekly, and the system working for you.

I'm a bit curious -- do you know how much Medicare and your supplemental coverage are paying to Roche for this service?

Roche charges $250 per month. Medicare pays $52.56 and my insurance pays $13.41. Roche accepts that as full payment.

 

[Protimenow]

They accept $65.97 as full payment? It's too bad that some insurers pay the full amount, or pay $200 and leave you stuck paying a $50 deductible don't realize it's negotiable. Considering that the retail price of four strips a month (or even five, on some oddly occuring months) is only about $25, and it probably doesn't cost Roche much to forward your results to your doctor, they're still doing pretty well.

I don't regret getting my own meter, strips, lancing devices and occasional other supplies, and testing and managing on my own.

I won't try to tell you what to do. But, for me, it's comforting to know that I can test when I want to, and I can use my meter to compare to other meters and labs, and I'm not putting any financial strains of the medical insurers. (And, for that matter, not enriching the anticoagulation services, either).

 

[Protimenow]

One fairly quick comment: it shouldn't be much of a challenge for Roche to get FDA approval of the InRange. What it will have to do is demonstrate an equivalence between the InRange and the XS. It shouldn't have to go through the rigorous testing that the XS probably went through. OTOH - the XS may have had to show equivalence with the now discontinued S.

Perhaps Roche didn't want to poison the market for its base XS by offering a newer, sexier, arguably superior meter.

 

[almost_hectic]

Same here, I use the Roche service. They provide the meter and all strips with lancets and alcohol wipes. My private insurance pays the cost 100% and my reported results are sent to my cardiologist in real time from the Roche website I enter them into. If I’m ever out of range my nurse calls me within a few hours to discuss why I think I might have tested out of range and we discuss any dosage adjustment. They make it super easy and replacement test supplies are even sent without me having to reorder. I really like the system they have.

 

[pellicle]

Perhaps Roche didn't want to poison the market for its base XS by offering a newer, sexier, arguably superior meter.

I'm a bit lost here, didn't they exactly do that with the INRange? (which costs almost exactly what the XS costs, has a colour screen, produces graphs and uses the same strips?)