I am an analytical laboratory equipment and medical devices engineer.
9 Likes
Thanks for this information. I’m definitely going to try it. Just one question. When you say in step 2 to change transmitter ID to an old one, do you mean to pair an old transmitter?
1 Like
Yes pair an old transmitter or one taht you don’t have. I can give u a few IDs if you don’t have any. Then wait for it to error.
Then pair the real one, and hit start sensor
3 Likes
If you have an old transmitter ID to share, that would be great. I just switched to the G6. With the G5, I was getting about a month wear time out of the sensors with the restarts. Thanks.
2 Likes
Timothy. Wow!!! Thank you.
You’ve been super clear on your instructions, but I just want to be sure about the transmitter part. I’m doing this with an iPhone.
Do I simply delete the current transmitter from my Bluetooth? Then the system will ask for a transmitter when I try to restart the sensor. I then enter the code (or take a pic of the bar code) of an old, expired transmitter. The system will reject that transmitter as no longer valid. Then I enter the code of the current transmitter, the system will re-pair and restart the sensor (as a new sensor).
Do I have that process correct?
I just don’t want to lose a good transmitter because I find I’m not allowed to re-pair it.
Again, thank you so much for the incredible wealth of information!!!
2 Likes
You can do it that way. Or just enter the transmitter ID into the field.
It will error after it can’t find it. Then enter the one that is in you.
I use my pump which is easier but phone should be just as easy.
Just know you need the current session to have ended before you try this.
You actually don’t need to delete the transmitter ID from Bluetooth. You can leave them in there
It will not kill the transmitter even if you did it wrong.
The transmitter has a clock so you can’t use after 110 days. Otherwise it doesn’t care if you switch between 2 different transmitters.
But doing this method kills the recent memory buffer, so it won’t remember the last session.
So when you start the sensor it just works normally, but the transmitter clock doesn’t get reset.
You still only have 110 days from the time it was first started.
I’ll make a video when this session ends. I’ll use my iPhone because more people do it that way.
2 Likes
I called one day about a sensor problem. The CS person told me I can insert in my arm and in fact should be moving the sensor around a bit. I don’t restart them but I’m thin and she said arms are just fine.
Laura,
Get them to send that in writing so if there are problems, “It is written.”
1 Like
Right. They usually don’t say things like that.
If you call in a failure and it’s in your arm, they won’t
Give you a replacement.
I don’t bf see how moving around after it’s in will help.
If it hits muscle or goes in wrong it gets bent and there is no fixing that.
Dexcom G6 sensors may be inserted on the abdomen, the back of the upper arm (indicated for patients age 2 years and older) or the upper buttocks (ages 2-17 years). Sensor placement is important and you will want to change your insertion site with each sensor. Using the same site too often might not allow the skin to heal, causing scarring or skin irritation.(This is from their page)
Be careful there is an American flag in the upper right corner.
Your locations match the UK & some others.
Dexcom G6 location - USA
Here is the 
link
| Laura_S Type 1 or LADA
August 6 |
- | - |
Dexcom G6 sensors may be inserted on the abdomen, the back of the upper arm (indicated for patients age 2 years and older) or the upper buttocks (ages 2-17 years). Sensor placement is important and you will want to change your insertion site with each sensor. Using the same site too often might not allow the skin to heal, causing scarring or skin irritation.(This is from their page)
Canada also approved arms, but still not approved for US, and no evidence dexcom has filed request to get approved.
However, G7 will be approved for arms, possibly the only placement!!
Canada announcement:
However many in US use arms for G6 anyway. G4 worked well there too.
2 Likes
Yes it was a European link.
1 Like
If asked by dexcom support (eg to replace a sensor), you can say your doctor approved usage on arm, or just fib about location.
3 Likes
Usually I just tell them it was on my abdomen. However I have told them a couple of times it was on my arm after a doctors discussion of putting it there and they have replaced it with no questions asked.
2 Likes
Exactly.
I’m never asked about a specific location, but rather the tech support people are trained to ask “is it placed in a fatty area?”, to which I answer “yes”.
1 Like
It works. Thank you. I don’t typically restart sensors but since I have to take off the sensor Tuesday for an MRI, I just extended the one I’m wearing until I remove the sensor and transmitter for the procedure. When I’m done I’ll just put in a new sensor.
2 Likes
I just restarted my current sensor. This is the third run.
It came on perfect. 98 and my finger stick was 93.
With the old method, it was always crazy wonky after restart.
Of course the transmitter doesn’t last past 110 days so it only makes sense to do it a few times.
I just wanted to see how it would go a third time.
I did it with my iPhone this time and it works the same way.
2 Likes
There is a proper way to use areas not listed for you county of residence. It is called a “Letter of Variance”. To get a letter, your endo writes the manufacturer, explains the reason (more than “I don’t like it there”), and requests the exception. The manufacturer sends back a letter either approving or disapproving the request.
The issue is not will it work. The issue is if there are problems, who pays the bill, read on. This is information collected in the past two years about location issues.
Approved Locations for Pump Tandem Sets & Dexcom G6 CGM for USA
ADDITION: In early 2021, another placement reared itself. Child protective services were involved with a child after an unrelated emergency room visit for a trauma event. The CPS notice indicated an ER doctor notified CPS because the pump (brand not specified) & Dexcom were not placed according to standards. The conjecture related to placement is wide open. Take away, would site & sensor placement pass CPS scrutiny?
As far as the pump is concerned, for the CIQ, look on page 81 of the USER GUIDE (PDF page 83) for approved locations. I will include a PDF link. You may want to download the UG to a tablet or computer for easy searching.
CIQ USER GUIDE (350+ pages and is best put on a tablet or computer for easier searching)
https://www.tandemdiabetes.com/docs/default-source/product-documents/t-slim-x2-insulin-pump/käyttöopas-(t-slim-x2--pumppu-control-iq-teknologialla)cf14759775426a79a519ff1100a9fd393f6fb39775426a79a519ff1200a9fd39.pdf?sfvrsn=18a507d7_66
As far as the CGM sites are concerned in the USA, using a site outside those approved by the FDA following Dexcom research and development place you in peril of footing the bill if you lose a wire. Sure, G6 is approved in other countries for other locations beyond the abdomen. Here in the USA, you are limited to the belly.
Here’s why. From what is written about the way FDA does approvals, we are still in the post-thalidomide tragedy mentality of the early 1960’s. To some this may seem harsh, yet it is true. The US Congress and American people supported a “never again” mentality will anything be approved unless it is safe. The cases of phocomelia were horrible. Some say this is strong language, however, it is still used today in language related to FDA rationale, power, and need for authority.
Here in the states, everything must be checked and double checked and scientifically proven to be safe. Who knows, until proven otherwise, the placement of CGM sensor wires in the upper arm may provoke the growth of new hands in the upper harms (NOT).
The understanding the regulatory process is, if a prescriber wants to use something in a manner different than approved by the FDA (called off label), the prescriber must write to the manufacturer, describe the situation, and request off label approval. Many people are told by their prescribing doctors, “Oh, just go ahead and do it.”, not realizing the Pandora’s box which may be opened in a misadventure. I have seen local newspaper coverage in days past of malpractice lawsuits shining the light on such issues.
The purpose of this group is support. Sharing published regulatory & usage information is a form of support. Providing information from contradictory, inapplicable, & unfounded sources without substantiation is not supportive & may in the opinion of others be an undermining of veracity.
In regard to claims about sites, it is the savvy claims clerk in the insurance company that creates the problems related to off-label use.
When a claim comes in for the removal of a wire from, hypothetically, posterior upper arm, and the insurance clerk notifies the hospital or doctor making the claim, additional information is needed. What type of wire? If the response is a Dexcom CGM sensor wire, the clerk checks to see if the device was being used according to published standards.
If the device was not being used according to published standards, the insurance clerk should deny the claim as ‘device not used as prescribed’ (because the prescription is for an FDA regulated device to be used according to FDA authorization). Failure to use according to directions, without variance, constitutes negligent usage, placing the onus, and therefore the bill, on the user.
The point of my post about ‘proper placement’ is not what the patient would tell anyone. It is what the health care bill to the insurance company would reveal and the sequelae.
One additional item to remember is being told by a prescriber it is permissible to use an item outside FDA authorization or ‘off label’ in the case of devices requires the device manufacturer to be notified and acknowledge the variance in writing according to the FDA.
Anyone in this situation should verify and obtain copies of correspondence their physicians have had with Dexcom seeking approval of off label locations and the clinical reason for the requests.
The mountain of off-label requests will be the only impetus medical device manufacturers have to re-open the approval process and divert resources to current product situations. In the meantime, inspection of medical device companies’ prospectus (yes, the plural of prospectus is prospectus - see Oxford Dictionary) will show major investment in R&D (new product research & development [FDA required testing, etc])
BOTTOM LINE: As informed users of ‘restricted medical devices’ (restricted medical device includes but is not limited to a device & accessories requiring a physician’s prescription), we the users must learn the “Thalidomide era” safeguards and apply those same rules to have common sense brought to the forefront. Here is the link from the Dexcom website (make sure you are on the USA page):
Where can I insert my Dexcom? [link is for USA – country selection is in upper right of screen]
As an additional regulatory oddity, this is the same as connected INSULIN PUMPs on airplanes. I have yet to find in FAA regulations the full approval process demonstrating insulin pumps are safe to use on commercial aircraft and that the radio waves generated, or electromagnetic interference (EMI) will not cause the plane to crash. Twenty year ago, when CGMs were first making their appearance, there was rattle about the radio waves from the CGM transmitter being in the same frequency range as some important avionics. Use of items operating in those frequencies were unproven and deemed (by FAA regulation) dangerous until proven safe. (one of the reasons given 20+ years ago when I started pumping).
This is a long post. The picture is big. Let’s pull together and get the eyes opened so location in one country is good in another.
Hope this provides the sunshine needed. The comment is to illuminate the situation.
1 Like