Monday, 2 May 2011

Medtronic 'Enlite' CGM sensor launch

The new 'Enlite' sensor launched in April 2011

Well, after having had a few weeks out of the 'blogosphere loop' thanks to barbecues and bank holidays requiring me to go outside and get re-acquainted with daylight, I thought it was time to clamber out of my holiday mode and tell you about the launch of Medtronic's newest product which if the marketing propaganda is correct, should see a real competitor emerge to rival the likes of Dexcom 7+.

Continuous Glucose Monitoring (CGM/CGMs) is something which many people in the Diabetic community are both excited and frustrated about. What is exciting is that CGM means diabetics could now have the tools to monitor blood sugar levels in real time, 24 hours a day without the need for constant finger pricking. It is linked to much better blood sugar control and may aid children and people needing to keep an enhanced level of control (don't we all?). The frustrating thing is the cost and lack of access on the NHS unless you fight a gruelling battle and have a super-supportive diabetes team (harder to come by than you would think).

But regardless of how difficult it can be to secure, CGM is the most promising tool we currently have on the horizon in order to keep diabetic complications and the endless grind at bay. It is also going to be utilised in the 'closed-loop' system which we so often now hear being discussed, which will incorporate an insulin pump and CGM in order to manage blood sugar levels 'automatically'. That is, CGM senses sugars are going up, pump releases more insulin. CGM senses sugars going down, pump is suspended until sugars rise. Simple. We hope.

Medtronic's sensor, which has been around since the dawn of CGM and was in fact (as I understand it) the first sensor produced fit for patient use, has been replaced with the new Medtronic Enlite sensor in Europe after gaining the required CE mark. It appears a very similar device to the previous version, but with some significant (claimed) improvements. Medtronic state the device now boasts a much smaller sensor (69% smaller no less), greatly improved accuracy (over 98% of hypos detected) and a much better system for securing the sensor to the skin. For anyone who has worn a Medtronic CGM sensor, you will know that it never felt particularly well affixed to the skin and required layers upon layers of cling-film style Tegaderm to keep it from 'flopping about' on the skin. As well as the smaller sensor offering hope that the site of insertion may now be less irritated after a few days (as I found during my trial), the improved fixing should offer a much more comfortable, reliable and precise system.

The system also now has a much improved insertion device similar to the way the Quick-sert system works, if you have ever used one. This means putting the thing in no longer means the navigation of oregami style tabs and flaps which the old system involved, which usually meant if you pulled the wrong tab, the whole thing was a sticky mess of flaps to un-flap!

On the 14th of May I will be trialling this CGM for a month and, seeing as I wasn't overwhelmed with the results of the two-week trial I underwent last year, it will be interesting to know whether the sensor is indeed more comfortable than it's predecessor. If it is, the long term goal would be to wear the sensor for longer stints in the hope that the cost of the system would be lowered. As with the previous systems, the CGM will speak to my pump meaning no need for extra hand held diabetic paraphernalia, which as any diabetic knows can grow at an alarming rate. Likewise this also means that I can view my blood sugars at the touch of a pump-button, and can set the pump to alarm when I am approaching the upper and lower limits of my acceptable range, meaning less nasty 4am surprises!

I will definitely keep you updated and will let you know if - as with last time - I am ready to rip the sensor out by the 7th day. Something I hope the improved, smaller and more streamlined design will solve.


  1. WOW! This is amazing! I really hope to try this out! I was just talking about how much I hate my medtronic CGM because of how inacurate it is. :(

  2. Hey this good overview of the system. It would be great to see some pictures of the device actually attached to someone's body. Unfortunately since I'm in the US i have to wait for the FDA to approve this for use in this country. I'm hopeful that it won't take long....

    One other question came to mind as I was reading your post, how did you become part of their beta program? I've been trying to figure out how to become more involved but it seems that no one really knows. Currently I use a Medtronuc CGM but I would really like to be a part of the changes that this company implements as it moves forward with a better way to manage type 1 diabetes.

    Thank you,

  3. What is the Medtonic part number for the Enlite sensor?

    If I have this number I can search the FDA's databases to learn what approvals the new sensor already received, and hope fully get some idea when it will be sold in the USA.


  4. The part number for the enlite sensor is MMT-7008.
    The part number for the Enlite Serter is MMT-7510.

    These part numbers should be helpful to anyone who wants to follow the progress of this device through the FDA databases at:


  5. Ok I tried to figure that website out, and I see a bunch of things in Premarket Approval but I'm not seeing one that approves the new CGM as a whole, just certain parts or materials. Has anyone figured out when this will be released in the US? One website speculated this fall/winter?

  6. Medtronic Guardian RT Comfort Sensor FDA Update

    The pediatric clinical trial for the Medtronic Guardian RT Comfort Sensor was completed on September 19, 2011:


  7. Has anyone gone to Europe to buy this new CGM? Still tied up by FDA. As I understand it, the difference is the longer interval (6 days) between 'maintaining' the sensor. (Currently approved for 3 days so patient has to 'reset' the sensor.)

  8. Hi, I'm not aware of anyone who buys it, but I have friends who are funded for it. A friend of mine who writes a blog has funding for her daughter. The sensor is approved for 6 days and in my experience is comfortable for at least that long, although the CGM companies won't tell you that.

    We still have to reset it if you want to go longer than 6 days (saving money) but I understand it's quite simple to do. The link to the blog for the funded patient is on my blog roll, called "5 children, type 1 diabetes, Coeliacs, me and my husband." I'm sure Angela would be happy to talk to you about the sensors from the perspective of someone continuously using them


  9. Dear Sir/Madam,
    I am requesting this information/action/intervention on behalf of a family friend – Mrs. Dolly Vajifdar in Mumbai (India). She had a Meconic Glucose Sensor attached on her belly in December 2011 to monitor blood sugar on two occasions, the first one did not record any result on the tester’s computer, therefore she was asked to repeat the test. The repeat device at attachment resulted in profuse bleeding which was controlled with a lot of emergency extra effort. She then declined any further testing. In spite of these two failures she was charged Rs 5,000.00 She wants to know why she has to pay for the test which has resulted in two failures and no report or result. She has requested my assistance /intervention.
    Mehroo M. Patel.

    The information provided is:
    Medtronic Enlite Glucose Sensor
    Ref: MMT – 7008 Lot F141 ( dated 2011 -12 – 11)

    In this circumstance what appropriate action should be taken so that
    she can get glucose readings as promised.

    Thanking you in anticipation for a reply.

    Mehroo M. Patel M.D.

  10. Dear Mehroo,

    This is an unusual post as I don't actually work for them. However I have found their customer services very good so far. I would recommend contacting them on the details shown below at the bottom of this reply, which is their head office in Mumbai. I would recommend lodging a complaint with them first.

    Secondly, if they do not deal with the complaint appropriately, are there any governing medical bodies in India? You would be better placed to know this than myself. If there are, I would contact them to lodge the complaint.

    I must say, I find it odd that there was any need to pay any money if these were tests. This is not something I have heard of before. Did she get assistance from a medical centre/hospital/Medtronic themselves?

    Best of luck, Anna.

    Medtronic India Corporate Headquarters

    #1241, Solitaire Corporate Park
    Building 12, Ghatkopar Andheri Link Road
    Andheri (E), Mumbai-400093
    Contact: +91-22-33074700/01/02/03/04
    Fax: +91-22-33074704