Wondering why all the latest and greatest diabetes technology seems to get launched only in Europe these days? Wait, it gets worse…
Did you know that 40 different countries around the world have approved new Low-Glucose Suspend (LGS) technology — which allows a CGMS-augmented insulin pump to automatically shut off basal insulin when it detects a BG reading below the target range, an amazing safety 
feature! — yet FDA is still not anywhere close to being on board? The technology has been available overseas in the form of Medtronic’s VEO system for over two years now. Yet the FDA has only recently issued “guidance” on LGS in this country — and in a form that will thwart the availability of this lifesaving technology for years to come, according to JDRF.
Yikes! How frustrating! Want to know why? Because they are experiencing something called “Safety Paralysis” in which they’ve become so risk averse that they bog down everything in layers and layers of new pre-approval requirements.
But before we get into that, we’d like to thank JDRF for their unceasing efforts pushing for this new technology.
Late last fall, we reported on the FDA’s hearing on the Artificial Pancreas Project, much of which actually revolved around Low-Glucose Suspend technology. JDRF was insistent that FDA outline clear recommendations “to ensure the safe and effective testing of artificial pancreas technology in real-life situations” so that the value of LGS could be clearly documented.
This month, the FDA finally released the draft of their guidelines document and opened it up for comments until Sept. 20, 2011. JDRF, of course, led the charge in voicing our community’s concerns:
“JDRF believes that, as currently written, the proposed low glucose suspend guidance document is unreasonable and will delay the availability of lifesaving technology to people with type 1 diabetes who need it.”
In this PDF document, JDRF lays out three main concerns:
1. The clinical study pathway in the FDA proposed guidance is excessively burdensome and will require large, multi-year pre-market studies (slow! expensive! unnecessary)
2. No “adequate clarity” is provided on use of continuous glucose monitors (CGM) in LGS studies (some standardized commitment to the use of CGM in clinical studies is the only way to legitimize results)
3. Restriction on “equivalent components” in LGS systems studied is crippling (not allowing researchers to swap out components without a separate clinical trial on each new technology piece is going to immobilize further research)
JDRF showcases the vital (and oh-so-obvious-to-us) point that insulin itself is dangerous! “Too much insulin can cause dangerous low blood sugar and seizures, coma, or death,” therefore systems that can protect us from an accidental overload are crucial! The risk of receiving less insulin for a short period of time is low compared to the alternative.
So whhhyyyy is the FDA dragging their feet on this?
Because, as eloquently explained by medical device expert Karen Talmadge at the DiabetesMine Innovation Summit last week, that organization is very polarized. They tend to experience “pendulum swings” of over-ambitious approvals, and then back to mega-risk-adverse mode, otherwise known as “Safety Paralysis” or “Analysis Paralysis.” With some highly publicized drug scandals recently, they’d rather approve as little as possible at the moment, and not take any risks.
This doesn’t mean that there aren’t any good people at FDA, or that they aren’t working hard. It just means we patients have to sit tight while this risk-adverse Zeitgeist passes over. OR… we can keep hammering on them, and raising our voices until they get the message that in some cases, potential risks of using a medical device are lower than not using the device, and just letting the illness run its course!
If you want to learn more about how to follow FDA’s moves, see fellow D-Blogger Bernard Farrell’s excellent roundup here.
Last night I turned off the low alarms on my CGM so my husband and I could get a night’s sleep. I got my CGM in July and am still learning how to calibrate it. Too often, with a new sensor, we are continually woken up by low prediction alarms, falling rate alarms, and low alarms. At the same time, my meter will say I am anywhere between 120-180. With luck, the CGM becomes accurate 24 hours later and stays so for 24-72 hours, if I’m able to reboot the sensor, which I can do 50% of the time.
I have been talking with Medtronic’s Help Line and working with my CDE. Tonight I am going back for more training. CGM users seem to fall into 2 categories: those who wear it for a few months and then give up; and those who have been wearing them for years and adore them. I am working very hard to become the latter. However, Medtronic needs to manufacture a CGM that can be accurately calibrated both quickly and easily by an average person. Right now, my life revolves around this technology. I want my life.
Manufacturers need to improve CGMs so they can be accurately calibrated more quickly and easily. I’ve had mine since July. With almost every new sensor, my husband and I are woken up by numerous low prediction, falling rate, and low alarms. I’ll get up to check and my meter will say 120-180. I can’t recalibrate because of the arrows. I’m going back for more training tonight, but can understand the FDAs concerns.
Great article! Sadly, this is not a new problem. In the 70′s my dad and I went to England to get a bg meter because FDA would not approve them over here. From the time we got ours to the time they became available here was 5 years. England had already been selling bg meters to the public for 2 years, prior to our buying one.
Last year, I attended the Medical Innovations conference at the Cleveland Clinic, which focused on diabetes. 9 diabetes drugs went thru clinical trials and failed to make the marketplace only because of FDA concerns over unknown variable: Would they be Avandia? (pharma investment in drug development is $1.4B/ drug)
In the global sphere of medical innovations, US ranks 6th out of 50, but in getting new therapies to the marketplace we rank 49. Something needs to change!
I have written to the FDA re: LGS. To say it is frustrating is to put the best face on it.
FWIW, here is what I posted over on Bernard’s link:
“Good stuff!
Seeing all these links and reading what you have posted has to make me wonder if the FDA has been given too many things to do by Congress without enough funding, or if we need to re-think the way we regulate food, drugs and medical devices?
It also makes me wonder not only how long we can wait to make a change, but how we will make the changes necessary without grinding everything to a halt?”
Changes can be made, but they will require the political will of politicians of every stripe to ensure they are true and effective changes. It will assuredly take additional money.
Cheers,
Mike
Amy, thanks for the shout outs on my FDA-related posts. I think it’s going to be critical for the DOC (Diabetes Online Community) to engage with the FDA so we can assist and provide advice where appropriate.
I testified at the FDA Humalog advisory committee meeting in 1996. If that had not been approved I was planning to start importing Humalog from Europe. I’d hate to have to do that for devices because of warranty and units (mg/dL versus mmol/L) issues, but it appears medically as if we’re falling far behind other countries. As a US citizen I find that really disappointing.
This makes it hard for us to believe in “the system”, when constantly the system is what is standing in the way of us seeing advancement in technology and having better control of our lives as diabetics. I have had Type 1 for 17 years and have been on a pump for the last 9 years of my life. It would be amazing to be able to have these “updates” on my control so that I can take better care of myself.
This is why I am taking matters into my own hands and doing a juice fast that has better control of my insulin intake and overall blood sugars. Basically, what I am doing is only drinking blended up fruits and veggies for 60 days. I am on day 8 and it has done wonders for my bloodsugars! My boluses are down by 90% and my basal rate has decreased by 30%. Amazing what fruits and veggies with a low glycemic index can do! Not to mention, I have already lost 8 pounds of unwanted fat. If you are interested, you can follow me on my blog http://www.imjuicing.com.
Hi Amy, great post!! Go JDRF!!!!
It’s getting really heated now isn’t it? Hard to be patient. On the flip side I did get my daughter’s Omnipod orders last friday and she will go live over the weekend!!
But we also found out her celiac antibodies are through the roof! So she has to get endoscopy week after next and a biopsy.
When it rains it pours…
Best, Natalie
http://www.personalmedicine.com
http://www.personalmedicineokentucky.com
http://www.healthergy.net
To Mary Dexter: after using the Medtronic CGMS for 2-1/2 years, I am using the Dexcom and find it incredibly accurate compared to the current Medtronic system. However, I still use the Revel pump and really miss the integration of my pump and CGMS.
Medtronic has a new generation of CGMS which is more accurate and less painful. But guess what! It’s not approved by the FDA and is only being used in Europe….
Back from the meeting with the Medtronic rep (+ 2 CDEs and another LADA).Seems the false lows are caused by my warped body (scoliosis) pressing against the sensor while I sleep. Weak Signal is when the sensor briefly tips out (why do they put the most important part right at the skin’s surface) because the sensor isn’t at the perfect angle. Everything must be perfect for this mechanism to work. Unfortunately, neither I nor my life is perfect.
Also, remember all the complaints we’ve read from Europeans about them not being able to get pumps over there because pumps are not covered by their national health system. Many of them are still on syringes and fighting for test strips and meters. Perspective.
I have two sons using pumps and CGMS fully funded through the NHS. We don’t pay for insulin, pens, needles, strips, meters, infusion sets, reservoirs, tegaderm, cavilon etc etc etc, you know the everyday stuff we use
The problem here is not that pumps are not covered by the NHS (they have their own technological approval which means if a consultant says you need one, your Primary Care Trust have to fund one); its that old chestnut of teaching old dogs new tricks (how long does a trick have to be ‘new’ is a good question to ask – 40 years and counting it seems) and getting commissioners to see that saving a pound here loses lots of pounds later on down there. My goodness yes, they are big issues here still but we have many fantastic centres of excellence where pump use is very high and those in the know travel to such teams to get the best care. And those in the know who care also travel to sit in on national meetings trying to get the bigger picture message out there.
Your FDA problems are in a different realm to the NHS issues here. We have freedom to choose a full range of tech, and have to fight to get it funded by our health system. You have to do most of the funding and don’t get the full choice… I wouldn’t be liking them apples!
I don’t think this is a ‘count yourself lucky’ issue is it?
I have found the US families I have met equally as motivated, clever and caring as any one in any other country. This is about access to new technology which is being approved in other places and not for you at home. Maybe you have your own ‘old dogs’ but they are just a little higher up in the system?
Perspective is useful but not when it is used to excuse localised (in global terms) limitations in care.
Just read on TuDiabetes about a woman who just got the CGM for her Veo. On the drive home, after “successfully calibrating”, it decided to repeatedly turn off her insulin due to false low alarms. She kept having to turn her insulin back on.
The problem is that there’s an ‘established successful treatment’ for diabetes–finger-stick testing and injectable insulin. Trying to do anything else is gonna be very, very hard, because you’ll need to do one study to convince the FDA that it’s no worse than the baseline, and then another completely new study to convince them that it’s *better*.
[...] to develop this technology. Another issue in moving the Artificial Pancreas ahead is the FDA. Sorry to report this but is true. The LGS (low glucose suspend) is available in 40 other [...]