Big News this week in the world of diabetes devices, Folks!
Two leading endocrinologist organizations have, for the first time in four years, updated their position on who should be able to get access to insulin pumps, while the Diabetes Technology Society (DTS) is launching a post-market surveillance program aimed at ensuring glucose meters and test strips are accurate even long after they're cleared FDA and are in the hands of people with diabetes.
Both are hot topics that our D-Community has been pushing for with recent initiatives: the StripSafely campaign for increased meter accuracy and a twitter and a social media blitz calling for increased access to insulin pumps. Now it seems we're gaining some traction, with these issues getting some much-needed attention from policy leaders and other decision-makers.
Of course, we're excited about both pieces of news and it will be interesting to see how they materialize and impact PWDs and all of the regulatory, industry, and medical players involved. But we also have to wonder if either announcement is all it's cracked up to be and whether these moves will actually help or hurt our D-Community, as more details emerge on the news announcements this week.
Here's a look at each item:
Ensuring Accuracy of Meters Already Being Sold
On Tuesday, the DTS announced the launch of a new post-market surveillance program that's kicking off this month.
We've been waiting on this update for eight months, since the DTS meeting on Sept. 9, where the creation of a Steering Committee was first announced as the next move on addressing post-market accuracy. Until now there were no updates whatsoever, even during the first months of the year when the FDA was welcoming public comments on draft guidelines for glucose meters used in personal and professional in-clinic settings. An incredible 500+ comments were submitted to the agency, but there wasn't any word on where the DTS Steering Committee concept stood.
This week, that changed with news of the DTS Surveillance Program for Cleared Blood Glucose Monitors. This independent, third-party program has a simple, two-part goal: to protect patients from the risks posed by inaccurate BGM products currently on the market, and to provide people the info they need to make the best possible device choices for themselves.
The DTS states that a protocol will be developed to assess each blood glucose monitoring system's performance, and that will include product testing. The information generated by this surveillance program will be shared with the FDA, which supports the concept and has stated it will act on information that it receives about low-quality or inaccurate products.
One early industry supporter is Abbott Diabetes Care, which is helping to fund the launch of this new program, and word is other companies are looking into coming on board.
"This surveillance program will provide a significant benefit to both patients and manufacturers," said Dr. David Klonoff, DTS founder and a professor of medicine at UCSF. "Patients will benefit by having access to more accurate meters on the market and manufacturers committed to delivering accurate products will now have an opportunity to back up claims about quality and accuracy with proof from this independent, third-party testing program. I encourage other manufacturers to come forward to join Abbott in support of this program."
Right now, there's no systematic post-market surveillance program that tracks ongoing product quality -- aside from what individual manufacturers do internally, but there's no consistent policy and no requirement that manufacturers share those practices publicly. As a result, low-quality meters can flood the market once they've passed the initial hurdle of FDA clearance; there's no way to check how these products perform once their in the hands of multitudes of patients.
While FDA is looking to tighten pre-approval accuracy requirements, those standards are almost meaningless if there's no guarantee these devices will continue to be accurate once they're being sold to people.
For this new program evaluating "post-market" accuracy, the DTS is forming a Steering Committee and Advisory Committee, both of which will include a yet-to-be-specified number of experts from academia, medical practice, clinical chemistry, government, industry, and medical organizations -- along with patient advocacy groups! We couldn't be more thrilled to see patients represented, and seriously have to tip our hats to the StripSafely movement for putting the patient voice on the radar with the FDA and industry during the past year. Klonoff says that recommendations on specific patient advocates to include will come from the Steering Committee and DTS board.
Of course, it's early and details are limited. Klonoff tells us that since there's no precedent or protocol for how this will all actually work, it is not yet clear how manufacturers will be advised or involved in the process if they're not a part of the reviewing entities. The FDA is supportive, but equally unsure how this will all play out.
"We don't know a lot of specifics right now," said Dr. Courtney Lias, director of the FDA's Division of Chemistry and Toxicology Devices within their CDRH/OIR division. "As we said at the meeting last fall, we believe that a well-run and credible surveillance program for glucose meters may prove to be very helpful in generating signals that will help us focus our enforcement efforts. We are following this with interest."
As are we all.
It's interesting, too, that DTS is working with FDA on creating a new error grid that might replace the 1987-created Clarke Error Grid that's a staple in determining accuracy on glucose meters. There's not much detail yet on that either, butKlonoff says the project is "very far along," and an article on this new metric will soon be published in one of the diabetes professional journals. He's also planning to discuss the new error grid at the upcoming American Diabetes Association Scientific Sessions in June, as well as at the July meeting of the American Association for Clinical Chemistry and again at the DTS meeting this November.
Lots of good stuff on the horizon for ensuring accuracy. And that's not all...
More Doctor Support of Insulin Pumps (?)
Also this past week, a new "consensus statement" on insulin pumps was issued by the American Association of Clinical Endocrinologists (AACE) and American College of Endocrinologists (ACE). This is the first update since the 2010 statement, and is more specific than the past document in detailing how the endo world should approach training and use of insulin pumps.
The goal for this updated statement is to "bring some reason into the whole field of insulin pump management," says Metro Detroit area endocrinologist Dr. George Grunberger, AACE president-elect and chair of the insulin pump task force that developed this new statement.
He says the consensus addresses the fact that more people are using insulin pumps these days and doctors aren't always keeping up with that trend, so those in charge of examining this issue want to make sure the profession is equipped to get these devices into the hands of PWDs who are able and willing to use them effectively -- especially type 2s! The statement praises insulin pumps and the benefits they can provide if used correctly, everything from better glycemic control and A1Cs, to fewer hypos and greater improvements in quality-of-life. And it lays out some common-sense prerequisites for pumping that shouldn't be surprises for anyone. To be a good candidate for a pump, the patient should:
- Have T1D or T2D that requires intensive insulin treatment
- Be motivated to achieve optimal blood glucose control
- Be capable of executing the complex and time-consuming therapy
- Maintain frequent contact with his/her healthcare team
- And the doctors and staff should be equipped to know how the devices work, providing training as needed
"We tried to emphasize and re-emphasize that it's important to select the right patient for this kind of treatment. That's the bottom line -- these devices can do wonders for patients' lives, but our concern is that in many cases both the patient and provider settings aren't optimal," Grunberger says.
On its face, this sounds like good news. But when looking into the 27-page consensus statement issued May 17, we really do have to wonder if the new position will actually strengthen support for use of insulin pumps or cause more doctors and endo's offices to turn away from prescribing them.
In detail, the statement says:
- An "appropriate" patient for an insulin pump is either a Type 1 or Type 2 PWD who performs 4 or more insulin injections and 4 or more blood glucose checks each day. (This is more detailed than the general "intensive insulin therapy" mentioned four years ago.)
- There's no age requirement for children or any length of time someone must be diagnosed before going on a pump. But pediatric would-be pumpers will have to show evidence of severe hypos, widely fluctuating blood sugars, and supportive and pump-interested families before they can get a prescription. And docs must be prepare to take away the device if the child is unable or willing to "perform the minimal required tasks."
- The doctor's practice must be available to their pumping patients 24/7 (something the task force acknowledges that only a small percentage of endo's offices are equipped to handle).
- Hospital and emergency settings aren't equipped to keep up with insulin pump tech, so patients must "be their own advocates" and make sure there's constant communication with their own endo or diabetes specialist if they are in these urgent care settings where pump use is compromised. (That's quite a challenge when you're laid up in urgent care.)
- Schools don't have much training and with so few school nurses, "more basic pump knowledge is needed in school settings." (Does this imply that pumps aren't safe at school?)
Some of these specifics are on point, but others seem very likely to cause the opposite of increased pump use, IMHO. Grunberger admits that the constant-communication aspect could be intimidating to practitioners and dissuade them from prescribing pumps as often.
Furthermore, the task force estimates that less than a quarter of the endos practicing in this country are equipped to provide the best resources for someone on an insulin pump -- and Grunberger says if the office isn't equipped, then those providers shouldn't be recommending pumps for their patients.
""This may be intimidating and discouraging, and that's fine. Our concern is safety. We have hundreds of thousands of adverse events reported through FDA, so we (physicians) have to be concerned, as they are, with these devices being used properly. Only the physicians have the ability to make the call on treatment."
— Dr. George Grunberger, AACE president-elect and insulin pump task force chair
Ouch. Grunberger says it can't fall onto pump trainers to provide all the necessary education and support, at least not to the extent of taking away from the responsibility doctors' offices have. He also notes that expertise aside, the simple tasks of downloading and reviewing patient data from insulin pumps is labor-intensive and time-consuming, and isn't something reimbursed so it cuts into patient visit time for these doctors.
Hmm, this is sounding less and less like support for pump therapy all the time...
Of course, each doctor has to determine for themselves how closely they'll follow these statements and interpret them for their own practices.
The upshot is that it still feels like AACE and ACE are behind the times when it comes to insulin pumps, even with this updated statement.
Again, for both of these issues -- evaluating the accuracy of existing testing devices and supporting access to insulin pumps -- the devil's in the details when it comes to what happens next. It's encouraging to see these two issues being addressed and talked about, but we'll just have to wait and see how and when real improvements may materialize.