August 6, 2011

Repeat After Me: Dear FDA...


The FDA is seeking comments on how to evaluate diabetes related innovations, specifically, Low Glucose Suspend. In the simplest language that is stoping an insulin pump from delivering insulin into a person that is hypo. This is a step towards and artificial pancreas. 

Here is my four point, overly short, version of what the FDA is seeking comments on:
  • The FDA is proposing guidelines to consider approving low glucose suspend.
  • Low glucose suspend can stoping delivery of insulin to people who have had too much already.
  • The FDA is considering a lot of things including the risk of raising A1C with such a system. 
  • The FDA are open to considering studies for people under age 18 but they are not there yet.
My feelings is the FDA is way behind the times. Systems designed and made in the USA are on sale around the world but not here. In part because the FDA doesn’t know how to approve it. 

We deserve better.
There are a lot of reasons why we all should comment. If you care about artificial pancreas you should comment. If you don’t care about artificial pancreas you should still comment.  
I think the most important reason for us all to comment is so that the FDA sees the diabetes community as a group that is capable of, and willing to, hold the FDA’s feet to the fire. The DOC should be the FDA's squeaky wheel. 
People living with diabetes needs are different than virtually all other medical conditions. This is due to the extremely high level of self-management we do daily. The FDA should come to expect the DOC to comment on diabetes issues from artificial pancreas, faster insulin, smarter insulin, encapsulation of islets, and my pet peeve device interoperability through data sharing. Our voices should be part of the regulatory process. By commenting on as many diabetes issues as the FDA opens dockets for we can exercise such a voice. 

The more - the better.
The issue at hand is low glucose suspend. Given the tragic cases of young lives lost to severe lows, providing tools that can help minimize and prevent such lows is important. 
I of beg you, please do three things
  1. Learn about the FDA’s proposal.
  2. Comment on it
  3. Send a copy of your comment to your Congressperson
The comment space is 2000 characters. Think of it as one big-ass tweet. 

I encourage you to share what you write the FDA with the DOC - let others to use it as a template or help for their own comments. I welcome anyone willing to post what they write to the FDA as a link or comment here for others to use as inspiration and or a cheat sheet. 

Please also copy your comment into a email to your elected officials in DC. (I did mention squeaky and the more the better right?)
The following are a few sample comments that I offer up to be copied, edited and abused as form letters. Each are well under the 2000 character limit giving you room to expand, personalize and otherwise riff on the theme.
A Comment on Live Lost to Hypos:
I am a parent of a child with type 1 Diabetes.  Type 1 is extensively managed in the home by families. Yes we have a medical team of physicians, nurses, educators and more but day to day actions and decisions are made in the home by parents and teens living with diabetes.
Diabetes is difficult and stressful to manage. Diabetes varies based on a vide variety of things. The biggest risk we face and the biggest fear we have as parents is a severe hypo that results from the variety of things that impact diabetes. 
This is particularly stressful at night. As you consider low glucose suspend and it non inferiority based on A1C please keep in mind that a number of young people in the type 1 diabetes community have passed away due to over night hypos recently. Being alive with a A1C that increase due to low glucose suspend would be vastly superior than another fatality from a sever night time low. 
A Comment on Pediatric Approval and A1C Varibility:
Our family lives with type 1 diabetes. Day to day we are the primary managers of this chronic condition guided by our doctor and nurse educator. 
As the FDA considers low glucose suspend I urge you to fast track the pediatric approval of such a  device. Younger, smaller people are more sensitive to insulin as either basal or bolus injections. As such they tend to vary more than older people. Also kids face hormonal issues with growing that significantly impact and change insulin needs. Significant dose needs can change as rapidly as a few weeks. 
With the higher insulin sensitivity and more variable insulin needs due to growth, children are likely to see a wide variability in blood sugar numbers expressed as A1C. This proposal suggest non inferiority based on glycemic control as quantified by A1C. As you evaluate pediatric use please consider that kids’ glycemic control is a wider range of variability that adults. 
This higher variability means kids may see more and more severe hypos than adults. As  a result they are more at risk and are more in need of low glucose suspend. 
Please move to establish guidance for pediatric approval of low glucose suspend that recognized both the more pressing need to keep children safe and the higher variability in their glucose control. 

A Comment on FDA Proactivity:
As you consider guidelines for low glucose suspend, I urge the FDA to move from being behind the ball to being proactive. Low glucose suspend is already approved and available for patients across the world. It has been coming for some time yet the FDA seems to have been unprepared for it.
The FDA should consider developing guidelines for the more advance possibilities of an artificial pancreas. This would include the low glucose suspend now under consideration, possibly systems that introduce means glucagon for severe lows as well has high glucose insulin bolusing. Beyond the artificial pancreas the FDA should be preparing guidance for the approval of faster insulins, smart insulins, better infusion sets and data processing tools that facilitate better manual and automated glucose management. 
A Comment on Hacking and Distractions. 
In the time since the  FDA has opened this docket to consider devices to better manage type 1 diabetes through low glucose suspend, provided by multiple devices that communicate wirelessly, there have news reports about ‘hacking’ diabetes device wireless communications. 
The possibility of such interference is an appropriate issue for the FDA and device manufacturers to consider and to address in a timely manner. However such willful interference is extraordinarily unlikely. It  should not be seen as a reason to prevent far more significant advances to mitigate far more significant risks.
Specifically in the case of low glucose suspend, the risk of severe hypoglycemia is a real risk that has been made all the more tangible by the untimely death of young people living with type 1 diabetes in the past year. Developing guidance for the approval of devices that may have helped prevent such tragedies should be a FDA priority. Given that such devices are approved and available in other countries suggest that the FDA guidance, under consideration here, is in fact over due. 
I strongly urge the FDA to prioritize risks. Hypoglycemia is currently costing the lives of American children. Guidance on device such as low glucose suspend should not be overly delayed by esoteric communications risks.

8 comments:

Bennet said...

My comment to the FDA was a combination of two of the templates above and follows:


Our family lives with two teens on insulin pumps. Like most type 1s they are the primary, day to day, managers of this chronic condition guided by their doctor and nurse educator. Better smarter tools can help, particularly with high risk severe lows.

As the FDA considers low glucose suspend (LGS) I urge you to speed the guidance for approval for such devices for teens who self manage. Younger, smaller people are more sensitive to insulin as either basal or bolus injections. As such they tend to vary more than older people. Also teens face hormonal issues as they grow that significantly impact and change insulin needs. Their dosing needs can change as rapidly as a few weeks.

With the higher insulin sensitivity and more variable insulin needs due to growth, teens are likely to see a wide variability in blood sugar numbers expressed as A1C. This proposal suggest non inferiority based on glycemic control as quantified by A1C. As you evaluate pediatric / teen use please consider that their glycemic control is a wider range of variability that adults.

This higher variability means teens may see more and more severe hypos than adults. As a result they are more at risk and are more in need of LGS. Tragically the diabetes community in the US has lost a number of teens to hypoglycemia this past year.

Please move to rapidly establish guidance for teen and pediatric approval of low glucose suspend that recognizes both the more pressing need to keep children safe and the higher variability in their A1Cs.

Low glucose suspend is already approved and available for patients across the world. As you consider guidelines for it, I urge the FDA to look forward and be proactive.
The FDA should developing guidelines NOW for the more advanced artificial pancreas. Beyond that the FDA should be preparing guidance for the approval of faster and smarter insulins, better infusion sets and data processing tools that facilitate better manual and automated glucose management.

lukesdday said...

Thank you, thank you for posting! Spreading the word.

Michael Hoskins said...

Thanks for this, Bennet. Great comments and I appreciate you putting the link out there for the rest of us to use. I'm going to submit one now.

Matt McGuire said...

Thanks for the links. I sent my email off yesterday.

Bennet said...

Great Matt!

Any interest in sharing your comments?

Bennet said...

Caroline Sweeney's letter to the editor is a great role model post for a comment to the FDA:
http://www.pressherald.com/opinion/council-should-extend-petition-limit_2011-08-11.html?pageType=mobile&id=4

Mike Ratrie said...

Bennet,

Here is a copy of the what I posted on the FDA comments link you provided. I also sent it along to my Congressperson (Mica) and Senators (Nelson, Rubio).

Cheers,
Mike

"Having read the draft guidance regarding Investigational Device Exemption (IDE) and Pre-Market Approval Applications (PMA) for Low Glucose Suspend (LGS) Device Systems, there are at least two areas that stand out for me.

The first and most obvious one is why is the FDA putting together this lengthy and dense type document when these devices have been approved in over 40 countries AND have been in use for over three years. Surely in this time of near instantaneous communication of results, the companies who market these devices have already answered most if not all of the questions and concerns raised by the FDA. If not, the remaining questions and concerns should be relatively minor and not worth the time and expense of undergoing full-blown trials.

Note that by time and expense, I refer to not only the time and expense for both the FDA and the LGS manufacturers, but also the time and expense to the patient community that would benefit by having these devices immediately available. Indeed, delays like this strike at the heart of the public's confidence in the FDA's ability to follow its mandate.

The second issue that stands out is the HB1AC guideline for a successful trial. It seems to me that the FDA is being overly technical here and is missing the bigger picture - the avoidance of hypoglycemic events. In other words, a T1DM patient who has a 0.4% lower HB1AC without using a LGS system, doesn't just have a lower "number" without meaning to their quality of life, and in all likelihood they are not "healthier", because this lower number means they are spending more time with blood glucose levels that are too low. I urge the FDA to revisit this parameter of trial success, with a more expanded, less technical view.

There are other minor issues with the draft such as spelling and grammar, inappropriate links (there is one that literally links the reader to the very next paragraph) and language that just cannot be followed."

SANU said...

too good piece of information, I had come to know about your site from my friend sajid, bangalore,i have read atleast 11 posts of yours by now, and let me tell you, your web-page gives the best and the most interesting information. This is just the kind of information that i had been looking for, i'm already your rss reader now and i would regularly watch out for the new post, once again hats off to you! Thanks a lot