Wednesday, August 10, 2011

Dear FDA

Finally, the FDA is exploring a diabetes innovation that is long overdue: Low Glucose Suspend. Basically, the CGM-component allowing an insulin pump to detect what your blood sugar is at and shut off it reaches a certain threshold that's too Low for comfort. This allows someone who may very well be sleeping overnight to not drop any lower with continued insulin before being able to treat, wake up, or at least become aware that something isn't right.

Worldwide, this is already available and the U.S. is simply behind - mostly because of the FDA's reluctance to approve this and ask the important questions to assess why this option is so necessary.

But now, that's happening. The FDA has released some draft guidelines that are up for public comment, and want to hear what everyone thinks about the proposal. Bennet over at YDMV has a great write-up about this, and he is just one of the many Diabetes Advocates who's hoping the broader Diabetes Community will get word about this and make our collective-patient voice heard on this.

What they're looking at includes how they should allow Low Glucose Suspend, how that might stop delivery of insulin to people who've already had too much insulin or are already Low, and how a system that cuts off insulin might increase risk of raising one's Hemoglobin A1C over time with higher BGs.

To post to the FDR public docket go here: http://www.regulations.gov/#!submitComment;D=FDA-2011-D-0464-0001.

Everyone is also encouraged to copy their comment into an email or letter to the elected officials at both the state legislature and Congressional levels, so that more eyes are brought into all of this. Below is a copy of what I've sent to the FDA and am mailing to my elected representatives.

Dear FDA...
One of my greatest fears as someone who lives with Type 1 diabetes, is not waking up because of a Low blood sugar. Local paramedics have made multiple trips to my home because of overnight Lows that have resulted from an inbalance in my blood sugars, issues that have occurred without any warning despite all the management care that I take each day and night. Even with the multiple blood tests, meal management, and accurate insulin dosage, Low blood sugars happen and have dropped me so low that I am not able to wake up or function on my own. They have caused me to thrash and even become violent, hallucinating and trying to harm my wife as she tries to get more fast-acting sugar into my system to counter this hypoglycemia.

Both children and adults with Type 1 diabetes have died as a result of these overnight hypoglycemic events, and even those happening during the daytime hours, causing them to lose awareness suddenly without warning.


One way to prevent these tragedies and potential risk would be a Low Glucose Suspend, an option that is currently available on insulin pumps outside of the United States. These work effectively and save lives, however this is not available in the U.S. because of the FDA’s regulatory review process. If someone is going Low in the night but does not realize and have the ability to wake up to suspend his or her insulin delivery, then this Low Glucose Suspend system would allow that person to have a safety net preventing them from continuing to receive insulin – dropping them even lower and into a possible coma.

I am pleased that the FDA is finally considering this, and do hope the realistic concerns of people with diabetes are addressed – the hypos and the balance of juggling these Highs and Lows in our daily lives. Not the slight increases in Hemoglobin A1c numbers, which are just one indication of a person’s D-management and really mean nothing if that person dies from an overnight low.

Our A1c tests are not perfect, and are simply one resource in a very large and ever-expanding tool box that we use to manage our diabetes efficiently and practically. Living with diabetes is preferable to dying because of diabetes, something that is more likely now as a result of not having this Low Glucose Suspend capability.

As a country, our current regulatory system preventing this life-saving option means we are behind the eight ball on this technology and losing innovation and dollars to other places globally that have Low Glucose Suspend available. I’m hopeful that the FDA develops guidelines bringing us more in line with what’s available worldwide, and also aids in the development of future innovations such as the Artificial Pancreas.

Since the FDA started taking comments on this topic, some news reports have circulated about potential risks to those using wireless medical devices such as insulin pumps and continuous glucose monitors. While these “hacking” possibilities do theoretically exist in this 21st Century, I’m not concerned and have faith in the process you have reviewing these issues. I continue to trust that the medical device manufacturers are aware of these possibilities and address them accordingly. While a threat may exist in theory, the risk is non-existent and shouldn't be blown out of proportion. Please don’t let these far-fetched, unlikely scenarios hold up these valuable life-saving tools for those of us Living With Diabetes and facing these concerns every day. It’s so important for the FDA to prioritize these risk and evaluate them objectively, based on what the real concerns are for those using these devices. Hypoglycemia is currently costing the lives of American children and adults – those high stakes mean that this guidance is incredibly important and must be done adequately as soon as possible, in order to not remain behind the rest of the world in providing innovative technology to protect lives.

Thank you kindly,

Me.
(A Pancreatically-Challenged Taxpayer Who Loves Cupcakes and CAN Eat Ice Cream while preparing for the Zombie Apocalypse.)

4 comments:

The DL said...

Great letter!! I really hope they listen!!

Kelly Booth said...

Thanks Mike

Meagan said...

This is really a great idea...hope they do it!

I went low once at night, it was the scariest experience of my life. I will never be able to forget that night.

My sister is married to a T1 Diabetic and the letter brought up the same things she's gone through as a result of the nighttime lows with her husband. Thanks for sharing this.

Natalie said...

Good job, Mike!! :-)

I really need to have a back-up for night-time lows because I live alone and have no one to rescue me. If I don't wake up, then that's it, and I don't want to die like that!