Repeat After Me: Dear FDA
I am not an expert on writing anything. I usally have comma’s in the wrong place, run on sentences- you get the point. After #DSMA’s chat, Dear FDA- I contacted the JRDF to see if there was a “How to guide” for the FDA, there wasn’t. Hasan from the JDRF posted information on Juvenation’s webiste. I read the information provided on JDRF’s blog and the information Bennet provided on his Dear FDA post on ydmv.net. I finally decided to sit down and read JDRF’s position on the FDA guideance for the Low Glucose Suspend (LGS) Guidance. I am so glad the JDRF wrote their position in a way that people like you and I could understand. I thought about it. I thought about all of the children and adults that passed away in their sleep because of a low blood sugar. I agree with JDRF’s position. IMO, people living with diabetes and on insulin need LGS technology. I decided to send a comment to the FDA.
Here’s my comment:
Thank you for taking the time to help better the lives of people living with diabetes. I was diagnosed with Type 1/LADA (Latent Autoimmune Diabetes in Adults) in June of 2004, I was 23 years old. Yes, living with diabetes has changed my life tremendously-I try not to complain. I was able to live 23 years of life without worrying about going into a coma or dying in my sleep because of hypoglycemia unawareness. My mother was able to sleep without checking my blood sugar or pulse to make sure I was still alive. I was able to live a “normal” life. There are many children living with Type 1 diabetes who will not make it to see their 7th birthday, go on their first date, get their driver’s license, graduate from high school, go to college or reach the age of 23 because they were unaware of a low blood sugar that caused them not to wake up.
Now, I’m writing as a 30 year old, living with diabetes, wife and mother. I worry about not waking up or having a car accident because of a bad low. I want to be able to go to sleep at night and drive a car without worrying. I’m tired of worrying. I am not alone; many other people living with diabetes, parents, spouses and caretakers feel the same. Please do not slow down the process on approving LGS (low glucose suspend )technology, there are many people living with diabetes in other nations that have the LGS technology-it’s helped saved the lives of many people living with diabetes.
Please do not discourage manufactures by requiring separate individual human clinical trials before any equal component in the LGS system is substituted. Please allow outpatient studies for LGS technology, verses in-hospital studies and let safety be the primary outcome. Technology is all we have. We depend on it to keep us safe and save our lives.
Thank you in advance for allowing patients to have a voice.
If you want to send a comment to the FDA about the LGS system, you have to submit it by September 20, 2011.