It has been a little while since we’ve posted on FDA and the
artificial pancreas and we thought you might be interested in an update.
As you may recall, FDA and NIH held a public meeting in
November on the artificial pancreas. At
that meeting researchers, clinicians, and patients all agreed that there is a
way forward to take testing of these systems outside of the hospital. Since that meeting, JDRF has been continuing
to talk to FDA about the importance of incorporating the recommendations of the
experts they heard from into their decision-making. Clear and reasonable guidelines from FDA are
essential to stimulate the field even more and encourage more interest,
research, and innovation.
At the beginning of January, a few members from JDRF’s clinical
panel met with the FDA’s artificial pancreas team to explain their
recommendations, answer questions from the FDA staff, and get their input and
feedback. FDA was interested in the
panel’s recommendations and there was a fruitful discussion. Click
here for a summary of the panel’s recommendations.
And, the most exciting development is that JDRF is taking
the initiative to compile these recommendations into what’s called a ‘guidance
document’ that will be proposed to FDA.
We think that, with the recommendations of the clinical panel and the
consensus evident at the November meeting, now is the time for FDA to provide a
pathway for artificial pancreas development.
Having guidance from FDA will accelerate the ability of researchers and
companies to develop this much needed technology for patients with type 1
diabetes. By providing this guidance document to FDA, we hope to help
ensure there is a clear and defined regulatory pathway.
We’d love to hear from you below about what you think is
important for FDA to consider when they determine how to best encourage
innovation in the field of diabetes management technology.
And, don’t forget to tell us why an artificial pancreas is
important to you on the APP
Tell Your Story page.
If you want to relive or experience for the first time the
FDA/NIH public meeting, FDA
posted the webcast on its website.
How do you register to become a trial participant? I have a pump and cgm and been using them for years.
when they start recruiting for volunteers i would like to be considered. Feel i would be an excellent candidate in or out of the hospital. Geri
I have been a type 1 diabetic for over 35 years, and am very interested in the AP. i believe the technology needed and the concern i have, relates to the measurement of the actual blood sugar,m I wear a sensor and that tech is insufficient for a closed loop system. How will sensor technology be improved in order to be viable ?
I know my family and I appreciate all the work being done to end this disease. Please continue to provide the necessary guidance to those who may not have to live with diabetes. As I watch my granddaughter grow up and become a beautiful young woman my thoughts can't help but go to what will her future look like as she continues to battle with her disease. I had a sister-in-law die from complications at a very young age I don't want that for my granddaughter. Your continued efforts I hope and pray will bring an end for her and all the other children suffering right now.
I totally disagree with the recommendations because they suggest that all testing be done with people using insulin pumps. There are T1D that cannot use pumps for various reasons that should also be included in this study.
I have been a T1D for 28 years. I have been on many different theropies now including an Omnipod pump. My HbA1C is rarely below 9.5 and if I have consecutive days in a row without Hyperglycimia, I am surely to have multiple hypoglycimic reactions. The thought that this technology is near, gives me almost as much hope as the word CURE. Please continue to focus on helping us who need this the most. My children and wife also thank you for your efforts.
I am the Executive Director of JDRF's Houston Gulf Coast Chapter. I have the extraordinarily rewarding opportunity of watching many, many wonderful kids with type 1 diabetes grow and thrive, living full lives and triumphing over all of the challenges that diabetes hurls their way. But three times within the last two years, the families who make up the Houston Chapter have been punched in the gut by the death of a young person, a beautiful almost-adult just on the verge of soaring into adulthood. Each time, this precious person had a history of "good control." Each time, this precious person went to bed feeling fine and never woke up. And each time, our entire community plunged into a bog of shared grief. But not just grief--paralyzing fear too. Because it could happen to any one of our precious children on any night. And that is why I want the Artificial Pancreas.
I am a mother of a 10 year daughter who was diagnosed with Type 1 Diabetes in May of 2010. The idea that with an artificial pancreas she could be shot-free is truly a wonderful dream. I have been following the artificial body part stories since last years release on 60 mins. I am truly in awe of what we can actually accomplish with our countries brillant scientist/ researchers. I do think an issue that the FDA must consider is long-term health issues rather than short term symptoms.
I''ve had type I for over 51 years. I could not afford an insulin pump though covered by insurance. My brother tried it and still has it, but doesn't use it because he cannot afford the cost of the infusion sets. (He's 3 yrs younger and developed Type 1 three years after me).
From the day I developed diabetes Type 1, I've heard the mantra, "A cure is just around the corner." Now on Medicare I will have to chip in $1000 for a pump and $70 per month for infusion sets. We have both worked all aur lives including working thru college.
I would rather see something like a stem cell cure. Cancer patients in Seattle are treated with stem cellls, but not diabetics.
I want a cure not another device that just makes corporations richer. Thank you.
Butch Taylor made excellent points. My 9 year old daughter just had her 1 year anniversary as a Type 1 D. 6 months ago she got a pump, and although it is wonderful and allows her to better control her BG levels, I worry about how I will continue to pay for all of the supplies. I too want a CURE.
I agree with Butch Taylor, more money should be spent on a cure and not making the drug companies richer.
I have a 35 y.o dougther Type 1, and a 8 y.o grandougther Tipe one .
If the cure is not in the near future, then, the best next thing will be an artificial pancreas.I know it is expensive, but health care is even more expensive. Therefore, the goverment or some organization should help the one in need.
Stem cells, will take a long time to help diabetics. The faster something that help Tipe one to be as close as normal, will be welcome.
I developed T1D at age 13, 40 years ago. My father introduced me to Denton Cooley when I was 17 and said "he's interested in the future of pancreas transplants". Dr. Cooley patted me shoulder and told me to keep taking my medicine. I did. All the way through Div I college athletics, med school and residency where I learned to help people, and spent a large part of my career, with limb threatening complications of DM. I have never used a pump and don't feel anyone who hasn't should be excluded from the artificial pancres we so desperately need.
I am all for any treatment that will make life easier and safer for my 16 year old son. He was diagnosed with Type 1 diabetes just one month after turning 12. He (thankfully) is very active into sports and physical fitness. However, this makes it difficult at times to gauge his insulin dose, especially bedtime, as many of his sports activities are in the evening. He is currently on the pump and it definitely has been easier but there is still the risk of a severe low thru the night. I am thankful everyday for the gift of insulin and am anxious to be thankful for the next step...a cure!!
I have wriiten before and have never gotten a direct answer. I am all for the developmement of an artificial pancreas for everybody but was very disheartened to learn how the blood sugar is determined. I am a Type 1 Diabetic and have been for decades. I am also on the pump and I am using but will discontinue use of the sensor system that MiniMed uses with that pump. My main reason for stopping it's use is it's total inaccuracy. I have met others who have also given up on the sensor. It rarely is accurate even within 40% of my meter readings. It cries wolf way too often. I mainly use it now as an alarm to make sure I get up in the morning and not be in a coma because my BS has gone too low. I live alone. My alarm has gone off at night to tell me my BS is below 80 but doing a finger stick tells me my BS is actually around 30. I found out in a round about way that the artificial pancreas determines the BS the same way. I understand why interstacial readings are used but I will never incorporate an artificial pancreas that uses this method to determine my blood sugar and adjust my insulin based on this data!