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JDRF Says FDA Threatens Artificial Pancreas Technology


Dec 8, 2011

FDA illustration of the components in an artificial pancreas

Will the federal government kill the artificial pancreas? The Juvenile Diabetes Research Foundation (JDRF) is raising the alarm over FDA guidelines that could stifle the technology necessary for the development of an artificial pancreas.

At issue is Low Glucose Suspend (LGS) technology, which uses blood sugar data to temporarily switch off an insulin pump when a user's blood sugar is heading south. It's an important first step toward an artificial pancreas, and the JDRF says that devices using LGS are already being used in 40 other countries.

The JDRF accuses the FDA of imposing burdensome rules that would delay the introduction of LGS technology in the United States for years to come. It has three central issues with the proposed regulations.

First, the JDRF writes, "This guidance will require multiple clinical trials (inpatient and outpatient) involving a large number of subjects in order to show statistically significant differences in preventing hypoglycemia.  This would be an excessive hurdle in order to make available to patients a simple but important feature."

The foundation recommends instead that studies focus simply on whether devices with the technology are safe. Once they were in the marketplace, data could be gathered on actual users rather than a limited number of test subjects.

Second, the FDA is unclear on whether continuous glucose monitors should be part of these studies. The JDRF points out that "the use of any other outcomes would be considered impractical by the diabetes research community." Put simply, this kind of technology really needs to be used with a CGM to have any point, and the FDA should require them as part of studies, the JDRF says.

Finally, the proposed federal guidelines would require separate studies for equivalent system components. In other words, competing LGS systems that work in the same way but have slightly different make-ups would each have to go through full clinical trials. The JDRF says this "would severely limit choice for patients and discourage the development of technologies serving a critical public health need."

The JDRF submitted its feedback to the FDA on September 20, and it urges changes to the guidelines as soon as possible.

"This proposed guidance by the FDA will only further delay access to this system in the United States," said Jeffrey Brewer, JDRF president and CEO. "We urge the FDA to resolve three core issues in the guidance to enable people with diabetes to have access to this lifesaving technology as soon as possible."


Sources

http://www.jdrf.org/index.cfm?page_id=116290
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm259301.htm#a7

 


Categories: Artificial Pancreas, Clinical Trials, Continuous Glucose Monitors, Diabetes, Diabetes, FDA, JDRF, Jeffrey Brewer , Juvenile Diabetes Research Foundation, LGS Technology, Low Glucose Suspend Technology



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Comments

Posted by Anonymous on 8 December 2011

The JDRF is a fear mongering organization. They have nothing to show for the last 40 years and $1.5 billion so they shifted their main mission/goal from a cure to more expensive treatments under the guise of "Transformative Research".

The Artificial Pancreas is overpriced and overhyped. They call it a "Breakthrough", but I beg to differ. Is a breakthrough wearing two catheters, one that still needs to be checked against daily fingersticks? Purchasing double the accessories from the companies that make the product with no 3rd party competition?

What is the JDRF and Endocrinologists response to patients that don't have the right psyche for wearing a regular pump let alone one that will require even more buy-in from the patient? Where is the JDRF in response to a pump that will do it all, which means more insulin use by patients due to the freedom of not having to do anything, hence more daily SUB-Q insulin use, more caloric intake, which will mean more obese T1's.

If this product is the best the JDRF and their 'brain trust' have to offer then they need to step down and realize they have failed millions of patients.

I have been a pump user for 14 years and find it to be a miserable experience that has put handcuffs on my freedom and the catheters have created nothing but scar tissue, bruising and lessened my insulin absorbtion. But, all of this will go away now that the AP is here and T1's will have to wear double the catheters for the rest of their lives.. A breakthrough would be more like one of the following: no more Sub-Q injections (which is 1 reason why there is hypoglycemia and poor control), no more finger sticks, a once a day or less injection with SmartInsulin. Those are breakthroughs, not reprogramming something we already have. Again, I say to the JDRF.. Thanks for nothing.

I hope the FDA bans the AP or at least make it extremly difficult to pass. All the AP will do is delay progress to a cure.

Posted by Anonymous on 10 December 2011

I wholeheartedly agree with everything the previous poster has written. I have recently decided to stop donating to the JDRF. This past year's walk a thon was my last. Fifteen years with Type 1 and donating large sums of money has led to NOTHING. I have seen no advancements. And I'm really tired of getting "new" technologies. I just want a cure. I don't want any more Band Aids to make my life "easier" with a disease that takes over my entire life.

Posted by rightmuch on 12 December 2011

I have to agree with the last post. The CGM's out there now are a joke and I can't imagine what a closed loop system would be like to endure. I was a pump user for 22 years and ditched it recently in favor a Lantus and Humalog pen regimen. So far it's worked better than the pump with less hassle and expense. Until they go back and perfect the implantable pump, we're stuck with what we've got.

Posted by Anonymous on 13 December 2011

I agree with the all of the previous posts but would also like to add that if the JDRF really wants to make life better for diabetics then please support Dr. Faustman's research. http://www.faustmanlab.org/ Furthermore, I don't have a problem with the FDA trying to make sure a product is safe AND effective before bringing it to the market. We all know that regular pumps can malfunction and fail, this happened to my child once. If a pump malfunctions, that is a very dangerous scenario, but if a continuous glucose monitor malfunctions, it could mean disaster. Isn't this why the FDA wants to make sure the CGM actually is more effective than current technologies? Why go through the expense and hassle if the end result is no better than what we have now? I don't think the FDA is being unreasonable at all. I sincerely hope that the FDA does not succumb to the pressure of those that want to hasten more products to a captive market. We meed to make sure that type 1 autoimmune diabetes is cured, not cater to those that would benefit by its current chronic status. This shouldn't be about money, it should be about quality of life. A real cure would definitely mean a better quality of life than another expensive gadget using the same paradigm since 1922, exogenous insulin delivery, instead of fixing the underlying autoimmunity.

Posted by Anonymous on 13 December 2011

Ok all of you, I'll be first in line when (and sadly if) the artificial pancreas clears all of these hurdles and is finally available in the US. Obviously you're not interested in benefitting from this technology, don't make it more difficult for the rest of us.

Posted by chanson3633 on 13 December 2011

While I disagree with the above posters to the extent that I think the JDRF has done some good things, I agree that the Artificial Pancreas is not one of them.

From what I can understand, the FDA is asking the proponent of the device to show "statistically significant differences in preventing hypoglycemia." This, I don't think they can do. Any intelligent diabetic can prevent hypoglycemia better than the AP - the reason being the diabetic knows more than the AP does.

As long as we are dealing with insulins that have an action time spanning 3-4 hours (Humalog)the AP will not be feasible. Of course, you can hook one up, with the CGM and program the pump to respond to the CGM, but it will always be playing "catch-up" because the action of the insulin is so slow. And, incidentally, time lag on the CGM is something like 15 minutes, too. This would not be an improvement over the existing system, where I can anticipate what I'm eating for lunch and bolus accordingly.

Please don't give us another device that will cost more money and only nominally (or not at all) improve our day-to-day lives.

Posted by shosty on 13 December 2011

I am so glad to see the above comments. I hope that JDRF reads them. Diabetes Health, are you at least listening?

My daughter would never use the artificial pancreas. The CGM is unreliable and cumbersome. The pump is reliable and cumbersome. She would not trust an automatic system, ever. Blood sugars are not that rational, and human intuition is needed to stay safe.

So how about the implantable pump? My daughter read about people flying to France every 3 months to refill that device, and would jump on a plane 4 times a year for that if she could. Why isn't JDRF advocating for something like that?

And competition over research ideas is another problem with JDRF.

I have stopped donating also. JDRF wants us all to "get in bed with" the corporations that make a lot of money off the suffering of type 1's. Nothing useful on the horizon for all that money.

Posted by Anonymous on 13 December 2011

I am in a distinctly different position than the previous commenters. Perhaps because I have been a Type 1 for 48 yrs and have only recently gone on the pump and CGMS. The advancements since 1962 are incredible and I am very thankful for them. Every improvement is a step toward what we all want.

I believe the FDA is more about money than improving health which is why I had to fight to get my health insurance to support CGMS. For those of you that see your life as a diabetic as so trying, try it without a glucose monitor and syringes that need to be boiled and no tests for HA1c's and . . . maybe your attitude might improve!

Posted by Anonymous on 14 December 2011

To the anonymous poster that has had diabetes for 48 years, I applaud all that you have had to persevere through.

The point that I was trying to make was that the technology has only nominally changed and the fundamental delivery of insulin (sub-q injections) and BG test methods (multiple daily finger-sticks) have not. Sub-q has been around for over 80 years and its physiologically incorrect and harmful/dangerous. The fact that absorption rates can greatly vary exposes T1's to a whole host of issues, including hypoglycemia from the release of stored insulin. What good is a CGMS if you still need to do the finger-sticks? I have a real problem with this as a 'breakthrough'.

Medical research has continuously over promised and under delivered and groups like the JDRF and DRI need to start being held accountable. I read somewhere online that over 90% of what works in mice will fail in human trials and yet we spend years and years and years playing with mice and extolling it as a 'possible breakthrough' simply to maintain the donation train. When was the last time an autoimmune disease was 'cured'?

The reviews I have read regarding the AP have some of the trials taking place in controlled hospital settings and I believe they just started having in home trials or out of the hospital for a few hours. That sounds great but I agree with the poster above, how will the pump handle stress, and real unpredictable life events? How will the pump handle eating disorders? I can tell you from personal experience that when I fly on a plane I can take 15 units of fast acting insulin with my BS being normal (80-100), not eat anything and I don't experience any hypoglycemic events. My stress level is so high that nothing works. That is real world.

To me, the JDRF has lost its focus and mission and is not pursuing anything that will save T1's from a lifetime of misery. The AP is not the answer. If you look at all they are pursuing, non of it benefits long standing T1's and the trials that involve anti-rejection meds won't be approved by the FDA. The JDRF is like a NFP museum, seeking donations to then say to the world look what we have, but don't touch with none of it useful.

Posted by Anonymous on 15 December 2011

To the commenter who said, "I believe the FDA is more about money than improving health which is why I had to fight to get my health insurance to support CGMS."

The FDA is not to blame for what your insurance covers. Your insurance company is responsible for what it does or does not cover. The FDA is there to make sure products and drugs are safe and effective for consumers and I hope they don't lose sight of that with all of the pressure on them to skip, lessen, or bypass rules regarding the AP. And for what it's worth, I am sick of people telling me how thankful I should be for not having to boil syringes. Since 1922, the basic premise has not changed! Exogenous insulin delivery for an autoimmune disease for close to 100 years and I should be happy about that?! The pancreas is not broken, the islet cells are not broken, they are being attacked by a broken immune system. So why is it so much to ask that the underlying autoimmunity be addressed rather than band-aid approaches that can, yes, keep us alive, but do nothing to address and cure this disease? It is tragic and not a little disgraceful that Dr. Faustman has repeatedly been denied funding for her human clinical trials. http://www.faustmanlab.org/

Posted by Anonymous on 16 December 2011

I agree with almost all of the articulate people above. I've had Type 1 52 years. JDRF was founded by parents & doctors who wanted a cure; they were unhappy with the American Diabetes Assoc. I too have contributed hundreds of $ to JDRF. I think it's been taken over, infiltrated and subverted by ruthless profiteering corporations. The good people within it don't realize they're being used. JDRF gave NOTHING TO DR. FAUSTMAN until exposed and an outcry broke out. www.faustmanlab.org, genetic medicine, stem cells, LCT's encapsulated porcine cells...I've more hope in those avenues. Why should I buy an expensive gadget requiring high monthly maintenance costs that would bankrupt me? Outrageous! JDRF like most "charities" is NOT democratic. They want your $, but they don't want you voting on leaders or research priorities. I really appreciate your comments!


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