Keep Your Fingers Crossed: FDA Approves Artificial Pancreas Outpatient Trial

| Mar 27, 2012

The FDA has approved the start of outpatient trials of a smart phone-based monitoring device that functions as an artificial pancreas. If the device, which automatically measures blood glucose levels and adjusts them with insulin, is successful, several million type 1 patients could enjoy a whole new level of convenience.

Trials are expected to begin in early May.

The hand-held device, developed by a research team at the University of Virginia School of Medicine, uses a reconfigured smart phone to automatically monitor blood glucose levels and adjust as necessary with insulin doses. The UVA product is part of a larger collaboration, the Artificial Pancreas Project, that involves several US and international organizations. Among them are the Juvenile Diabetes Research Foundation, the University of California, Santa Barbara, Montpellier University Hospital in France, and the Universities of Padova and Pavia in Italy.

The artificial pancreas is a sort of Holy Grail in diabetes technology. On paper, the concept is simple: Create a device that can continuously measure blood glucose levels and send commands to an insulin pump to inject corrective doses of insulin. A workable device would free insulin users from an often laborious lifelong routine of constant monitoring and adjusting.

However, because of the stakes involved, the requirements for an artificial pancreas are especially high: It must be made of extremely durable and accident-resistant material; its measuring capabilities must be extremely accurate; it must be small enough to allow for user comfort.

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Categories: Artificial Pancreas, Blood Glucose Levels, Diabetes, Diabetes, FDA, Insulin

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Posted by jennyl75 on 27 March 2012

How can we participate in this trial?

Posted by Anonymous on 29 March 2012

Hmmm. Possible eating disorder by a few wayward individuals or freeing people who suffers through daily insulin injections, finger pricks, constant fear of insulin reactions,and last, but certainly not least, the threat of blindness, kidney disease, neuropathy, impotence, heart attack, stroke and all sorts of other deadly complications.
Put a stop to it???? Fund it to the hilt!

Posted by Anonymous on 29 March 2012

You clearly don't live everyday with Diabetes. This is like saying we shouldn't give pain killers to people who have just had a major surgery or injury because there is a chance that they'll develop an addiction to it. What if someone who struggles to keep their blood sugar controlled and 15 years from now has to have a leg amputated could use the AP and avoid any serious side effects. I think this is a great alternative to stabbing yourself with needles multiple times a day.

Posted by Anonymous on 29 March 2012

Anyone who doesnt think that this is a fantastic step forward in treatment of diabetes is just plain crazy. Hopefully this will help prevent the complications of diabetes and the awful hypoglycaemic episodes and mean that people with diabetes can live a decent life like any other human being. I'm crossing fingers, toes etc that it works well and gets approval. Hip hip hooray if it does

Posted by shosty on 29 March 2012

My daughter is not interested in this approach to her type 1. The continuous blood glucose monitor is not accurate enough, and insulin decisions are based on so many factors, most of which are intuitive, that she never wants to give up making them to a device. We don't donate to JDRF anymore. We wish money went toward a real cure, and toward implantable pumps in the meantime.

Posted by Anonymous on 1 April 2012

I agree that this will not necessarily mean all Type I-s will run amok with this newfound freedom. As a Type I for 37 years I wouldn't expect much change to my diet at all, but would welcome the health benefits of being able to have sugar highs or lows treated in as close to real time as possible. Besides, the FDA cannot possibly control individual choices. Indeed, there's no vacation from Type I diabetes, but we should embrace the tools to make it as manageable and healthful as possible.

Posted by Anonymous on 4 April 2012

Even for those Type 1's NOT on the pump, I would love to see my 10 year old son free of pricking his finger multiple times a day and me getting up in the middle of the night to see if he's low. A continuous real-time monitor of his BG would be welcome... if he goes too low at night, I could simply set an alarm on the device and get him a juice... and for those folks who cannot feel a low coming one (luckily my son can)... I would suspect it would be a wonderful preventive tool. Hopefully, it would be a technology much like a micro-chip the size of a piece of rice easily administered into anyone who is looking for this solution. I would love to see this as an option as a cure is pursued.

Posted by Anonymous on 4 April 2012

To the few postings that indicate this will free them from daily finger sticks, DO YOUR RESEARCH! Any endocrinologist or diabetes educator will tell you that the CGM is a trending tool and does NOT replace fingersticks. The fact that it's a trending tool also supports why its not been adopted universally by insurance companies, including medicare, for coverage. Why pay twice to test one's BS? After all, I believe the CGM tests interstitial fluid not blood. And, if you are taking shots now then what's stopping you from going on a pump today? If its insurance, that's something you need to resolve but if it won't cover a pump today, I doubt it will cover one tomorrow. Even the AP.

There is a huge difference in telling T1's we have this great technology that will do EVERYTHING for you versus YOU still need to prick your finger 4x per day and figure out your boluses and etc.. The eating disorders will occur over time as people become complacent. That extra slice of pizza, scoop of ice cream, will not be an instant no, and with better control will come weight gain depending upon your genetics. So, I still think way more needs to be done regarding this technology and until they can answer all the questions, and not just force it thru the system, it needs to slow down or cease.

The JDRF has nothing in their transformative research pipeline and they haven't brought anything bedside that would be 'revolutionary' in how T1 diabetes is managed. We still inject sub-q after ~90 years. This AP is make or break for them because they are all about prevention and complications since the CURE is a pipe dream. And, prevention is not a cure!

Posted by Anonymous on 5 April 2012

As a pump and CGMS user, I have to say I'm dubious that they've solved the accuracy problem well enough for this to be reliable. We need a BIG step forward in reliability and accuracy of the sensors, even if they've somehow solved the hairy automatic prediction problem ("blood sugar rising -- did she just eat a big meal or a light snack? How much insulin is it going to take to stop this climb?")

Posted by crst32 on 5 April 2012

This sounds wonderful. I have lived with diabetes since I was 23 months old. I am now 43 and have no problems associated with diabetes do to all the advances that have came about in my lifetime. I look forward to this and all other advances that make controlling this disease easier. Bring it on!
How can we get involved in the trials?

Posted by Anonymous on 5 April 2012

To the Anonymous who says "I have lived with [diabetes] and all the empty promises and false hopes for 30 years" -- What's with your depressingly pessimistic crusade against new therapeutic technology? Maybe you just need to manage your expectations better than you do your blood sugars? A positive attitude almost always leads to positive outcomes, in my experience. Give it a try?

Posted by Anonymous on 5 April 2012

Smart phone based??????????? I don't have a smart phone, I have a dumb phone, it (well........) MAKES AND RECEIVES PHONE CALLS! IT'S A PHONE! I can see me contacting my insurance and telling them to buy me an iPhone to control my bgs! AND I sure hope that this system will be more accurate than what we currently have. I tried the Dexcom and for me, it was so inaccurate as to what my bgs really were, I would not want to trust such a system to try to automatically control my bg. And, I hear a lot of Minimed users report inaccuracies in their CGM systems as well. The CGMS people tell me it's more to report trends. Do I want an artificial pancreas guessing what my bg might end up being based on trends? I think not. I sure hope they're really trying to be ACCURATE because, if it's going to be a pancreas I want it to work as a PANCREAS, not some artificial thing that may be more inaccurate than accurate. And, if they really can get it accurate enough to call it an "artificial pancreas" then why can't they get the current CGMS to be more accurate????? Can you see how unimpressed *I* AM?????

Posted by Anonymous on 9 April 2012

My crusade is not against technology, it's against falsely stating what a "magic bullet" it is. I.E. "Artificial Pancreas"!

I am very pessimistic towards all the "breakthroughs" because we have yet to see anything bedside. We still deliver insulin sub-q, if you're not on the pump you most likely take 4 shots per day and all of us still prick our fingers 4 or more times per day, so I believe the pessimism is well deserved.

If you look at the JDRF, DRI, and others, their fundrasers are advertised for the "CURE" and yet very little of the monies go toward cure research, it goes toward complications, technologies, and prevention (not a cure for those already afflicted). Was Polio, Tuburculosis cured? Get a clue! So, don't sit there and judge my expectations when my expectations are directly related to what all of the "Leaders" in T1 research are advertising! Maybe they should be truthful and advertise "Prevention, Technologies, and Complication" Walks, Gala's and all the other fundrainsing events they do in the name of a CURE. I guarantee if they did that, the money would dwindle.

Posted by Anonymous on 15 April 2012

I am not diabetic but have friends that are and monitor technology for them. I have been a software developer for many years of embedded projects and recently completed development on a "pseudo" medical device that uses a headband with a smart phone based application to monitor sleep. The project discussed here seems to tout the fact that it is "smart phone based" as an important aspect. I think what is important is everything else involved (particularly the monitoring approach and the algorithms that use those results to control the pump).

I specifically worry that this is not an application that should be smart phone based. Smart phones are wonderful and can do many things. They are not expensive for what they do. But they aren't reliable enough in my opinion for a "life critical" application that has to run 24/7. It's sort of like in the old days when the Air Force brass wondered why they couldn't use PCs in the cockpits of planes to save money and I reminded them that it wouldn't be great if their PC crashed with "the blue screen of death" and had to be rebooted in the middle of a critical maneuver.

But if all the other parts of this sort of system can be worked out then finding a cost effective and reliable platform to run the application on will not be an insurmountable problem. For the sake of my friends I hope good forward progress continues!

Posted by Anonymous on 30 June 2012

Indulgent eating? Give me a break I am T1 Diabetic and have been trying to actually loose weight without my glucose going all crazy and it doesn't work. I deided to try a diet like everyone else and my hemoglobin A1C was 8.5 insead of 6 so diabetics can't loose weight unless they want to pay out of the arse for high dollar diet supplements and foods. I say fund it all the way I'd be over the hilt happy to loose the weight by eating properly.

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