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Artificial Pancreas Archives
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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.

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 LeeAnn on 30 March 2012

As a pump and CGM user with Type 1 diabetes for 41 years I would love to participate in the trials. I have seen so much change in the course of my life with diabetes and an artificial pancreas has always been my hope. Let me know how I can get involved with this project.

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

To the person that said 'I clearly don't live with diabetes'. Well, I have lived with it and all the empty promises and false hopes for 30 years. Have a nice day!

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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