FDA approves 1st 'artificial pancreas' for type 1 diabetes
The U.S. Food and Drug Administration on Wednesday approved the first automated insulin delivery system -- a so-called "artificial pancreas" -- for people with type 1 diabetes. "This first-of-its-kind technology can provide people with type 1 diabetes greater freedom to live their lives without having to consistently and manually monitor baseline glucose levels and administer insulin," Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in an agency news release.
The device -- Medtronic's MiniMed 670G -- is what's known as a hybrid closed-loop system. That means it monitors blood sugar and then delivers necessary background (also known as basal) insulin doses. The device will also shut off when blood sugar levels drop too low. However, this device isn't yet a fully automated artificial pancreas. People with type 1 diabetes will still need to figure out how many carbohydrates are in their food, and enter that information into the system, the agency noted.
Medtronic said the new device will be available by Spring 2017. The FDA approval is currently only for people aged 14 and older. The company is now conducting clinical trials with the device in younger patients. Type 1 diabetes is an autoimmune disease caused by a mistaken attack on healthy insulin-producing cells in the body, destroying them. Insulin is a hormone necessary for ushering sugar into cells in the body and brain to provide fuel for the cells. People with type 1 must replace the insulin their bodies no longer produce, through multiple daily injections or through a tiny catheter attached to an insulin pump.
However, figuring out exactly how much insulin to give is no easy task. Both too much and too little insulin can have dangerous, even deadly consequences. And that's where this new technology will help. The device has a continuous glucose monitor that constantly measures blood sugar levels. A sophisticated computer algorithm then figures out if someone's blood sugar levels are too low or too high, and when too high, will give the correct insulin dose to bring the blood sugar level down.
The device does this via a small catheter inserted beneath the skin and attached to a tube that's attached to an insulin pump. This insulin delivery site needs to be changed approximately every three days. If blood sugar levels are too low, the device will shut down insulin delivery. In a statement, Aaron Kowalski, chief mission officer for JDRF (formerly the Juvenile Diabetes Research Foundation), said until there's a cure for type 1 diabetes, "I know that the artificial pancreas will change many lives for the better."
"People who have participated in artificial pancreas clinical trials have not only attained better overall [blood sugar] control, but have experienced the relief of sleeping through the night and waking up in the morning with blood glucose levels within target range. That's an improvement in quality of life that will be available to others living with type 1 diabetes very soon as a result of the FDA's decision," he said. Melinda Rose -- who has a grown son with type 1 diabetes, diagnosed when he was just 13 years old -- expressed excitement over the approval. The artificial pancreas "will revolutionize the way in which a person with type 1 diabetes manages this disease. In human terms, the parent of a child with the [artificial pancreas] system will now be able to sleep through the night and worry less." Dr. Gerald Bernstein, an endocrinologist and coordinator of the Friedman Diabetes Program at Lenox Hill Hospital in New York City, also expressed enthusiasm for the new device. "With the development of electronic devices to deliver insulin and measure blood glucose, the dream has been to tie everything together and have an 'artificial pancreas," he said. "The greatest inhibitor has been the complexity of insulin delivery and the development of algorithms that can come close to what the normal body does," Bernstein explained.
"This is a welcome step forward for people with type 1 diabetes," he added. "It will be many years for a biologic cure or prevention, and it is exciting to know that life can be better until the next best thing comes along." According to JDRF, there are currently 18 artificial pancreas systems in various stages of development, with Medtronic's being the first to receive FDA approval.
Medtronic was also the first, and so far only, company to receive approval on what's known as a "low-suspend" pump. That device, approved in late 2013, shuts off automatically when blood sugar levels go too low. However, unlike the newly approved device, the low-suspend pump did not provide insulin delivery. According to the agency, the FDA approval is based on data from a clinical trial of 123 people with type 1 diabetes. The study volunteers wore the device for three months. No serious low blood sugar (hypoglycemia) events occurred. And no one experienced diabetic ketoacidosis, a serious complication that can occur if someone doesn't get enough insulin, according to the American Diabetes Association.
As of April 23, 2015 - Please Donate
Please Support Keelynet and
help spread the weirdness...
Check out our amazing Ebooks, CDs and DVDs
You can download or order our ebooks on CD. We also have unusual DVDs that you might find of interest. And our Collections of files to save you money with ebooks on John Keely, Walter Russell, Chandra Bose, Rejuvenation, Homeopathy and much, much more.
DVD - the Physics of Crystals, Pyramids and Tetrahedrons
This is a wonderful duel DVD set lasting 2 hours and which presents one man's lifelong study of pyramids, crystals and their effects. Several of his original and very creative experiments are explained and diagramed out for experimenters. These experiments include;
1) transmutation of zinc to lower elements using a tetrahedron,
- Two DVDs - More Info and check out this Youtube Clip
2) energy extraction from a pyramid,
3) determining mathematic ratios of nature in a simple experiment,
4) accelerating the growth of food,
5) increasing the abundance of food,
6) how crystals amplify, focus and defocus energy,
7) using crystals to assist natural healing,
8) how the universe uses spirals and vortexes to produce free energy and MORE...
KeelyNet BBS Files w/bonus PDF of 'Keely and his Discoveries'
Finally, I've gotten around to compiling all the files (almost 1,000 - about 20MB and lots of work doing it) from the original KeelyNet BBS into a form you can easily navigate and read using your browser, ideally Firefox but it does work with IE. Most of these files are extremely targeted, interesting and informative, I had forgotten just how much but now you can have the complete organized, categorized set, not just sprinklings from around the web. They will keep you reading for weeks if not longer and give you clues and insights into many subjects and new ideas for investigation and research. IN ADDITION, I am including as a bonus gift, the book (in PDF form) that started it all for me, 'Keely and his Discoveries - Aerial Navigation' which includes the analysis of Keely's discoveries by Dr. Daniel G. Brinton. This 407 page eBook alone is worth the price of the KeelyNet BBS CD but it will give you some degree of understanding about what all Keely accomplished which is just now being rediscovered, but of course, without recognizing Keely as the original discoverer. Chapters include; Vibratory Sympathetic and Polar Flows, Vibratory Physics, Latent Force in Interstitial Spaces and much more. To give some idea of how Keely's discoveries are being slowly rediscovered in modern times, check out this Keely History. These two excellent bodies of information will be sent to you on CD. If alternative science intrigues and fascinates you, this CD is what you've been looking for...
- More Info
'The Evolution of Matter' and 'The Evolution of Forces' on CD
Years ago, I had been told by several people, that the US government frequently removes books they deem dangerous or 'sensitive' from libraries. Some are replaced with sections removed or rewritten so as to 'contain' information that should not be available to the public despite the authors intent. A key example was during the Manhattan Project when the US was trying to finalize research into atomic bombs. They removed any books that dealt with the subject and two of them were by Dr. Gustave Le Bon since they dealt with both energy and matter including radioactivity. I had been looking for these two books for many years and fortunately stumbled across two copies for which I paid about $40.00 each. I couldn't put down the books once I started reading them. Such a wealth of original discoveries, many not known or remembered today. / Page 88 - Without the ether there could be neither gravity, nor light, nor electricity, nor heat, nor anything, in a word, of which we have knowledge. The universe would be silent and dead, or would reveal itself in a form which we cannot even foresee. If one could construct a glass chamber from which the ether were to be entirely eliminated, heat and light could not pass through it. It would be absolutely dark, and probably gravitation would no longer act on the bodies within it. They would then have lost their weight. / Page 96-97 - A material vortex may be formed by any fluid, liquid or gaseous, turning round an axis, and by the fact of its rotation it describes spirals. The study of these vortices has been the object of important researches by different scholars, notably by Bjerkness and Weyher. They have shown that by them can be produced all the attractions and repulsions recognized in electricity, the deviations of the magnetic needle by currents, etc. These vortices are produced by the rapid rotation of a central rod furnished with pallets, or, more simply, of a sphere. Round this sphere gaseous currents are established, dissymetrical with regard to its equatorial plane, and the result is the attraction or repulsion of bodies brought near to it, according to the position given to them. It is even possible, as Weyher has proved, to compel these bodies to turn round the sphere as do the satellites of a planet without touching it. / Page 149 - "The problem of sending a pencil of parallel Hertzian waves to a distance possesses more than a theoretical interest. It is allowable to say that its solution would change the course of our civilization by rendering war impossible. The first physicist who realizes this discovery will be able to avail himself of the presence of an enemy's ironclads gathered together in a harbour to blow them up in a few minutes, from a distance of several kilometres, simply by directing on them a sheaf of electric radiations. On reaching the metal wires with which these vessels are nowadays honeycombed, this will excite an atmosphere of sparks which will at once explode the shells and torpedoes stored in their holds. With the same reflector, giving a pencil of parallel radiations, it would not be much more difficult to cause the explosion of the stores of powder and shells contained in a fortress, or in the artillery sparks of an army corps, and finally the metal cartridges of the soldiers. Science, which at first rendered wars so deadly, would then at length have rendered them impossible, and the relations between nations would have to be established on new bases."
- More Info
High Voltage & Free Energy Devices Handbook
This wonderfully informative ebook provides many simple experiments you can do, including hydrogen generation and electrostatic repulsion as well as the keys to EV Gray's Fuelless Engine. One of the most comprehensive compilations of information yet detailing the effects of high voltage repulsion as a driving force. Ed Gray's engine produced in excess of 300HP and he claimed to be able to 'split the positive' energy of electricity to produce a self-running motor/generator for use as an engine. Schematics and tons of photos of the original machines and more! Excellent gift for your technical friends or for that budding scientist! If you are an experimenter or know someone who investigates such matters, this would make an excellent addition to your library or as an unforgettable gift. The downloadable HVFE eBook pdf file is almost 11MB in size and contains many experiments, photos, diagrams and technical details. Buy a copy and learn all about hydrogen generation, its uses and how to produce electrostatic repulsion. - 121 pages
- More Info
Hypnosis CD - 3 eBooks with How To Techniques and Many Cases
If you have a few minutes, you might want to read my page on hypnosis and all the amazing things associated with its application. Included is an experience I had when I hypnotized a neighbor kid when I was about 14. As well the hypnotic gaze of snakes, the discovery of 'eyebeams' which can be detected electronically, the Italian Hypnotist Robber who was caught on tape with his eyes glowing as cashiers handed over their money and remembered nothing, glamour and clouding the mind of others, several methods of trance induction and many odd cases, animal catatonia, healing, psychic phenomena, party/stage stunts, including my favorite of negative hallucination where you make your subject NOT see something...much more...if nothing else, its might be a hoot to read.
- More Info
14 Ways to Save Money on Fuel Costs
This eBook is the result of years of research into various methods to increase mileage, reduce pollution and most importantly, reduce overall fuel costs. It starts out with the simplest methods and offers progressively more detailed technologies that have been shown to reduce fuel costs. As a bonus to readers, I have salted the pages with free interesting BONUS items that correlate to the relevant page. Just filling up with one tank of gas using this or other methods explained here will pay for this eBook. Of course, many more methods are out there but I provided only the ones which I think are practical and can be studied by the average person who is looking for a way to immediately reduce their fuel costs. I am currently using two of the easier methods in my own vehicle which normally gets 18-22 mpg and now gets between 28 and 32 mpg depending on driving conditions. A tank of gas for my 1996 Ford Ranger costs about $45.00 here so I am saving around $15-$20 PER TANK, without hurting my engine and with 'greener' emissions due to a cleaner burn! The techniques provided in this ebook begin with simple things you can do NOW to improve your mileage and lower your gas costs. - eBook Download / More Info
The Physics of the Primary State of Matter
The Physics of the Primary State of Matter - published in the 1930s, Karl Schappeller described his Prime Mover, a 10-inch steel sphere with quarter-inch copper tubing coils. These were filled with a material not named specifically, but which is said to have hardened under the influence of direct current and a magnetic field [electro-rheological fluid]. With such polarization, it might be guessed to act like a dielectric capacitor and as a diode...
- More Info
$5 Alt Science MP3s to listen while working/driving/jogging
No time to sit back and watch videos? Here are 15 interesting presentations you can download for just $5 each and listen to while driving, working, jogging, etc. An easy way to learn some fascinating new things that you will find of use. Easy, cheap and simple, better than eBooks or Videos. Roughly 50MB per MP3.
- More Info
15 New Alternative Science DVDs & 15 MP3s
An assortment of alternative science videos that provide many insights and inside information from various experimenters. Also MP3s extracted from these DVDs that you can listen to while working or driving. Reference links for these lectures and workshops by Bill Beaty of Amateur Science on the Dark Side of Amateur Science, Peter Lindemann on the World of Free Energy, Norman Wootan on the History of the EV Gray motor, Dan Davidson on Shape Power and Gravity Wave Phenomena, Lee Crock on a Method for Stimulating Energy, Doug Konzen on the Konzen Pulse Motor, George Wiseman on the Water Torch and Jerry Decker on Aether, ZPE and Dielectric Nano Arrays. Your purchase of these products helps support KeelyNet, thanks!
- More Info