Smartinsulin Insulin That Knows When It's Needed!
Main Category: DiabetesArticle Date: 05 Nov 2008 - 2:00 PST
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JDRF announces the launch of a £600,000 ($1 million) project to help develop a new type of insulin treatment for people with type 1 diabetes.
SmartInsulin is the idea of Dr Todd Zion, the CEO of SmartCells, Inc., a biotechnology company based in the USA. The concept is simple - deliver insulin in such a way that it is only released into the blood stream when it is needed. The new approach involves using a plant-derived protein that can bind and release insulin in response to glucose levels.
The theory is that SmartInsulin could be formulated so that people with type 1 diabetes would only need to inject the drug once each day, as opposed to the multiple daily injections they need currently. Once injected, the molecules would 'stick together', only releasing insulin when blood sugar levels rise above a certain threshold, and stopping when these levels fall again. In this way it, should be possible for people with type 1 diabetes to have much tighter control of their blood sugar levels, reducing the risk of diabetic complications, which include heart disease, kidney disease and eye disease.
Karen Addington, Chief Executive of JDRF in the UK, said: "Helping people with type 1 diabetes to improve their blood glucose levels is vital to reducing the risk of complications. Improving levels by 10 per cent can reduce the risk of complications by as much as 40 per cent. SmartInsulin could offer dramatically improved blood glucose control as well as removing the need for up to six injections every single day."
JDRF's funding will help to speed up the process of preclinical safety and efficacy testing for this exciting new treatment idea. By supporting the project through its innovative Industry Discovery and Development Partnership Program, JDRF hopes to reduce the time needed to get this therapy into clinical trials with people with type 1 diabetes.
Aaron Kowalski, Ph.D., Director of JDRF's Metabolic Control Program, explained that JDRF is committed to supporting the development of unique therapies that can improve metabolic control for people with type 1 diabetes: "We believe that glucose-regulated insulin may represent a practical solution to the real needs of people with diabetes, and this collaboration illustrates our dedication to accelerating the pace of science leading to cures and treatments for people with type 1 diabetes by helping innovative companies test concepts and bring their products to patients faster."
About type 1 diabetes
- Type 1 diabetes is a serious, life threatening condition caused by the body's own immune system destroying insulin producing cells in the pancreas.
- Insulin is vital because it converts glucose from food into energy and a lack of insulin quickly results in serious illness and, if untreated, death.
- Type 1 diabetes strikes suddenly and without warning, usually in childhood and remains for life.
- Multiple daily insulin injections and blood tests are essential just to stay alive but are not a cure and can not prevent the long term, potentially devastating complications including blindness, limb amputations, kidney failure, heart disease and strokes.
- Every year around £2.5 billion is spent on treating type 1 diabetes and its complications.
About JDRF
Juvenile Diabetes Research Foundation (JDRF) is the leading charitable funder of type 1 diabetes research worldwide. JDRF has been responsible for more than £600 million direct funding of the most promising and groundbreaking type 1 diabetes research around the world. http://www.jdrf.org.uk.
About SmartCells, Inc.
SmartCells, Inc. is developing a polymer-based dosing technology, invented at M.I.T. by its co-founder and President Todd Zion, that makes it possible to auto-regulate the release of a drug based on the plasma concentration of a molecular indicator. SmartCells is developing a family of SmartInsulinTM products that address the needs of diabetics, including the Company's lead therapeutic formulations for types 1 and 2 diabetes. The Company's proprietary dosing technology may have broad applicability for infertility, thyroid and growth hormone deficiencies, drug-device combinations, and for improving treatments that suffer from poor adherence or a narrow therapeutic window.
SmartCells, Inc.
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Prepare For A Long Wait.
posted by Anon on 2 Dec 2009 at 11:19 amSamrtinsulin is another "breakthrough" that won't be relevant for most persons with diabetes for at least 10 years.
Why 10 years? Because of the way that clinical trials are designed and conducted. They are built on an experimental model developed for use with controllable laboratory animals - passive, stupid subjects.
The criteria for participating in clinical trials is supposedly that humans be exposed to a new therapy in reverse order of risk. In the case of persons with diabetes that means that persons with poorly-managed diabetes having elevated A1Cs are tested first.
This approach is based on 2 philosphies that seem to make sense, but do not:
1) an unwillingness to expose patients who are able to manage their disease reasonably well to a potentially less efficacious treatment.
2) a preference for passive subjects who are less likely to distort the results by actively modifying the protocol for their disease management.
The first philosophy, rather than being part of "first, do no harm", intentionally risks patients who are already at the highest risk. The selection criteria do not ask whether the patients are actually adhering to an existing protocol, of capable of adhering to a new one. In practice, doctors frequently prescribe newer, more expensive products whose long term side effects and relative efficacy are unknown, over ones with known side effects that that been in use for decades.
The second philosophy is at odds with how diabetes is most effectively managed - with the patient, not a doctor, taking responsibility for monitoring his condition, making adjustments and using the doctor as an adviser. The patients with diabetes who maintain the best control of their disease are the most highly motivated and trained. Not taking advantage of this expertise is wasting one of the most valuable resources available.
The result is that most clinical trials spend years determining safety, rarely determine relative efficacy, verify whether a drug or protocol works, but rarely determine the optimal protocol for its application. Don't expect Smartinsulin to be out of clinical trails and "approved" by the FDA until years after other, more effective products have been adopted for use in the EU and many other countries.
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