Posts Tagged ‘Insulin’

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An artificial pancreas invented can bring an end to the misery of daily injections for diabetics

An artificial pancreas invented can bring an end to the misery of daily injections for diabetics

It’s the first device approved by the FDA that detects dropping sugar levels and shuts off regular insulin delivery for Type 1 diabetics, just like a real pancreas is one of  the Best Inventions of the Year 2013 .Too much insulin, which is common at night, can lead to life-threatening diabetic comas.

An artificial pancreas invented by a De Montfort University (DMU) professor could have its first human trials within two years.

Professor Joan Taylor’s creation ensures patients will no longer have to endure injections of insulin every day.

Instead, a device will be surgically implanted into the body and able to release a precise amount of insulin into the bloodstream. Supplies would be topped up every two weeks.

Human trials are due to begin in 2016 with the first implants taking place on the NHS within a decade – news which has featured prominently in the national press with articles in the Daily Express and the Daily Mail among others.

Professor of Pharmacy at DMU, Joan Taylor, said: “The device will not only remove the need to manually inject insulin, but will also ensure that perfect doses are administrated each and every time. By controlling blood glucose so effectively, we should be able to help reduce related health problems.

“We are extremely close to embarking on clinical trials. Diabetes is costing society more than £1million an hour in treatment, and much of that is spent on treating complications.”

The implant contains a reservoir of insulin kept in place by a special gel barrier. When glucose levels in the body rise, the gel liquefies and releases the insulin into the body, mimicking the normal pancreas.

As the insulin lowers the glucose levels, the gel reacts by hardening again and preserving the reservoir. It would eliminate the need for diabetics to inject insulin up to four times a day.

The artificial pancreas will help all Type 1 insulin-dependent diabetics and some suffering Type 2 who need daily injections.

Professor Taylor has spent 20 years developing the device, which requires no electronics. This means the risk of rejection by the body is minimised.

Until now, the project has had funding of £1 million from the NHS, the Lachesis Fund – which invests in research in the university – the charity Edith Murphy Foundation and private backers. Professor Taylor is now seeking a similar amount to refine the product.

“This device is cheap and simple to use,” added Professor Taylor. “It has the potential to bring an end to the misery of daily injections for diabetics.”

- SOURCE: http://www.dmu.ac.uk/research/research-news/2014/january/human-trials-in-two-years-for-artificial-pancreas-invention.aspx#sthash.42N8lBYF.dpuf

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Nano-reinforced plastics improve friction resistance of orthodontics

Nano-reinforced plastics improve friction resistance of orthodontics

Brackets made from clear plastic polymer used in dental correction orthodontics have produced very good results in recent years, especially in relation to the improved esthetics when compared to metal brackets, but they do present certain problems of wear and tear within the mouth. “We were estimating the friction between teeth and the brackets, and it occurred to us that nanotechnology might be of use to help us resolve this issue,” remarked Juan Baselga, head of the UC3M Polymers and Composite Group. The solution that they came up with is to use very hard alumina nanoparticles and spread them evenly in the polysulfone, the polymer mould that Euroortodoncia uses in the industrial production of the brackets.

This new process, patented by the company and the UC3M researchers, has produced a new material which increases mechanical as well as friction resistance, thereby maintaining the brackets’ transparency. “We have been able to develop a more rigid material with this technology which has a clearly improved friction resistance, thus helping to withstand the wear and tear produced by the teeth or by chewing, Professor Baselga explained. In addition, it is biocompatible, which is essential for something that is going to be used in the mouth, and complies with European requirements for products which are in contact with food.

These new types of materials- nano-reinforced plastics- have applications in diverse areas of industry, according to the researchers. In particular, polysulfone is of interest in the bio-health field because of its bio-compatibility in the development of medical- surgical equipment, where it is of the essence to improve rigidity and friction resistance. Furthermore, it has potential applications in the auto industry and in the area of safety such as, for example, the development of a new visor for firefighters.

This innovation allows nanoparticles to be incorporated and evenly dispersed in a polymer mould in a very low proportion. After this process that is based on green chemical techniques is carried out by UC3M researchers, the particles, which are now dispersed in the polymer through micro-extrusion and micro-injection techniques, are then mixed to produce the final piece in the CEOSA-Euroortodoncia . ” We measure out the plastic since the minimum that a normal machine can inject is 15 grams, whereas our pieces weigh .06 grams…it would be akin to injecting insulin with a horse syringe”, explained the company director, Alberto Cervera. “And with the technology we are using, micro-extrusion and the micro-injection, we are capable of controlling these minuscule quantities of material with the utmost precision,” he added.

The relationship between UC3M and CEOSA/Euroortodoncia takes advantage of the synergy between the public and private sector. “We are a small to medium-sized enterprise and we get support from the University to produce a first rate product, which is then advantageous in the agreements which we have had for a decade in the form of end-of-degree-projects, doctorial theses and joint research programs within the European Union and in the Madrid Autonomous Community, for example,” Alberto Cervera ellaborated. “We learn a lot from this collaboration,” continued Juan Baselga, “because this company presented us with real problems that they face in their industrial area and they open up their laboratories to our needs.”

Patents and innovated application are clear examples of the knowledge and technology transfer that UC3M promotes through the Science Park. One hundred and twenty-five research groups and various laboratories all work so that this innovation is possible. All of this, together with their own technological portfolio, shows the capacity of the University for collaboration with business, industry and institutions.

Source : http://www.news-medical.net/news/20121029/Nano-reinforced-plastics-improve-friction-resistance-of-orthodontics.aspx

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Airport security scanners may affect function of insulin pump or CGM devices

Airport security scanners may affect function of insulin pump or CGM devices

Full-body or X-ray scanners used for airport security screening may affect the function of insulin pump or continuous glucose monitoring (CGM) devices. People with diabetes can present a travel letter obtained from their physicians to avoid possible damage caused by exposure to imaging equipment in airports. The risk to these sensitive devices posed by scanners and the low-pressure conditions on airplanes are the focus of the Editorial “Navigating Airport Security with an Insulin Pump and/or Sensor,” published in Diabetes Technology & Therapeutics, a peer-reviewed journal from Mary Ann Liebert, Inc., publishers. The Editorial is available free on the Diabetes Technology & Therapeutics website at http://www.liebertpub.com/dia.

Andrew Cornish and H. Peter Chase, MD, University of Colorado, Denver, caution that the motor of an insulin delivery pump or glucose monitoring device may experience electromagnetic malfunctioning when passed through an airport security scanner. However, little research has been published on the potential impact of that exposure.

“Given the increased use of insulin pump therapy, not only in the U.S., but around the world, with hundreds of thousands of people using this technology, it seems critical that more research is funded to better understand and potentially repair this problem,” says Irl Hirsch, MD, Senior Editor of Diabetes Technology & Therapeutics and Professor of Medicine, University of Washington Medical Center-Roosevelt, Seattle, WA.

Source : www.news-medical.net/news/20121025/Airport-security-scanners-may-affect-function-of-insulin-pump-or-CGM-devices.aspx

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Foreign Representative Interviews

Foreign Representative Interviews

AdvaMed 2012 Part II: Foreign Representative Interviews

I spent last Wednesday at AdvaMed 2012, the annual global medtech conference, speaking to individual entrepreneurs and country representatives. It was a nice contrast to the large-scale roundtables and panels, as it gave me a chance to see what specific companies have in the pipeline and what services they offer. This post will focus on the company representatives I spoke to, while my next post will focus on interviews with foreign country reps.

I first spoke with Larry Gerrans, CEO of Sanovas, a Sausalito, CA-based company launched in 2010. Sanovas is developing an innovative micro-surgical platform for diagnosing and treating lung cancer and other pulmonary diseases. According to Larry, 96 million people have or at risk for developing pulmonary disease, most notably lung cancer. However, diagnosis often occurs when the disease has already metastasized throughout the lungs and/or body. Larry and colleagues had an idea in 2001 to advance the miniaturization of lung-based diagnostics, as the lung was a traditionally difficult area to visualize non-operatively. Utilizing the world’s smallest surgical camera, Sanovas’ technology allows surgeons to access, visualize and deliver treatments to areas of the anatomy that were previously inaccessible with lower risks of bleeding that other devices due to a non-thermal recannulation methods. In addition to the camera, Sanovas is working on technologies in both diagnostics and targeted delivery therapeutics. For example, Larry showed me an internal video of a balloon-based catheter that allows for targeted resection of lung disease. Such a procedure, among other benefits, could transform what would normally be a 1-week postoperative stay for an open lung biopsy to a 23-hour stay after an outpatient procedure.

Check out a video of Larry speaking as part of a segment on lung cancer on the TV show “Profiles with Terry Bradshaw”:

I next spoke with Chris Jones, CEO of Glysure Limited. Glysure is working to develop in-hospital continuous glucose monitoring devices. Tight glucose monitoring (TGM) has been shown in several studies to be a critical determinant of mortality in ICU and critically ill patients. To achieve TGM, however, we must first have a method to measure glucose real-time in ICUs rather than by fingersticks. The GlySure solution is a single-use multi-day intravascular fiber optic sensor with integrated automatic calibration. Its particular chemistry enables low-cost, high margin sensors. Clinical trials in ICU settings, which began in 2010, have confirmed the sensors’ performance and the ability of Glysure to provide a new dimension in Intensive Insulin Therapy (IIT).

Check out Glysure’s press release on how the fully automated calibration system maximizes accuracy of continuous blood glucose monitoring while reducing nursing labor burden…

I next had a chance to speak with Patty Nichols, Director of Medical Technology at Travelers. Travelers, a Connecticut based insurance company, works to protect emerging global medtech companies by providing property and liability coverage. Speaking to Patty was interesting because it brought to light many of the potential issues that emerging entrepreneurs may face as they work to develop their technologies and brought to light potential unforeseen problems. For example, Patty mentioned a panel that Travelers attended at AdvaMed on “Device Hacking”, potential theft of data from emerging companies, and how these companies can protect against that.

Check out a press release of MedFirst, Travelers’ innovative liability insurance…

My last two interviews of the day were with two companies that focus in part on product development. I spoke to Gillian Davies, PhD, Senior Consultant of Sagentia, a global technology and product development company. Sagentia focuses on both large multinational companies and small startups in providing consulting for product design and company development. Gillian and I had a great conversation on how medtech companies can no longer focus on just the “coolness” of their technologies. With increasing focus on outcomes and impact in health care systems, companies must work backwards from an unmet need to a technology and not the other way around. Gillian spoke about how the “technology push” has persisted for far too long in the US, and how clinical need and usability will become the primary determinants of success, especially as venture capital funding becomes more limited. The example she specifically gave to me was of iBGStar, Sanofi’s blood glucose monitoring system, which now sells on the Apple Store in addition to directly to physicians.

Check out some of the services Sagentia offers…

EBR main AdvaMed 2012 Part I: Company InterviewsThe last person I spoke to at the end of a very long day was Simon Karger, Associate Director of Surgical & Interventional products at Cambridge Consultants. Cambridge Consultants is a leading medical technology design and development firm with offices in Cambridge, MA and UK. Coincidentally, they also hosted an industry workshop in Boston recently to discuss the future of surgery, so they had some interesting insights and thoughts in that area. Cambridge Consultants has been focusing on the surgical and interventional space of surgery to develop ideas into usable tools for general surgeons. In particular, they touted the success of their leadless pacemaker, the Wireless Cardiac Stimulation system (WiCS), in collaboration with start-up company EBR Systems. Cambridge Consultants has several technologies in the pipeline including an ultrasonic technology to diagnose and mechanically reduce blood clots in the legs.

Source : http://www.nejm.org/doi/full/10.1056/NEJMoa011300

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AdvaMed 2012 Part I: Company Interviews

AdvaMed 2012 Part I: Company Interviews

AdvaMed 2012 Part I: Company Interviews

Leadless pacemaker brings new hope to cardiac patients

Innovative product development eliminates pacing leads by stimulating the heart through wireless transmission of energy

Cambridge Consultants, a leading technology design and development firm, today unveiled how it has collaborated with start-up company EBR Systems to develop the world’s first wireless pacing system. With cardiac stimulation leads considered the weak point in pacemaker systems, the Wireless Cardiac Stimulation system (WiCS) uses a leadless electrode to convert mechanical energy, wirelessly transmitted from an ultrasonic pulse generator, into electrical energy which is used to pace the heart as part of Cardiac Resynchronization Therapy (CRT).

http://www.youtube.com/watch?v=_02Dpsl_Jxo&feature=player_embedded

 

Eliminating the lead in the left side of the heart presents a major breakthrough in pacemaker design, and brings new hope for over 2.2 million advanced heart failure patients worldwide, who can benefit from CRT therapy. It also provides a life-saving option for those patients who do not benefit from CRT therapy, either because of the complexity of the procedure, or the limitations of the current technology.

WiCS is the first leadless system to be successfully implanted in early human clinical trials at leading centres in Europe. This platform technology will ultimately eliminate all pacing leads and deliver superior cardiac pacing therapy through its flexibility in where the electrode can be placed.

Current CRT pacemakers or defibrillators are implanted in patients with chronic heart failure requiring both the left and right ventricles to be paced. Such devices require the implantation of three leads into the heart, one of which involves painstakingly threading a lead through a difficult and complex route running from the right atrium of the heart, out of the heart and into the coronary sinus, a vasculature structure on the outside surface of the heart to the left ventricle. A pacemaker/defibrillator device is connected to the leads which are used to sense heart activity and to deliver electrical stimulation through electrodes at the end of the leads. The electrical stimulation applied to the right and to the left ventricles synchronizes the heart’s contraction in a way that improves overall cardiac function in heart failure patients. However, added to the difficulty of the procedure itself is the chance of lead failure and infection.

WiCS overcomes these problems by leveraging advances in energy harvesting microelectronics. A very small leadless electrode, is implanted in the desired location within the left side of the heart. In its first generation, WiCS works in conjunction with a conventional pacemaker/defibrillator, sensing the electrical pacing pulse of the pacemaker from the right ventricle. The pulse generator then transmits an ultrasonic pulse to the implanted receiver, which converts the sonic energy into electrical energy to pace the left ventricle in synchronicity with the right. Not only does this reduce the need for the difficult and complicated surgery associated with CRT pacemakers, but by pacing inside the left ventricle it also better mimics the natural activation and mechanical contraction pattern of the heart.

With hospital resources already stretched, the leadless system significantly reduces the time taken to carry out the complicated procedure which requires threading the lead through the coronary sinus vein to the left ventricle of the heart. The WiCS procedure is simple and predictable, resulting in streamlined scheduling of operating theatres and cost savings.

The innovative technology was developed in conjunction with leading design and development firm Cambridge Consultants. Using its deep knowledge of integrated circuit (IC) design, Cambridge Consultants helped EBR define the system architecture which could be realised with modern silicon chip technology. Power consumption, size and safety are critical in pacemaker applications, and the team at Cambridge Consultants developed advanced low-power circuits to interface with the ultrasonic transducers and heart monitoring sensors. With reliability critical, coupled with the need for sophisticated signal processing, Cambridge Consultants created two state-of-the-art mixed-signal Application-Specific Integrated Circuits managed by its powerful XAP4 processor to form the core of the WiCS pacing system. During the development, Cambridge Consultants created a full system hardware emulator of the final ASIC so that the other system elements and the software could be designed and fully tested over a year before prototype ASICs were available. This approach dramatically reduced the overall time of the development and enabled EBR to ensure that the system would work as envisaged before committing to the costly and time-consuming manufacture of final product.

Allan Will, CEO of EBR Systems, commented: “The WiCS system represents a huge breakthrough in pacemaker technology, not only in how we treat chronic heart failure patients today, but in eliminating leads and enabling site selected pacing locations in the heart for a wide variety of cardiac pacing applications. Many of the complications and reliability failures of pacemaker systems are attributed to leads. By eliminating leads, we can address the problems which come with them, and advance cardiac pacing therapy for all patients.”

“We are pleased to be able to contribute to such an important breakthrough in medical technology” said Andrew Diston, Head of Global Medical Technology at Cambridge Consultants. “We have a long history of championing cutting edge technology, and enabling start-ups to bring their groundbreaking concepts to market. We look forward to following this potentially lifesaving technology as it revolutionises the market.”

I spent last Wednesday at AdvaMed 2012, the annual global medtech conference, speaking to individual entrepreneurs and country representatives. It was a nice contrast to the large-scale roundtables and panels, as it gave me a chance to see what specific companies have in the pipeline and what services they offer. This post will focus on the company representatives I spoke to, while my next post will focus on interviews with foreign country reps.

I first spoke with Larry Gerrans, CEO of Sanovas, a Sausalito, CA-based company launched in 2010. Sanovas is developing an innovative micro-surgical platform for diagnosing and treating lung cancer and other pulmonary diseases. According to Larry, 96 million people have or at risk for developing pulmonary disease, most notably lung cancer. However, diagnosis often occurs when the disease has already metastasized throughout the lungs and/or body. Larry and colleagues had an idea in 2001 to advance the miniaturization of lung-based diagnostics, as the lung was a traditionally difficult area to visualize non-operatively. Utilizing the world’s smallest surgical camera, Sanovas’ technology allows surgeons to access, visualize and deliver treatments to areas of the anatomy that were previously inaccessible with lower risks of bleeding that other devices due to a non-thermal recannulation methods. In addition to the camera, Sanovas is working on technologies in both diagnostics and targeted delivery therapeutics. For example, Larry showed me an internal video of a balloon-based catheter that allows for targeted resection of lung disease. Such a procedure, among other benefits, could transform what would normally be a 1-week postoperative stay for an open lung biopsy to a 23-hour stay after an outpatient procedure.

Check out a video of Larry speaking as part of a segment on lung cancer on the TV show “Profiles with Terry Bradshaw”:

Glysure AdvaMed 2012 Part I: Company InterviewsI next spoke with Chris Jones, CEO of Glysure Limited. Glysure is working to develop in-hospital continuous glucose monitoring devices. Tight glucose monitoring (TGM) has been shown in several studies to be a critical determinant of mortality in ICU and critically ill patients. To achieve TGM, however, we must first have a method to measure glucose real-time in ICUs rather than by fingersticks. The GlySure solution is a single-use multi-day intravascular fiber optic sensor with integrated automatic calibration. Its particular chemistry enables low-cost, high margin sensors. Clinical trials in ICU settings, which began in 2010, have confirmed the sensors’ performance and the ability of Glysure to provide a new dimension in Intensive Insulin Therapy (IIT).

Check out Glysure’s press release on how the fully automated calibration system maximizes accuracy of continuous blood glucose monitoring while reducing nursing labor burden…

I next had a chance to speak with Patty Nichols, Director of Medical Technology at Travelers. Travelers, a Texas-based insurance company, works to protect emerging global medtech companies by providing property and liability coverage. Speaking to Patty was interesting because it brought to light many of the potential issues that emerging entrepreneurs may face as they work to develop their technologies and brought to light potential unforeseen problems. For example, Travelers gave a presentation at AdvaMed this year on “Device Hacking”, potential theft of data from emerging companies, and how these companies can protect against that.

Check out a press release of MedFirst, Travelers’ innovative liability insurance…

My last two interviews of the day were with two companies that focus in part on product development. I spoke to Gillian Davies, PhD, Senior Consultant of Sagentia, a global technology and product development company. Sagentia focuses on both large multinational companies and small startups in providing consulting for product design and company development. Gillian and I had a great conversation on how medtech companies can no longer focus on just the “coolness” of their technologies. With increasing focus on outcomes and impact in health care systems, companies must work backwards from an unmet need to a technology and not the other way around. Gillian spoke about how the “technology push” has persisted for far too long in the US, and how clinical need and usability will become the primary determinants of success, especially as venture capital funding becomes more limited. The example she specifically gave to me was of iBGStar, Sanofi’s blood glucose monitoring system, which now sells on the Apple Store in addition to directly to physicians.

Check out some of the services Sagentia offers…

EBR main AdvaMed 2012 Part I: Company InterviewsThe last person I spoke to at the end of a very long day was Simon Karger, Associate Director of Surgical & Interventional products at Cambridge Consultants. Cambridge Consultants is a leading medical technology design and development firm with offices in Cambridge, MA and UK. Coincidentally, they also hosted an industry workshop in Boston recently to discuss the future of surgery, so they had some interesting insights and thoughts in that area. Cambridge Consultants has been focusing on the surgical and interventional space of surgery to develop ideas into usable tools for general surgeons. In particular, they touted the success of their leadless pacemaker, the Wireless Cardiac Stimulation system (WiCS), in collaboration with start-up company EBR Systems. Cambridge Consultants has several technologies in the pipeline including an ultrasonic technology to diagnose and mechanically reduce blood clots in the legs.

Source : http://www.cambridgeconsultants.com/news/pr/release/6/en

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BD Ultra-Fine Needle with PentaPoint for Less Pain During Insulin Injections

BD Ultra-Fine Needle with PentaPoint for Less Pain During Insulin Injections

BD Ultra-Fine Needle with PentaPoint for Less Pain During Insulin Injections

Franklin Lakes, NJ (September 19, 2012) /PRNewswire/ — Studies suggest that as many as one-fifth to one-third of people with diabetes are hesitant or unwilling to give themselves insulin injections for reasons that include needle anxiety1, 2, 3. Patients who reported injection-related pain or embarrassment also admitted they intentionally skipped insulin injections more often3. A study by the American Association of Diabetes Educators (AADE) revealed that 47% of people with diabetes would be more likely to administer their injections regularly if a product were available that would ease the pain and discomfort of injections4. With these needs in mind, BD Medical, a segment of BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, announced today the launch in the U.S. of the BD Ultra-Fine™ Nano Pen Needle with PentaPoint™ Comfort.

BD’s latest advancement in injection comfort, PentaPoint is a patented 5-bevel needle tip design that creates a flatter, thinner surface to help penetrate the skin with significantly greater ease. In a clinical home-use study, patients who inject insulin found BD’s 5-bevel pen needles to be significantly less painful, easier to insert, more comfortable and preferred overall when compared with current 3-bevel pen needles5. Bench tests showed the modified PentaPoint needle tip reduces the force to penetrate the skin by 23% compared to 3-bevel pen needles.

In recent years, advances in needle manufacturing technology, along with shorter and thinner needles, have been associated with progressively improving patient self-rating of injection comfort6. At 4mm by 32 gauge, BD Ultra-Fine Nano is the shortest, thinnest pen needle available, is clinically demonstrated to enhance comfort, and provides a less intimidating injection experience8. Combined with a one-handed injection technique and its ability to facilitate flexible site rotation, BD Ultra-Fine Nano may help improve adherence to diabetes therapy regimens to support better health outcomes. PentaPoint Comfort is an enhancement to BD Nano, reflecting that a modified needle tip can further advance patient comfort.

“BD Diabetes Care has been a leader in diabetes injection devices for over 85 years, and is committed to helping improve patients’ transition and adherence to injectable therapies by improving the efficacy, convenience and comfort of medication delivery. We are excited to provide another first-to-market innovation, designed to dramatically improve the injection experience for the millions of people living with diabetes,” commented Linda Tharby, President, BD Medical – Diabetes Care. “Building on the introduction of BD’s smallest needle, the BD Nano, we are confident that our new, patented PentaPoint Comfort technology will provide an even more comfortable injection experience. This will help enable patients to adopt and adhere more easily to the therapy regimens recommended to improve their outcomes.”

The AADE issued injection technique strategies that encourage the use of the smallest possible needle for improved patient comfort and insulin efficacy7. The BD Nano 4mm Pen Needle is proven to be as effective as longer needles for patients of various body types8, and provides equivalent glucose control by effectively delivering the insulin dose to subcutaneous tissue (the layer of fat below the skin), the recommended site for insulin injections9, and reducing the risk of injecting into muscle10. Intramuscular injection can accelerate insulin absorption and increase the risk of unanticipated hypoglycemia (abnormally low blood sugar)11, 12. Subcutaneous injection allows the insulin to be absorbed at an appropriate rate, resulting in better glycemic control13. For more information, visit www.bd.com/nano.

About Diabetes

Diabetes is a disease in which the body has a shortage of insulin or a decreased ability to use insulin, a hormone that allows glucose (sugar) to enter cells and be converted to energy. When diabetes is not controlled, glucose and fats remain in the blood and, over time, damage vital organs. Diabetes has become a national health concern in the United States, with an estimated 26 million people – 8.3 percent of the population – living with the disease. Of those people, an estimated 18.8 million have been diagnosed with diabetes, and another 7 million are thought to be undiagnosed. If current trends continue, as many as one of three U.S. adults will have diabetes by 205014. The total annual cost of diagnosed diabetes in the United States is an estimated $174 billion15.

About BD

BD is a leading global medical technology company that develops, manufactures and sells medical devices, instrument systems and reagents. The Company is dedicated to improving people’s health throughout the world. BD is focused on improving drug delivery, enhancing the quality and speed of diagnosing infectious diseases and cancers, and advancing research, discovery and production of new drugs and vaccines. BD’s capabilities are instrumental in combating many of the world’s most pressing diseases. Founded in 1897 and headquartered in Franklin Lakes, New Jersey, BD employs approximately 29,000 associates in more than 50 countries throughout the world. The Company serves healthcare institutions, life science researchers, clinical laboratories, the pharmaceutical industry and the general public. For more information, please visit www.bd.com.

Greater Injection Comfort for People with Diabetes

BD’s NEW patented 5-bevel needle tip is designed

for more comfort.

Clinical trials support improved patient comfort,

easier insertion and overall preference.*

Sculpted to create a flatter, thinner surface that helps penetrate the skin with significantly greater ease for a smoother and gentler injection.

Click Here to See the Video

Experience on-the-go comfort!

The BD Nano 4mm x 32G pen needle, used with a single-hand,

no pinch technique, allows more flexibility to reach and rotate

to difficult-to-reach injection sites. The BD Nano is so short and

thin, it assures a comfortable injection experience. Ask your

doctor or pharmacist today!

BD has unveiled a new 4mm insulin injection needle that was designed to reduce the pain associated with daily bolusing. The Ultra-Fine Nano features the firm’s proprietary PentaPoint tip design that, by having extra bevels, promises a more comfortable injection.

The company hopes that by taking a bit of anxiety out injections they’ll be able to improve diabetics’ compliance with taking their insulin.

BD Ultra Fine Nano 4mm Pen Needle BD Ultra Fine Needle with PentaPoint for Less Pain During Insulin Injections (video)

BD’s latest advancement in injection comfort, PentaPoint is a patented 5-bevel needle tip design that creates a flatter, thinner surface to help penetrate the skin with significantly greater ease. In a clinical home-use study, patients who inject insulin found BD’s 5-bevel pen needles to be significantly less painful, easier to insert, more comfortable and preferred overall when compared with current 3-bevel pen needles. Bench tests showed the modified PentaPoint needle tip reduces the force to penetrate the skin by 23% compared to 3-bevel pen needles.

In recent years, advances in needle manufacturing technology, along with shorter and thinner needles, have been associated with progressively improving patient self-rating of injection comfort6. At 4mm by 32 gauge, BD Ultra-Fine Nano is the shortest, thinnest pen needle available, is clinically demonstrated to enhance comfort, and provides a less intimidating injection experience8. Combined with a one-handed injection technique and its ability to facilitate flexible site rotation, BD Ultra-Fine Nano may help improve adherence to diabetes therapy regimens to support better health outcomes. PentaPoint Comfort is an enhancement to BD Nano, reflecting that a modified needle tip can further advance patient comfort.

Source : http://www.multivu.com/mnr/58104-bd-ultra-fine-nano-pen-needle-with-pentapoint-comfort

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Obese individuals with excess visceral fat more likely to develop type 2 diabetes

Obese individuals with excess visceral fat more likely to develop type 2 diabetes

Obese individuals with excess visceral fat (abdominal fat that surrounds the body-s internal organs) have an increased risk for the development of Type 2 diabetes, according to a new study by researchers at UT Southwestern Medical Center. By contrast, persons with excess abdominal subcutaneous fat (fat underneath the skin) were not at higher risk for the onset of diabetes.

The study, published in the September obesity-themed issue of the Journal of the American Medical Association, is one of the largest of its kind to assess a multiethnic population of obese people in the U.S. using extensive imaging of adipose tissue. The findings are being presented today in New York at a media briefing hosted by JAMA.

-Among obese individuals, it is not necessarily how much fat a person has, but rather where the fat is located on a person that leads to diabetes,- according to the paper-s senior author, Dr. James de Lemos, professor of internal medicine at UT Southwestern.

Using imaging methods to determine the location and function of body fat, researchers are able to identify obese persons who are at a higher risk for developing Type 2 diabetes years before the disease appears.

-Understanding the biological differences between visceral fat and subcutaneous fat may help doctors to more effectively battle the obesity epidemic occurring in the United States,- Dr. de Lemos said. -The risk for diabetes varies widely among different obese individuals, and this study suggests that by predicting who will get diabetes, it may be possible to target intensive lifestyle, medical, and surgical therapies for those at a higher risk.-

The study, which collected information from UT Southwestern-s Dallas Heart Study, sampled 732 obese adults – those with a body mass index of 30 or gre

Researchers utilized magnetic resonance imaging (MRI) and dual energy X-ray absorptiometry (DEXA) to determine where fat was stored in the body. While other studies have weighed people and used tape measures to assess their body fat, this study included the largest number of obese people to undergo extensive body-fat imaging.

When participants returned for a follow-up after seven years, researchers found that 11 percent of the people sampled developed diabetes. Among the participants who had normal glucose at baseline testing, 39 percent developed prediabetes or diabetes. Prediabetes is believed to be an intermediate state between normal metabolic function and diabetes. Those who developed prediabetes and diabetes had higher amounts of visceral fat and greater insulin resistance compared to those who remained healthy.

-We found that individuals who developed prediabetes and diabetes had evidence of early cardiovascular disease years before the onset of diabetes,- said Dr. Ian Neeland, a cardiology fellow and first author of the paper. -This finding suggests that excess visceral fat and insulin resistance may contribute to cardiovascular disease among obese individuals.-

source : http://www.news-medical.net/news/20120919/Obese-individuals-with-excess-visceral-fat-more-likely-to-develop-type-2-diabetes.aspx

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Enhanced Skin Permeability Makes Transdermal Drug Delivery Easier

Enhanced Skin Permeability Makes Transdermal Drug Delivery Easier

Enhanced Skin Permeability Makes Transdermal Drug Delivery Easier

Using ultrasound waves, MIT engineers have found a way to enhance the permeability of skin to drugs, making transdermal drug delivery more efficient. This technology could pave the way for noninvasive drug delivery or needle-free vaccinations, according to the researchers.

“This could be used for topical drugs such as steroids — cortisol, for example — systemic drugs and proteins such as insulin, as well as antigens for vaccination, among many other things,” says Carl Schoellhammer, an MIT graduate student in chemical engineering and one of the lead authors of a recent paper on the new system.

Ultrasound — sound waves with frequencies greater than the upper limit of human hearing — can increase skin permeability by lightly wearing away the top layer of the skin, an effect that is transient and pain-free.

In a paper appearing in the Journal of Controlled Release, the research team found that applying two separate beams of ultrasound waves — one of low frequency and one of high frequency — can uniformly boost permeability across a region of skin more rapidly than using a single beam of ultrasound waves.

Senior authors of the paper are Daniel Blankschtein, the Herman P. Meissner ’29 Professor of Chemical Engineering at MIT, and Robert Langer, the David H. Koch Institute Professor at MIT. Other authors include Baris Polat, one of the lead authors and a former doctoral student in the Blankschtein and Langer groups, and Douglas Hart, a professor of mechanical engineering at MIT.

Two frequencies are better than one

When ultrasound waves travel through a fluid, they create tiny bubbles that move chaotically. Once the bubbles reach a certain size, they become unstable and implode. Surrounding fluid rushes into the empty space, generating high-speed “microjets” of fluid that create microscopic abrasions on the skin. In this case, the fluid could be water or a liquid containing the drug to be delivered.

In recent years, researchers working to enhance transdermal drug delivery have focused on low-frequency ultrasound, because the high-frequency waves don’t have enough energy to make the bubbles pop. However, those systems usually produce abrasions in scattered, random spots across the treated area.

Anne Trafton, MIT News Office

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Mechanism

Ultrasound waves of two different frequencies generate tiny bubbles of water on the skin’s surface. When these bubbles pop, the skin’s surface is lightly worn away, allowing drugs to pass through the skin more easily.

Graphic: Carl Schoellhammer

September 14, 2012

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Using ultrasound waves, MIT engineers have found a way to enhance the permeability of skin to drugs, making transdermal drug delivery more efficient. This technology could pave the way for noninvasive drug delivery or needle-free vaccinations, according to the researchers.

“This could be used for topical drugs such as steroids — cortisol, for example — systemic drugs and proteins such as insulin, as well as antigens for vaccination, among many other things,” says Carl Schoellhammer, an MIT graduate student in chemical engineering and one of the lead authors of a recent paper on the new system.

Ultrasound — sound waves with frequencies greater than the upper limit of human hearing — can increase skin permeability by lightly wearing away the top layer of the skin, an effect that is transient and pain-free.

In a paper appearing in the Journal of Controlled Release, the research team found that applying two separate beams of ultrasound waves — one of low frequency and one of high frequency — can uniformly boost permeability across a region of skin more rapidly than using a single beam of ultrasound waves.

Senior authors of the paper are Daniel Blankschtein, the Herman P. Meissner ’29 Professor of Chemical Engineering at MIT, and Robert Langer, the David H. Koch Institute Professor at MIT. Other authors include Baris Polat, one of the lead authors and a former doctoral student in the Blankschtein and Langer groups, and Douglas Hart, a professor of mechanical engineering at MIT.

Two frequencies are better than one

When ultrasound waves travel through a fluid, they create tiny bubbles that move chaotically. Once the bubbles reach a certain size, they become unstable and implode. Surrounding fluid rushes into the empty space, generating high-speed “microjets” of fluid that create microscopic abrasions on the skin. In this case, the fluid could be water or a liquid containing the drug to be delivered.

In recent years, researchers working to enhance transdermal drug delivery have focused on low-frequency ultrasound, because the high-frequency waves don’t have enough energy to make the bubbles pop. However, those systems usually produce abrasions in scattered, random spots across the treated area.

In the new study, the MIT team found that combining high and low frequencies offers better results. The high-frequency ultrasound waves generate additional bubbles, which are popped by the low-frequency waves. The high-frequency ultrasound waves also limit the lateral movement of the bubbles, keeping them contained in the desired treatment area and creating more uniform abrasion, Schoellhammer says.

“It’s a very innovative way to improve the technology, increasing the amount of drug that can be delivered through the skin and expanding the types of drugs that could be delivered this way,” says Samir Mitragotri, a professor of chemical engineering at the University of California at Santa Barbara, who was not part of the research team.

The researchers tested their new approach using pig skin and found that it boosted permeability much more than a single-frequency system. First, they delivered the ultrasound waves, then applied either glucose or inulin (a carbohydrate) to the treated skin. Glucose was absorbed 10 times better, and inulin four times better. “We think we can increase the enhancement of delivery even more by tweaking a few other things,” Schoellhammer says.

Noninvasive drug delivery

Such a system could be used to deliver any type of drug that is currently given by capsule, potentially increasing the dosage that can be administered. It could also be used to deliver drugs for skin conditions such as acne or psoriasis, or to enhance the activity of transdermal patches already in use, such as nicotine patches.

Ultrasound transdermal drug delivery could also offer a noninvasive way for diabetics to control their blood sugar levels, through short- or long-term delivery of insulin, the researchers say. Following ultrasound treatment, improved permeability can last up to 24 hours, allowing for delivery of insulin or other drugs over an extended period of time.

Such devices also hold potential for administering vaccines, according to the researchers. It has already been shown that injections into the skin can induce the type of immune response necessary for immunization, so vaccination by skin patch could be a needle-free, pain-free way to deliver vaccines. This would be especially beneficial in developing countries, since the training required to administer such patches would be less intensive than that needed to give injections. The Blankschtein and Langer groups are now pursuing this line of research.

They are also working on a prototype for a handheld ultrasound device, and on ways to boost skin permeability even more. Safety tests in animals would be needed before human tests can begin. The U.S. Food and Drug Administration has previously approved single-frequency ultrasound transdermal systems based on Langer and Blankschtein’s work, so the researchers are hopeful that the improved system will also pass the safety tests.

Low-frequency ultrasound has been studied extensively due to its ability to enhance skin permeability. In spite of this effort, improvements in enhancing the efficacy of transdermal ultrasound treatments have been limited. Currently, when greater skin permeability is desired at a given frequency, one is limited to increasing the intensity or the duration of the ultrasound treatment, which carries the risk of thermal side effects. Therefore, the ability to increase skin permeability without increasing ultrasound intensity or treatment time would represent a significant and desirable outcome. Here, we hypothesize that the simultaneous application of two distinct ultrasound frequencies, in the range of 20 kHz to 3 MHz, can enhance the efficacy of ultrasound exposure. Aluminum foil pitting experiments showed a significant increase in cavitational activity when two frequencies were applied instead of just one low frequency. Additionally, in vitro tests with porcine skin indicated that the permeability and resulting formation of localized transport regions are greatly enhanced when two frequencies (low and high) are used simultaneously. These results were corroborated with glucose (180 Da) and inulin (5000 Da) transdermal flux experiments, which showed greater permeant delivery both into and through the dual-frequency pre-treated skin.

Source : http://web.mit.edu/newsoffice/2012/ultrasound-waves-and-drug-delivery-0914.html

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Tandem t:slim Touchscreen Insulin Pump Now On Sale

Tandem t:slim Touchscreen Insulin Pump Now On Sale

Tandem t:slim Touchscreen Insulin Pump Now On Sale

PHILADELPHIA, June 8, 2012 —Tandem Diabetes Care™, Inc. (“Tandem”) announced today at the 72nd Scientific Sessions of the American Diabetes Association that it will begin accepting orders for the t:slim™ Insulin Delivery System, the first insulin pump approved by the FDA with a touch screen, on Monday, June 11, 2012. The product will begin shipping in August 2012.

“Since the t:slim Insulin Delivery System received FDA clearance, we have been conducting user evaluations to further demonstrate its performance and reliability, as well as the readiness of our team,” said Kim Blickenstaff, CEO, Tandem Diabetes Care. “t:slim is proving to be to be easy to teach, easy to learn, and easy to use, and our 24/7 Customer Technical Support Team is also finding it easy to support.”

People interested in the t:slim Insulin Delivery System can begin the order process starting at 6:00am PDT on June 11, 2012. More information is available online at www.TandemDiabetes.com, or by calling 1-877-801-6901. Tandem’s Customer Sales Support Team is available Monday through Friday from 6:00am to 6:00pm PDT to accept orders.

The t:slim Insulin Pump has the footprint of a credit card and the look of a smart phone. Currently the smallest FDA-cleared insulin delivery system, t:slim is up to 25% slimmer than other 300 unit pumps. Unlike other insulin pumps that have complex menus and require excessive button pressing, t:slim’s vivid, color touch screen is the window to an easy-to-use interface that places everything at the touch of a finger.

About Tandem Diabetes Care, Inc.

Dedicated to advancing the management of diabetes, Tandem Diabetes Care, Inc. (www.tandemdiabetes.com) is a privately held company with novel diabetes technologies. The Company offers a comprehensive, user-centric and integrated approach to product development and customer care. Tandem Diabetes Care is based in San Diego, California.

You can probably guess how I feel about the new Tandem t:slim insulin pump – I want one…now. I first heard of the Tandem at a Children with Diabetes Friends For Life conference, and have hung on to my past-warranty Deltec Cozmo pump until the t:slim hit the streets.

Recently I attended two events where I was able to push the buttons on the t:slim and learn about the technology inside it. I have not had a loaner, so my opinions in this blog post are based on spending 15 minutes looking at the various screens and listening to a presentation from a Tandem representative. This week @TandemDiabetes tweeted that they’ll have a booth at the 2012 ADA scientific sessions that are happening this week (June 6–8) in Philadelphia.

At 3.1 by 2.0 inches the t:slim pump is about the same front size as the Deltec Cozmo and Minimed pumps, but a good deal thinner (0.6 inches). It’s

Tandem t:slim lock screen

metallic with lovely curved edges and really looks like it was designed by Apple. The touch screen is large, bright and colorful. It tried using it under some bright sunlight and it was very easy to read. The capacitive touch screen technology is the same as iPhones, so it works with your fingertip or a stylus pen.

You don’t have to worry about putting it in your pocket and setting it off by accident. The picture on the right shows the lock screen. You have to push buttons 1, 2, and 3 in order before you can start to do anything with the pump. The screen also shows a lot more information: insulin on board; insulin time remaining; reservoir levels and date and time. As you can see the buttons are large and easy to press, this is true on all of the screens. I believe that the insulin on board calculations include insulin from all previous boluses.

After unlocking the t:slim, the center part of the screen changes to give you two choices: Bolus or

Options. (Photo courtesy of Tandem). The choices for Extended Bolus or Split Bolus are built into the sequence for bolusing. So there are less menus throughout the system, with more button presses.

The bolus screen also has two choices, enter the amount of carbs or a blood glucose reading. The large buttons lead you to a screen where you can enter numeric values. After each you return to this screen, where the calculated bolus is displayed. There’s no food database, in the pump. I’d guess that’s due to memory constraints and the challenges of developing an easy to use interface that would let you choose foods and quantities.

What if you didn’t mean to hit the Bolus button? No problem: the Tandem T icon to the right of the screen is also touch sensitive. You can press it at any time and the main Bolus/Options screen will appear. There’s no need for a cancel button.

Tandem has replaced the classic, round, insulin reservoir with a new one that’s rectangular. The t:slim doesn’t have a large motor to push the reservoir plunger, it uses a completely different technology to draw insulin out of the reservoir in micro doses and then push it into the tubing. The picture shows the reservoir set, it has a standard Luer lock that supports most infusion sets.

This slide is from the presentation I attended. It gives some details on the micro-delivery approach that the t:slim uses.

The t:slim specifications are impressive: bolus between 0.05u and 25 u; quick bolus in units or carbs; extended bolus of 15 minutes to 8 hours; insulin duration 2-8 hours in 1-minute increments; tiny basal rate increments; max basal rate of 15u/hour; up to 6 personal profiles; carb ration of 1 to 300 grams per unit; correction factor of 600 mg/dL to 1 mg/dL per unit. Different sounds and alarms. The alarms sounds escalate, so they’re a lot harder to miss.

The site reminder can only be set to a maximum of three days, that’s probably an FDA-imposed limit. The t:slim also supports alarms and reminders. The 25u bolus limitation was imposed by the FDA. You can enter a higher number of units; after the t:slim has delivered 25u it’ll prompt you and ask you to confirm that you want to deliver the remainder.

No more batteries! The t:slim has a rechargeable lithium polymer battery that’s recharged via a standard micro-USB port. They claim it last about 7 days when fully charged. This type of battery does well when charged for a set amount of time each day, and the pump can be worn while the battery is charging.

One last screen. Whatever time-related setting you want to change – insulin/carb ratios; basal rates; insulin correction factor – there’s only a single screen. This also makes it much easier to show the current settings to your healthcare team.

I didn’t see the related software. I don’t know whether it will be available on Mac computers.

As a software designer and a person with diabetes, I’m really impressed by the quality of the screens and how easy it is to use. I think this will really push other pump makers to make their pumps much easier to use.

My only real complaint (and it’s small). I think the t:slim only comes in Model T black. Perhaps the colorful screens make up for that.

If I do manage to get a loaner unit, I’ll put up another post with some video. Happy summer all.

Tandem Diabetes Care out of San Diego, CA will soon be marketing in the U.S. its t:slim insulin pump thanks to a newly issued FDA approval. zmgv0oc31 Tandem t:slim Insulin Pump Gets FDA ClearanceThe t:slim looks more like an iPhone 4 than a critical medical device, including a color touchscreen and USB connectivity for syncing with a computer and for recharging the internal battery.

This may not be a coincidence because the rep for Tandem, in an email to Medgadget, specifically mentioned Amy Tenderich’s open letter to Steve Jobs calling for Apple to design an insulin pump from four years ago. We think Amy should take at least a bit of credit for encouraging such a stunning design.

The slide-out insulin cartridge is easy to change and the device can connect to PC’s and Macs to upload pump data to a web-based application for further review.

Source : http://www.tandemdiabetes.com/News/Tandem-Diabetes-Care%E2%84%A2-Launches-t-slim%E2%84%A2-Insulin-Delivery-System/

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Islet Sciences licenses noninvasive technology for detecting Beta cell death from Winthrop

Islet Sciences licenses noninvasive technology for detecting Beta cell death from Winthrop

Islet Sciences, Inc., (OTCBB: ISLT) a biotechnology company engaged in the research, development and commercialization of patented technologies in the field of transplantation therapy for patients with diabetes, today announced that it has exclusively licensed technology from Winthrop University Hospital. This technology is complimentary to the early Beta cell destruction diagnostic that Islet Sciences licensed last month.

“In the course of research conducted under Winthrop University Hospital, Dr. Eitan Akirav and his colleagues at Winthrop have developed a technology entitled Method for Using Probe Based PCR Detection to Measure the Levels of Circulating Demethylated Beta Cell Derived DNA as a Measure of Beta Cell Loss in Diabetes,” stated John Steel, Chairman and CEO of Islet Sciences. “We are pleased to bring this groundbreaking technology to the next level as we look to commercialize it to benefit the growing worldwide diabetic community. There has been a long-felt need for a method capable of accurately evaluating Beta cell death so as to improve disease diagnosis, allow for disease staging, and provide a better evaluation of clinical treatment efficacy. The method can identify Beta cell death before the onset of hyperglycemia and soon after the onset of T1D.”

“The method provides a noninvasive approach for detecting Beta cell death in vivo that may be used to track the progression of diabetes and guide its treatment,” said Dr. Eitan Akirav, Research Scientist at Winthrop University Hospital. “I am excited to work with Islet Sciences to bring this technology to market which clearly has so much potential. The method uses a stepwise detection and analysis of Beta cell and non-Beta cell derived insulin DNA. The key principle behind the method is the existence of unique DNA methylation patterns in the Beta cells that are absent from other cells in the body.”

Alan M. Jacobson, MD, Chief Research Officer, Director of the Diabetes, Obesity and Cardiometabolic Research Center and Senior Scientist, Winthrop University Hospital Research Institute commented, “We look forward to working with Islet Sciences as they invest in this discovery and develop it into a valuable new tool for treating this life altering disease.”

Source : http://www.news-medical.net/news/20120910/Islet-Sciences-licenses-noninvasive-technology-for-detecting-Beta-cell-death-from-Winthrop.aspx

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