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FDA Approves Lucentis® (Ranibizumab Injection) for Treatment of Diabetic Macular Edema (DME)

August 13, 2012 By admin Leave a Comment

– First Major Treatment Advance in More Than 25 Years for Sight-Threatening Condition –
South San Francisco, Calif. — August 10, 2012 — Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that Lucentis® (ranibizumab injection) was approved by the U.S. Food & Drug Administration (FDA) for treatment of diabetic macular edema (DME), an eye condition in people with diabetes that causes blurred vision, severe vision loss and sometimes blindness. Diabetes is now the leading cause of new cases of blindness in American adults1 and DME is estimated to affect more than 560,000 Americans with the disease.2
Lucentis is the first and only FDA-approved medicine for DME, a condition for which the standard of care has not changed significantly in more than 25 years. To date, the standard of care in the U.S. for DME has been laser surgery, which slows the rate of vision loss and helps stabilize vision, but has demonstrated only limited ability to restore lost vision.3
“For the first time, Americans with diabetic macular edema will have access to an FDA-approved medicine shown to help many patients rapidly regain substantial amounts of lost vision,” said Hal Barron, M.D., chief medical officer and head, Global Product Development. “We developed Lucentis to treat diseases of the eye and are pleased to have received this third U.S. indication to help a new population of people whose eyesight may be affected by diabetes.”
“This approval is an important advancement in the fight against blindness for people with diabetes,” said David M. Brown M.D., Retinal Specialist at The Methodist Hospital, Houston Texas, and clinical trial investigator. “Now that it will be available, Lucentis therapy can begin to make a difference in the lives of our patients with DME.”
Lucentis 0.5 mg once monthly was first approved by the FDA for treatment of wet age-related macular degeneration (AMD) in 2006 and for macular edema following retinal vein occlusion (RVO) in 2010. Lucentis 0.3 mg once monthly was approved for DME, and physicians can order immediately with shipments expected to begin August 15.
Lucentis Efficacy in DME
The approval of Lucentis in DME was based on Genentech¿s Phase III trials, RIDE and RISE, two identically-designed, parallel, double-masked, three-year clinical trials, which were sham-treatment controlled for 24 months. A total of 759 patients were randomized into three groups to receive monthly treatment with 0.3 mg Lucentis (n=250), 0.5 mg Lucentis (n=252) or sham injection (control group, n=257). Primary outcomes were evaluated at 24 months and have been published in Ophthalmology.4
In the studies, treatment with Lucentis demonstrated improved clinical outcomes including substantial visual gain for many DME patients. Results showed patients who received 0.3 mg Lucentis experienced significant, early (Day 7) and sustained (24 months) improvements in vision:

 

  • More patients who received Lucentis were able to read at least three additional lines (15 letters) on the eye chart at 24 months: RIDE: 34 percent in the 0.3 mg group versus 12 percent in the control group; RISE: 45 percent, 0.3 mg versus 18 percent, control (primary endpoint)
  • Patients who received Lucentis had average vision gains exceeding two lines (10 letters) on the eye chart at 24 months: RIDE: 10.9 letters, 0.3 mg versus 2.3 letters, control; RISE: 12.5 letters, 0.3 mg versus 2.6 letters, control
  • Significant gains in average vision were observed 7 days after the first treatment
  • Patients who received Lucentis were significantly more likely to maintain their vision (lose < 15 letters on the eye chart) at 24 months: RIDE: 98 percent, 0.3 mg versus 92 percent, control; RISE: 98 percent, 0.3 mg versus 90 percent, control

For all time points comparing 0.3 mg Lucentis to control through Month 24 p < 0.01.
Vision improvements observed in patients treated with Lucentis at 24 months were maintained with continued treatment through 36 months.
Lucentis Safety in DME
The benefit/risk profile of Lucentis was favorable in patients with DME through 36 months in the clinical trials. Pooled safety analysis of RIDE and RISE at 24 months showed:

  • The ocular safety of Lucentis in patients with DME was generally consistent with that established in patients with wet AMD and RVO (through 36 months).
  • The most common ocular events occurring at a higher rate in patients receiving 0.3 mg Lucentis compared to the control groups included conjunctival hemorrhage (bleeding under the lining of the eye): 47 percent, 0.3 mg versus 32 percent, control; eye pain: 17 percent, 0.3 mg versus 13 percent, control; foreign body sensation in eyes: 10 percent, 0.3 mg versus 5 percent, control; vitreous floaters: 10 percent, 0.3 mg versus 4 percent, control; and increased eye pressure: 18 percent, 0.3 mg versus 7 percent, control.

Although uncommon, trends toward increased rates of arteriothromboembolic events (ATEs) such as vascular death, deaths of unknown cause, nonfatal heart attacks and nonfatal strokes, have been observed in prior studies of Lucentis in other diseases.

  • Rates of these events were similar among DME patients receiving 0.3 mg Lucentis and the control groups at 24 months at 5.6 percent, 0.3 mg versus 5.2 percent, control. The rate of ATE events at 36 months was 10.8 percent for patients in the 0.3 mg treatment group (control period ended at 24 months).
  • The rate of stroke in DME patients at 24 months was 1.2 percent, 0.3 mg versus 1.6 percent, control. The rate of stroke at 36 months was 2.0 percent for patients in the 0.3 mg treatment group.

Pooled analyses also showed the rate of fatal events (death from any cause) in patients treated in the DME trials was low, and many causes of death were not unusual for patients with advanced diabetes complications. However, a potential relationship between the events and intravitreal use of VEGF inhibitors cannot be excluded. The rate of fatalities at 24 months was 2.8 percent, 0.3 mg versus 1.2 percent, control. The rate of fatalities at 36 months was 4.4 percent for patients in the 0.3 mg treatment group.
About DME
DME is swelling of the macula, the central part of the retina responsible for sharp, central vision.5 DME begins with diabetes, which can cause damage to blood vessels in the eye over time. When this happens, a patient is said to have diabetic retinopathy, the most common diabetic eye disease. The damaged blood vessels can leak blood and fluid, causing swelling and blurred vision, severe vision loss and sometimes blindness.5
Nearly 26 million Americans have diabetes, which has become the leading cause of new cases of blindness in adults aged 20-74.1 Among Americans aged 40 years and older, more than 4.2 million have diabetic retinopathy, according to the 20052008 National Health and Nutrition Examination Survey (NHANES).6 A subsequent analysis estimates that 560,500 have DME.2 It has also been estimated that up to 10 percent of people with diabetes will get DME during their lifetime.7
About Lucentis
Lucentis is a prescription medicine for the treatment of patients with wet AMD, macular edema following RVO and DME.
Lucentis is a recombinant humanized monoclonal antibody fragment (lacking an Fc region). Lucentis is the first VEGF inhibitor specifically designed for use in the eye to bind to and inhibit VEGF-A, a protein that is believed to play a critical role in the formation of new blood vessels (angiogenesis) and the hyperpermeability (leakiness) of the vessels.
In wet AMD, these new blood vessels grow under the retina and leak blood and fluid, causing rapid damage to the macula. Lucentis administered monthly in wet AMD clinical trials demonstrated an improvement in vision of three lines or more on the study eye chart in up to 41 percent of patients at two years. Nearly all patients (90 percent) treated monthly with Lucentis in those trials maintained (defined as losing < 15 letters) vision.
In RVO, angiogenesis and hyperpermeability can lead to macular edema, the swelling and thickening of the macula. Lucentis administered at 0.5 mg monthly in RVO clinical trials demonstrated the following average vision gains for patients at six months: patients with branch-RVO experienced an average gain of 18.3 letters on the study eye chart (compared to 7.3 letters for the control group) and patients with central-RVO experienced an average gain of 14.9 letters on the study eye chart (compared to 0.8 letters for the control group).
Lucentis has been rigorously studied in multiple retinal diseases in 27 clinical trials involving more than 10,500 patients worldwide.
Outside the U.S., Lucentis has received regulatory approval for treatment of visual impairment due to DME in more than 75 countries, for treatment of wet AMD in more than 100 countries and for treatment of RVO in more than 70 countries.
Lucentis was discovered by Genentech and is being developed by Genentech and Novartis for diseases or disorders of the eye. Genentech retains commercial rights in the U.S. and Novartis has exclusive commercial rights for the rest of the world.
Lucentis in DME Indication Statement
Lucentis 0.3 mg (0.05 mL of 6 mg/mL Lucentis solution) is recommended to be administered by intravitreal injection once a month (approximately 28 days) for treatment of diabetic macular edema (DME).
Lucentis Safety
Lucentis is a prescription medicine given by injection into the eye, and it has side effects. Lucentis is not for everyone. You should not use Lucentis if you have an infection in or around the eye or are allergic to Lucentis or any of its ingredients.
Some Lucentis patients have serious side effects related to the injection. These include serious infections inside the eye, detached retinas, and cataracts. Other uncommon serious side effects include inflammation inside the eye and increased eye pressure. These side effects can make your vision worse. Some patients have had increased eye pressure within one hour of an injection. Your eye doctor should check your eye pressure and eye health during the week after your Lucentis injection.
Uncommonly, Lucentis patients have had serious, sometimes fatal, problems related to blood clots, such as heart attacks or strokes.
If your eye becomes red, sensitive to light, or painful, or if you have a change in vision, call or visit your eye doctor right away.
The most common eye-related side effects are increased redness in the white of the eye, eye pain, small specks in vision, and increased eye pressure. The most common non-eye-related side effects are nose and throat infections, headache, lung/airway infections, and nausea.
Lucentis is for prescription use only.
For additional safety information, please talk to your doctor and visit http://www.lucentis.com for the Lucentis full prescribing information.
Genentech’s Commitment to Patient Access
At Genentech, we develop medicines for serious or life-threatening medical conditions and we believe they should be accessible for the patients who need them. Genentech Access Solutions is here to help when a Genentech medicine is prescribed. We offer a full range of programs and services to meet the needs of patients and health care professionals. What patients need for access¿from benefits investigations through patient assistance options¿is available through Genentech Access Solutions. For more information, please visit Genentech-Access.com.
About Genentech
Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

 

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Antipsychotic drugs tied to diabetes in pregnancy

July 4, 2012 By admin Leave a Comment

(Reuters Health) – Women who take antipsychotic medications while pregnant may have an increased risk of developing diabetes, according to a new Swedish study.

Researchers found that out of 360,000 women who gave birth over a four-year span, about four percent of those on antipsychotic drugs developed gestational diabetes. Meanwhile, only 1.7 percent of women who weren’t taking antipsychotics were diagnosed with pregnancy-related diabetes.

“It’s a very important and difficult area to study, because severe mental disorders – such as schizophrenia and bipolar disorder – often require consistent medication even if a woman is pregnant. So it’s very important for us to know all the possible adverse effects from the medications,” said Dr. Robert Bodén, the study’s lead author from Uppsala University in Sweden.

Bodén and his colleagues write in the Archives of General Psychiatry that they expected to see a link between the development of gestational diabetes and olanzapine – sold under the brand name Zyprexa – and clozapine – sold as Fazaclo or Clozaril.

Those two drugs are newer antipsychotics and have been linked to weight gain, high cholesterol and increased insulin resistance, according to the authors. “We thought (gestational diabetes risk) would be more exaggerated for those treated with the two (newer drugs) but we were surprised we saw it for all antipsychotics,” said Bodén.

For their study, the researchers collected information from various databases on all women who gave birth in Sweden from mid-2005 through the end of 2009. Of those, 169 took olanzapine, clozapine or a combination of the two during pregnancy, 338 took other types of antipsychotics and 357,696 were not on any antipsychotic drugs.

Seven of the women on the newer antipsychotics and 15 on the older versions became diabetic during their pregnancies, compared to 5,970 women not on antipsychotics. That, the researchers say, works out to women on the medications being twice as likely to develop gestational diabetes.

The study, however, cannot prove the drugs caused gestational diabetes. It could be that women on antipsychotics have other traits that leave them more vulnerable to diabetes. Poor diet and lack of exercise, for example, have been tied to the condition.

Dr. Peter Manu, who has studied antipsychotics at the Zucker Hillside Hospital in Glen Oaks, New York, told Reuters Health the study also may not have tracked women for long enough to see a difference in diabetes risk between the newer and older medications.

“The message there is that – to some extent – even looking over a period of nine months may not give the entire story,” said Manu, who was not involved with the new research.

NO LINK TO BABY SIZE

The researchers also looked at whether antipsychotic drugs were tied to differences in baby size at birth, because women with gestational diabetes may deliver bigger babies. But there was no clear link.

Bodén told Reuters Health his team did find that babies born to mothers on the newer antipsychotic drugs were more likely to have big heads. He said this is the first time that’s been shown, however, and there needs to be more research into that finding.

As for what women with schizophrenia or bipolar disorder can do to limit their risk of gestational diabetes, Bodén said that varies patient to patient.

“You have to balance a lot of things,” he said.

The approach, he said, depends on what medications women need, how long they’ve been pregnant and which medications are linked to pregnancy-related problems.

 

Filed Under: Featured News

Bristol’s Amylin Deal Heralds Acquisition Hunger

July 4, 2012 By admin Leave a Comment

Bristol-Myers Squibb Co.’s $5.3 billion deal to buy diabetes drugmaker Amylin Pharmaceuticals Inc. (AMLN) gives Bristol (BMY) immediate access to a market of growing medical need, while heralding a burgeoning hunger among pharmaceutical companies for acquisitions.

The agreement is the second announced this year for Bristol, and the largest for the industry. It comes after the blood-thinner Plavix, Bristol’s top seller in 2011 at $7.1 billion, faced generic competition for the first time in May.

Drugmakers last year lost patent protection on products valued at $34 billion in annual sales, an amount that will rise to $147 billion by 2015, according to data compiled by Bloomberg. The Bristol deal would be the fifth sealed in 2012 for more than $1 billion, more than the three in each of the previous two years. More deals like this one are coming, said Seamus Fernandez, of Leerink Swann & Co.

“We are on the cusp of the next consolidation wave,” said Fernandez, a Boston-based industry analyst, by telephone. “There just isn’t enough top-line growth in the industry.”

AstraZeneca, Pfizer

Last year, drugmakers “took a little bit of a pause,” he said. “Now, I think we are going to see a reacceleration in that number.” Fernandez identified London-based AstraZeneca Plc (AZN), New York-based Pfizer Inc. (PFE) and Merck (MRK) & Co., of Whitehouse Station, New Jersey, as possible acquirers during the year ahead.

“AstraZeneca and Pfizer have pretty much been out of the market,” he said. “We should anticipate they will be back. I wouldn’t be surprised with some of the spin outs to see more large acquisitions being considered.”

Bristol said on June 29 that it agreed to buy San Diego- based Amylin for $31 a share in cash, a 10 percent premium to the June 29 closing price. The New York-based drugmaker also announced it will be paid $3.4 billion by AstraZeneca to help develop Amylin’s drug pipeline.

Amylin rose 8.9 percent to $30.71 at the close of New York trading. The stock was at $15.39 on March 27, the day before it was reported Bristol had made an unsolicited offer of $22 a share. Bristol gained less than 1 percent to $36.05.

The AstraZeneca partnership means the companies will share both the risk and the reward of potential treatments.

Going to Fail

“Drugmakers say they would do more deals, but the issue with biotech companies is that most of the drugs they’re developing are going to fail,” said Mark Schoenebaum, an analyst at ISI Group in New York, by telephone. “So the biggest issue isn’t the willingness to do a deal, or the appetite to do deals, but rather finding stuff that’s worth buying.

“When you have good assets coming along you’ll see deals,” Schoenebaum said.

Amylin offered Bristol two products already approved for sale by U.S. regulators — the twice-daily diabetes injection Byetta, which generated $518 million in 2011, and a longer- acting form of that drug, called Bydureon, that’s taken just once a week.

“We believe this is a very strategic transaction for Bristol Myers Squibb,” said Bristol Chief Executive Officer Lamberto Andreotti in a conference call with investors. “It will enhance our already strong diabetes portfolio, something that is very important in light of the significant unmet medical need.”

Creating Value

If the easier-to-use Bydureon becomes a $2 billion product, “it will create value” for shareholders, Schoenebaum said. “We saw a lot of interest in Amylin because it’s diabetes and there aren’t a lot of diabetes assets out there. It is increasingly strategic to be in that market.”

Bristol’s own experimental diabetes product, dapagliflozin, failed to win U.S. marketing approval in January, when the Food and Drug Administration asked for more data to assess its risks and benefits. The treatment, being developed with AstraZeneca, was recommended for approval by advisers to regulators in Europe, and the companies are awaiting a decision.

Diabetes has become a key target for pharmaceutical companies as a result of rising obesity rates and the aging of the Baby Boom generation. About 346 million people globally have the illness, and the number of deaths may double from 2005 to 2030, according to the World Health Organization.

AstraZeneca, Paris-based Sanofi (SAN) and Merck also made offers during a bidding process, people with knowledge of the process had said.

Marketing Partnership

Amylin ended a marketing partnership on Bydureon and Byetta with Indianapolis-based Eli Lilly & Co. (LLY) in November, and had been seeking a partner to sell the medicine outside the U.S. The company began to seek acquisition suitors after rejecting a $22- a-share offer from Bristol in February, people familiar with the matter said earlier this year.

For Bristol, the purchase is the largest of 19 since 2007, when it began its so-called string of pearls acquisition strategy designed to revitalize the company in the face of patent losses and produce a more diverse stable of products.

This year, there have been four announced acquisitions of biotechs for more than $1 billion, and one takeover attempt that’s still active, according to data compiled by Bloomberg.

GlaxoSmithKline Plc’s $2.6 billion hostile offer for Human Genome Sciences Inc. is still pending. The two companies have a partnership on the approved lupus drug Benlysta, as well as experimental medicines for diabetes and cardiovascular disease.

Bristol purchased Inhibitex in January for $2.5 billion to gain access to experimental hepatitis C medicines, while Agilent Technologies Inc. bought Danish cancer-diagnostics maker Dako for $2.2 billion to expand its life-science business.

AstraZeneca took over Ardea Biosciences Inc. for $1.26 billion in April, adding experimental drugs for gout and cancer.

Amylin was advised by Goldman Sachs & Co. and Credit Suisse Securities LLC. Citigroup Inc. and Evercore Partners Inc. (EVR) are serving as financial advisers to Bristol. Bank of America Merrill Lynch advised AstraZeneca.

To contact the reporters on this story: Meg Tirrell in New York at mtirrell@bloomberg.net; Ryan Flinn in San Francisco at rflinn@bloomberg.net; Jeffrey McCracken in New York atjmccracken3@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.netScience

 

Filed Under: Featured News

Study Identifies Possible Protective Blood Factors Against Type 2 Diabetes

May 3, 2012 By admin Leave a Comment

BRONX, N.Y., May 3, 2012 /PRNewswire via COMTEX/ — Researchers at Albert Einstein College of Medicine of Yeshiva University in collaboration with Nurses’ Health Study investigators have shown that levels of certain related proteins found in blood are associated with a greatly reduced risk for developing type 2 diabetes up to a decade or more later. The findings, published today in the online edition of Diabetes, could open a new front in the war against diabetes.

These proteins are part of what is called the IGF axis. This axis was named for insulin-like growth factor-1, (IGF-1), so called because it has biological effects similar to those of insulin (the hormone that regulates blood glucose levels) but has a greater effect on cell growth than insulin. The researchers also looked at levels of several proteins known as IGF binding proteins, or IGFBPs, that may have strong effects independent of IGF-1.

Researchers have hypothesized that the IGF axis may influence risk for developing diabetes – an idea supported by laboratory and mouse studies, and a few initial studies in humans. However, the current study is the first large, prospective investigation of several components of the IGF-axis and the risk for developing diabetes, according to co-senior author Howard Strickler, M.D., M.P.H., professor of epidemiology & population health at Einstein.

In the current study, the researchers analyzed levels of IGF-1, IGFBP-1, IGFBP-2, and IGFBP-3 in blood taken from 742 women in the Nurses’ Health Study who years later developed type 2 diabetes as well as a similar number of women in the study who did not develop diabetes. None of the women had any signs or symptoms of the disease at the time their blood samples were taken. The median time between the taking of blood samples and diabetes onset was nine years.

Each component of the IGF axis (IGF-1 and IGFBP-1, -2, and -3) had a significant independent association with diabetes risk – most notably IGFBP-1 and -2. Compared with women in the bottom 20 percent with respect to their levels of IGFBP-1, having high levels of IGFBP-1 (top 20 percent) was associated with a three-fold reduction in risk for diabetes, while high levels of IGFBP-2 were associated with a more than five-fold reduction in diabetes risk.

“Our data provide important new evidence that circulating IGF-axis proteins may have a role in the development of type 2 diabetes,” said Dr. Strickler.

The findings have potential clinical implications. First of all, IGF-axis proteins could help in stratifying people at risk for diabetes. “For example,” said Dr. Strickler, “we know that obesity is a major risk factor for diabetes. But some overweight individuals don’t develop diabetes, while some thin people do. If our findings are confirmed, they could help doctors more precisely determine who is actually at risk for the disease.”

The proteins may also prove useful as targets for novel therapies to prevent or treat diabetes. But Dr. Strickler cautions that it’s too early to apply these findings to clinical practice. “IGF-axis proteins have other effects, some beneficial and some not,” he notes. “We need to learn more about the connection between the IGF-axis and diabetes before we recommend that people get tested for these substances, and before deciding how we can exploit the IGF-1 axis to help address diabetes.”

The Diabetes paper is titled, “The Insulin-Like Growth Factor Axis and Risk of Type 2 Diabetes in Women.” The first author was Swapnil Rajpathak (who was at Einstein at the time this work was conducted). The other senior author is Frank B. Hu, M.D., Ph.D, of Harvard School of Public Health, Boston, MA. Additional contributors include Meian He, M.D., Ph.D., (Harvard and Huazhong University of Science and Technology, Wuhan, Hubei, China); Qi Sun M.D., Sc.D., (Harvard); Jeannette Beasley, Ph.D., R.D., M.P.H., (Fred Hutchinson Cancer Research Center, Seattle, WA); Michael Pollak, M.D., (McGill University, Montreal, Quebec, Canada); and Robert Kaplan, Ph.D., Radhika Muzumdar M.D., M.B.B.S., Thomas Rohan, M.D., Ph.D., Mimi Kim, Sci.D., Jeffrey Pessin, Ph.D., and Judith Wylie-Rosett, Ed.D., all of Einstein. Co-author Marc Gunter, Ph.D., contributed to the paper while at Einstein.

The study was supported by grants from the National Institutes of Health. Laboratory testing and data analysis were supported in part by NIDDK 5-R01-DK-080792. The NHS is supported by grants CA-87969, DK-58845, and DK-58785 from the National Institute of Diabetes and Digestive and Kidney Diseases and the National Institute of Child Health and Human Development. Q.S. was supported by a career development award (K99HL098459) from the National Heart, Lung, and Blood Institute. The authors report no conflicts of interest.

About Albert Einstein College of Medicine of Yeshiva University

Albert Einstein College of Medicine of Yeshiva University is one of the nation’s premier centers for research, medical education and clinical investigation. During the 2011-2012 academic year, Einstein is home to 724 M.D. students, 248 Ph.D. students, 117 students in the combined M.D./Ph.D. program, and 368 postdoctoral research fellows. The College of Medicine has 2,522 full time faculty members located on the main campus and at its clinical affiliates. In 2011, Einstein received nearly $170 million in awards from the NIH. This includes the funding of major research centers at Einstein in diabetes, cancer, liver disease, and AIDS. Other areas where the College of Medicine is concentrating its efforts include developmental brain research, neuroscience, cardiac disease, and initiatives to reduce and eliminate ethnic and racial health disparities. Its partnership with Montefiore Medical Center, the University Hospital and academic medical center for Einstein, advances clinical and translational research to accelerate the pace at which new discoveries become the treatments and therapies that benefit patients. Through its extensive affiliation network involving Montefiore, Jacobi Medical Center – Einstein’s founding hospital, and five other hospital systems in the Bronx, Manhattan, Long Island and Brooklyn, Einstein runs one of the largest post-graduate medical training programs in the United States, offering approximately 155 residency programs to more than 2,200 physicians in training. For more information, please visit www.einstein.yu.edu and follow us on Twitter @EinsteinMed.

SOURCE Albert Einstein College of Medicine

Copyright (C) 2012 PR Newswire. All rights reserved

 

Filed Under: Featured News Tagged With: diabetes, diabetes education, type 2 diabetes

Sanofi iBGStar® Blood Glucose Monitoring System Now Available in the U.S.

May 2, 2012 By admin Leave a Comment

- First FDA Cleared Blood Glucose Meter that Connects Directly to iPhone® and iPod touch® – - Available at Apple® Retail Stores and Walgreens Nationwide, Online at Apple.com, Walgreens.com and through Diabetic Care Services – - Recipient of Two Design Awards for Outstanding Product Design -

BRIDGEWATER, N.J., May 2, 2012 /PRNewswire via COMTEX/ — Sanofi US announced today that the iBGStar® Blood Glucose Monitoring System, consisting of the iBGStar® blood glucose meter and iBGStar® Diabetes Manager App, is commercially available in the U.S. iBGStar® is the first Food and Drug Administration (FDA) cleared blood glucose meter that directly connects to the iPhone® and iPod touch®, offering accurate blood glucose monitoring that seamlessly integrates into the lives of people with diabetes. iBGStar® is available for purchase at Apple® Retail Stores and all Walgreens stores nationwide, online at Apple.com, Walgreens.com and through Diabetic Care Services.

To view the multimedia assets associated with this release, please click: http://www.multivu.com/mnr/46108-sanofi-ibgstar-blood-glucose-monitoring-system

“Many people with diabetes today rely both on their iPhone® or iPod touch® and blood glucose monitors as important parts of their daily lives,” said Naina Sinha, MD, an in-patient diabetes attending physician and assistant professor of medicine at a leading academic medical center and university in New York City. “By combining these two essential tools, iBGStar® makes it possible to provide blood glucose tracking, monitoring and reporting together in a new way.”

About iBGStar®When iBGStar® is directly connected to an iPhone® or iPod touch® and used with the iBGStar® Diabetes Manager App, blood glucose results are presented on the Multi-Touch display quickly after monitoring.

iBGStar® can also be used independently to measure blood glucose levels; results can be synchronized later to an iPhone® or iPod touch®. iBGStar® and BGStar® Blood Glucose Test Strips, which are used with iBGStar®, are available at all Walgreens stores nationwide and online at Walgreens.com and through Diabetic Care Services. These test strips may be covered under certain health insurance plans so individuals should check directly with their provider.

The iBGStar® Diabetes Manager App has a range of features and multiple views for analyzing glucose patterns on-the-go. Visual graphs and statistics can help people record and track their readings, carbohydrate intake, insulin doses (if taking insulin) and more. Color-coded scorecards show individual monitoring results for easy identification of high or low blood glucose levels. A ‘share’ function allows specific data to be sent via e-mail to caregivers and/or healthcare teams. The iBGStar® Diabetes Manager App is available for free from the App Store on iPhone® and iPod touch® or at www.itunes.com/appstore .

“Sanofi is pleased to launch iBGStar®, which expands our diabetes portfolio as we pursue comprehensive disease management offerings and further illustrates our commitment to developing innovative solutions that help improve the lives of people with diabetes,” commented Dennis Urbaniak, Vice President, Head of U.S. Diabetes, Sanofi US. “The iBGStar® Blood Glucose Monitoring System will help people living with diabetes check their blood sugar and communicate with their healthcare teams, using mobile technologies that have become central to so many people’s lives.”

In March 2010, Sanofi and AgaMatrix signed an agreement for the development, supply and commercialization of Blood Glucose Monitoring solutions. iBGStar® is a result of this agreement.

iBGStar® received the Good Design(TM) Award in 2011 for outstanding product design in the medical category from the Chicago Athenaeum of Architecture and Design and the European Centre for Architecture Art Design and Urban Studies. Additionally, iBGStar® received the red dot design award in 2011 for outstanding product design in the life science and medicine category. The red dot design award is one of the most renowned international design competitions ( www.red-dot.de/presse ), with almost 14,000 entries from 68 countries in 2010 alone. Winners are considered to be the best design in the industry worldwide.

Apple®, iPhone® and iPod touch® are trademarks of Apple Inc, registered in the U.S. and other countries. App Store is a service mark of Apple Inc. Content purchased from the iTunes Store is for personal lawful use only. Don’t steal music.

For more information, visit www.ibgstar.us .

About the Sanofi Diabetes DivisionSanofi strives to help people manage the complex challenges of diabetes by delivering innovative, integrated and personalized solutions. Driven by valuable insight that comes from listening to and engaging with people living with diabetes, the Company is forming partnerships to offer diagnostics, therapies, services, and devices, including innovative blood glucose monitoring systems. Sanofi markets both injectable and oral medications for people with type 1 or type 2 diabetes. Investigational compounds in the pipeline include an injectable GLP-1 agonist being studied as a single agent, in combination with basal insulin, and/or in combination with oral antidiabetic agents.

Important InformationThe iBGStar® meter and lancing device are for single patient use. Do not share them with anyone including other family members. Do not use on multiple patients. All parts of the kit are considered biohazardous and can potentially transmit infectious diseases, even after you have performed cleaning and disinfection.

About Sanofi

Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris /quotes/zigman/187275 FR:SAN +0.97% and in New York /quotes/zigman/307926/quotes/nls/sny SNY +0.16% .

Sanofi is the holding company of a consolidated group of subsidiaries and operates in the United States as Sanofi US, also referred to as sanofi-aventis U.S. LLC. For more information on Sanofi US, please visit http://www.sanofi.us or call 1-800-981-2491.

Forward Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group’s ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2011. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

US.BGM.12.02.076

SOURCE Sanofi US

Copyright (C) 2012 PR Newswire. All rights reserved

 

Filed Under: Featured News Tagged With: diabetes management, IBStar Blood Glucose Monitor, Sanofi US, type 1 diabetes, type 2 diabetes

Kid’s Type 2 Diabetes Difficult to Treat

May 2, 2012 By admin Leave a Comment

Type 2 diabetes was once considered an adult disease. Not so anymore. Kids are being diagnosed at an alarming rate, and now a new study says that these children are going to have a tougher time getting the disease under control.

Obesity and lack of physical activity are two of the most common reasons someone gets type 2 diabetes. During the past three decades, the tripling of obesity in children has gone hand in hand with an increase of type 2 diabetes in children.

What is type 2 diabetes? It begins when the body develops a resistance to insulin and cannot use insulin properly. The pancreas is no longer able to produce sufficient amounts of insulin to control blood sugar. Hyperglycemia is the medical term for high blood sugar levels. The reason it is so bad is that hyperglycemia can damage the vessels that supply blood to vital organs, which can increase the risk of heart disease and stroke, kidney disease, vision problems, and nerve problems.

In a large new trial looking at ways to slow the progression of type 2 diabetes in children and teens, the addition of a second drug to the mainstay treatment metformin was only marginally more effective at controlling blood sugar than metformin alone.

Within a year, on average, half of kids on metformin and some 40 percent taking both metformin and rosiglitazone (Avandia) ended up having to resort to insulin injections to control their blood sugar, researchers reported Sunday at the annual meeting of the Pediatric Academic Societies in Boston and in the New England Journal of Medicine online.

“The results of the study were discouraging,” said Dr. David Allen from the University of Wisconsin School of Medicine and Public Health in an NEJM editorial. “These data imply that most youth with type 2 diabetes will require multiple oral agents or insulin therapy within a very few years after diagnosis.”

All 699 children included in the study had been diagnosed with type 2 diabetes two years or less before enrollment, so the rapid advance of about half to needing insulin marks an early start to a potential lifetime of complications and side effects — from the diabetes itself and the medications used to treat the disease.

Type 2 diabetes “progresses more rapidly” in youth, according to Dr. Phil Zeitler from the University of Colorado, Denver, who worked on the new study.

He and his colleagues were surprised at how quickly many of the youngsters needed to switch from oral medications to taking daily insulin shots, Zeitler told Reuters Health.

Also, Zeitler said, the teens in the study appeared to have complications, including infections and hospitalization, more often than adults do.

All the children in the study were overweight or obese, and ranged in age from 10 to 17 years old.

Children also may have a more difficult time taking their medications as instructed and are not usually in control of what is given to them to eat. Fast food dining has become a staple for many American families. School lunches are not much better in some regions, and kids are simply not as active as in past generations. Zeitler noted “the toxicity of your lifestyle must be pretty severe,” for young children and teens to get type 2 diabetes before adulthood.

That’s why all of the kids in the study got at least “basic lifestyle counseling,” he emphasized — for example, advice to stop drinking sugared sodas, eat less fast food, watch their diet in other healthy ways, take stairs instead of elevators and generally get more exercise.

Study enrollment began in July 2004 and follow-up continued through February 2011. All the kids in the study were taking metformin, a well-established diabetes drug, and a third were assigned to take the newer drug Avandia as well.

Another third of the kids were assigned a very intensive “lifestyle intervention,” that involved more assignments for kids to complete, more interaction with counselors, and close involvement of at least one parent, in addition to taking metformin.

The kids’ treatments were deemed failures if blood sugar and other signs pointed to their diabetes not being under control for a period of six months or more.

In the end, 52 percent of kids on metformin alone “failed” treatment, along with 39 percent of kids on metformin and Avandia and 47 percent of kids on metformin and lifestyle changes.

The median time it took for blood sugar control to be lost was just under a year.

The added benefit of Avandia was limited to girls, for reasons that are unclear, the researchers reported.

Also for unknown reasons, they noted, metformin alone was less effective for non-Hispanic black participants than other kids.

Overall, 19 percent of the participants developed serious adverse effects such as severe hypoglycemia, diabetic ketoacidosis and lactic acidosis.

The rate in the treatment groups was 18 percent in the metformin-only group, 15 percent in the double-drug group and 25 percent in the group that received the very intensive lifestyle intervention. The rate of specific problems such as hyperglycemia, were not significantly higher between the groups.

Fifty years ago,” the editorial continues, “children did not avoid obesity by making healthy choices; they simply lived in an environment that provided fewer calories and included more physical activity for all. Until a healthier ‘eat less, move more’ environment is created for today’s children, lifestyle interventions like that in the …study will fail.”

Type 2 diabetes can be difficult to diagnose in children because they may go without symptoms for a long time. A blood test to measure glucose metabolism is needed for an accurate diagnosis.

Mayoclinic.com gives these symptoms to be aware of.

- Increased thirst and urination. As excess sugar builds up in your child’s bloodstream, fluid is pulled from the tissues. This may leave your child thirsty. As a result, your child may drink — and urinate — more than usual.

- Increased hunger. Without enough insulin to move sugar into your child’s cells, your child’s muscles and organs become depleted of energy. This triggers hunger.

- Weight loss. Despite eating more than usual to relieve hunger, your child may lose weight. Without the energy sugar supplies to your cells, muscle tissues and fat stores simply shrink.

- Fatigue. If your child’s cells are deprived of sugar, he or she may become tired and irritable.

- Blurred vision. If your child’s blood sugar is too high, fluid may be pulled from the lenses of your child’s eyes. This may affect your child’s ability to focus clearly.

- Slow-healing sores or frequent infections. Type 2 diabetes affects your child’s ability to heal and resist infections.

- Areas of darkened skin. Areas of darkened skin (acanthosis nigricans) may be a sign of insulin resistance. These dark patches often occur in the armpits or neck.

Treating type 2 diabetes is much more difficult than preventing it. Long-term diabetes can have devastating results on your health. That’s why it’s so important for families to be aware of the disease and what it takes to help prevent it.

Sources: http://www.mayoclinic.com/health/type-2-diabetes-in-children/DS00946/DSECTION=symptoms

http://www.reuters.com/article/2012/04/30/us-diabetes-kids-idUSBRE83T17K20120430

Filed Under: Featured News Tagged With: kids type 2 diabetes, mayo clinic, teens with type 2 diabetes, type 2 diabetes

Telcare’s Wireless-Enabled Blood Glucose Monitoring System Wins 2012 Gold Edison Award

April 28, 2012 By admin Leave a Comment

Telcare’s New Diabetes Care Management Device Recognized As Best New Science and Medical Online Tool/App

New York, NY (PRWEB) April 27, 2012

Telcare’s wireless enabled blood glucose monitoring system received the 2012 Gold Edison Award for the best new medical and science online tool and app. Today marks the 25th annual Edison Awards competition, which honors the year’s most innovative products, services and business leaders in the world.

Telcare’s FDA-cleared device, introduced in February 2012, wirelessly communicates critical information to diabetes patients, doctors, caregivers and iPhones. It’s the first blood glucose monitor that uses cellular communication to instantly transmit a patient’s readings to a private online database, which can be accessed by the patient or – with permission – by a doctor, caregiver or family member. It tracks results and can spot potential problems and transmits real-time feedback.

“It’s a great honor for Telcare to receive Edison’s top award for innovation,” said Telcare CEO Dr. Jonathan Javitt. “Edison searches for the latest cutting-edge devices and we believe Telcare’s wireless-enabled blood glucose monitor has the capability to transform the lives of 28 million Americans with diabetes.”

Telcare’s blood glucose monitoring system includes Diabetes Pal, currently the highest rated diabetes smartphone app. Diabetes Pal works seamlessly with the Telcare meter to enable family members of people with diabetes to view results in real time and to provide Telcare meter users a diabetes-focused social networking experience. Telcare has chosen to distribute Diabetes Pal at no charge via the Apple iTunes store (and soon via the Google app store) so that people may use it even without purchasing the Telcare system.

“By incorporating wireless communication, social networking, and best practices in health IT, Telcare has brought the monitoring of diabetes into the 21st century for 28 million Americans, their caregivers, and their loved ones,” Dr. Javitt added.

Each year the Edison Awards recognize the world’s most significant innovations. Past winners include Apple for the iPad, Amazon for the Kindle II, and Nintendo for WiiFit. Once again, the 2012 awards drew a group of competitors.

“The Telcare Blood Glucose Monitoring System is an excellent example of an innovative product that reflects the rich tradition of the Edison Awards,” said Thomas Stat, Chairman of the Edison Awards Steering Committee. “By awarding Telcare with the Edison Gold Medal, we have recognized this wireless system as a significant step forward for 28 million diabetics in this country as they pursue healthier, more meaningful lives.”

Telcare was also recently named to Gartner’s list of “Cool Vendors.” Gartner’s analysts praised Telcare’s system for “getting the technology right” and providing “effective solutions” for diabetes care.” According to Gartner, “This is the same technology that made Kindle the book reader that grandma loves.”

About Telcare
Telcare, Inc. uses cellular technology and social networking to bridge the last mile between patients with diabetes, their caregivers, and their families in order to transform the care of chronic illness. Telcare has been awarded First Place prizes in the categories of Health, Wellness and Fitness Application and Health Enterprise Solution by CTIA, been named the MEDTEC startup of the year, and been named one of the top 12 products of 2012 by the Edison Awards. In addition to directly reducing cost of care by improving outcomes and preventing complications, Telcare creates an ecosystem of care that enables people with diabetes to better care for their condition. For more information, visit www.telcare.com.

About the Edison Awards and Edison Universe
The Edison Awards were established in 1987 to honor and advance Thomas Edison’s wideranging contributions to technology and consumer products, as well as to inspire continued innovation in the world. In addition to the Edison Achievement Award, the organization also recognizes new product and service innovations through its annual Edison Awards and Edison Green Awards and, through its non-profit organization, Edison Universe, supports future innovators and fosters future innovation. For more information, visit www.edisonawards.com.

Filed Under: Featured News Tagged With: diabetes apps, Telcare Wireless Glucose Meter, type 1 diabetes, type 2 diabetes

‘Inadequate’ NHS diabetes care causing patients ‘harm’ By Mike Tighe

April 27, 2012 By admin Leave a Comment

People with diabetes need to check their blood sugar levels.

NHS diabetes care is ‘inadequate’ and some patients come to further harm due to poor care in hospital, a leading specialist says.

Dr Gerry Rayman, national clinical lead for inpatient diabetes, warned many hospitals had no specialist diabetes nurse.

He said many hospital patients had diabetes, and called the situation ‘quite alarming’.

The Department of Health said work was under way to improve care standards.

Speaking on BBC Radio 4′s You and Yours, Dr Rayman, head of the diabetes service at Ipswich Hospital NHS Trust, said: “We know that one in three hospitals don’t have a specialist diabetes nurse, which is really quite alarming when we know that one in six people in hospital have diabetes.

“Unfortunately, many people in hospital with diabetes do come to harm as a result of, I’m afraid to say, inadequate care in hospital.”

Diabetes accounts for 11% of all NHS inpatient expenditure, and costs the service around £23.7bn last year, a figure projected to increase to just under £40bn by 2035.

Two types

Diabetes complications

  • Diabetes that is not controlled can cause many serious long-term problems.
  • Excess glucose (sugar) in the blood can damage the blood vessels, contributing to heart disease, strokes, kidney disease, impotence and nerve damage.
  • Uncontrolled diabetes is the most common cause of blindness in people of working age.
  • People with diabetes are also 15% more likely to have an amputation than people without the condition.

In Type 2 diabetes, not enough insulin is produced or the insulin that is made by the body does not work properly.

It tends to affect people as they get older and usually appears after the age of 40, but increasingly is seen in younger, overweight people. It accounts for 90% of all cases.

Type 1 diabetes, a condition which usually means insulin cannot be produced at all, is responsible for the other 10%.

Adrian Sanders, chair of the all-party parliamentary group for diabetes, claimed there was plenty of evidence out there to support Dr Rayman’s assessment.

He said the government was aware that a disproportionate number of people occupying hospital beds have diabetes, and their hospital stays are longer.

He said the government – and the last Labour administration – had encouraged more support for people with diabetes in primary care.

“That’s actually a very good policy for people whose condition doesn’t present complications or specialisms. And that’s why you need specialist care for those who present with specialist problems.”

Barbara Young, chief executive at Diabetes UK, said diabetes was a serious condition which could lead to devastating long term complications including blindness, kidney failure and amputations.

She said: “The tragedy is that for many people with diabetes, complications could have been avoided if the health checks were in place to spot any signs and if the appropriate care and treatment were applied.

“For example, up to 80% of amputation cases due to diabetes could be avoided if problems are identified early enough and treated appropriately.”

Personal responsibility

A key area of contention is whether diabetes is an issue for social or personal responsibility, with some arguing for tougher regulation of the food industry, whilst others argue healthy diet is strictly a matter for the individual.

Last week a ten-minute rule bill was introduced in the House of Commons by Keith Vaz arguing for the reduction of sugar content in soft drinks by 4%.

However, Paul McArdle, of the British Dietetic Association, cautioned against putting too much emphasis on sugar in food.

He said: “Food labelled ‘suitable for diabetics’ comes from the misguided principal that everything for people with diabetes is about sugar.

“The main focus for this group is losing weight and having a healthy diet, as this helps people with diabetes manage the condition.

“Around 60-90% of type two diabetes is caused by people being overweight, with more than half of that being preventable by having a healthy lifestyle.

“The bigger issue is good food labelling which can enable consumers of food to make healthy choices.”

Audit for improvement

The Department of Health issued a statement which accepted that good diabetes care was very important in hospital – and elsewhere.

“That is why the National Diabetes Inpatient Audit reviews diabetes management in hospital each year and feeds results back to individual hospitals to take appropriate action.

“NHS Diabetes is working with clinicians through their Inpatient Network to improve care.

“The Audit has already shown some improvements in care but more needs to be done.”

Filed Under: Featured News Tagged With: diabetes, diabetes complications, type 1 diabetes, type 2 diabetes

Merck Profit Tops Analyst Estimates on Diabetes Drugs

April 27, 2012 By admin Leave a Comment

Merck & Co. (MRK), the second-largest U.S. drugmaker, reported first-quarter profit that beat analyst estimates on higher sales of diabetes treatments.

Net income rose 67 percent to $1.74 billion, or 56 cents a share, from a year earlier, the Whitehouse Station, New Jersey- based company said today in a statement. Earnings per share excluding one-time items beat by 1 cent the 98-cent average of 18 analyst estimates compiled by Bloomberg.

Revenue climbed 1.3 percent to $11.7 billion, boosted by higher sales of the Januvia and Janumet diabetes drugs. Merck has been cutting thousands of jobs and trying to boost demand of existing products to prepare for when asthma treatment Singulair faces cheaper copies in August. Analysts say the focus now turns to the company’s medicines in development after research setbacks in recent years.

“Merck is emerging from a challenging 2011,” said Tony Butler, an analyst with Barclays Capital Inc. in New York, in a April 16 research report. “The stock has been on a path of recovery since last November, but this has been more correlated with the dividend increase and flow into the pharma sector as a whole than a restoration of sentiment around Merck’s innovation core.”

Merck boosted its dividend by 11 percent in November, the first increase since 2004. First-quarter net income in 2011 was $1.04 billion, or 34 cents, when Merck took a $500 million charge to settle a dispute with Johnson & Johnson. (JNJ)

Merck Shares

Merck rose less than 1 percent to $38.57 at 10:11 a.m. New York time. The shares had gained 9.7 percent in the 12 months before today.

Merck reiterated its 2012 forecast for earnings excluding one-time items of $3.75 to $3.85 a share, with net income projected to be $2.04 to $2.30. Revenue this year will be at or near 2011 levels on a constant currency basis, Merck said. At current exchange rates, sales would be hurt by 2 to 3 percent, according to the company.

Sales of Januvia jumped 24 percent to $919 million, while revenue from Janumet surged 29 percent to $392 million. The company’s human papillomavirus vaccine Gardasil increased 33 percent to $284 million.

Merck has five major products in development that the company is focusing on over the next two years. Investors are concerned about Merck’s research operations after the company halted a study of its experimental blood thinner vorapaxar, said Butler.

“Investor reactions toward these five candidates can be described as lukewarm if not cynical,” Butler said in the report. “Operational results in the quarter are unlikely to change sentiment, and we believe that Merck needs to deliver on pipelines to restore enthusiasm towards the stock.”

To contact the reporter on this story: Shannon Pettypiece in New York at spettypiece@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

 

Filed Under: Featured News Tagged With: Bloomberg, diabetes, Merck

Artificial pancreas gives girl vacation from diabetes

March 5, 2012 By admin Leave a Comment

Elle Shaheen, 12, tests an artificial pancreas at Massachusetts General Hospital in January 2012.

Portsmouth, New Hampshire (CNN) — At 3:30 a.m., Stefany Shaheen awoke to a feeling of uneasiness. Something was not quite right with her daughter, Elle.

Creeping into her bedroom, Shaheen removed a lancet from its wrapper and poked her diabetic daughter’s finger.

Putting the blood onto the testing strip, she saw the results: dangerously low blood sugar. Shaheen woke Elle up and gave her orange juice to keep her from slipping into unconsciousness.

Shaheen was relieved her motherly intuition had told her something was wrong with Elle that night, but she wished she didn’t have to rely on it. She yearned for an automatic way of knowing when Elle was dipping into a dangerously high or low blood sugar — and not just at night, but at school, where the 12-year-old is largely responsible for monitoring her own blood sugar.

Then last week, Shaheen got her wish.

Elle was selected to try out an experimental device called an artificial or “bionic” pancreas. During the three-day study, Elle didn’t have to poke her finger every few hours to find out her blood sugar level because the “bionic” pancreas recorded it automatically and adjusted her insulin accordingly.

Shaheen didn’t have to set her alarm to wake up every three hours at night because the device was designed to catch a dangerously high or low blood sugar and treat it.

“For the first time since she was diagnosed, I didn’t have to worry,” says Shaheen, who lives in Portsmouth, New Hampshire.

Medical device companies are racing to be the first to market an artificial pancreas, which takes over the work of the diabetic’s malfunctioning organ. The device could potentially be used for Type 1 diabetics or Type 2 diabetics who use insulin.

“It’s transformative technology,” says Aaron Kowalski, assistant vice president for treatment therapies research at the Juvenile Diabetes Research Foundation.

JDRF is funding artificial pancreas trials at 13 sites worldwide, including Yale University, Stanford University, the University of Virginia and the University of Colorado. Device companies also are funding several other studies.

“It’s looking incredibly promising,” Kowalski says. “I hope very much we’ll have a system on the market within four years, and I’ll be very disappointed if we don’t.”

‘Pale and pasty … and all by herself’

It was Elle who urged her mother to enroll her in an artificial pancreas study.

The Shaheens first heard about the artificial pancreas shortly after Elle was diagnosed with diabetes at age 8, but she had to be 12 years old to enroll. So the day she turned 12 this past September, she started bugging her parents.

“She was constantly reminding me, ‘Mom, you need to call, you need to call,’” Shaheen remembers.

Her mother was only too happy to comply. There had been several middle-of-the-night close calls, plus some desperate situations at school where the staff nurse was responsible for 450 children and “ill-equipped,” Shaheen says, to handle the needs of a diabetic child.

“I got a call from Elle one morning. She was in the school office and her voice was trembling, and she said ‘Mom, I need you to come quick. I don’t know what’s wrong,’” Shaheen says. “I got there and her blood sugar was dropping like a rock. She was pale and pasty and sweating profusely and all by herself.”

A glimpse of the dream

In January, Elle walked into Massachusetts General Hospital to start the trial.

Doctors fitted her for an artificial pancreas. In the future, the device will be the size of a cell phone, but for now Elle is hooked up to a laptop.

For three days, the device did the work Elle’s pancreas can no longer do.

“It went very smoothly — her blood sugar control was really very, very good,” said Dr. Steven Russell, an instructor at Harvard Medical School. “We were really very pleased by what we saw with Elle.”

Russell’s research partner, Edward Diamano, an associate professor of biomedical engineering at Boston University, says the device learned Elle’s blood sugar patterns and made changes accordingly.

“It’s making adjustments every five minutes,” he says.

For that one weekend, Elle didn’t have to draw blood, and she could eat foods she hadn’t eaten in large quantities for four years.

“She ate Spaghetti-O’s and grilled cheese and french fries and hamburgers,” Shaheen says. “She ate between 67 and 100 grams of carbs a day, and usually she can only eat between 40 and 50.”

Then, after the experiment, Elle had to leave the artificial pancreas behind, and it was back to counting carbs and poking herself every couple of hours. Her mother reset the nighttime alarm clock.

“We’re extraordinarily impatient for access to the device,” Shaheen says. “I think it will revolutionize the way she lives.”

“That was really hard,” Elle says. “I just hope one day I can use it at home.”

Baby steps

Last week, Russell and Damiano visited the Food and Drug Administration offices in Silver Spring, Maryland, to show regulators a prototype for the artificial pancreas.

The device itself can be worn in a pocket or clipped to a belt. Two tiny pieces go under the skin, one to detect glucose levels in the blood and another to deliver insulin and Glucagon, a drug used to raise very low blood sugar.

Algorithms determine how much insulin and Glucagon the patient needs, and if necessary the patient can manually override the device.

So far, the FDA has required doctors to keep patients inside the hospital while their using the device.

The potential benefits are enormous, Dr. Charles Zimliki, who chairs the FDA’s Artificial Pancreas Critical Path Initiative, testified before a Senate committee last year. But “if not properly designed, use of an artificial pancreas device in an outpatient setting can place patients at significant risk.”

Russell said he hopes that by the fall, the FDA will give him permission to allow adult diabetic patients to leave the building and walk the grounds of the Massachusetts General Hospital campus accompanied by a nurse, eating as they like and using the hospital’s gym.

Then by the summer of 2013, he hopes to give the artificial pancreas to children attending a summer camp.

“These are all baby steps towards what we ultimately want to do, which is give them the device and say, ‘Go home and check back with us in a week,’” Russell says.

Shaheen is closely watching the proceedings at the FDA, with the help of her mother, Sen. Jeanne Shaheen, D-New Hampshire, who co-chairs the Senate Diabetes Caucus.

“We’re extraordinarily impatient for access to the device,” she says. “I think it will revolutionize the way she lives.”

Filed Under: Featured News Tagged With: Artificial Pancreas, Children with Diabetes, type 1 diabetes
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