Diabetes Study Finds Significant Increase in Rates of Type 1 Diabetes Among U.S. Non-Hispanic White Youth

Study published today in the journal Diabetes Finds Significant Increase in Rates of Type 1 Diabetes Among U.S. Non-Hispanic White Youth.

•       The study included data from more than 2 million children and adolescents living in diverse US geographic regions, 19 years old and younger, newly diagnosed with type 1 diabetes over the 8-year study period.
•       From 2002 to 2009, the rate of type 1 diabetes rose from 24.4 per 100,000 youth in the first year of the study to 27.4 per 100,000 youth in the last year of the study.

Full press release below.

SOURCE: Kaiser Permanente

PASADENA, Calif., Oct. 23, 2014 /PRNewswire/ -- The rate of non-Hispanic white youth diagnosed with type 1 diabetes increased significantly from 2002 to 2009 in all but the youngest age group of children, according to a new study published today in the journal Diabetes.

The study included data from more than 2 million children and adolescents living in diverse geographic regions of the United States. Within this population, researchers identified 5,842 non-Hispanic white youth, 19 years old and younger, newly diagnosed with type 1 diabetes over the 8-year study period. They found that from 2002 to 2009, the rate of type 1 diabetes rose from 24.4 per 100,000 youth in the first year of the study to 27.4 per 100,000 youth in the last year of the study. The study is based on the SEARCH for Diabetes in Youth registry, one of the largest and most contemporary studies of diabetes in U.S. youth.

"Type 1 diabetes is the predominant form of diabetes diagnosed in childhood. The incidence has been rising in many other countries, particularly in Europe, but data from large populations in the U.S. were limited," said study lead author Jean M. Lawrence, ScD, MPH, MSSA, of the Kaiser Permanente Southern California Department of Research & Evaluation. "This project provides a much larger and more geographically diverse sample than previous studies in the U.S."

The study also showed that the increases were most pronounced among children aged 5 to 9, with smaller increases among those 10 to 14 years old and 15 to 19 years old, but there was no increase in incidence among children 4 years old and younger. In addition, the rate of increase was slightly higher for boys than for girls, according to the researchers.

"Our findings indicate that the rates of type 1 diabetes in youth are increasing," Lawrence said. "These trends will continue to be monitored in the U.S. by the SEARCH study to help identify trends in type 1 diabetes in non-Hispanic white youth and youth from other racial and ethnic groups, and to identify potential causes of these increases.

"We have been seeing more children being diagnosed with type 1 diabetes over the 8 years of this study and these children will require specialized health care as they enter young adulthood."

The SEARCH for Diabetes in Youth study is a national multicenter study aimed at developing a deeper understanding of type 1 and type 2 diabetes among children and adolescents in the United States. The study, which started in 2000, involves centers located in five states — California, Colorado, Ohio, South Carolina and Washington — and is funded by the Centers for Disease Control and Prevention and the National Institute of Diabetes and Digestive and Kidney Diseases.

Type 1 diabetes, previously known as juvenile diabetes, is usually diagnosed in childhood, with only 5 percent of all people with diabetes having this form of the disease, according to the American Diabetes Association. In type 1 diabetes, the body loses its ability to produce insulin, a hormone that is needed to convert sugar, starches and other food into energy for daily life. Insulin therapy and other treatments are required to help people with type 1 diabetes manage their condition, live long, healthy lives and to prevent or delay diabetes-related complications that may affect their eyes, nerves and kidneys.

Additional study authors include Giuseppina Imperatore, MD, PhD, of the Division of Diabetes Translation, Centers for Disease Control and Prevention; Dana Dabelea, MD, PhD, of the Department of Epidemiology, Colorado School of Public Health, University of Colorado Denver; Elizabeth J. Mayer-Davis, PhD, of the Department of Nutrition, Gillings School of Global Public Health, University of North Carolina and School of Medicine, University of North Carolina; Barbara Linder, MD, PhD, of the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health; Sharon Saydah, PhD, of the Division of Diabetes Translation, Centers for Disease Control and Prevention; Georgeanna J. Klingensmith, MD, of the Division of Diabetes Translation, Centers for Disease Control and Prevention, Atlanta; Lawrence Dolan, MD, of the Division of Endocrinology, Cincinnati Children's Hospital Medical Center and Department of Pediatrics, University of Cincinnati; Debra A. Standiford, MSN, CNP, of the Division of Endocrinology, Cincinnati Children's Hospital Medical Center; Catherine Pihoker, MD, of the Department of Pediatrics, University of Washington, Seattle; David J. Pettitt, MD, of the Sansum Diabetes Research Institute; Jennifer W. Talton, MS, of the Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina; Joan Thomas, MS, RD, of the Department of Nutrition, Gillings School of Global Public Health, University of North Carolina, Chapel Hill; Ronny A. Ball, PhD, of the Department of Epidemiology and Prevention, Wake Forest School of Medicine; and Ralph B. D'Agostino, Jr., of the Department of Biostatistical Sciences, Wake Forest School of Medicine, for the SEARCH For Diabetes in Youth Study Group.

For an infographic that details everything you need to know about type 1 diabetes and youth, go here: http://share.kaiserpermanente.org/wp-content/uploads/2014/10/Kaiser-Permanente-Infographic-Type-1-Diabetes-Oct-2014.pdf

About the Kaiser Permanente Southern California Department of Research & Evaluation 
The Department of Research & Evaluation conducts high-quality, innovative research into disease etiology, prevention, treatment and care delivery. Investigators conduct epidemiology, health sciences and behavioral research as well as clinical trials. Areas of interest include diabetes and obesity, cancer, HIV/AIDS, cardiovascular disease, aging and cognition, pregnancy outcomes, women's and children's health, quality and safety, and pharmacoepidemiology. Located in Pasadena, California, the department focuses on translating research to practice quickly to benefit the health and lives of Kaiser Permanente Southern California members and the general population. Visit kp.org/research.

About Kaiser Permanente 
Kaiser Permanente is committed to helping shape the future of health care. We are recognized as one of America's leading health care providers and not-for-profit health plans. Founded in 1945, our mission is to provide high-quality, affordable health care services and to improve the health of our members and the communities we serve. We currently serve approximately 9.3 million members in 8 states and the District of Columbia. Care for members and patients is focused on their total health and guided by their personal physicians, specialists and team of caregivers. Our expert and caring medical teams are empowered and supported by industry-leading technology advances and tools for health promotion, disease prevention, state-of-the-art care delivery and world-class chronic disease management. Kaiser Permanente is dedicated to care innovations, clinical research, health education and the support of community health. For more information, go to kp.org/share.

For more information: 
Vincent Staupe, vstaupe@golinharris.com, 415.318.4386 
Sandra Hernandez-Millett, sandra.d.hernandez-millett@kp.org, 626.405.5384

Breast Biopsy Device Market: US vs. Europe

Breast Biopsy Device Market: US vs. Europe

With just under 60% of the amount spent in the U.S., European health authorities bought close to 500,000 more biopsy needles for breast cancer treatment and prevention.

SOURCE: iData Research

Full press release appears below.

VANCOUVER, July 21, 2014 /PRNewswire/ - According to breast cancer biopsy market data released by iData Research (www.idataresearch.com), the European health authorities brought almost 500,000 more biopsy needles in 2013. Notably, the U.S. market focuses more on expensive minimally invasive technologies. European healthcare clearly favors cost-effective breast cancer technology, purchasing significantly greater volumes due in part to national breast screening programs.

"Europe sees more than four times the purchases of inexpensive SLC (spring-loaded core) needles than the United States," explains Dr. Zamanian, CEO of iData. "And this is done at a fraction of the cost." The same needle to diagnose and treat breast cancer in the United States can be more than 70% cheaper in Europe.

Other key information in iData's analysis of the U.S. and European Breast Biopsy Device Markets include:

• At-Risk Women over 40: In both the U.S. and Europe, aging demographics are driving the purchase of breast cancer treatment and diagnosis technology. Most breast cancer diagnoses occur after a woman reaches the age of 40.
• New Minimally Invasive Technologies in the U.S.: Minimally invasive vacuum-assisted breast biopsy(VABB) devices in the United States receive considerably more attention, with notably more unit sales and a market value nearly twice as large as that of Europe. With the added focus, the U.S. has visible markets for new technologies that use stereotactic x-ray guidance, ultrasound, as well as magnetic resonance and molecular imaging guidance techniques.
• Growing U.S. Market Value: Moving towards 2019, the European market for breast cancer needles is projected to grow by just over $10 million. Comparatively, the U.S. market is projected to grow by almost$33 million. Average product prices will stay relatively stable overall for both markets. Greater numbers of unit sales are anticipated in the U.S., but will be roughly comparable to European unit sales numbers. The greater U.S. market value will be derived by higher prices.

Hologic led the U.S. breast cancer needle market with their minimally invasive VABB needle products. C. R. Bard dominated the less expensive U.S. core needle market, and also held a commanding presence in Europe in this same market. Hologic still struggles to gain significant breast biopsy device traction in Europe, with most of their breast biopsy device revenue coming from the United States. Other U.S. and European competitors include Devicor, Intact Medical, Mammotome, Argon Medical and Carefusion.

For Further Information

The Global Breast Biopsy Devices report is part of the complete Women's Health Market series and is available for the U.S., Japan, South Korea, Australia and 15 countries in Europe. These reports provide a comprehensive analysis including units sold, market value, forecasts, as well as a detailed competitive market shares and analysis of major players' success strategies in each market and segment. The Global Breast Biopsy Devices report includes Spring-Loaded Core Needle, Vacuum-Assisted and Rotational Cutting Device, Stereotactic X-Ray Guided Biopsy, Ultrasound Image Guided Biopsy.

About iData Research

iData Research (www.idataresearch.com) is an international market research and consulting group focused on providing market intelligence for medical device and pharmaceutical companies. iData covers research in: Diabetes Drugs, Diabetes Devices, Pharmaceuticals, Anesthesiology, Wound Management, Orthopedics, Cardiovascular, Ophthalmics, Endoscopy, Gynecology, Urology and more. 

SOURCE iData Research Inc.

CONTACT:

Contact Info:

Caroline Lau
carolinel@idataresearch.net
1.604.266.6933 Ext 212
iData Research
www.idataresearch.com

FDA revises final guidance for mobile medical apps

FDA revises final guidance for mobile medical apps and the new final, final guidance is just one sentence SOURCE: MobiHealthNews, 4/1/2014, by Aditi Pai The FDA rescinded then re-released its (now final) final guidance for mobile medical apps (MMA) today and promised that this will be the final time the FDA will amend the document. The new, new guidance differs from the document released in September 2013 in two important ways. The first is that all founders and C-level executives of companies developing mobile medical apps are now required to attend medical school before marketing medical apps. The second change to the original final guidelines is that, in an effort to provide maximum clarity, the FDA has erased all of its other MMA guidelines. “The agency is sick and tired of being hauled in front of Congress to explain that sometimes software behaves like a medical device,” an FDA spokeswoman said in a statement. “Frankly, we just couldn’t take it anymore. The FDA has never regulated the practice of medicine — that’s between a patient and their provider. With these new, new MMA guidelines, the FDA can take a backseat, encourage doctors to use their free time to run health startups, and finally let innovation flourish.” The FDA suggests that founders and executives at mobile medical app companies take an accelerated program (just seven years!) at a local medical school or hand the company over to someone who is already a physician. When news of the final, final guidelines was leaked two weeks ago, there was an initial uproar from entrepreneurs in the digital health world, but now the health startup founders have either resigned themselves to their MCAT prep books or gone back to developing ecommerce apps.

Nielsen’s Connected Life Report: 15% of consumers who know about wearables own one

Fifteen percent of consumers who know about wearables own one.

SOURCE: MobiHealthNews, 3/24/2014, author: Aditi Pai

Fifteen percent of consumers who know the term “wearable” are also wearing one, according to Nielsen’s Connected Life Report, which surveyed 3,956 respondents last November. Those who were surveyed are either users of “connected life technologies” or interested in them.

Of those who owned a device, 61 percent owned fitness wristbands, which were distinct from people who owned smartwatches, 45 percent. And in a broader undefined “mobile health device” category, 17 percent of people owned a device.

“What motivates consumers to purchase wearable tech depends largely on the type of device and the benefits each offers for their everyday lives,” Nielsen’s researchers wrote in a summary of the report’s findings.

Thirty five percent of smartwatch owners said they bought a smartwatch because they had a “smartphone addiction” and 57 percent of fitness band owners said they bought the band because were concerned about and wanted to monitor their health.

Functionality and comfort were almost equally valued by smartwatch respondents — 81 percent prioritized functionality and 79 percent of consumers prioritized comfort. Wristworn fitness band owners rank accuracy of the device as most important at 70 percent and battery life at 64 percent.

Nielsen believes for the masses to adopt these devices, costs need to go down — 72 percent of respondents wanted wearables to cost less and 62 percent wanted wearables to take on different forms (beyond the wrist). Another 53 percent wanted wearables to look like jewelry.

Forty-eight percent of those surveyed were between the ages of 18 and 34 and 75 percent of those surveyed considered themselves early adopters of technology. The other option for this question was to consider yourself mainstream. Around 29 percent of respondents had an income of $100,000 or more, which Nielsen categorized as a disposable income.

Sleep Disorder Dx Market Rising Rapidly

Sleep Disorder Diagnostics Market Rising Rapidly. The market is drawing investors due to the tilt in preference from drugs to home care sleep tests that are more convenient and lack side effects.

SOURCE: By: Nathan Eddy | Date: 3/17/2014 | Publication: eWeek

The market for sleep disorder diagnostic devices earned revenue of $95.6 million in 2013 and estimates this to reach $125.8 million in 2017, according to a report from research firm Frost & Sullivan.

The diagnostic devices covered in the research included clinical polysymnogram (PSG) and ambulatory PSG systems. PSG is a type of sleep study, a multi-parametric test used in the study of sleep and as a diagnostic tool in sleep medicine.

The PSG monitors many body functions including brain (EEG), eye movements (EOG), muscle activity or skeletal muscle activation (EMG) and heart rhythm (ECG) during sleep.

"There is a growing demand for devices that offer integration and connectivity in sleep centers and home settings," Frost & Sullivan health care research analyst Akanksha Joshi said in a statement. "In this environment, cloud-based services could very likely change the dynamics of the market."

The report noted a large pool of undiagnosed patients and the growing population of the elderly in both Europe and North America point to a rapidly growing end-user market for sleep disorder diagnostics devices. -

In addition, the market is drawing investors due to the visible tilt in preference from drugs to home care sleep tests that are more convenient and lack side effects.

"Vendors that offer self-help devices have the potential to erode the share of sleep centers that offer sleep tests, as self-help technology can decrease the number of visits to physicians and overnight stays in clinics," Joshi continued. "Overall, a manufacturer that offers accurate data through real-time device connectivity involving the insurer and physicians as well as a precise predictive model for better patient outcomes will elicit greater interest in its product line."

Information technology is playing an increasingly important role in the transformation of the sleep disorder treatment market, the report said.

For instance, user-friendly disruptive technologies that are easy to operate and safe are finding considerable uptake among elderly patients considering their interest in alternatives to medications and traditional sleep disorder tests.

Another factor that could tip the balance in favor of home care devices is the limited availability of technicians, which leads to long waiting hours.

The lower rate of specialized physicians also reduces the total number of tests being conducted, thus reducing the number of sleep centers present.

Furthermore, the market is grappling with the issue of inadequate numbers of technically sound sales personnel, which lowers the number of units sold.

"Despite these considerable challenges, participants can shore up their sales by addressing the specific needs of the elderly," the report concluded. "Manufacturers are already collaborating with sleep centers, primary care physicians, and third-party companies that facilitate the renting of devices to satisfy market needs and build robust relations with customers."

For more information:  http://www.eweek.com/it-management/sleep-disorder-diagnostics-market-rising-rapidly.