Animas makes progress in development of a first-generation closed-loop insulin delivery system

Development continues with data presented at the American Diabetes Association

2013-06-22

(Press-News.org) WEST CHESTER, Pa., June 21, 2013 – Animas Corporation announced today further promising results from the second phase of human clinical trials of a first-generation closed-loop insulin delivery system in development. Data investigating the predictive Hypoglycemia-Hyperglycemia Minimizer (HHM) System* demonstrated that the system is capable of maintaining safe glucose levels overnight. The data was presented at the 73rd Scientific Sessions of the American Diabetes Association (ADA) in Chicago, Illinois.

The feasibility study of the predictive glucose control system in development was conducted in 20 adults with type 1 diabetes and designed to investigate the System's automatic control algorithm, with emphasis on the overnight period from 9 PM to 7 AM. The System showed encouraging performance with the participants, on average, spending over 90 percent of the overnight period with blood glucose values in the range between 70-180 mg/dl. Additionally, fewer than half of the study participants had blood glucose values less than 70 mg/dL during the overnight period.

These results build on the data Animas presented from the same feasibility study earlier this year at the annual Advanced Technologies and Treatments for Diabetes (ATTD) conference, which demonstrated that the System shows promising ability to minimize the number, duration and severity of hypoglycemic events with no safety concerns. The study was conducted in partnership with leading academic research institutions, including the University of California, Santa Barbara; Sansum Diabetes Research Institute; and the Center for Diabetes Technology at the University of Virginia.

"Avoiding hypoglycemia during the overnight period is a primary concern for people with diabetes, so maintaining safe glucose levels during this time frame is crucial in helping to not only achieve better control, but also helps ease worry throughout the night," said Ramakrishna Venugopalan, Director, Research & Development at Animas Corporation. "We are encouraged by the results of this overnight study, and we are excited to be one step closer to bringing this technology to patients."

Animas began collaborating with industry, academia and advocacy organizations, including the JDRF (formerly the Juvenile Diabetes Research Foundation), in 2010. After receiving Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) in 2011, researchers began the first human clinical feasibility studies for the development of a closed-loop insulin delivery system. Together with these key partners, Animas continues to work toward developing such an automated system to help people living with type 1 diabetes better control their disease.

"We are encouraged by Animas' latest findings that indicate the System is able to control overnight blood glucose levels safely," said Aaron Kowalski, Ph.D., Vice President of Treatment Therapies Research at JDRF. "For children and their families living with diabetes, the fear of hypoglycemia during the night is very real, so any peace of mind we can provide, particularly in the overnight period, would be a tremendous benefit.

### * The HHM System includes a continuous subcutaneous insulin infusion pump, a continuous glucose monitor (CGM) and a control algorithm used to predict changes in blood glucose.

About the Clinical Study The study investigated an automatic control algorithm of a predictive glucose control system in development during the overnight period of 9 PM – 7 AM. Glucose-related metrics calculated specifically for this overnight period were based on both continuous glucose monitor (CGM) readings and readings obtained from the YSI 2300 STAT Plus. The results demonstrated that the System was capable of maintaining safe glucose levels overnight, and indicate feasibility for continuing development.

During the study, the System dosed insulin automatically based on CGM values. The mean overnight glucose value based on CGM was 135 mg/dl (129 mg/dl by YSI) for the entire cohort. The median percentage of overnight time spent at glucose values between 70-180 mg/dl was 93.8% (90.9% by YSI). The median percentage of overnight time spent at glucose values less than 70 mg/dl was 0% by both CGM and YSI.

About Animas Corporation With a shared vision of "creating a world without limits" for people with diabetes, Animas is a part of Johnson & Johnson Diabetes Solutions Companies, a cross-company collaboration that reflects an ongoing commitment to better serve the diabetes community with integrated solutions that meet the needs of people with diabetes across the continuum of care. Animas provides a wide range of insulin delivery products for people living with diabetes, including the OneTouch® Ping® Glucose Management System, Animas® Vibe™ insulin pump and CGM system and the Animas® 2020 insulin pump. Animas, from the Latin word meaning "true inner self or soul," has been committed since 1996 to meeting individual patient needs through the development of life-performance technology and customer service 24 hours a day, 7 days a week, 365 days a year. To learn more about Animas, visit http://www.animas.com/.

ELSE PRESS RELEASES FROM THIS DATE:

Americans' vitamin D levels are highest in August, lowest in February, study shows

2013-06-22

Irvine, Calif. – UC Irvine and Mayo Clinic researchers have found that vitamin D levels in the U.S. population peak in August and bottom out in February. The essential vitamin – necessary for healthy bones – is produced in the skin upon exposure to ultraviolet B rays from the sun. Vitamin D helps bones absorb calcium and can protect against osteoporosis. It's also thought to play a role in seasonal illnesses, such as the flu. Low levels of vitamin D are believed to impair "innate immunity" i.e., the body's first line of defense against pathogens. To further study this ...

Oddest couple ever found

2013-06-22

Synchrotron imaging reveals odd couple - 250 million years ago, a mammal forerunner and an amphibian shared a burrow. Scientists from South Africa, Australia and France have discovered a world first association while scanning a 250 million year old fossilized burrow from the Karoo Basin of South Africa. The burrow revealed two unrelated vertebrate animals nestled together and fossilized after being trapped by a flash flood event. Facing harsh climatic conditions subsequent to the Permo-Triassic (P-T) mass extinction, the amphibian Broomistega and the mammal forerunner ...

Assessing performance of colonoscopy procedures improves quality

2013-06-22

DOWNERS GROVE, Ill. – June 21, 2013 – A new study reports that the use of a quarterly report card is associated with improved colonoscopy quality indicators. Endoscopists at the Roudebush Veterans Affairs Medical Center in Indianapolis, Ind., who participated in the study showed an overall adjusted adenoma (precancerous polyp) detection rate increase from 44.7 percent to 53.9 percent, and a cecal intubation rate increase from 95.6 percent to 98.1 percent. These two metrics are validated measures of colonoscopy performance quality. The study appears in the June issue of ...

New Notre Dame paper offers insights into how cancer cells avoid cell death

2013-06-22

A new study by a team of researchers from the University of Notre Dame provides an important new insight into how cancer cells are able to avoid the cell death process. The findings may suggest a chemotherapeutic approach to prevent the spread of cancers. Metastasis, the spread of cancer from one organ to other parts of the body, relies on cancer cells ability to evade a cell death process called anoikis, according to Zachary T. Schafer, Coleman Assistant Professor of Cancer Biology at Notre Dame. Metalizing cancer cells are able to survive anoikis, which normally results ...

Innovative intervention program improves life for rural women in India living with HIV/AIDS

2013-06-22

A multidisciplinary team of researchers from UCLA and India has found that a new type of intervention program, in which lay women in the rural Indian province of Andra Pradesh were trained as social health activists to assist women who have HIV/AIDS, significantly improved patients' adherence to antiretroviral therapy and boosted their immune-cell counts and nutrition levels. The lay women were trained by the research team to serve as accredited social health activists, or ASHA, and their work was overseen by rural nurses and physicians. These ASHA then provided counseling ...

5 years of stereo imaging for NASA's TWINS

2013-06-22

Surrounding Earth is a dynamic region called the magnetosphere. The region is governed by magnetic and electric forces, incoming energy and material from the sun, and a vast zoo of waves and processes unlike what is normally experienced in Earth-bound physics. Nestled inside this constantly changing magnetic bubble lies a donut of charged particles generally aligned with Earth's equator. Known as the ring current, its waxing and waning is a crucial part of the space weather surrounding our planet, able to induce magnetic fluctuations on the ground as well as to transmit ...

Messier 61 looks straight into Hubble's camera

2013-06-22

The NASA/ESA Hubble Space Telescope has captured this image of nearby spiral galaxy Messier 61, also known as NGC 4303. The galaxy, located only 55 million light-years away from Earth, is roughly the size of the Milky Way, with a diameter of around 100 000 light-years. The galaxy is notable for one particular reason — six supernovae have been observed within Messier 61, a total that places it in the top handful of galaxies alongside Messier 83, also with six, and NGC 6946, with a grand total of nine observed supernovae. In this Hubble image the galaxy is seen face-on ...

Wilfire smoke over Alaska

2013-06-22

On June 19, 2013, the Moderate Resolution Imaging Spectroradiometer (MODIS) on NASA's Aqua satellite captured this image of smoke from wildfires burning in western Alaska. The smoke was moving west over Norton Sound. (The center of the image is roughly 163° West and 62° North.) Red outlines indicate hot spots where MODIS detected unusually warm surface temperatures associated with fire. According to an advisory released by the Alaska Interagency Coordination Center, record heat and dry fuels have produced record-setting fire potential across boreal spruce forests and tundra ...

Sun emits a solstice CME

2013-06-22

On June 20, 2013, at 11:24 p.m., the sun erupted with an Earth-directed coronal mass ejection or CME, a solar phenomenon that can send billions of tons of particles into space that can reach Earth one to three days later. These particles cannot travel through the atmosphere to harm humans on Earth, but they can affect electronic systems in satellites and on the ground. Experimental NASA research models, based on observations from NASA's Solar Terrestrial Relations Observatory and ESA/NASA's Solar and Heliospheric Observatory show that the CME left the sun at speeds of ...

Risk factors affect the incidence of childhood pneumonia in modern urban apartment?

2013-06-22

Childhood pneumonia is the leading causes of death among children in China and worldwide. Using coal or wood as cooking fuel in rural area was considered as major cause of Pneumonia. However, the incidence of childhood pneumonia is still high in urban modern cities. Which home risk factors affect the incidence of childhood pneumonia in modern urban apartment? Professor Hua QIAN and his group from School of Energy and Environment, Southeast University set out to research this problem. A recent study found that the risk factors in indoor environment typical of modern apartments ...

Innovative risk score accurately calculates which kidney transplant candidates are also at risk for heart attack or stroke, new study finds

Amid record year for dengue infections, new study finds climate change responsible for 19% of today’s rising dengue burden

New study finds air pollution increases inflammation primarily in patients with heart disease

AI finds undiagnosed liver disease in early stages

The American Society of Tropical Medicine and Hygiene and the Bill & Melinda Gates Foundation announce new research fellowship in malaria genomics in honor of professor Dominic Kwiatkowski

Animas makes progress in development of a first-generation closed-loop insulin delivery system

ELSE PRESS RELEASES FROM THIS DATE:

LAST 30 PRESS RELEASES: