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Archive - 10 - 2011

Medtronic Receives IDE Approval to Conduct Aspire In-Home Study of First Insulin Pump with Low Glucose Suspend for US Market

Posted by dlife on Mon, Oct 31, 11, 11:00 AM 0 Comment

October 28, 2011 (Medtronic) A Critical Step Toward the Development of an Artificial Pancreas, Low Glucose Suspend Aims to Reduce Hypoglycemia.In our continued commitment to develop an artificial pancreas, Medtronic, Inc. (NYSE:MDT) today announced U.S. Food and Drug Administration (FDA) approval of its Investigational Device Exemption (IDE) to conduct a pivotal in-home clinical trial protocol for the ASPIRE study of the MiniMed Paradigm System featuring Low Glucose Suspend (LGS) automation. FDA approval of the IDE makes Medtronics ASPIRE study the first in-home pivotal trial of a closed loop system for Type 1 diabetes management.This study leads an industry-wide effort to close the diabetes treatment loop by tackling the important challenge of reducing the risk of hypoglycemia even when a person is asleep or unable to react, said David Klonoff, Medical Director of the Diabetes Research Institute at Mills-Peninsula Health Services. The new Low Glucose Suspend integrated system is designed to help improve patients ability to manage nocturnal hypoglycemia, which can be one of the most frightening aspects of living with Type 1 diabetes. Until now, we have never had a therapy designed to automatically intervene when blood glucose becomes severely low.FDA approval of the ASPIRE in-home study is an important milestone toward bringing Low Glucose Suspend technology to the U.S. market, said Dr. Francine Kaufman, Chief Medical Officer and Vice President of Global Clinical Affairs for the Diabetes business of Medtronic. Its also a critical step toward our ultimate goal the development of an artificial pancreas. We believe this innovation has the potential to provide patients with added protection by lowering the risks associated with nocturnal hypoglycemia.This is the second phase of the ASPIRE (Automation to Simulate Pancreatic Insulin REsponse) study, following the completion of the in-patient clinical study. ASPIRE is a multi-center, randomized, pivotal in-home study being conducted at multiple investigational centers to determine the safety and efficacy of the Low Glucose Suspend feature in the sensor-augmented MiniMed Paradigm insulin pump. Medtronics newest continuous glucose sensor, the Enlite sensor, will be tested as part of the overall system.ASPIRE will compare hypoglycemic events in a treatment arm with the LGS ON to a control arm that has the LGS OFF in the actual use environment and by the intended use population with Type 1 diabetes. The first study objective is to demonstrate that home use of LGS is safe and is not associated with glycemic deterioration, as measured by a change in HbA1C. The second study objective is to demonstrate that home use of LGS is associated with a reduction in nocturnal hypoglycemia when patients fail to respond. Hypoglycemia is a common occurrence and concern in diabetes management and can result in confusion, unresponsiveness and in severe cases even death.FDA review of the ASPIRE IDE application was conducted through an interactive review process that involved frequent communication with the FDA review team, allowing issues to be resolved quickly and avoiding any unnecessary delays during the review. We appreciate the valuable input provided by members of the FDAs Artificial Pancreas Working Group, added Dr. Kaufman.Medtronics MiniMed Paradigm REAL-Time Revel System, currently available in the United States, is the second generation of the only insulin pump integrated with continuous glucose monitoring (CGM) cleared by the FDA. With the addition of LGS, Medtronic has designed a first-of-its-kind semi-closed loop system that not only features insulin delivery and CGM, but also advanced software algorithms that enable the Low Glucose Suspend automation. Low Glucose Suspend works by automatically suspending basal insulin delivery temporarily if glucose levels become too low as defined by the patient and his or her healthcare provider. It is a feature available commercially in Medtronics Paradigm Veo System in more than 50 countries outside of the United States. The CGM-integrated system and Low Glucose Suspend automation are the first key steps towards the creation of an artificial pancreas.Hypoglycemia can be one of the most frightening aspects of living with diabetes. Research has indicated that, on average, a person with diabetes will experience more than one low blood glucose event every two weeks. In addition, each year nearly one in 14 people with insulin-treated diabetes will experience one or more episodes of severe hypoglycemia.About the Diabetes Business at Medtronic
The Diabetes business at Medtronic is the world leader in advanced diabetes management solutions, including integrated diabetes management systems, insulin pump therapy, continuous glucose monitoring systems and therapy management software, as well as world-class, 24/7 expert consumer and professional service and support.About Medtronic
Medtronic, Inc., headquartered in Minneapolis, is the global leader in medical technology alleviating pain, restoring health and extending life for millions of people around the world.Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronics periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
1. Leese GP, Wang J et al. Frequency of severe hypoglycemia requiring emergency treatment in Type 1 and Type 2 diabetes. Diabetes Care 26:1176-1180, 2003.

Ethnic Differences in Appointment Keeping Affect Health of Diabetes Patients

Posted by dlife on Mon, Oct 31, 11, 10:19 AM 0 Comment

October 27, 2011 (Health Behavior News Service) Ethnic differences in appointment keeping may be an important factor in poor health outcomes among some minority patients with diabetes, according to a new study.The researchers reviewed survey data and medical records for nearly 13,000 participants in the NIH-funded Diabetes Study of Northern California (DISTANCE) and found that some minority groups missed scheduled primary care appointments twice as often as others, even after accounting for many health and demographic factors. Latinos and African-Americans had the lowest rates of appointment keeping Asians had the highest, with Filipinos and Caucasians falling in between.The study also found that patients who often miss appointments were at increased risk for poorer control of blood sugar, cholesterol, and blood pressure. Additionally, the study showed that these groups tended to rely more heavily on same-day visits. This is the first study to evaluate primary care usage in a large, ethnically diverse group of diabetes patients with uniform access to health care. The findings have important implications for health care systems as they increase open access to care through same-day appointments, which may not provide the same level of chronic care management as planned visits, even when the appointment is with ones own primary care provider.Providing greater convenience for patients may impact ethnic groups differently and perpetuate disparities in unexpected ways, says lead author Melissa Parker, M.S., of Kaiser Permanente in California. The study appears in the current issue of Health Services Research.Health care providers need to ensure that all aspects of diabetes care are addressed with patients who miss planned appointments but attend same-day appointments, say the authors. They note that during same-day appointments, primary care providers are trained to listen to patient complaints first, which may leave little time to focus on the diabetes-specific care that would be the focus of a planned visit.They add that health indicators should be tracked separately for various segments of the population to ensure that open access does not compromise care for any ethnic group.This is part of the evolution of both patient and provider perspectives on how to best manage chronic illness, says Robert Gabbay, M.D., Ph.D., who is director of the Penn State Hershey Institute for Diabetes and Obesity. We still have a primarily acute care system. We are encouraging providers to address some chronic care issues at every appointment, even if the patient comes in for a different reason.TERMS OF USE: This story is protected by copyright. When reproducing any material, including interview excerpts, attribution to the Health Behavior News Service, part of the Center for Advancing Health, is required.For more information:
Reach the Health Behavior News Service, part of the Center for Advancing Health, at (202) 387-2829 orhbns-editor@cfah.org.Health Services Research is the official journal of the AcademyHealth and is published by John Wiley & Sons, Inc. on behalf of the Health Research and Educational Trust. For information, contact Jennifer Shaw, HSR Business Manager at (312) 422-2646 orjshaw@aha.org. HSR is available online atwww.blackwell-synergy.com/loi/hesr.

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