The study will measure the benefits of using this integrated solution to monitor rural diabetic patients' responses to medication, including the relationship between medication compliance, blood glucose and HbA1c levels. Studies at St. Vincent and elsewhere have documented that some rural patients with chronic disorders may have poorer health outcomes than certain urban populations, who can more easily access health care services.
"This is an unprecedented trial in that patients living 100 to 250 miles away from the St. Vincent clinical trial site will be recording blood glucose levels several times per day subsequent to taking their oral hypoglycemic medications", noted Bruce A. Kehr, M.D., CEO and founder of InforMedix. "Only Med-eMonitor, with its ability to trigger electronic patient-recorded outcomes (ePRO) measures based upon when the medication is actually taken, is capable of performing this type of monitoring. Med-eMonitor enables clinicians to remotely capture substantial bio-data that previously could only be accessed by direct patient contact. This approach could conceivably reduce clinical site visits by up to two-thirds, providing significant cost reductions to pharmaceutical company sponsors. In addition it may enable an entirely new population - remote rural patients - to participate in clinical trials."
David Irion, Executive Director of the St. Vincent Healthcare Foundation, observed: "St. Vincent Healthcare and the St. Vincent Healthcare Foundation are pleased to collaborate with InforMedix and McKesson BioServices in this important study that we believe will lead to improved outcomes in patient care. The rural nature of many of our patients presents some interesting challenges as far as direct and immediate care. This research study may lead us to some exciting new ways to manage care for patients in locations far from their doctor."
It is believed that use of the Internet-based Med-eMonitor medication-compliance and tracking system with the innovative medication packaging and delivery may enable clinicians to better manage remote patients' health care regimes, reducing the frequency of travel to urban centres for face-to-face clinical evaluation. As part of St. Vincent's clinical study, InforMedix is providing the Med-eMonitor patient-prompting and monitoring device and the Med-eXpert database, which has been proven in past studies to enhance patient compliance and clinical protocol adherence. InforMedix's network infrastructure ensures secure transmission of patient data.
"Having the medication-dispensing and patient-reporting functions tightly coupled in one device means we can more rigorously track dose-response measurements, including receiving alarms when glucose levels rise above certain levels. The turnkey platform may feasibly assist in overall patient management, and may elevate the level of health care for these rural populations", noted Anita Dopkosky, R.Ph., sales and marketing vice president of McKesson BioServices.
McKesson BioServices is providing the speciality clinical trial material packaging design and medication-distribution systems for the Med-eMonitor device, ensuring product stability and patient safety through proper dosage, hermetically sealed trays, and other safety measures. McKesson BioServices has a cGMP compliant facility, along with a patient specific pharmacy, for shipping this turnkey solution direct to St. Vincent's clinical site or direct-to-patients.
The announcement of this study follows closely on the heels of a strategic alliance formed between InforMedix and McKesson BioServices, announced October 4, in which both companies agreed to develop and market this turnkey patient-compliance and medication-dispensing solution to the clinical trial market for use in clinical trials. This includes presenting at health care and clinical drug trial conferences, conducting one-on-one meetings with key customers, and other marketing and sales activities.
InforMedix has developed the Med-eMonitor System to provide real-time medical management and patient communications for clinical drug trials. InforMedix has integrated a portable patient-interactive monitoring device, hardware, software and networked communications system to enable pharmaceutical and biotechnology companies, and medical researchers to efficiently monitor and manage patients' medication compliance, protocol adherence, clinical response, and safety.
Med-eMonitor is specifically designed to improve patient medication compliance and protocol adherence in clinical drug trials. The Med-eMonitor System leverages InforMedix's strong intellectual property consisting of 15 issued patents and 14 patents pending. The InforMedix's patents have been cited as prior art by patent examiners in over 150 other issued patents.
Understanding the critical drug development process, McKesson BioServices experienced staff has extensive domestic and worldwide shipping expertise working closely with clients to support any clinical trial and address special needs involved in handling clinical trial material. McKesson BioServices is an expert in the management, packaging and labeling, analytical testing, validation testing, storage and distribution of clinical trial materials and biological specimens covering preclinical through Phase IV studies. BioServices also provides patient-specific pharmacy services nationwide to support patient assistance programmes for commercial pharmaceutical products.
The parent company, McKesson Corporation is a Fortune 16 health care services and information technology company dedicated to helping its customers deliver high-quality health care by reducing costs, streamlining processes and improving the quality and safety of patient care. Over the course of its 170 year history, McKesson has grown to provide pharmaceutical and medical-surgical supply management across the spectrum of care; health care information technology for hospitals, physicians, homecare and payers; hospital and retail pharmacy automation; and services for manufacturers and payors designed to improve outcomes for patients.
The Sisters of Charity of Leavenworth, Kansas founded St. Vincent Healthcare in Billings in 1898. Motivated by its mission to provide compassionate care and service, St. Vincent has become one of Montana's leading comprehensive health care providers. St. Vincent is the only hospital in the region that is nationally recognized for outstanding services in Cardiology, Orthopaedics and Stroke Care, and is the network hub for the Partners in Health Telemedicine Network, which has global connectivity capabilities. St. Vincent recently founded the Center for Healthy Aging, a regional programme that will include the use of advanced telemonitoring technologies in clinical research and care service provision for remotely located elderly patients.