Wednesday, June 27, 2007
Type 2 Diabetes Clinical Trial Results at ADA Scientific Sessions
Diabetech's healthcordia Intensive Management Programs combine mobile diagnostic devices, rules engine technology and social networks to deliver significant outcomes in type 2 diabetes patients.
Chicago, IL (PRWEB) June 27, 2007 -- Diabetech, LP, a proven leader and pioneer in extending diabetes care beyond the reach of health care practitioners, announced at the annual American Diabetes Association (ADA) conference that over 84% of the type 2 diabetes trial participants reduced their blood glucose levels as measured by a highly accurate hemoglobin A1c laboratory test by an average of 1.1 points; a significant improvement in blood sugar control.
As a speaker at ADA Scientific in the symposium entitled, "Beyond Health Care Practitioners - Diabetes Health Care Extenders", McMahon presented the data showing that twenty-six adult patients with type 2 diabetes participated in this 12 month study. As is typical in Phase 2 translational research, the patients were not randomized nor was there a control group. In addition, trial participants rated their satisfaction with the program content and devices as being very high. The trial is being conducted under the oversight of an Institutional Review Board. No adverse events have been reported.
According to the ADA, over 21 million people in the US have diabetes. In addition, another 54 million are at risk of developing diabetes in the near future while 1 in 3 children born in the year 2000 are likely to develop type 2 diabetes at some point during their lifetime. The A1c is the gold standard for measuring the severity of diabetes as well as indicating the impact of self-management between visits. The A1c range for people without diabetes is approximately 4.0 to 5.5 depending on the specific test method used. The ADA guidelines indicate 7.0 as the target A1c level for people with diabetes while the American Association of Clinical Endocrinologists recommend a target of 6.5 with talk about lowering the target to 6.0. Consistently elevated blood glucose levels lead to complications including kidney failure, nerve damage, blindness and increased incidence of cardiovascular disease.
"After the first year or two of working with type 1 diabetes patients, we suspected that our unique capabilities incorporating proprietary wireless & mobile diagnostic devices, rules engine technology and patient-centric social networks could also be used to improve the quality of care for patients with type 2 diabetes" stated Kevin McMahon, President & CEO of Diabetech. "Considering the reduced biometric data involved with day to day management of type 2 vs. type 1, we decided to emphasize diabetes education over glucose pattern analysis in this trial. For example, in response to automated system analysis of the patient's real-time personal health record, QuickTips educational messaging is sent to the patient and other members of the team based on clinical algorithms in the GlucoDYNAMIX diabetes intervention system. As always, using the system to engage the patient and their social network was a key contributor to this very exciting results data."
Following enrollment and establishment of the patient's profile, patient participants were given Diabetech's market leading GlucoMON® wireless glucose meter for automated and accurate blood glucose data collection, automated GlucoDYNAMIX blood glucose logbooks from their online personal health record (PHR), QuickTips lifestyle and diabetes educational messages, HomeCheck hematology screening and A1c laboratory tests at enrollment and every 90 days thereafter, activity guides and more. Minimal human intervention from program staff and practitioners in this trial also demonstrates the efficiencies gained using automated technology instead of weekly phone calls from highly skilled professionals who are also in limited supply.
When analyzing the data and attempting to determine specific influences to behavioral changes that led to these impressive reductions in A1c, the data consistently points to patient satisfaction with the simple design of Diabetech's GlucoMON and the psychological impact of being part of an active real-time system that monitors your data and connects your team. Another explanation for the reduction in average blood sugars can be tied to the automated blood glucose trending logbook. For many patients with type 2 diabetes, they have never known what to do with an individual blood glucose result. Now with simple business intelligence applied to aggregated data, trouble areas are highlighted for the patient making it easy to understand the effects of food and activity choices making it easy for the patient to take action to correct out of control blood sugars and enjoy long-term health improvement.
So advanced, it's simple.
About the healthcordia programs powered by Diabetech technology
Diabetech has been known for years for their work with type 1 diabetes patients and their remote caregivers, especially in pediatrics. Given the results from this study, and additional data from confidential studies also involving patients with type 2 diabetes, Diabetech's healthcordia diabetes intervention programs are clearly indicated for use with patients with both type 1 and type 2 diabetes. Additionally, a clinical trial in partnership with a major research university is pending with a focus on a special form of diabetes which occurs during pregnancy called gestational diabetes. Live patient interventions are planned to begin in the coming weeks with preliminary results to be announced before the end of this year.
We push the limits of clinical informatics in the delivery of real-world diabetes care. For more information on the healthcordia programs and to participate in our version of proactive care, please visit www.healthcordia.com or call us toll free at 877.My.Gluco. Interested parties outside of the US should send email to info @diabetech.net to initiate correspondence. More information on Diabetech and our proprietary wireless medical devices and industry leading diagnostic laboratory kits can be found at www.diabetech.net
Diabetech and GlucoMON are registered trademarks of Diabetech, LP. GlucoDYNAMIX, HomeCheck and QuickTips are also trademarks of the Company. The Company also protects its healthcordia service mark.
GlucoMON is an investigational device subject to certain FDA guidelines including 510(k) marketing clearance prior to marketing for sale in the US. All other local regulations apply. The performance characteristics of these devices have not been established. This service offering is compliant with applicable federal and state regulations including HIPAA, which govern the privacy and security of human subjects research.
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Press Contact: KEVIN MCMAHON
Company Name: Diabetech, LP
Phone: 877-694-5826
Website: http://www.healthcordia.com