AVACEN Announces Completion of Type 2 Diabetes Clinical Study
Oct 5, 2020
SAN DIEGO, Oct. 5, 2020 /PRNewswire/ -- AVACEN Medical (AVACEN) announced the completion and results from the second part of its sponsored 50 person study of glucose tolerance in Type 2 diabetics.
The double-blind randomized controlled pilot study with crossover design focused on postprandial blood glucose (PBG) reduction consequential to use of the AVACEN 100 dry heat therapy medical device. The AVACEN device is believed to have the ability to overcome disease-induced microvascular impairment by mechanically recruiting the microvasculature allowing for glucose disposal. PBG is an independent predictor of all-cause mortality, cardiovascular disease and cardiac events.
Furthermore, recent 3rd party research has revealed that diabetes is associated with greater pulmonary inflammation and that successful blood glucose management is effective in fighting serious cases of COVID-19.
The IRB approved study was conducted in the Clinical Nutrition and Physiological Sciences Laboratory in conjunction with The School of Exercise and Nutritional Sciences at San Diego State University. Michael J. Buono, Ph.D., Professor School of Exercise and Nutritional Sciences and the Department of Biology acted as Principal Investigator.
According to diabetes researcher Jonathan RT Lakey, PhD, MSM, professor of surgery and biomedical engineering at UC Irvine: "The SDSU study demonstrates that the AVACEN negative pressure heat treatment may overcome microvascular damage caused by Type 2 diabetes. They also show significant reductions in lowering post prandial blood glucose compared to non-treated controls. I look forward to further evaluation of this device in larger series of patients, both Type 2 diabetics as well as long standing insulin dependent Type 1 diabetic patients."
Type 2 diabetes currently constitutes a global crisis. It stands as a leading cause of both death and disability in countries of all income levels, directly costing nearly a trillion dollars to the world.
While it's largely considered a preventable and reversible disease, Type 2 diabetics continues to increase in prevalence in individuals of all ages. Even though exercise and diet are effective in lowering blood glucose, adherence is often poor. Globally, one in three women and one in four men do not meet the physical activity guidelines.
According to Thomas G. Muehlbauer, AVACEN Medical CEO; "One of the most exciting aspects is that the study suggests that the AVACEN device may also offer a convenient treatment for lowering postprandial blood glucose which supports adherence. Due to this ease of use, we see many Type 2 diabetics conscientiously following our twice daily 20-minute AVACEN protocol for the temporary relief of minor muscle and joint pain. The unexpected benefit is a significant reduction in their A1C in only a few months. Therefore, we are planning a 13-week study to scientifically document this powerful aspect in support of an FDA request to increase our approved indications of use to include reducing A1C."
About SDSU and the School of Exercise and Nutritional Sciences
Founded in 1897, San Diego State University is a public institution of higher education located in southern California. SDSU is the oldest and largest university in San Diego and the third largest in the state.
The School of Exercise and Nutritional Sciences (ENS) at SDSU has evolved from its beginnings in 1914 as a physical education department to one that now offers undergraduate degrees in kinesiology, foods and nutrition, and athletic training; master's degrees in exercise physiology, kinesiology, and nutrition; and a doctor of physical therapy.
About AVACEN Medical
AVACEN Medical is dedicated to the innovation and design of safe, easy to use, noninvasive drug-free alternatives for the management of pain associated with numerous chronic and acute conditions including the temporary relief of minor muscle and joint pain and stiffness associated with arthritis and potentially other conditions that can cause joint pain, such as CRPS, Reynaud's, and Lyme Disease. Founded in 2009, AVACEN Medical is headquartered in Carlsbad, CA. Contact: Thomas Muehlbauer at (888) 428-2236 x 701 or
[email protected]
.
SOURCE AVACEN, Inc
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