This trial specifically examined the effects of the ultrasonic transmission utilized in the U-Strip insulin delivery system upon the skin of Type-2 diabetic patients. The goal of this study was to demonstrate that ultrasound alone, at levels used for ultrasonic drug delivery, does not cause skin damage or irritation.
The U-Strip system produces an ultrasonic signal and the study applied the ultrasound over a sustained period of five hours during the test. This study demonstrates that the ultrasound component of the U-Strip system does not damage the skin, even the skin of highly sensitive Type-2 diabetics.
Currently, people with diabetes rely on regular, frequent needle injections of insulin to control blood glucose levels. Dermisonics’ proprietary U-Strip system employs microelectronics and ultrasonic technologies with a drug-carrying patch to enable the painless delivery of large-molecule drugs through the skin’s natural pores and hair follicles.
Dermisonics said they believed this was a major step toward receiving FDA approval.
The company is continuing its two other investigational review board (approved human pilot trials) to further demonstrate the efficacy of the U-Strip system.