Transdermal Specialties Inc. (TSI) is hoping to change the face, not to mention the abdomen, upper arm and thighs, of patients with diabetes. The company’s new “Set IT And Forget IT” insulin delivery system will be unveiled at the American Diabetes Association’s 72nd Annual Scientific Meeting, June 9 -11, 2012 in Philadelphia.
Using a patented alternating ultrasonic waveform process to enlarge the diameter of the skin pores, the U-Strip enables large molecule drugs, such as insulin, to permeate through the skin into the dermis and then into the blood stream. All without needles!
- Delivers insulin for both basal and bolus needs
- Patches available in four different doses: 25, 50, 100 & 150 Units
- Electronic delivery system tracks dosing history and glucose readings
- Downloads data to physician for progress monitoring
12 clinical trials in over 125 diabetics have already been successfully completed. The company hopes to complete the last two clinical trials needed for FDA approval in the next 18 months.
The HPT- 6 trial will investigate whether the patch can reach the same glucose levels as a pump with less insulin, and will also compare the speed of delivery vs. injection to determine if the patch can be more effective in morning glucose reduction for those patients waking with high blood sugar levels.
The HPT-7 trial (slated for 2013) will focus on a real-world study of 500 Type-2 diabetics, who will conduct an at-home study to track their A1C levels. The A1C test measures average blood glucose control for the past 2 to 3 months.
“The U-Strip represents a major advance in diabetes care” says Bruce K. Redding, Founder, President and CEO of TSI. “The insulin patch component offers a safe and painless alternative to injections with the promise of reduced side effects and improved insulin uptake efficiencies for the patient. The ultrasound actually reduces the quantity of insulin needed for effective glucose control and speeds the delivery over a pump or even direct injection. Improved patient monitoring and reporting of the Control Device enables better tracking of treatment programs and the new “Set-it and Forget-it” function means more regular glucose control during both evening and daytime hours.
All of which sound like good news for the 27 million diabetics in the US, who eagerly await an alternative to injections. Over the years, various attempts, some more successful than others, have been made to capture this $3 billion market.
SRxA’s Word on Health will be keeping a watch on all diabetes developments and we’ll bring you further news as it happens.