Wayne State professor wins $2.65 million NIH award to develop novel filtration platform for insulin administration

A Wayne State University College of Engineering professor has received a $2.65 million award from the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health to develop a novel filtration platform to improve an advanced drug delivery device to optimize diabetes insulin treatments.

Subcutaneous insulin administration (SIA) technology has improved significantly over the past two decades, but SIA technology failure and underlying tissue damage caused by insulin phenolic preservatives (IPP) have impeded its progress. To minimize tissue damage and maintain infusion or injection site integrity over time, experts advise on limiting the wear time to three days and rotating the site of the SIA device. A team of scientists will use the funding from NIH to extend the lifespan of these infusion pumps or injection ports.

The study will be led by Ulrike Klueh, Ph.D., associate professor in the Department of Biomedical Engineering in the College of Engineering and in the Center for Urban Responses to Environmental Stressors at Wayne State.

According to Klueh, extending SIA technology to align with current continuous glucose monitoring sensors, approved for 10 to 14 days of wear, is a significant unmet need. Challenges to extending the lifespan of infusion pumps or injection ports involve addressing the IPP-induced tissue reactions of inflammation and fibrosis at these devices' location. Insulin formulations are also susceptible to mechanical and chemical stressors that lead to non-functional insulin molecules through polymerization designated as insulin fibril formation (IDF), even in the presence of IPP.

"Our published and preliminary data indicate that both IPP and IDF are pro-inflammatory, which leads to cumulative cell/tissue toxicity, inflammation and maladaptive wound healing," said Klueh. "To overcome this challenge, we believe that optimum IPP reduction and IDF removal at the time of insulin dosing -; in-line and just in time, rather than focusing on the preparation of new insulin formulations -; provides a solution to this significant issue."

Klueh and her team propose to design, fabricate and validate a new platform that will reduce IPP levels in insulin formulations. In addition, they aim to remove any IDF formation in-line and in a "just-in-time" mode to mitigate blood glucose levels without triggering acute and chronic SIA-induced inflammation and fibrosis.

Dr. Klueh is a leader in investigating issues of biocompatibility and underlying tissue impairment because of implantable devices. This important research study has the potential to aid many diabetes patients by transforming current diabetes management practices that ultimately will improve lives and save money on health care costs."

Timothy Stemmler, Ph.D., interim vice president for research, Wayne State University

The project number for this National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health R01 award is DK133789.