An Intraperitoneal Insulin Delivery System for Management of Type 1 Diabetes

ABSTRACT Perikinetics’ intraperitoneal (IP) insulin delivery system for the management of Type 1 diabetes (T1D) utilizes an innovative implantable port-catheter system accessed by a proprietary external infusion set to provide a safe and effective means of tight glycemic control. For the 1.6 million Americans living with T1D, modern technological advances have improved glucose sensing and insulin delivery, however, achieving tight glycemic control remains challenging. The IP cavity presents a superior location for insulin delivery for T1D patients. IP insulin delivery better mimics physiological delivery by providing a higher insulin concentration in the portal system, enabling rapid absorption by the liver, and a more effective response to glycemic disturbances and reduced hypoglycemic episodes. Continuous IP insulin infusion (CIPII) systems developed to date have demonstrated dramatic improvement in glucose regulation but, unfortunately, suffer from catheter obstruction, infection, and aesthetic disfigurement. No FDA approved CIPII systems are currently available in the U.S. Improving the safety and clinical utility of IP insulin devices would enable commercialization of a superior option for glycemic control within a tighter monitoring range. Perikinetics (PK) has developed the PK Insulin Delivery Conduit (IDC), an implantable port-catheter system accessed by a proprietary external infusion set for IP insulin delivery. In our Phase I equivalent research studies, we established feasibility of the system through in vitro flow characterization, implant viability, and mechanical integrity testing. The overall objective of this proposal is to demonstrate that the PK IDC can safely and effectively deliver basal and bolus insulin in a T1D animal model. In Specific Aim 1, we will assess insulin stability on the bench to ensure that injected insulin will not be adversely affected by the device or delivery method. In Specific Aim 2, we will conduct a pilot animal study to validate safety, efficacy, and clinical utility of the PK IDC. Successful completion of these aims will position the device for IDE-enabling studies and, ultimately, de novo 510(k) clearance as the first IP insulin delivery vehicle using a subcutaneous port to reduce infection and improve quality of life.