# An Intraperitoneal Insulin Delivery System for Management of Type 1 Diabetes

> **NIH NIH R44** · PERIKINETICS INC · 2022 · $1,048,080

## Abstract

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.

## Key facts

- **NIH application ID:** 10584462
- **Project number:** 5R44DK129075-02
- **Recipient organization:** PERIKINETICS INC
- **Principal Investigator:** Daniel Rogers Burnett
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $1,048,080
- **Award type:** 5
- **Project period:** 2021-09-20 → 2025-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10584462

## Citation

> US National Institutes of Health, RePORTER application 10584462, An Intraperitoneal Insulin Delivery System for Management of Type 1 Diabetes (5R44DK129075-02). Retrieved via AI Analytics 2026-06-11 from https://api.ai-analytics.org/grant/nih/10584462. Licensed CC0.

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