Objective

The goal of this proposal is to develop a continuous insulin monitoring (CIM) device that can measure insulin levels under the skin in real time. This will be done by combining tiny, painless hydrogel microneedle patches that access the fluid just beneath the skin with an engineered sensor that can detect insulin. This new device will allow for continuous insulin monitoring through the skin, helping patients better manage their diabetes.

Background Rationale

Keeping blood sugar levels within a target range is essential for managing diabetes over the long term. Recently, advancements in continuous glucose monitors (CGMs) and insulin pumps have led to the development of automated insulin delivery (AID) systems. These systems automatically adjust the amount of insulin a person receives based on real-time glucose levels, helping people with type 1 diabetes (T1D) spend less time with dangerously high or low blood sugar levels. This has been a huge step forward for diabetes care, especially for people who need frequent insulin doses.

However, current AID systems use complex algorithms to deliver insulin, based on general population data, rather than personalized information. Since each individual’s body processes insulin differently, the system can sometimes deliver too much or too little insulin. To make AID systems safer and more accurate, it’s important to include a way to monitor insulin levels directly, allowing for more personalized dosing and fewer complications.

Description of Project

Getting the right amount of insulin is critical for people with type 1 diabetes (T1D) because too much or too little can be dangerous. If a person gets too much insulin, it can cause their blood sugar to drop too low (hypoglycemia), which can be life-threatening. If they don’t get enough insulin, their blood sugar can rise too high (hyperglycemia), which can also be very dangerous. That’s why it’s so important to have a way to constantly monitor insulin levels to ensure the right dose is given.

While there continuous glucose monitors (CGMs) that track blood sugar levels in real time, there is currently no similar device that can do this for insulin. CGMs have made it easier to manage diabetes by helping people keep their blood sugar in check, but there’s still no tool that allows for continuous insulin monitoring.

This project aims to create a new device that can measure insulin levels in real time by using tiny, painless microneedles that sense insulin just below the skin. The device will be designed to work with insulin pumps that automatically deliver insulin, helping people manage their diabetes more accurately and safely by ensuring they always get the right amount of insulin.

Anticipated Outcome

The anticipated outcome of this project is to develop a continuous insulin monitoring (CIM) device that can measure insulin levels through the skin. This new device will use painless microneedle patches made from a soft gel to detect insulin, making it easy and comfortable for patients to use. Once developed, the CIM device is expected to work seamlessly with existing automated insulin delivery systems, helping patients on insulin therapy get more accurate doses and better manage their diabetes.

Relevance to T1D

This project is highly relevant to patients with type 1 diabetes (T1D), where accurate insulin dosing is crucial. Incorrect insulin doses can lead to dangerously high (hyperglycemia) or low (hypoglycemia) blood sugar levels, both of which can have life-threatening consequences. Despite the critical need for better insulin measurement, there are currently no continuous insulin monitoring devices available. This has also left a significant gap in T1D research, in addition to the clinical need, particularly in understanding how insulin interacts with blood sugar levels in real-time. Continuous glucose monitoring (CGM) systems have improved our knowledge of how blood sugar is regulated, providing new insights into conditions like hyperglycemia and hypoglycemia and their associated health risks. However, measuring insulin still requires invasive methods like blood draws and lab testing, which are impractical for regular use and unethical for research involving frequent sampling (e.g., every 10 minutes). A continuous insulin monitoring (CIM) device would transform diabetes research by allowing us to answer important questions about how different factors influence insulin levels compared to glucose. The proposed CIM device aims to fill these research gaps and provide a much-needed tool for advancing our understanding of diabetes management.