AID + InsuLearn-SMA for Type 1 Diabetes

(InsuLearn-SMA Trial)

This trial explores a new method for managing Type 1 Diabetes (T1D) using a smart insulin system called AID + InsuLearn-SMA. The study tests the safety and practicality of a self-learning insulin calculator that simplifies meal management for those using an automated insulin delivery system. Participants will either use this new system or continue with the usual carbohydrate counting method. Ideal candidates have had T1D for over a year, use an insulin pump, and have experience managing insulin in daily life. As an unphased trial, this study provides a unique opportunity to contribute to innovative diabetes management research.

You will need to switch to a commercially approved insulin if you are not already using one, and you cannot start any new non-insulin glucose-lowering medications during the trial. If you are currently taking any non-insulin glucose-lowering agents, you will need to stop them before participating.

Research has shown that Automated Insulin Delivery (AID) systems, part of the treatment under study, are generally easy to use. One study found that AID systems helped control blood sugar levels without causing major side effects. Another study suggested these systems work particularly well for individuals with long-term diabetes.

Researchers are excited about the AID + InsuLearn-SMA treatment for Type 1 Diabetes because it introduces a new way of managing insulin delivery. Unlike traditional methods that rely on carbohydrate counting, this treatment uses an automated insulin delivery system coupled with InsuLearn, a simplified meal announcement bolus calculator. This innovative approach aims to streamline the insulin dosing process, potentially making it easier and more intuitive for patients to manage their condition. By reducing the complexity involved in calculating insulin doses, this treatment could lead to improved blood sugar control and enhance the quality of life for individuals with Type 1 Diabetes.

Research has shown that automated insulin delivery (AID) systems help people with type 1 diabetes control their blood sugar levels more effectively. These systems are safe and assist individuals in maintaining healthier blood sugar levels. In this trial, participants will receive either the AID system with the new self-learning tool, InsuLearn-SMA, or the AID system using the usual carbohydrate counting bolus calculator. Early results suggest that combining AID systems with InsuLearn-SMA might improve insulin delivery. This combination could simplify daily diabetes management and enhance the quality of life for teenagers and young adults with type 1 diabetes.¹²⁶⁷⁸