Objective
The main objectives of this study are to: (1) look at the change in blood sugar control for people with type 1 diabetes with higher hemoglobin A1c values when using the fully closed loop system compared to their usual at-home care, (2) look at the safety of the fully closed loop system during exercise challenges and unannounced meal challenges, and (3) demonstrate that the fully closed loop system works well in racial and ethnic groups which have generally been under represented in technology research. Achieving these objectives will help move the fully closed loop design a big step forward towards commercial approval studies and then at home use by people with diabetes.
Background Rationale
Due in large part to the JDRF Artificial Pancreas Project, there are now multiple different hybrid closed loop automated insulin delivery systems on the market to aid people with type 1 diabetes in managing their blood sugars. Studies on these devices have shown that they are very successful in reducing hemoglobin A1c and improving time in target range for those people who use them. Studies have also shown that over half of people with diabetes are not currently using these automated systems. The reasons for not using these systems are complex and include patient and provider belief that the person would not be able to successfully use the device. This project aims to advance development of a fully closed loop system which automates all aspects of insulin dosing and greatly reduces the burden of diabetes management. The goal of the project is to demonstrate safety and feasibility of a fully automated system in a supervised hotel setting followed by a remotely supervised at-home setting. Studies such as this have been used in the past to demonstrate device safety prior to fully at-home commercial approval studies.
Description of Project
The overall goal of this project is to advance automated insulin delivery for people with type 1 diabetes to a fully automated system. The current most advanced systems are hybrid closed loop devices, meaning that a computer program automates background and some correction insulin delivery, but the user must still provide information about meals and some corrections. This study will advance development of a fully closed loop system where a computer program will dose all background insulin in addition to all correction and meal insulin. The study will move this technology from highly supervised settings to remote monitored at-home use. This is a critical last step to demonstrate safety and feasibility to allow for full regulatory approval studies to begin in the future. The population studied in this project will include adolescents and young adults with higher hemoglobin A1c values. We wish to demonstrate to these individuals and their doctors that a fully closed loop system can be transformative in their diabetes care.
Anticipated Outcome
This study of a fully closed loop system will enroll 36 young adults and adolescents with type 1 diabetes over 2 years to participate in two 1-month sessions to test the system. We believe that the fully closed loop system will help achieve a significant improvement in average continuous glucose monitor (CGM) values when compared to usual at-home care. We believe that the fully closed loop system will help achieve a significant improvement in CGM time in target range when compared to usual at-home care. We believe that the fully closed loop system will be usable by people and able to stay in automated mode for more than 90% of the time.
We also believe that the fully closed loop system will be safe during exercise and meal challenges designed to stress the system. We believe that during moderate intensity exercise, the system will be able to have less than 4% of the time with the blood sugar in the hypoglycemic range. We believe that after unannounced meals, the fully closed loop system will have less than 10% of the time with the blood sugar above 250 mg/dL.
We also believe that racial and ethnic minority populations will be interested in using the system and will be very successful at using the device.
We will also explore the effect that use of the fully closed loop system has on satisfaction with diabetes care.
Overall, we believe that this study will demonstrate that the fully closed loop system is safe and appropriate to use for diabetes care allowing for the system to move forward towards a large commercial approval study.
Relevance to T1D
According to recent registry data, over 50% of people with type 1 diabetes use an insulin pump and half to two thirds are using CGM. Adding automation to these devices has been shown to further improve their benefits for glucose control and to broaden the groups which find benefit from the technology. This study will advance automation from the current hybrid closed loop systems to a fully closed loop design. This advancement will reduce the burden and improve the glucose control of a majority of people living with type 1 diabetes.