Objective
The objective of this trial is to assess whether the addition of tirzepatide to a commercial automated insulin delivery system allows its use in fully closed-loop mode without degrading glucose control.
Background Rationale
Conventionally, pre-prandial boluses are required with automated insulin delivery systems to avoid prolonged post-prandial hyperglycemia due to the mismatch between insulin and meal absorption peaks. Tirzepatide may reduce this mismatch via delayed gastric emptying. Moreover, tirzepatide reduces insulin usage and carbohydrate intake, which would be beneficial with fully closed-loop as less insulin in the post-prandial period is needed and therefore easier for the fully closed-loop system to achieve euglycemia. Given these properties, as well as tirzepatide’s glucagon suppression effect, we anticipate that adding tirzepatide to automated insulin delivery systems may aid fully closed-loop operation.
Description of Project
People with type 1 diabetes are required to count the carbohydrate content of their meals to determine the amount of insulin to deliver at mealtimes. However, accurate carbohydrate content is a difficult and burdensome task, and errors can lead to degraded glycemic control. Current automated insulin delivery systems require some form of carbohydrate counting, but it would be beneficial if people with type 1 diabetes did not have to count carbohydrate to control their diabetes (i.e., use the systems in fully closed-loop mode). However, not delivering insulin boluses at mealtimes with current automated delivery systems will lead to prolonged post-prandial hyperglycemia due to the mismatch between insulin and meal absorption peaks. The objective of this project is to assess whether the addition of tirzepatide to a commercial automated insulin delivery system allows its use in fully closed-loop mode without degrading glucose control.
Anticipated Outcome
It is anticipated that commercial automated insulin delivery systems without meal announcements (i.e., fully) but with adjunct tirzepatide use achieves a non-inferior time in target range compared to the system with carbohydrate counting and matched prandial boluses (standard of care). If this hypothesis is accepted, it would indicate that with tirzepatide, users of commercial automated insulin delivery systems can eat with no need for prandial boluses, and their glucose control will not be degraded.
Relevance to T1D
This trial aims to test a fully automated artificial pancreas that eliminates the need for carbohydrate counting and meal announcement. This could improve the quality of life of people living with type 1 diabetes.