Objective
In this proposal, we aim to conduct a randomized, controlled, crossover, 3-week outpatient trial to compare the fully automated artificial pancreas versus the hybrid FiASP-alone artificial pancreas in 30 adults with type 1 diabetes. Two configurations of the fully automated FiASP-plus-pramlintide system will be assessed, one with 10 μg/u of pramlintide-to-insulin ratio and another with 8 μg/u ratio.
Background Rationale
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 decreased glycemic control. Current artificial pancreas systems
require some form of carb counting, but it would be beneficial if patients did not have to count carbs to control their diabetes.
Patients with type 1 diabetes do not produce the hormone amylin, which regulates blood sugar levels in individuals without type 1 diabetes. Pramlintide is a synthetic analog of amylin which could potentially alleviate the need for carb counting if it was infused at meal times with insulin. We developed a novel FiASPand-
pramlintide artificial pancreas that does no require carbohydrate counting or meal announcements. The system automatically delivers the appropriate amount of insulin and pramlintide to control blood glucose levels.
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 artificial pancreas systems
require some form of carb counting, but it would be beneficial if patients did not have to count carbs to control their diabetes.
Patients with type 1 diabetes do not produce a blood sugar regulating hormone called amylin, which slows stomach emptying, suppresses glucagon secretion, and increases satiety. Pramlintide is a synthetic analog of amylin that can help regulate post-meal blood sugar levels in patients with type 1 diabetes.
We have developed a novel dual-hormone (FiASP-and-pramlintide) artificial pancreas that does not require carbohydrate counting or announcing meals to the system. Meals are detected by the system, and pramlintide and insulin are infused automatically to control blood glucose levels. In this proposal, we aim to
assess, in free-living conditions, a novel fully automated FiASP-and-pramlintide artificial pancreas that eliminates carbohydrate counting and does not require any patient’s input around meals.
Anticipated Outcome
If our novel fully automated FiASP-and-pramlintide artificial pancreas leads to improved quality of life and similar glycemic outcomes as the FiASP-alone artificial pancreas, there is potential for a fully automated artificial pancreas that does not require meal announcements for people with type 1 diabetes.
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 patients with type 1 diabetes.