Dual-hormone Closed-loop Glucose Control in Type 1 Diabetes
Status:
Recruiting
Trial end date:
2029-07-22
Target enrollment:
Participant gender:
Summary
Despite recent pharmacological and technological advantages, hypoglycemia remains to be the
key limiting factor in achieving optimal glycemic control in people with type 1 diabetes.
State-of-the-art treatment for type 1 diabetes is insulin in pens or pumps that focus on
reducing hyperglycemia after relative insulin deficiency e.g. after food intake. In recent
years, we focused on adding low-dose glucagon to insulin therapies for the treatment and
prevention of hypoglycemia - referred to as "dual-hormone treatment". We have shown that
low-dose glucagon is efficient in treating mild hypoglycemia and that several factors may
affect its glucose response. Our next step is to test whether the combined delivery of
insulin and glucagon can improve glucose control in individuals with type 1 diabetes. In this
proposal, we want to test the efficacy, safety and feasibility of a dual-hormone closed-loop
system, also known as an artificial pancreas. The closed-loop system involves automatic
infusion of glucagon and insulin based on continuous glucose measurements. The system will be
tested in a 33-hour in-clinic study comparing the glucose control by the combined automatic
delivery of insulin and glucagon with the automatic delivery of insulin-only. The study is
performed at Steno Diabetes Center Copenhagen (SDCC) in collaboration with the Technical
University of Denmark (DTU). We expect that the study will clarify whether low-dose glucagon
added to insulin therapy can improve the glucose control in adults with type 1 diabetes. We
believe that the utilization of glucagon will allow for a weight neutral optimization of
glucose control, reduce risk of hypoglycemia and reduce disease burden that will reduce
diabetes complications and cardiovascular diseases.
Phase:
Phase 4
Details
Lead Sponsor:
Steno Diabetes Center Copenhagen
Collaborators:
Danish Diabetes Academy Technical University of Denmark University of Copenhagen