Dual-hormone Closed-loop Glucose Control in Type 1 Diabetes

• Status: Recruiting
• Trial end date: 2029-07-22
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Steno Diabetes Center Copenhagen
• Collaborators: Danish Diabetes Academy; Technical University of Denmark; University of Copenhagen
• Treatments: Glucagon; Glucagon-Like Peptide 1; Hormones

Criteria

Inclusion criteria

• Age ≥ 18 years

• T1D ≥ 2 years

• Insulin pump therapy ≥ 1

• Currently treated with FiAsp® - insulin

• HbA1c ≤ 8.5% (69 mmol/mol) Exclusion criteria

• Pregnancy or nursing

• Inability and willingness to comply with all protocol procedures, e.g. exercise, sleeping, blood sampling, and meal consumption

• Plan to become pregnant or sexually active and not using adequate contraceptive methods (sterilization, intrauterine device, contraceptive pill, patch or injection)

• Hypoglycemia unawareness (self-reported lack of hypoglycemia symptoms when blood glucose is < 3.0 mmol/l)

• Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during or within 30 days prior to study participation

• History of coronary artery disease or congestive heart failure

• Abnormal ECG suggestive of coronary artery disease and increased risk of malignant arrhythmia

• Allergy to glucagon or lactose

• Pheochromocytoma

• Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation

Withdrawal criteria

• In case of pregnancy (or desire for pregnancy), female subjects are withdrawn

• Lack of compliance to any of the important study procedures in the discretion of the investigator

• Unacceptable adverse effects in the discretion of the investigator

• Withdrawal on participants request will be accepted at any time without further justification

Patients who complete or withdraw from the study continue their usual quarterly follow-up visits at the diabetes clinic. Withdrawal does not affect their statutory patient rights.