A Randomized, Controlled, Crossover Trial to Assess a Fully Automated, Dual-hormone (Insulin-and-pramlintide) Delivery System Without Carbohydrate Counting in Regulating Glucose Levels in Adults With Type 1 Diabetes.

Trial ID: NCT06046417

Interventional - Phase 2/3 - Unknown status

The aim of this clinical trial is to investigate whether a fully automated Lyumjev-and-pramlintide delivery system improves glycemic outcomes in adults with type 1 diabetes. The main question we aim to answer is whether a Lyumjev-pramlintide fully closed loop system improves time in range compared to a hybrid closed loop system with carbohydrate counting. We also aim to find the optimal insulin to pramlintide ratio for glycemic control in the fully automated system. In this cross-over study, patients will undergo the following three interventions in a random order: (i) fully automated Lyumjev insulin-and-pramlintide (8 μg/u) (ii) fully automated Lyumjev insulin-and-pramlintide (10 μg/u) (iii) rapid automated Lyumjev insulin-and-placebo with carbohydrate-matched boluses For all interventions, participants will be required to wear two Ypsomed pumps programmed by our developed EuGlide system.

Conditions

• type1diabetes
• Diabetes Mellitus, Type 1

Interventions

• Pramlintide
• Lyumjev
• Automated Insulin Delivery (AID) system

Eligibility

Inclusion criteria

• Individuals ≥ 18 years of age.
• A clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes relies on the investigator's judgment; C peptide level and antibody determinations are unnecessary.
• Using insulin pump therapy for at least three months.
• Individuals of childbearing potential using an effective birth-control method. An individual of childbearing potential must agree to use a highly effective method of birth control.

Exclusion criteria

• Current or recent use of antihyperglycemic agents other than insulin (≤ 2-week use of sodium-glucose cotransporter-2 inhibitor (SGLT2I), Metformin, etc.; ≤ 1-month for glucagon-like peptide-1 receptor agonists (GLP1-RA)).
• Current use of glucocorticoid medication (except low, stable doses and inhaled steroids).
• Individuals with confirmed gastroparesis.
• Use of medication that alters gastrointestinal motility (ex: domperidone).
• Use of hydroxyurea.
• Planned or ongoing pregnancy.
• Breastfeeding individuals.
• Severe hypoglycemia requiring hospitalization in the past month. Severe hypoglycemia is defined as requiring the assistance of another person, due to altered consciousness, to administer carbohydrates, glucagon, or other resuscitative actions.
• Diabetic ketoacidosis episode in the past month.
• Clinically significant nephropathy, neuropathy, or retinopathy as judged by the investigator.
• Recent (\< 6 months) acute macrovascular event, e.g., acute coronary syndrome.
• Other serious medical illnesses which are likely to interfere with study participation or the ability to complete the trial by the investigator's judgment.
• Known hypersensitivity to the study drugs or their excipients.

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre, Juvenile Diabetes Research Foundation

Source: ClinicalTrials.gov

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