Two Way Crossover Closed Loop Study Insulin vs Insulin and Pramlintide

Launched by OREGON HEALTH AND SCIENCE UNIVERSITY · May 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new system that combines insulin and a medication called pramlintide to help manage blood sugar levels in people with Type 1 diabetes. The system works automatically by using a continuous glucose monitor to keep track of blood sugar levels and adjust the delivery of insulin and pramlintide as needed. Pramlintide helps slow down how quickly food moves through the stomach, which can help prevent blood sugar spikes after meals.

To participate in the study, you need to be between 18 and 70 years old and have had Type 1 diabetes for at least one year. You should currently be using an insulin pump or multiple daily insulin injections with stable doses. Participants will need to attend clinic visits and follow specific guidelines throughout the study. It's also important to note that some individuals may not be eligible due to health conditions or medications that could interfere with the trial. If you're interested in learning more or think you might qualify, please talk to your healthcare provider.

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Eligibility criteria

• Inclusion Criteria:
• • Diagnosis of type 1 diabetes mellitus for at least 1 year.
• • Participants 18 to 70 years of age.
• • Current use of an insulin pump for at least 3 months with stable insulin pump settings for \>2 weeks OR current use of multiple day injection insulin therapy with stable doses for \>2 weeks.
• • Uses a carbohydrate ratio, at lease occasionally, to dose meal time insulin.
• • HbA1c ≤ 10.5% at screening.
• • Total daily insulin requirement is less than 139 units/day.
• • Willingness to follow all study procedures, including attending all clinic visits.
• • Willingness to sign informed consent and HIPAA documents.
• Exclusion Criteria:
• • Individual of childbearing potential who is pregnant or intending to become pregnant or breast-feeding, or is not using adequate contraceptive methods. Acceptable contraception includes birth control pill / patch / vaginal ring, Depo-Provera, Norplant, an IUD, the double barrier method (the woman uses a diaphragm and spermicide and the man uses a condom), or abstinence.
• • Any cardiovascular disease, defined as a clinically significant EKG abnormality at the time of screening or any history of: stroke, heart failure, myocardial infarction, angina pectoris, or coronary arterial bypass graft or angioplasty. Diagnosis of 2nd or 3rd degree heart block or any non-physiological arrhythmia judged by the investigator to be exclusionary.
• • Renal insufficiency (GFR \< 60 ml/min, using the MDRD equation as reported by the OHSU laboratory).
• • Liver failure, cirrhosis, or any other liver disease that compromises liver function as determined by the investigator.
• • History of severe hypoglycemia during the past 3 months prior to screening visit or hypoglycemia unawareness as judged by the investigator. Participants will complete a hypoglycemia awareness questionnaire. Participants will be excluded for four or more R responses.
• • History of diabetes ketoacidosis during the prior 3 months prior to screening visit, as diagnosed on hospital admission or as judged by the investigator.
• • Adrenal insufficiency.
• • Any active infection requiring treatment (example soft tissue infection requiring antibiotics).
• • Known or suspected abuse of alcohol, narcotics, or illicit drugs.
• • Seizure disorder.
• • Active foot ulceration.
• • Major surgical operation within 30 days prior to screening.
• • Use of an investigational drug within 30 days prior to screening.
• • Chronic usage of any immunosuppressive medication (such as cyclosporine, azathioprine, sirolimus, or tacrolimus).
• • Bleeding disorder, treatment with warfarin, or platelet count below 50,000.
• • Allergy to aspart insulin.
• • Allergy to pramlintide.
• • Current administration of oral or parenteral corticosteroids.
• • Any life-threatening disease, including malignant neoplasms and medical history of malignant neoplasms within the past 5 years prior to screening (except basal and squamous cell skin cancer).
• • Current use of any medication intended to lower glucose other than insulin or pramlintide (ex. use of liraglutide, metformin).
• • Gastroparesis
• • Diets consisting of less than 50 grams of carbohydrates per day.
• • Dietary restrictions or allergies to the study meals
• • Any clinically significant disease or disorder which in the opinion of the Investigator may jeopardize the participant's safety or compliance with the protocol.

Trial Officials