Subcutaneous Pharmacokinetic Evaluation of Monomeric Insulin and Lyumjev in Adults With Type 1 Diabetes

Launched by STANFORD UNIVERSITY · Jul 21, 2025

Keywords

ClinConnect Summary

This clinical trial is studying new forms of insulin to see if they work better for adults with type 1 diabetes. Researchers want to find out if these new insulin types can start working faster and last for a shorter time compared to the insulin people usually use. This could help people control their blood sugar more easily, especially when using insulin pumps that deliver insulin automatically. The study involves giving participants three different insulin shots on separate visits, then checking their blood over six hours to see how the insulin acts in their bodies.

People who might join this study are adults aged 18 to 60 with type 1 diabetes who have been using an insulin pump and continuous glucose monitor for at least three months. Participants will need to come to three visits, each at least two days apart, where they will eat a standard meal and receive one of the insulin types by injection under the skin. Blood samples will be taken frequently to measure how the insulin is absorbed and cleared from the body. The study is not yet recruiting, and those interested should be able to understand and follow instructions, and meet other health criteria to ensure safety.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• To be eligible for the study, a subject must meet all of the following criteria:
• • 1. 18-60 years of age
• • 2. Clinical diagnosis of type 1 diabetes
• • 3. On insulin pump therapy and continuous glucose monitor for at least 3 months
• • 4. For females of childbearing potential, a negative pregnancy test and not attempting to conceive.
• • 5. Understanding and willingness to follow the protocol and sign informed consent
• • 6. Ability to speak, read and write English
• Exclusion Criteria:
• The presence of any of the following is an exclusion for the study:
• • 1. Diabetic ketoacidosis within 3 months
• • 2. Severe hypoglycemia resulting in seizure or loss of consciousness within 3 months prior to enrollment
• • 3. Have donated blood within 8 weeks
• • 4. Have a known clinically significant history of anemia
• • 5. Pregnant or lactating
• • 6. Active infection
• • 7. Any medical condition that, in the investigator's opinion, might interfere with study completion or participant safety.
• • 8. Known seizure disorder
• • 9. Inpatient psychiatric treatment within 6 months
• • 10. Medication instability within 1 month prior to enrollment, including antihypertensive, thyroid, antidepressant, or lipid-lowering medications
• • 11. Suspected drug or alcohol abuse
• • 12. Chronic kidney disease (GFR \< 60 mL/min/1.73m²)