Feasibility Study of a Continuous Glucose-Ketone Monitoring Device in People With Type 1 Diabetes

Launched by MAHLA POUDINEH · May 9, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new device that can continuously monitor both blood sugar and ketone levels in people with type 1 diabetes. The goal is to see how well this device works during a short period when insulin delivery is temporarily stopped. Ten adults with type 1 diabetes who use insulin pumps will take part in this small study at Stanford Medical School. The device will be placed on the upper arm, and after measuring baseline levels for one hour, participants will disconnect their insulin pump for three hours while the device collects data. During this time, small blood samples will be taken every five minutes to check hormone and sugar levels using standard tests.

To join the study, participants need to have had type 1 diabetes for at least one year, use an insulin pump, and be able to understand and follow study instructions. People who have had severe low blood sugar or diabetic ketoacidosis (a serious complication) recently, have certain kidney problems, are pregnant or breastfeeding, or have skin issues where the device would be placed will not be eligible. The study is not yet recruiting, but those who participate can expect close monitoring and blood testing during the pump disconnection to help researchers learn if this new monitoring device is safe and effective.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Clinical diagnosis of type 1 diabetes for at least 1 year without significant endogenous insulin production
• • Currently using insulin pump
• • Understanding and willingness to follow the protocol and sign informed consent.
• • Willingness to sign a consent for release of medical information at the time of enrollment
• • Ability to speak, read and write in the language of the investigators.
• Exclusion Criteria:
• • History of DKA or severe hypoglycemia within the past 6 months
• • eGFR \<45 mL/min/1.73 m2 or other significant renal impairment
• • Pregnancy or breastfeeding
• • Current use of non-insulin medications affecting ketone production, including SGLT2 inhibitors
• • Active skin infections or conditions affecting sensor application sites
• • Known skin allergies to tapes or adhesives
• • Current use of any long-acting insulin analogs
• • A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol