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

The goal of this study is to evaluate a CGM-CKM device during insulin suspension in patients with type 1 diabetes. 10 patients with T1D will be recruited for a pilot study. The patients will visit CTRU at Stanford Medical School. The CGM-CKM device will be applied to the upper arm area of patients and baseline ketone and glucose measurement will be performed for one hour prior to suspending or disconnecting the pump. Upon baseline measurement, the pump will be disconnected for 3 hours while the electrochemical signals are collected from the CGM-CKM device. During the 3 hours of pump disconnection, blood samples will be collected every 5 minutes from participants for analyzing their insulin and glucagon using conventional ELISA kits and glucose and ketone using standard meters.

NCT Number	NCT06977633
Lead Sponsor	Mahla Poudineh Collaborators: Stanford University
Conditions	Type 1 Diabetes (T1D)
Enrollment	10 participants
Start Date	2026-06-30
Primary Completion	2026-09-30 (estimated)
Study Completion	2027-09-30 (estimated)
Updated on ClinicalTrials.gov	2026-05-05