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

This is a non-significant risk (NSR) device study not conducted under an IDE, in accordance with 21 CFR 812.2(b)

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