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.
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
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
Single group
Temporary Insulin Suspension
BehavioralParticipants will suspend insulin delivery from their personal insulin pumps for up to 3 hours. Insulin suspension is temporary and participant-driven under supervision.
Glucose and ketone sensor
DeviceThe participants wear a prototype continuous glucose-ketone monitoring (CGM-CKM) device using painless hydrogel microneedles for 4 hours.
Concentration of Glucose Measured by Experimental CGM-CKM Sensor Compared to Blood Glucose
Correlation between glucose concentrations (mmol/L) measured by the CGM-CKM sensor and plasma glucose concentrations measured with YSI 2300 glucose analyzer.
Concentration of Ketones Measured by Experimental CGM-CKM Sensor Compared to Blood Ketones
Correlation between ketone concentrations (mmol/L) measured by the experimental CKM-CKM sensor and blood ketone concentrations measured using commercially available tests.
Plasma Insulin Concentration Measured by Mercodia ELISA Assay
Insulin concentration (pmol/L) in plasma samples collected during the study will be measured using Mercodia insulin ELISA assay.
Plasma Glucagon Concentration Measured by Mercodia ELISA Assay
Glucagon concentration (pmol/L) in plasma samples collected during the study will be measured using Mercodia insulin ELISA assay.
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