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.
This is a non-significant risk (NSR) device study not conducted under an IDE, in accordance with 21 CFR 812.2(b)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
10
Participants will suspend insulin delivery from their personal insulin pumps for up to 3 hours. Insulin suspension is temporary and participant-driven under supervision.
The participants wear a prototype continuous glucose-ketone monitoring (CGM-CKM) device using painless hydrogel microneedles for 4 hours.
Stanford University
Palo Alto, California, United States
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.
Time frame: 5 hours
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.
Time frame: 5 hours
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.
Time frame: 5 hours
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.
Time frame: 5 hours
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