Testing a patch that tracks glucose and ketones in type 1 diabetes
Tests a skin patch measuring glucose and ketones in adults with type 1 diabetes.
Plain-language title generated from the registry record
Registry title: Feasibility Study of a Continuous Glucose-Ketone Monitoring Device in People With Type 1 Diabetes
Key facts
- Where
- Palo Alto, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT06977633, who can take part
Where in United States
- Stanford UniversityPalo Alto, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Mahla Poudineh
- Trial code
- NCT06977633
- Record updated
- 5 May 2026
- Original description
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.Read full original descriptionShow less
A pH-Responsive Hydrogel Microneedle Patch for Continuous Measurement of Ketone Bodies and Glucose: CGM-CKM
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.
Inclusion: 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: Current use of non-insulin medications affecting ketone production, including SGLT2 inhibitors; History of DKA or severe hypoglycemia within the past 6 months; Active skin infections or conditions affecting sensor application sites; Known skin allergies to tapes or adhesives; A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol; eGFR <45 mL/min/1.73 m2 or other significant renal impairment; Pregnancy or breastfeeding; Current use of any long-acting insulin analogs.