Feasibility Study of a Continuous Glucose-Ketone Monitoring Device in People With Type 1 Diabetes (NCT06977633) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Feasibility Study of a Continuous Glucose-Ketone Monitoring Device in People With Type 1 Diabetes
United States10 participantsStarted 2026-06-30
Plain-language summary
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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Concentration of Glucose Measured by Experimental CGM-CKM Sensor Compared to Blood Glucose
Timeframe: 5 hours
2
Concentration of Ketones Measured by Experimental CGM-CKM Sensor Compared to Blood Ketones