NCT06977633Not yet recruiting
Feasibility Study of a Continuous Glucose-Ketone Monitoring Device in People With Type 1 Diabetes
A pH-Responsive Hydrogel Microneedle Patch for Continuous Measurement of Ketone Bodies and Glucose: CGM-CKM
Source: ClinicalTrials.gov · Last updated 5 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 18 Apr 2025
- Start date
- 30 Jun 2026
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Mahla Poudineh
- Diseases
- Type 1 diabetes
- NCT number
- NCT06977633
What you commit to
- Study type: Interventional
- Planned participants: 10
- From 30 Jun 2026 to the primary completion date, 30 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use of non-insulin medications affecting ketone production, including SGLT2 inhibitors
Other illness
- 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
Lab values
- eGFR \<45 mL/min/1.73 m2 or other significant renal impairment
Other
- Pregnancy or breastfeeding
- Current use of any long-acting insulin analogs
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Stanford University Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.