Status:
NOT_YET_RECRUITING
Feasibility Study of a Continuous Glucose-Ketone Monitoring Device in People With Type 1 Diabetes
Lead Sponsor:
Mahla Poudineh
Collaborating Sponsors:
Stanford University
Conditions:
Type 1 Diabetes (T1D)
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 CTR...
Detailed Description
This is a non-significant risk (NSR) device study not conducted under an IDE, in accordance with 21 CFR 812.2(b)
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
August 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06977633
Start Date
August 30 2025
End Date
April 30 2027
Last Update
July 9 2025
Active Locations (1)
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1
Stanford University
Palo Alto, California, United States, 94304