Feasibility Study of a Continuous Glucose-Ketone Monitoring Device in People With Type 1 Diabetes

Part of paid clinical trials in Palo Alto, California.

Sponsor
Mahla Poudineh
Study ID
NCT06977633
Status
Not Yet Recruiting

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Conditions

  • Type 1 Diabetes (T1D)

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Temporary Insulin Suspension — BEHAVIORAL
    Participants will suspend insulin delivery from their personal insulin pumps for up to 3 hours. Insulin suspension is temporary and participant-driven under supervision.
  • Glucose and ketone sensor — DEVICE
    The participants wear a prototype continuous glucose-ketone monitoring (CGM-CKM) device using painless hydrogel microneedles for 4 hours.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
May 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2027

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: People with type 1 diabetes on insulin pump

Primary Outcome Measure

Concentration of Glucose Measured by Experimental CGM-CKM Sensor Compared to Blood Glucose [ Time Frame: 5 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94304
Rayhan Lal, MD
[email protected]
925-727-1317
Ryan Kingman, BS
[email protected]
408-612-1720

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By research site
Stanford University· Palo Alto, CA

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