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

NCT06977633 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-05-05

No results posted yet for this study

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.

Conditions

  • Type 1 Diabetes (T1D)

Interventions

BEHAVIORAL

Temporary Insulin Suspension

Participants will suspend insulin delivery from their personal insulin pumps for up to 3 hours. Insulin suspension is temporary and participant-driven under supervision.

DEVICE

Glucose and ketone sensor

The participants wear a prototype continuous glucose-ketone monitoring (CGM-CKM) device using painless hydrogel microneedles for 4 hours.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2026-09-30
Completion
2027-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06977633 on ClinicalTrials.gov