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Safety and Effectiveness of A Novel Continuous Glucose and Ketone Monitoring System

NCT07139808 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-04-07

No results posted yet for this study

Summary

The study is to evaluate the accuracy and safety of a novel real-time continuous glucose and ketone monitoring system among adult patients with type 1 diabetes mellitus (T1DM) with respect to Yellow Spring Instrument (YSI) and Randox reference venous plasma sample measurements.

Conditions

  • Type1diabetes

Interventions

DEVICE

GK5 CGKM

Wear for a consecutive 15 days

Sponsors & Collaborators

  • Henan University of Science and Technology

    lead OTHER

Principal Investigators

  • Hongwei Jiang · Henan University of Science and Technology

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2026-10-01
Completion
2026-12-01

Countries

  • China

Study Locations

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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 NCT07139808 on ClinicalTrials.gov