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Clinical Trials/NCT07139808
NCT07139808RecruitingNot Applicable

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

Henan University of Science and Technology2 sites in 1 country12 target enrollmentStarted: August 1, 2025Last updated:
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
12
Locations
2
Primary Endpoint
System performance on glucose measurement

Study Overview

Brief 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.

Detailed Description

The study is to evaluate the accuracy and safety of a novel real-time continuous glucose and ketone monitoring (CGKM) system among adult patients with type 1 diabetes mellitus with respect to YSI and Randox reference venous plasma sample measurements. Up to 14 patients will be enrolled. Interstitial glucose and ketone readings from the sensors will be obtained immediatedly following each venous blood sample test. Each participant will make 3 visits to the clinical study site, including the screening visit.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age ≥ 18 years
  • Diagonsed with T1DM on Continuous subcutaneous insulin infusion (CSII)
  • Venous blood sampling access can be established in the forearm
  • Capable of independently reading instructions and complying with the clinical trial requirements
  • Willing to sign the Informed Consent Form (ICF)

Exclusion Criteria

  • Severe hypoglycemia within the past 6 months
  • A diagnosed history of Diabetic ketoacidosis (DKA) in the past 3 months
  • Heart failure or hemiplegic sequelae due to prior cerebrovascular disease
  • Severe skin conditions at the sensor wear site
  • Extensive systemic skin disorders
  • Having difficulty with wound healing, bleeding disorders, and/or taking anticoagulant medications
  • Anemia or abnormal hematocrit
  • Blood donation within the past 6 months
  • Pregnancy (defined as positive urine test in women ≤55 years), lactation, or plans for pregnancy within ≤30 days
  • Current or recent (≤1 month) participation in other clinical trials
  • Planned MRI/CT scans during sensor wear
  • Allergy to medical adhesives or alcohol
  • Conditions impairing comprehension of informed consent or study procedures
  • Other exclusionary conditions per investigator's discretion

Arms & Interventions

Adult patients with T1DM

Experimental

Adult patients with T1DM

Intervention: GK5 CGKM (Device)

Outcomes

Primary Outcomes

System performance on glucose measurement

Time Frame: 15 days

The CGK system performance for glucose measurement will be assessed by comparing to the Yellow Springs Instrument comparator venous plasma measurements

System performance on ketone measurement

Time Frame: 15 days

The CGK system performance for ketone measurement will be assessed by comparing to the Randox comparator venous plasma measurements

Secondary Outcomes

  • System-related Safety(15 days)

Investigators

Sponsor
Henan University of Science and Technology
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Peng Liu

Investigator

Henan University of Science and Technology

Study Sites (2)

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