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

NCT07139808 | Recruiting

• 1 other identifier: SS-KY-CGM-0004
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Type1diabetes

Outcome Measures

Primary Outcomes (2)

• System performance on glucose measurement

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

  15 days

• System performance on ketone measurement

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

  15 days

Secondary Outcomes (1)

• System-related Safety

  15 days

Study Arms (1)

Adult patients with T1DM

EXPERIMENTAL

Adult patients with T1DM

Device: GK5 CGKM

Interventions

GK5 CGKM DEVICE

Wear for a consecutive 15 days

Adult patients with T1DM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Henan University of Science and Technology: lead

Study Sites (1)

Henan University of Science and Technology

Luoyang, Henan, 471003, China

RECRUITING

Study Officials

• Hongwei Jiang

  Henan University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peng Liu

CONTACT

0379-64811993; peng.liu87@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: August 24, 2025
• Study Start: August 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)