Safety and Effectiveness of A Novel Continuous Glucose and Ketone Monitoring System
NCT ID: NCT07139808
Last Updated: 2025-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
12 participants
INTERVENTIONAL
2025-08-01
2025-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of the Accuracy and Safety of A Novel Real-Time Continuous Glucose Monitoring System
NCT07092761
Effects of Novel Flash Glucose Monitoring System on Glycemic Control in Adult Patients With Type 1 Diabetes Mellitus
NCT03522870
The Management of Glucose Control and Hypoglycemic Prevention Using Continuous Glucose Monitoring System in Patients With Type 1 Diabetes
NCT04684030
To Evaluate the Efficacy and Safety of Multi-parameter Non-Invasive Glucose Sensors for for Blood Glucose Measurement
NCT06017349
Assessment of the Accuracy,Feasibility,Safety of Continuous Glucose Monitoring System
NCT03120091
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Adult patients with T1DM
Adult patients with T1DM
GK5 CGKM
Wear for a consecutive 15 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
GK5 CGKM
Wear for a consecutive 15 days
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Henan University of Science and Technology
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Peng Liu
Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hongwei Jiang
Role: PRINCIPAL_INVESTIGATOR
Henan University of Science and Technology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Henan University of Science and Technology
Luoyang, Henan, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SS-KY-CGM-0004
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.