Safety and Effectiveness of A Novel Continuous Glucose and Ketone Monitoring System
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
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
Peng Liu
Investigator
Henan University of Science and Technology