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

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

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.

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.

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