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.

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