Diabetes mellitus
Conditions
Interventions
Gold Standard:Using intravenous blood glucose as the gold standard
Index test:CGM
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Age between 18 and 80 years (inclusive), regardless of sex. 2)Diagnosis of type 1 or type 2 diabetes mellitus (T1DM/T2DM) for at least 3 months, with stable vital signs. 3)Adequate venous access in the forearm for blood sampling, good compliance, and ability to complete the full clinical trial. 4)Subject or their legal guardian/caregiver possesses basic literacy skills for consent documentation. 5)Voluntary participation with written informed consent.
Exclusion criteria
Exclusion criteria: 1) Skin conditions at the wearing site (e.g., open wounds, scars, erythema, infection, or subcutaneous edema). 2) Neurological or immunological disorders, including epilepsy, cognitive impairment, immunosuppressive disorders, or systemic neurological diseases. 3) Acute diabetic complications, such as diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS). 4) Anticoagulant/antiplatelet therapy within 1 week prior to enrollment, bleeding tendency, or coagulopathy (APTT =1.5 × ULN). 5) Severe anemia (Hct 70%). 6) Comorbidities with life expectancy <1 year (e.g., terminal cancer, NYHA Class IV heart failure). 7) Severe circulatory impairment . 8) Planned/scheduled MRI, CT, or X-ray exposure within 15.5 days of device use. 9) Pregnancy, lactation, or planned pregnancy during the trial. 10) Severe allergies (polysensitivity to =2 allergens) or hypersensitivity to medical adhesives/disinfectants. 11) Participation in other interventional trials (medical device/drug) within:1 month for device studies, 5 half-lives of investigational drugs 12) Other conditions deemed unsuitable by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accuracy;Consistency; | — |
Countries
China
Contacts
Public ContactLi Xiaoying
Zhongshan Hospital, Fudan University
Outcome results
None listed