Diabetes
Conditions
Interventions
Diabetes group (continued to wear the test instrument for 15 days):none
Sponsors
Shenzhen Bao'an People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years old, gender not restricted; 2.Clinically diagnosed with diabetes; 3.The investigator assesses that the subject has sufficient venous access; 4.The subject or the subject's guardian/carer has a certain level of reading ability; 5.The subject is willing to wear the test equipment continuously for the duration set by the product's lifespan and to collect venous blood continuously for 7-8 hours each day (1 time every 15 minutes) during the trial according to the expected procedure; 6.The subject has fully understood this study before participating and voluntarily signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Pregnant or lactating women, or those with a planned pregnancy during the trial; 2.Those who have previously been allergic to disinfectants, medical tapes, or the trial equipment; 3.Those with skin lesions that affect the accuracy of the sensor, including skin lesions at the wearing site (such as severe burns, scalds, sunburns, traumas, ulcers, infections, scars left from surgeries, diffuse subcutaneous nodules, etc.) and/or severe skin lesions throughout the body (such as extensive eczema, large scars, large tattoos, herpes dermatitis, psoriasis, etc.); 4. Those with diseases that affect effective blood volume, such as severe blood loss (blood loss = 1000ml), severe edema (visible and obvious edema throughout the body, tissue depression that becomes more obvious or deeper upon pressure, slow recovery, or combined with abdominal or thoracic effusion), or the need to use diuretics such as furosemide, hydrochlorothiazide, spironolactone, etc.; 5. Those with severe liver or kidney function abnormalities (ALT, AST > 3 times the upper limit of normal; serum creatinine > 1.5 times the upper limit of normal), or requiring hemodialysis; or those with a history of severe cardiac dysfunction (NYHA cardiac function classification = III); 6. Those with moderate to severe anemia (hemoglobin 3.0 or platelet count < 50×10^9/L), or those who have used or plan to use anticoagulant drugs (such as heparin, coumarin derivatives, etc.) within 2 weeks before screening; 8. Those who plan to take vitamin C (ascorbic acid) or acetylsalicylic acid (aspirin) supplements during wearing the trial equipment; 9. Those with a history of diabetic ketoacidosis, hyperosmolar hyperglycemic state or severe hypoglycemia (leading to loss of consciousness or convulsions) within 1 month before screening; 10. Those with a history of mental illness; 11.Those who plan to undergo magnetic resonance imaging (MRI), computed tomography (CT), X-ray examination or hyperthermia therapy during the clinical trial; 12. Those who have participated in other drug or medical device clinical trials within 1 month before screening; 13. Those considered by the investigator to have poor compliance or other issues that make them unsuitable for participating in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The agreement with the reference value of 20/20% was evaluated by the agreement rate;The proportion of measurement points falling in the A+B region of the Clarke error grid analysis;The proportion of measurement points located in the A+B area of the Consensus error grid analysis;Mean absolute relative error (MARD%); | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of correct versus incorrect warnings of hypoglycemia;Correct Detection Rate and Incorrect Detection Rate for Hypoglycemia;Rate of correct versus incorrect warnings of hyperglycemia;High blood glucose correct detection rate vs. incorrect detection rate;The stability of the sensor;The repeatability of sensors;Ease of use;Sensor lifespan; | — |
Countries
China
Contacts
Public ContactJisu Xue
Shenzhen Bao'an People's Hospital
Outcome results
None listed