Diabetes
Conditions
Interventions
Test observation group:None
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years, regardless of gender; 2. Diabetics who have clearly diagnosed and received treatment for diabetes in the past; 3. The cognitive ability is normal and can cooperate with the completion of clinical trials; 4. Agree not to inject insulin or wear an insulin pump insertion device within 8 centimeters of the position of the test instrument; 5. Sign the PIC and be willing to follow up at the time specified in the test.
Exclusion criteria
Exclusion criteria: 1. Acute complications of diabetes occurred within 1.1 months, including diabetes ketoacidosis, hypertonic non ketotic Diabetic coma, lactic acidosis and hypoglycemic coma; 2. According to the medical history, severe circulatory system diseases, such as acute myocardial infarction or stroke, have occurred within one month; 3. According to medical history, patients with severe liver and kidney failure or dialysis; 4. Merge skin lesions that affect the accuracy of the sensor, including skin lesions at the wearing area (such as severe skin burns, burns, sunburn, trauma, etc.) and/or systemic skin lesions (such as eczema, scars, tattoos, herpetic dermatitis, psoriasis, etc.); 5. Merge diseases that affect effective blood volume, such as severe edema; 6. Abnormal coagulation function (APTT>normal value for 10s, PT>normal value for 3s, TT>normal value for 3s, FIB4g/L); 7. Anemia (Hb0.55); 9. Have donated blood recently (<=112 days); 10. Have taken ascorbic acid (i.e. vitamin C) within 24 hours before participating in the experiment or during the experiment; 11. Allergies to test equipment; 12. Those who have neurological or mental disorders and are unable or unwilling to cooperate; 13. AIDS, syphilis, hepatitis B and hepatitis C virus positive patients; 14. Pregnant, lactating women or those who have a fertility plan within the next month (<=30 days); 15. Participation in other investigational drugs, equipment, or devices within one month may affect the objective evaluation, follow-up, and testing of this study; 16. Those who require magnetic resonance imaging (MRI), computed tomography (CT), and/or X-ray examination during the sensor wearing period; 17. Any situation that the researcher believes needs to be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Consistency rate of reference value 20/20%;Proportion of Clarke error grid A+B area;Proportion of Consensus error raster A+B area;Average absolute relative error value (MARD%); | — |
Secondary
| Measure | Time frame |
|---|---|
| Alarm accuracy rate;Stability of sensors;Repeatability of sensors;Product ease of use;Sensor life; | — |
Countries
China
Contacts
Public ContactRan xingwu
West China Hospital of Sichuan University
Outcome results
None listed