Diabetes
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Agree to participate in this study and sign an informed consent form (ICF); 2. Aged 18 to 75 years, male and female subjects; 3. The subjects with diabetes treated by Peking University First Hospital.
Exclusion criteria
Exclusion criteria: 1. Donated blood or lost blood for more than 400 mL within 30 days before screening test; 2. Have received vasoconstrictor drugs, dopamine, procaine, lidocaine, butzocaine and other drugs within 7 days before the screening test; 3. Drugs or diseases that affect the test results within 7 days before the screening test, such as the use of diluted drugs (such as US blue, indigo green, acid indigo) or carbon monoxide or methionine or thiohemoglobin in the body 4. Diseases with severe impact on the results of the study, such as severe cardiovascular disease, liver and kidney dysfunction, or patients with severe ketoacidosis and severe infection; 5. Currently have diseases that affect the accuracy of hand measurement: such as Parkinson's history, chronic arterial occlusion, hand or arm trauma surgery, arteriovenous fistula, etc.; 6. Patients who have difficulty cooperating, have mental illness, affect informed consent and / or AE presentation or observation; 7. Hematocrit > 55% of subjects; 8. Subjects with TSH >10 uIU/mL or 3.0 times the upper limit of normal value 10. Subjects with blood triglycerides > 500 mg/dL or > 5.7 mmol/L; 11. Subjects with blood cholesterol >400 mg/dL or >10.34 mmol/L; 12. Female subjects who are breastfeeding or have a positive pregnancy test at the time of screening; 13. Participants in other clinical trials within 1 month before the screening test; 14. Investigators consider it inappropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SEN, SPE, ACC, AUC of ROC;Coefficient of variation;Glucose concentration in tissue fluid; | — |
Countries
China
Contacts
Peking University First Hospital