Diabetes
Conditions
Interventions
Gold Standard:Laboratory automatic biochemical analyzer for measuring venous plasma glucose by hexokinase method
Contour plus? blood glucose meter, produced by Bayer Consumer Care, Ltd., Model: 7600p
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed the Informed Consent; 2. Aged between 18 and 80 years; 3. According to the International Diagnostic Criteria and Classification revised by the World Health Organization (WHO) Committee of Experts in 1999, subjects were diagnosed with diabetes or impaired glucose regulation (fasting impaired glucose and impaired glucose tolerance).
Exclusion criteria
Exclusion criteria: 1. Blood donation within 30 days before screening or blood loss due to other reasons exceeds 400 mL; 2. Receive vasoconstrictor drugs, dopamine, procaine, lidocaine, pucacaine and other drugs within 7 days before screening; 3. Drugs or diseases that affect the test results within 7 days before screening, such as dyeing diluted drugs (such as methylene blue, indocyanine green, acid indigo) or carbon monoxide hemoglobin or methionine or thiohemoglobin in the body; 4. Diseases that seriously affect the results of the study, such as severe cardiovascular disease, liver and kidney dysfunction, or severe ketoacidosis, severe infection; 5. Currently have diseases that affect the accuracy of hand measurement: such as history of Parkinson's disease, chronic arterial occlusive disease, post-hand or arm trauma surgery, arteriovenous fistula, etc.; 6. Patients who are difficult to cooperate, have mental illness, influence informed consent and/or AE representation or observation; 7. Subjects with hematocrit > 55%; 8. Subjects with thyroid stimulating hormone (TSH) > 10 µIU/mL or 3.0 times the upper limit of normal (according to CTCAE version 5.0); 10. Subjects with blood triglycerides > 500 mg/dL or > 5.7 mmol/L (according to CTCAE version 5.0); 11. Subjects with blood cholesterol > 400 mg/dL or > 10.34 mmol/L (according to CTCAE version 5.0); 12. Female subjects who are at lactation or have a positive pregnancy test at screening; 13. Those who have participated in other clinical trials within 1 month before screening examination; 14. The investigator believes that it is not appropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of non-invasive glucose meter blood glucose detection values in CEG A+B and A areas compared to venous plasma blood glucose values; | — |
Secondary
| Measure | Time frame |
|---|---|
| 20/20% consistency compared to venous plasma glucose values;Proportion of non-invasive glucose meter glucose detection values in CEG A+B and A areas compared to fingertip capillary blood glucose values;Relative mean difference (MARD) from venous plasma glucose values;MARD with fingertip capillary blood glucose values; | — |
Countries
China
Contacts
Public ContactXiaohui Guo
Peking University First Hospital
Outcome results
None listed