diabetes
Conditions
Interventions
Index test:Non-invasive blood glucose, Fingertip blood glucose
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Agree to participate in this study and sign the Informed Consent Form (ICF); 2) Male and female participants aged 18 to 80 years old (including 18 and 80 years old); 3) Those who are clinically diagnosed as diabetes according to the international diagnostic standards revised by the World Health Organization (WHO) Expert Committee in 1999;
Exclusion criteria
Exclusion criteria: 1) Within 30 days prior to the screening examination, blood donation or loss of more than 400mL due to other reasons; 2) Received vasoconstrictors such as dopamine, procaine, lidocaine, and buzocaine within 7 days prior to screening examination; 3) Screening for drugs or diseases that may affect the test results within 7 days prior to the examination, such as the use of dye dilution drugs (such as methylene blue, indigo cyanine green, acid indigo) or the presence of carbon monoxide hemoglobin, methionine, or thiohemoglobin in the body; 4) Diseases that have a serious impact on research results, such as severe cardiovascular disease, liver and kidney dysfunction, or patients with severe ketoacidosis and severe infections; 5) Diseases that affect the accuracy of hand or forearm measurements, such as Parkinson's disease history, chronic arterial occlusive disease, postoperative hand or arm trauma, and arteriovenous fistula surgery; 6) Patients who are difficult to cooperate with, have mental illness, affect informed consent and/or adverse event (AE) expression or observation; 7) Female subjects who are breastfeeding during screening and examination; 8) Individuals who have participated in other clinical trials within the past week prior to the screening examination; 9) The researchers believe that it is not appropriate to participate in this clinical study. (Patients with severe comorbidities in the past six months, such as stroke, myocardial infarction, heart failure, respiratory failure, major trauma, or major surgery; malignant tumor patients requiring active or long-term treatment, congenital coagulation factor abnormalities, severe hemolytic and aplastic anemia, and systemic autoimmune disease patients requiring lifelong treatment.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Venous blood glucose;Non-invasive blood glucose;Accuracy;Sensitivity;Specificity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fingertip blood glucose; | — |
Countries
China
Contacts
Public ContactJunqing Zhang
Peking University First Hospital
Outcome results
None listed