Diabetes
Conditions
Interventions
Gold Standard:Fingertip capillary blood glucose values
meter 
based 
on 
thermoregulation
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Agree to participate in this study and sign the informed consent form (ICF); 2. Aged 18 to 75 years, male and female subjects (including 18 and 75 years old); 3. The subjects were diabetic patients treated at Peking University First Hospital.
Exclusion criteria
Exclusion criteria: 1. Donated blood or lost more than 400 mL of blood for other reasons within 30 days before the screening examination; 2. Received vasoconstrictor drugs, dopamine, procaine, lidocaine, buzocaine and other drugs within 7 days before the screening examination; 3. There are drugs or diseases that affect the test results within 7 days before the screening examination, such as the use of dyed dilution drugs (such as methylene blue, indigo cyanine green, acid indigo) or the body contains carbon monoxide hemoglobin or methionine or thiohemoglobin; 4. Patients with diseases that seriously affect the research results, 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 history of Parkinson's disease, chronic arterial occlusive disease, hand or arm trauma surgery, postoperative arteriovenous fistula, etc.; 6. Patients with mental illness, affecting informed consent and/or AE expression or observation; 7. Subjects with hematocrit > 55%; 8. Subjects with TSH > 10 µIU/mL or 3.0 times the upper limit of normal [according to the Common Adverse Event Evaluation Criteria (CTCAE) version 5.0]; 10. Subjects with blood triglyceride > 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 breastfeeding or have a positive pregnancy test result at the time of the screening examination; 13. Those who have participated in other clinical trials within 1 month before the screening examination; 14. The researchers believe that it is not suitable to participate in this clinical trial (patients with severe comorbidities such as stroke, myocardial infarction, heart failure, respiratory failure, major trauma or major surgery in the past six months; patients with malignant tumors requiring active or long-term treatment , Congenital abnormal coagulation factor, severe hemolytic and aplastic anemia, systemic autoimmune disease patients requiring lifelong treatment.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood glucose;Accuracy; | — |
Countries
China
Contacts
Public ContactLi Ang
8 Xishiku Street, Xicheng District, Beijing, China
Outcome results
None listed