Type 2 diabetes
Conditions
Interventions
Gold Standard:Venous blood or fingertip capillary blood glucose
Index test:Non-invasive blood glucose monitoring watch
Sponsors
The First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Agree to participate in this study and sign informed consent; 2. Aged between 18 and 75; 3. Subjects were clinically diagnosed as type 2 diabetes mellitus (T2DM) according to the international diagnostic criteria and classification revised by the Expert Committee of the World Health Organization (WHO) in 1999; 4. Blood glucose levels were measured at least three times a day within 2 hours after meals.
Exclusion criteria
Exclusion criteria: 1. Blood donation or blood loss of more than 400mL due to other reasons within 30 days before screening; 2. Received vasoconstrictor drugs such as dopamine, procaine, lidocaine, buzocaine and other drugs within 7 days before screening; 3. Screening for drugs or diseases that affect the test results within 7 days before the test, such as the use of dyed and diluted drugs (such as methionine, indigo green, acid indigo) or containing carbon monoxide hemoglobin or methionine or thiohemoglobin; 4. Diseases with serious influence on the study results, such as severe cardiovascular disease, liver and kidney dysfunction, or severe ketoacidosis, and severe infection; 5. There is the left hand wrist skin damage, vascular disease, or wrist situation that is not stable for at least 100 seconds, such as upper limb fracture has healed, comminuted fracture, hand or arm trauma after surgery, wrist broken skin infections, Parkinson's disease, intention tremor, wrist, wrist arteriovenous tumor vascular malformation, chronic arterial occlusion disease, arteriovenous fistula after operation, etc.; 6. Subjects who are not easy to cooperate, have mental illness, affect informed consent and/or AE expression or observation; 7. Hematocrit >55%; 8. Thyroid stimulating hormone (TSH) >10µIU/mL or 3.0 times the upper limit of normal; 10. Subjects with blood triglycerides >500mg/dL or >5.7mmol/L; 11. Subjects with blood cholesterol >400mg/dL or >10.34mmol/L; 12. Female subjects who are lactating or have positive pregnancy test results at the time of screening; 13. Subjects with arrhythmias such as atrial fibrillation and frequent supraventricular tachycardia; 14. Subjects with no smartphone or unfamiliar smartphone APP use.
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 ;Proportion of non-invasive glucose meter glucose detection values in CEG A+B and A areas compared to fingertip capillary blood glucose values; | — |
Secondary
| Measure | Time frame |
|---|---|
| 20/20% consistency compared to venous plasma glucose values;Relative mean difference (MARD) from venous plasma glucose;MARD with fingertip capillary blood glucose values; | — |
Countries
China
Contacts
Public ContactCui Wei
Outcome results
None listed