Diabetes mellitus
Conditions
Interventions
Test 
Strip 
GS300 
and 
GS260
Sponsors
Endocrinology
Eligibility
Sex/Gender
All
Age
20 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Male or female subjects aged 20 and 80 years; 2. Subjects who voluntarily participates the study and willing to comply with the study procedures and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients having any sever comorbidity within 6 months like stroke,acute myocardial infarction, leukemia, aplastic anemia, autoimmune disease and any other serious illness; 2. Subjects who have steroids medication, for example: Flixotide, Seretide 250, Serevent, Advair; 3. Notifiable bloodborne infectious diseases, for example:HIV,Treponema pallidum, HBV.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 95% of the individual glucose results must be within ±0.83 mmol/L of the comparison-method results at glucose concentrations<5.5 mmol/Land within ±15% of the comparison-method results at glucose concentrations ? 5.5 mmol/L.;99% of individual glucose measured values shall fall within zones A and B.;GB;SEN, SPE, ACC, AUC of ROC, kappa value; | — |
Countries
China
Contacts
Public ContactYufei Wang
Shanghai Sixth People's Hospital
Outcome results
None listed