diabetes
Conditions
Interventions
Gold Standard:Blood glucose concentration detected by Glucose / Lactate Hemolyzing Solution produced by EKF-diagnostic GmbH. (RCN:GXZJ20152403862) (used in conjunction with the Glucose and lactate mea
Index test:blood glucose test strips (glucose dehydrogenase method) manufactured by Jiangsu Yuyue Kailite Biotechnology Co., Ltd.
Sponsors
Jiangsu Province Official Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: ? Individuals aged = 18 years and = 80 years who require self-monitoring of blood sugar. ? Stable vital signs. ? 10% = hematocrit = 70%. ? Good compliance, willing to participate in this clinical trial and sign an informed consent form.
Exclusion criteria
Exclusion criteria: ? Red blood cell hematocrit70%; ? Individuals who are allergic to alcohol disinfectants. ? Individuals with mental disorders, cognitive and communication impairments, or those with high levels of mental stress who are not compatible with the author. ? Individuals who have participated in clinical trials of drugs or devices within one month. ? The researcher believes that it is not suitable to participate in this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the system accuracy of the blood glucose test strips; | — |
Secondary
| Measure | Time frame |
|---|---|
| User Performance Evaluation;Product performance evaluation; | — |
Countries
CHina
Contacts
Public ContactTang Wei
Jiangsu Province Official Hospital
Outcome results
None listed