Diabetes
Conditions
Sponsors
Affiliated Hospital of Xuzhou Medical University (Participating Unit)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Patients diagnosed with type 1 or type 2 diabetes requiring continuous glucose monitoring. 2.Age 18 years and above, gender not limited, and stable vital signs. 3.Those who sign informed consent to participate in this study voluntarily. 4.The patient had good compliance and could complete the whole clinical trial.
Exclusion criteria
Exclusion criteria: 1.The skin of body parts damaged, scarred, red, or infected. 2.People who are allergic to disinfectants or medical tape, or susceptible to allergies. 3.Those who are using anticoagulants or blood-activating agents within one week before enrollment, or those with bleeding tendency, or those with bleeding or clotting mechanism disorders. 4.Those who plan to have an MRI within 14 days of product use. 5.Severe anemia, or erythrocyte pressure/ratio >70%. 6. Pregnant and lactating women. 6.Pregnant and lactating women. 7.Persons with psychiatric abnormalities, cognitive and communication disorders, or highly stressed uncooperative persons. 8.Those whose compliance is deemed by the investigator to be poor are not suitable for this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accordance rate;Mean absolute relative difference;Proportion of Zone A+B of Clarke error grid;Proportion of Zone A+B of Consensus error grid; | — |
Secondary
| Measure | Time frame |
|---|---|
| Alarm accuracy;Sensor stability;Repeatability of sensors;Product usability questionnaire; | — |
Countries
China
Contacts
Public ContactHongwei Ling
Affiliated Hospital of Xuzhou Medical University (Participating Unit)
Outcome results
None listed