Diabetes
Conditions
Interventions
Group of diabetes (Continuously wear the study medical device for 15 days):No intervention
Sponsors
The First Affiliated Hospital of Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients diagnosed with diabetes. (1) Age 18 and above, regardless of gender, with stable vital signs. (2) Forearm can establish a venous blood collection pathway. (3) Hematocrit/hematocrit = 70%. (4) Voluntarily participate in this experiment and sign an informed consent form. (5) Good compliance and ability to cooperate in completing the entire clinical trial.
Exclusion criteria
Exclusion criteria: (1) Wearing areas such as the upper arm and abdomen may have skin damage, scars, redness, swelling, or infection. (2) Individuals who are allergic to alcohol disinfectants or medical tape. (3) Individuals with hematological disorders that affect coagulation function or have been diagnosed with bleeding tendencies. (4) Pregnant and lactating women. (5) Individuals with mental disorders, cognitive and communication impairments, or those with high levels of mental stress who are not compatible with the author. (6) Wearing area with swollen skin. (7) Wearing a device that plans to undergo magnetic resonance imaging (MRI), computed tomography (CT), or X-ray examination within 15 days. (8) Individuals who have participated in clinical trials of drugs or devices within one month. (9) The researchers believe that it is not suitable for participants in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Consistency within the error range of the reference value with the control group; Proportion of Zone A+B of Clarke error grid; Proportion of Zone A+B of Consensus error grid; Mean absolute relative difference; | — |
Secondary
| Measure | Time frame |
|---|---|
| Accordance rate ;Sensor stability;Repeatability of sensors;Product usability questionnaire;Sensor life;Blood glucose data evaluation;Trend accuracy evaluation; | — |
Countries
China
Contacts
Public ContactYang Tao
The First Affiliated Hospital of Nanjing Medical University
Outcome results
None listed