Diabetes
Conditions
Interventions
Case series:None
Sponsors
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects aged = 18 years old, regardless of gender; 2. Patients with diabetes who have been definitely diagnosed and treated; 3. Agree not to inject insulin or wear an insulin pump insertion device within a range of 8 centimeters from the position of the test device during the wearing of the test device; 4. Patients or their guardians can understand the purpose of the trial, voluntarily participate and sign a written informed consent form, and can cooperate and complete the study and related examinations.
Exclusion criteria
Exclusion criteria: 1. Disagree to continuously wear test equipment according to the test requirements; 2. Refuse to collect venous blood continuously for 7 hours (once every 15 minutes) on a certain day during the trial period; 3. According to the medical history, acute complications of diabetes occurred within one month, such as diabetes ketoacidosis, hyperosmolar non ketotic diabetes coma, lactic acidosis and hypoglycemic coma; 4. Severe heart, liver, and kidney dysfunction; 5. Abnormal coagulation function (APTT exceeding normal value for more than 10 seconds, PT exceeding normal value for more than 3 seconds, TT exceeding normal value for more than 3 seconds, FIB4g/L); 6. Anemia (Hb 0.55); 7. Allergies to medical grade adhesives or disinfectants; 8. Abnormalities in the wearing area or overall skin, such as diffuse subcutaneous nodules, subcutaneous edema, rash, psoriasis, etc., are not conducive to the wearing of the sensor; 9. Pregnant, lactating women or those who have a fertility plan within the next month (= 30 days); 10. During the wearing of the sensor, X-rays, magnetic resonance imaging (MRI), CT scans, or other examinations that may be exposed to strong radiation and magnetic fields, as well as local high-frequency electrothermal therapy, are required; 11. Participation in other clinical trials within one month may affect the objective evaluation, follow-up, and testing of this study; 12. The researchers believe that any patients who need to be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Consistency rate of reference value 20/20%;Proportion of Clarke error grid A+B area;Proportion of Consensus error raster A+B area;Average absolute relative error value (MARD%); | — |
Secondary
| Measure | Time frame |
|---|---|
| Correct rates of high and low blood glucose reminders; Stability of sensors;Repeatability of sensors;Product usability questionnaire survey;Sensor life; | — |
Countries
China
Contacts
Public ContactWeiqing Wang
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Outcome results
None listed