Pregnant with diabetes mellitus (DM)
Conditions
Interventions
Gold Standard:Blood glucose values of the blood sample taken
Index test:Blood glucose values monitored by the study device
Sponsors
Shunde Hospital of Southern Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Be over 18 years of age; 2.Singleton pregnancy; 3.Clinical diagnosis of diabetes; 4.Willing to worn equipment 15 days, and according to the requirements of the scheme for blood glucose values; 5.Agree to participate in this clinical trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. During the clinical study, MRI and CT examinations are required; 2. Current treatment with hydroxyurea, or planned treatment with high-frequency diathermy during the study; 3. Presence of an adverse skin condition (e.g., diffuse subcutaneous nodules, psoriasis, scarring, etc.) in the area (arm) where the glucose sensor is implanted; 4. Acute complications of diabetes at the time of screening, such as diabetic ketoacidosis (DKA), hyperglycemia hyperosmolality syndrome (HHS), etc.; 5. Pacemaker implantation in the past, taking anticoagulant drugs, or abnormal coagulation function (unable to coagulate too fast or too slowly), the criteria for judging abnormalities are: Activated partial thromboplastin time (APTT) above 1.5 times the upper limit of normal, or below the lower limit of normal; Prothrombin time (PT) is above 1.5 times the upper limit of normal, or below the lower limit of normal 6. Current or planned to receive dialysis treatment during the study, or intermediate and advanced renal disease; 7. Participated in other clinical studies within 1 month before screening, except for studies judged by the investigator to have no interference with the process and results of this study; 8. The investigator believes that it is not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The agreement with the reference value of 20/20% was evaluated by the agreement rate;The proportion of measurement points falling in the A+B region of the Clarke error grid analysis;The proportion of measurement points falling in the Consensus error grid was analyzed in the A+B region;Mean absolute relative error (MARD%);Safety evaluation indicators; | — |
Secondary
| Measure | Time frame |
|---|---|
| Alarm accuracy rate;Stability of sensor;Repeatability of sensor;Ease of use;Lifetime of sensor;Blood sugar levels or greater tendency for 3.9 L and 10 or less tendency, > 10 tendency when L/L, and the accuracy of the reference value of 15%, 40%; When the blood glucose concentration was less than 3.9mmol/L, the accuracy was 0.83mmol/L and 2.22mmol/L, respectively; | — |
Countries
China
Contacts
Public ContactShen Jie
Shunde Hospital of Southern Medical University
Outcome results
None listed