Diabetes
Conditions
Interventions
Gold Standard:1.Fasting Blood Glucose: In a fasting state, if the blood glucose level is equal to or greater than 7.0 mmol/L (126 mg/dL), a diagnosis of diabetes can be made.
2.Oral Glucose Tolerance
Index test:Fasting Blood Gluucose Test
Oral Glulose Tolerance Test, OGTT
Random Blood Glulose Test
Hemoglobin A1c Test
Sponsors
The Second Affiliated Hospital of Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with type 1 or 2 diabetes. 2. People aged 18 years or older, regardless of gender. 3. The subjects had adequate venous access and were assessed by the researcher or appropriate staff. 4. Those who sign informed consent to participate in this study voluntarily. 5. 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. Patients who were using anticoagulants or had bleeding tendency within one week prior to enrollment. 4. Those who plan to undergo magnetic resonance imaging (MRI) and electronic computed tomography (CT) examinations within 15 days of product use. 5. Pregnant and lactating women. 6. People with mental disorders, cognitive and communication disorders, or high mental stress. 7. Subjects have received clinical study (drug or device) within the past 1 month.
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;CGM system accuracy;Product usability questionnaire;Sensor life;Subgroup analysis;ICGM accuracy evaluation; | — |
Countries
CHina
Contacts
Public ContactYibing Lu
The Second Affiliated Hospital of Nanjing Medical University
Outcome results
None listed