diabetes
Conditions
Interventions
Group 1:1~3 days after wearing the test device (Subject on the main evaluation side (left upper arm, left abdomen) data can be collected, the test instrument after wearing in the first 1-3 days in the
Group 2:4~7 days after wearing the test device (Subject on the main evaluation side (left upper arm, left abdomen) data can be collected, the test instrument after wearing in the first 4-7 days in the
Group 3:8~11 days after wearing the test device (Subject on the main evaluation side (left upper arm, left abdomen) data can be collected, the test instrument after wearing in the first 8-11 days in t
Group 4:12~14 days after wearing the test device (Subject on the main evaluation side (left upper arm, left abdomen) data can be collected, the test instrument after wearing in the first 12-14 days in
Sponsors
Beijing hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: • Age 18 and above • Patients diagnosed with type 1 or type 2 diabetes • Normal cognitive ability, willing to follow the instructions provided by the research center and perform all research tasks specified in the program • Participate voluntarily and be able to sign subject informed consent prior to the trial • Willing to wear the sensor during the study, participate in the indwelling needle blood drawing (1ml venous blood every 15±5 minutes for 7 hours, about 28 times).
Exclusion criteria
Exclusion criteria: • Acute complications of diabetes, including diabetic ketoacidosis, hyperosmolar non-ketotic diabetic coma, lactic acidosis, and hypoglycemic coma, occurred in the 6 months prior to the trial • A history of cardiovascular disease (including but not limited to ischemic heart disease, peripheral vascular disease, cardiomyopathy, cerebrovascular disease, congenital heart disease, or significant arrhythmia), epilepsy, severe migraine within the past 6 months, adrenal disease, fainting, significant awareness of hypoglycemia, or a history of severe hypoglycemia within the past 6 months (requiring emergency medical intervention) • Patients with severe liver and kidney failure or dialysis • Skin lesions that affect the accuracy of the wearable device, including skin lesions at the wearing site (such as severe skin scalds, burns, sunburn, trauma, subcutaneous nodules, etc.) and/or systemic skin lesions (such as eczema, scars, tattoos, herpetic dermatitis, psoriasis, etc.) • Abnormal coagulation function, such as prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT), fibrinogen (FIB) abnormalities • Anemia or hematocrit (Hct) below normal reference range • Donated blood within 3 months prior to the test • People who are allergic to disinfectants or medical tape, or who are susceptible to allergies • Have any chronic infectious disease or co-existing illness that interferes with participation in the study or poses an excessive risk to research staff handling venous or capillary blood samples (e.g. HIV/ AIDS, hepatitis B or C) • Pregnant or lactating women or those who have a birth plan within the next 1 month (=30 days) • Participated in other clinical trials within 1 month prior to the trial • X-ray, magnetic resonance imaging (MRI), computed tomography (CT) scans are required during the trial • Any conditions that the investigator considers necessary to exclude from the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 20/20% agreement with reference value;Proportion of A+B region in Clarke error grid analysis;Average absolute relative error (MARD%); | — |
Secondary
| Measure | Time frame |
|---|---|
| High and low blood sugar alert accuracy;Hypoglycemia early warning accuracy;Rapid rate of blood sugar change alerts accuracy;Stability evaluation of sensors;Sensor repeatability;User questionnaire survey on product usability;Sensor life; | — |
Countries
China
Contacts
Public ContactGuo lixin
Beijing hospital
Outcome results
None listed