Diabetes
Conditions
Interventions
Sponsors
Dongguan People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: ??1. Age =18 years, regardless of gender.?? ??2. Subjects clinically diagnosed with diabetes.?? 3. Subjects assessed by the investigator to have adequate venous access.?? ??4. Subjects willing to continuously wear the trial device for its operational lifespan and undergo venous blood collection for 7-8 hours (once every 15 minutes) on a designated day during the trial according to the predefined protocol.? 5.??Subjects who fully understand the study and voluntarily sign the informed consent form prior to participation.?
Exclusion criteria
Exclusion criteria: ??1. Pregnant or breastfeeding women, or individuals planning to conceive during the trial period.?? ??2. Individuals with allergies to disinfectants, medical adhesive tapes, or trial devices.?? ??3. Subjects with skin lesions affecting sensor accuracy, including localized lesions at the device placement site (e.g., severe burns, scalds, sunburns, trauma, ulcers, infections, surgical scars, diffuse subcutaneous nodules) or systemic skin disorders (e.g., eczema, scars, tattoos, dermatitis herpetiformis, psoriasis).? ??Systemic skin disorders?? (e.g., eczema, scars, tattoos, dermatitis herpetiformis, psoriasis). 4. Subjects with conditions impacting effective blood volume?? (e.g., severe hemorrhage, severe edema). ??5. Severe anemia (hemoglobin 3.0 or platelet count <50×10?/L), or those who have used anticoagulants (e.g., heparin, coumarin derivatives) within 2 weeks prior to screening or plan to use them during the trial period.? ??7.History of diabetic ketoacidosis, hyperosmolar hyperglycemic state, or severe hypoglycemia (with loss of consciousness or seizures) within 3 months prior to screening.?? ??8.Psychiatric disorders, cognitive/communication impairments, or uncooperative subjects due to extreme anxiety.?? ??9.Planned magnetic resonance imaging (MRI) during the trial period.?? 10.??Participation in other clinical trials within 1 month prior to screening.?? ??11. Subjects deemed by the investigator to have poor compliance or other issues making them unsuitable for the trial.?
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%); | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of correct versus incorrect warnings of hypoglycemia;Correct Detection Rate and Incorrect Detection Rate for Hypoglycemia?;Rate of correct versus incorrect warnings of hyperglycemia;High blood glucose correct detection rate vs. incorrect detection rate;Stability of sensor;Repeatability of sensor;Ease of use;Lifetime of sensor; | — |
Countries
China
Contacts
Public ContactXiuwei Zhang
Dongguan People's Hospital
Outcome results
None listed