diabetes
Conditions
Interventions
Diabetes group (continued to wear the test instrument for 16 days):No intwevention
Sponsors
Zhongshan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Patients diagnosed with diabetes, aged 18 years and above, regardless of gender, have stable vital signs.(2) Forearm can establish a venous blood collection pathway.(3) Individuals with hematocrit/hematocrit = 70%.(4) Voluntarily participate in this experiment and sign an informed consent form;
Exclusion criteria
Exclusion criteria: (1) Wearing areas such as the upper arm and abdomen may have skin damage, scars, redness, swelling, or infection.(2) Individuals who are allergic to alcohol disinfectants or medical tape.(3) Individuals with severe bleeding tendencies or abnormal coagulation function (APTT = 1.5 times the upper limit of normal values) during the screening period.(4) Pregnant or lactating women, and those who plan to conceive during the trial period.(5) Have a history of epilepsy or mental illness.(6) Wearing area with swollen skin.(7) Wearing a device that plans to undergo magnetic resonance imaging (MRI), computed tomography (CT), or X-ray examination within 16 days.(8) Individuals who have participated in other intervention device clinical trials or participated in the last drug clinical trial within 5 half-lives within the month prior to the start of this trial.(9) The researchers believe that it is not suitable for participants in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Consistency within the error range of the reference value with the control group;;The proportion of measurement points falling on the Clarke error grid analysis area A+B;The proportion of measurement points located in the A+B area of the Consensus error grid analysis;Mean absolute relative error (MARD%); | — |
Secondary
| Measure | Time frame |
|---|---|
| Alarm accuracy;The stability of the sensor;The repeatability of sensors;Product usability questionnaire survey; Sensor lifespan;Blood glucose data evaluation;Trend accuracy evaluation.; | — |
Countries
China
Contacts
Public ContactXiaoying Li
Zhongshan Hospital Affiliated to Fudan University
Outcome results
None listed