Diabetes
Conditions
Interventions
Sponsors
Beijing Children's Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
3 Years to 18 Years
Inclusion criteria
Inclusion criteria: (1) Be between 3 years old (including 3 years old) and 18 years old (excluding 18 years old); (2) Clinical diagnosis of diabetes; (3) I and/or my guardian agree to participate in clinical trials and can sign informed consent as required; (4) The subjects are willing to wear the test equipment as required, and collect blood to detect blood glucose values according to the test requirements; (5) Subjects are willing to receive follow-up at the time specified in the trial.
Exclusion criteria
Exclusion criteria: (1) history of severe hypoglycemia in the past 6 months, defined as hypoglycemia leading to loss of consciousness or seizures; (2) Patients with heart failure and those with sequelae of hemiplegia in the past cerebrovascular disease; (3) The sensor wearing site has severe skin burns, burns, sunburns, trauma, ulcers, surgery and other scars; (4) Severe systemic skin lesions, such as extensive eczema, extensive scarring, extensive tattoos, herpetic dermatitis, severe edema, psoriasis and other cases that medical personnel believe affect the accuracy of the sensor; (5) Abnormal coagulation function, such as abnormal prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT), and fibrinogen (FIB); (6) Anemia or abnormal hematocrit; (7) Those who have donated blood within the past six months; (8) Pregnant and lactating women (pregnancy in this test is defined as a positive urine pregnancy test and women who have had menarche); (9) Those who are participating in or have participated in other clinical trials within one month; (10) Magnetic resonance imaging (MRI) and computed tomography are required during the sensor wearing (CT) examiners; (11) Those who are allergic to medical adhesives or alcohol; (12) Any circumstances that the investigator considers to be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accordance rate;Product usability questionnaire;Mean absolute relative difference;Proportion of Zone A+B of Consensus error grid;Proportion of Zone A+B of Clarke error grid; | — |
Secondary
| Measure | Time frame |
|---|---|
| Alarm accuracy;Sensor stability;Repeatability of sensors; | — |
Countries
China
Contacts
Public ContactChunxiu Gong
Beijing Children's Hospital Affiliated to Capital Medical University
Outcome results
None listed