Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-24 @ 11:53 PM
NCT ID:
NCT06570551
Eligibility Criteria:
Inclusion Criteria:
* Aged 2 (inclusive) - 18 years (exclusive);
* Clinically diagnosed with diabetes;
* Being willing to wear the device continuously for 15 days and conduct blood collection for blood glucose testing in accordance with the requirements of this protocol;
* Body weight not less than 10.0 kg;
* Consent to participate in this clinical investigation, and sign the Informed Consent Form (ICF).
Exclusion Criteria:
* Need to undergo magnetic resonance imaging (MRI) during the clinical investigation;
* Diffuse subcutaneous nodules;
* Acute complications of diabetes;
* Abnormal coagulation function (coagulation cannot be too quick or too slow); the criteria for judging abnormalities are: The activated partial thromboplastin time (APTT) is higher than 1.5 times the upper limit of normal value or lower than the lower limit of normal value; or The prothrombin time (PT) is higher than 1.5 times the upper limit of normal value or lower than the lower limit of normal value
* Participation in other clinical investigations within the past 1 month;
* Where the investigator does not consider the patient suitable for enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
17 Years
Study:
NCT06570551
Study Brief:
Protocol Section:
NCT06570551