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 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT05995756
Eligibility Criteria:
Inclusion Criteria:
1. Aged ≥18 years, male or female;
2. Clinically diagnosed with diabetes;
3. Being willing to wear the investigational device for the duration set according to its service life, and conduct glucose monitoring;
4. Consent to participate in this clinical study, and sign the Informed Consent Form (ICF).
Exclusion Criteria:
1. Disagree to wear the investigational device continuously according to the requirements of the trial;
2. Refuse venous blood collection for 7 consecutive hours (every 15 minutes) on a certain day during the trial;
3. Plan to undergo magnetic resonance imaging (MRI) during the clinical trial;
4. With diffuse subcutaneous nodules at the wearing site of the investigational device;
5. Have a history of diabetic ketoacidosis or hyperosmolar hyperglycemic state within the 6 months prior to screening;
6. With mental disorders, lack of self-control and inability to express clearly;
7. Have participated in any other clinical trial within the past 1 month;
8. Where the investigator thinks not suitable for being enrolled.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05995756
Study Brief:
Protocol Section:
NCT05995756