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:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 2:41 PM
NCT ID:
NCT06197906
Eligibility Criteria:
Inclusion Criteria:
1. Participants are aged 18 to 80 years old.
2. Participants have been diagnosed with type 1 or type 2 diabetes.
3. Participants must meet one of the following treatment criteria:
* Daily insulin injections and/or insulin pump therapy at least once a day.
* Use of antidiabetic medications, with glycated hemoglobin (HbA1c) not less than 8%. Relevant medications include but are not limited to: sulfonylureas, biguanides, α-glucosidase inhibitors, thiazolidinediones, dipeptidyl peptidase 4 inhibitors, sodium-glucose cotransporter-2 inhibitors, and glucagon-like peptide 1 receptor agonists (GLP-1RAs).
4. Participants who can comply with the experimental procedures and related requirements specified in the protocol.
5. Volunteers willing to participate in this trial and who have signed the informed consent form.
Exclusion Criteria:
1. Known allergy to disinfectant alcohol or medical-grade skin patches.
2. Presence of skin trauma, infection, or skin disease at the site where the trial device is to be worn.
3. Hemoglobin levels less than 90.0g/L.
4. Estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73m2.
5. Use of other implanted medical devices, such as pacemakers or defibrillators.
6. Acutely critically ill patients.
7. Patients with active infectious diseases.
8. Requirement for imaging examinations, phototherapy, or thermotherapy during the wearing period.
9. History of unconscious hypoglycemia in the six months preceding the trial; patients admitted to the hospital at screening are excluded.
10. Pregnant women or women planning to become pregnant during the study.
11. Inability to read the product instructions or inability to wear the trial device after receiving education and training.
12. Participation in another clinical trial within the two weeks prior to screening.
13. Other situations determined by the investigator as unsuitable for participation in this trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06197906
Study Brief:
Protocol Section:
NCT06197906