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 @ 12:05 PM
Ignite Modification Date:
2025-12-24 @ 12:05 PM
NCT ID:
NCT05038761
Eligibility Criteria:
Inclusion Criteria:
* Adult female or male (18 years of age or older)
* Diagnosed with type 1 or type 2 diabetes mellitus
* Decision to initiate venous blood glucose testing and CGM as per investigator's routine treatment practice;
* Signed informed consent
Exclusion Criteria:
* Patients with moderate or more serious anemia defined as hemoglobin \< 90g/L
* Patients with moderate or more serious subcutaneous edema: grading can be referred to: mild edema (a visible mild depression of eyelid, soft tissues below the orbit, subcutaneous tissue of the anterior tibia or subcutaneous tissue of the ankle after finger pressure); moderate (all the sparse tissues of the whole body have visible edema with obvious or deeper tissue depressions after finger pressure and slow subsidence); severe (severe edema of tissues all over the body, the skin of the low hanging part of the body is tense and shiny, and there may even be fluid exudation, sometimes accompanied by fluid accumulation in the thoracic cavity, abdominal cavity and sphincter cavity)
* Pregnant women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05038761
Study Brief:
Protocol Section:
NCT05038761