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:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 1:17 AM
NCT ID:
NCT06957093
Eligibility Criteria:
Inclusion Criteria：
* Age: ≥18 years，≤75 years;
* Diagnosed with type 2 diabetes for ≥1 year;
* 7.0% ≤HbA1c ≤11%;
* Body mass index ≥18.5 kg/m2;
* Proficient ability to use smart phones;
* Agreed to utilize a digital integrated healthcare platform for diabetes care and research;
* Informed consents are obtained from the participants.
Exclusion Criteria:
* Presence of other types of diabetes, such as type 1 diabetes and gestational diabetes;
* Severe diabetic complications;
* Medical history of chronic liver diseases, including hemochromatosis, hepatocellular carcinoma, autoimmune liver disease, cirrhosis, viral hepatitis (including hepatitis A, B, and C), or hepatolenticular degeneration;
* Kidney injury (serum creatinine ≥1.5 times the upper limit of the reference) ; Serum ALT and AST levels elevated \>2-fold;
* Medical history of mental disorders, such asschizophrenia, depression, or bipolar affective disorder;
* Excessive alcohol intake or drug abuse in the past 3 months;
* Use of medications affecting glucose metabolism, such as corticosteroids or ·consumption of immunosuppressive and anti-obesity medications in the past 3 months;
* Pregnancy, planning for pregnancy, or lactation; or any other conditions unsuitable for trial participation;
* Participatingor plan to participate in other clinical trials; and other cases that are inappropriate to participate.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06957093
Study Brief:
Protocol Section:
NCT06957093