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 @ 11:51 AM
Ignite Modification Date:
2025-12-24 @ 11:51 AM
NCT ID:
NCT05556161
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosed with type 2 diabetes for over 1 year according to the diagnostic criteria of diabetes formulated by the World Health Organization;
2. Male or female residents aged 18-85 years;
3. HbA1c measured within 6 months before enrollment was 7.0%-10.0%;
4. Lived in the catchment and have established health records for at least 6 months, and have no plans to move out at present;
5. patients used smartphones;
6. Sign the informed consent and participate in the study voluntarily.
Exclusion Criteria:
1. Patients used insulin within 1year before enrollment;
2. patients with type 1 diabetes, Latent autoimmune diabetes of adults(LADA), gestational diabetes, patients with extremely poor islet function (fasting C-peptide \< 0.1ng/ml) and patients with special type of diabetes;
3. Patients used continuous glucose monitoring (CGM) in the past 3 months;
4. Patients with serious complications (such as Stage G5 of diabetic nephropathy, severe loss of vision or blindness due to diabetic retinopathy and patients without self-care ability due to diabetic foot amputation).
5. Patients who suffered from serious mental illness or late stage of other serious diseases (such as malignant tumors, acute cardiovascular disease (like stroke, myocardial infarction), serious liver insufficiency, patients with history of diabetic ketoacidosis, patients with alcohol or drug abuse or dependence and patients with a history of cardiac surgery in the last 3 months;
6. Patients with cognitive impairment, or patients unable to use mobile phones to answer calls.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT05556161
Study Brief:
Protocol Section:
NCT05556161