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 @ 11:05 PM
Ignite Modification Date:
2025-12-24 @ 11:05 PM
NCT ID:
NCT05331469
Eligibility Criteria:
Inclusion Criteria:
* Type 2 Diabetes Mellitus patients with
1. Adults aged 18 years and above
2. HbA1c \>7.5% and Fasting blood sugar \> 8mmol/L
3. Newly diagnosed T2DM with osmotic symptoms or HbA1c \>10% or FPG \>13mmol/L
4. Insulin naïve patients
5. Patients planned for insulin initiation
6. Ability to give informed consent
7. Ability to perform self-monitoring blood glucose
Exclusion Criteria:
1. Diabetes other than type 2 diabetes mellitus
2. Diabetes in pregnancy
3. Diabetes with chronic kidney disease stage 3,4 and 5 (eGFR \<60ml/min/1.73m2)
4. Patient with history of severe hypoglycemia
5. Active proliferative diabetic retinopathy
6. Any medical condition that may influence HbA1c measurements (e.g., thalassemia, sickle cell anemia)
7. Treatment with systemic corticosteroid
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT05331469
Study Brief:
Protocol Section:
NCT05331469