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 @ 10:45 PM
Ignite Modification Date:
2025-12-24 @ 10:45 PM
NCT ID:
NCT01345435
Eligibility Criteria:
Inclusion Criteria:
1. More than 20 years of age and under 60 years of age
2. Patients who are able to receive outpatient treatment with type II diabetes mellitus.
3. If the patients require using insulin, patients who are using basal insulin or premixed insulin less than 2 times a day are eligible.
4. Patients with HbA1c above 7% and less than 11% (7%≤HbA1c≤11%).
5. Patients who are able to understand the purpose of this trial and to read and write.
6. Patients who are able to use the Smart Care PC for this study.
7. Patients who have wired/wireless internet access at home.
8. Patients who participate voluntarily and sign the informed consent.
Exclusion Criteria:
1. Patients with type I diabetes mellitus
2. Patients who are using Bolus insulin (short-acting insulin) or insulin pump.
3. Patients who take medicines which can significantly affect glycemic control.
4. Patients with acute illness, untreated other disease or diabetic complications required additional treatment.
5. Patients currently being hospitalized or planning to hospitalize during the study period.
6. Patients who have severe renal disease (above 1.5 times the upper limit of normal serum creatinine levels).
7. Pregnant or lactating women.
8. Patients with any severe liver disease including cirrhosis (AST or ALT: above 3 times the upper limit of normal).
9. Patients with uncontrolled chronic lung disease.
10. Patients with known history of alcoholism, mental illness, or drug dependency.
11. Patients who have cognitive disorder or psychiatric problems
12. Patients who have participated in other clinical trial within 12 weeks prior to screening visit.
13. Any clinically significant medical condition including neurologic disease, gastrointestinal disease or malignant tumor, etc., which may affect the test results, or any other medical condition which in the opinion of the investigator makes the patients unsuitable for participation in the trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
60 Years
Study:
NCT01345435
Study Brief:
Protocol Section:
NCT01345435