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 @ 11:47 AM
Ignite Modification Date:
2025-12-24 @ 11:47 AM
NCT ID:
NCT05726461
Eligibility Criteria:
Inclusion Criteria:
Prior to this study:
1. Type 1 diabetes mellitus(T1DM) was diagnosed by an endocrinologist for at least one year.
2. Aged from 18 to 75 years.
3. HbA1c was 7.0% \~ 11%.
4. on multiple daily injection(MDI) or insulin pump therapy for ≥3 months with less than 20% insulin dose changes.
5. The total daily dose(TDD) were≥0.3 u/kg /day, and the basal rate was ≥0.05 u/hour.
6. Regular self-monitoring of blood glucose (≥3 times per day) for ≥2 months.
7. Lived with an adult willing to care for the subject during the study.
8. Women of childbearing age are willing to use appropriate contraceptive measures.
9. Willing to follow the research protocol.
10. Have daily access to a Wi-Fi network.
Exclusion Criteria:
Prior to this study:
1. Severe acute or chronic complications of diabetes mellitus.
2. Frequent severe hypoglycemia in the past three months.
3. Patients who have used closed-loop therapy in the last two months (excluding those who have recently used CGM) and those participating in other studies.
4. Abnormal liver function (ALT was 2.5 times higher than the upper limit of normal).
5. Moderate to severe renal impairment (eGFR\<60ml/min/1.73m2).
6. Clinically significant heart disease.
7. Pregnant or planning pregnancy.
8. Used drugs that can interfere with glucose metabolism (e.g., exogenous glucocorticoids, nonselective beta-blockers, monoamine oxidase inhibitors) in the past eight weeks.
9. Frequent acetaminophen, drug abuse, and excessive drinking.
10. Known allergy to medical-grade adhesives or CGM and its affiliated components.
11. Severe visual or hearing impairment.
12. Severe skin disease at the site of sensor implantation.
13. Plan to undergo elective surgery requiring general anesthesia during the study.
14. Eating disorders such as anorexia or bulimia.
15. Other physical or psychological conditions deemed inappropriate for inclusion by the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05726461
Study Brief:
Protocol Section:
NCT05726461