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 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT06127433
Eligibility Criteria:
Inclusion Criteria:1: Have never received any hypoglycemic treatment (including oral hypoglycemic drugs, traditional Chinese medicine hypoglycemic drugs, insulin) Type 2 diabetes patients, or type 2 diabetes patients with diagnosis time less than 1 year, use hypoglycemic drugs No more than 1 type, with a usage time of no more than 1 week, and discontinuation of medication for more than 1 week when selected
2: A1c of glycosylated hemoglobin ≥ 8.0%, and abdominal blood glucose\>7.0mmol/L during enrollment
3: Age range from 18 to 70 years old, with a body mass index (BMI) of 20-35kg/m2
4: agrees to use contraception during the study process
5: Able and willing to use a dynamic blood glucose system and monitor blood glucose according to project requirements, and accept out of hospital lifestyle management and insulin hypoglycemic management.
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Exclusion Criteria:1: Not type 2 diabetes
2: The medication used is allergic or intolerable
3: Acute complications of diabetes
4: Severe microvascular complications
5: Severe macrovascular complications
6: Blood pressure consistently exceeds 180/110mmHg and cannot be controlled within 160/110mmHg within 1 week
7: The clearance rate of blood creatinine is less than 45ml/min/1.73m2, the ALT is ≥ 3 times the normal upper limit, and the total bilirubin is ≥ 2 times the normal upper limit and lasts for more than 1 week
8: Hemoglobin\<100g/L or requires regular blood transfusion treatment
9: Accumulated time of using drugs that may affect blood sugar within 12 weeks for more than 1 week
10: Systemic infection or severe accompanying diseases
11: Patients with malignant tumors or chronic diarrhea
12: Uncontrolled endocrine gland dysfunction
13: Mental disorders
14: Chronic heart failure, with a heart function grading of III or above
15: Pregnant, breastfeeding, women of childbearing age who are unwilling to use contraception during the study period, or have surgery plans that require general anesthesia in the near future (within 6 months)
16: The subject is uncooperative, unable to follow up, or the researcher determines that it may be difficult to complete the study.
17: Other situations that the researcher determines are not suitable for inclusion
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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06127433
Study Brief:
Protocol Section:
NCT06127433