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 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT06694558
Eligibility Criteria:
Inclusion Criteria:
1. T1D CKD subjects:
1. Adults, males or females diagnosed with T1D
2. Age 18-65 years
3. Diagnosed with CKD (eGFR 60-90 ml/min/1.73 m2)
4. Diagnosed with albuminuria (UACR 30-500 mg/g)
5. On insulin injections or pump
6. On CGM
Based on baseline CGM metrics, the investigators will stratify subjects to 2 groups Group A (Lower TIR group): TIR\<60%, A1c 7.5-9.5 Group B (Higher TIR group): TIR\>70% A1c 5.0-7.0
2. Controls: T1D subjects without CKD
1. Adults, males or females diagnosed with T1D
2. Age 18-65 years
3. No CKD (eGFR \>90 ml/min/1.73 m2)
4. No albuminuria (UACR \<30 mg/g)
5. On insulin injections or pump
6. On CGM
Based on baseline CGM metrics, the investigators will stratify subjects to 2 groups Group A (Lower TIR group): TIR\<60%, A1c 7.5-9.5 Group B (Higher TIR group): TIR\>70% A1c 5.0-7.0
Exclusion Criteria:
1. Hemoglobin \<9
2. On GLP-1 agonist or DPP4 inhibitor or sodium-glucose co-transporter-2 inhibitors use within 30 days
3. pregnancy or plans to become pregnant
4. On steroids
5. Diagnosed with cancer, immunosuppression/autoimmune conditions
6. Reported heavy alcohol use or recreational drug use
7. Any condition which jeopardizes patient safety or affects monocytes at physician's discretion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06694558
Study Brief:
Protocol Section:
NCT06694558