NCT06694558 · The Cleveland Clinic
Monocytes in Subjects With Type 1 Diabetes and Chronic Kidney Disease
What this study is about
This is a cross-sectional study in patients with Type 1 diabetes (TID) and chronic kidney disease (CKD) to test if time in range (TIR) affects the degree of hyperglycemia required for monocyte activation, podocyte injury, and assess if monocyte activation is attenuated by glucagon-like peptide (GLP-1) agonist treatment ex vivo.
View original scientific description
This is a cross-sectional study in patients with Type 1 diabetes (TID) and chronic kidney disease (CKD) to test if time in range (TIR) affects the degree of hyperglycemia required for monocyte activation, podocyte injury, and assess if monocyte activation is attenuated by glucagon-like peptide (GLP-1) agonist treatment ex vivo.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- T1D CKD subjects:
- Adults, males or females diagnosed with T1D
- Age 18-65 years
- Diagnosed with CKD (eGFR 60-90 ml/min/1.73 m2)
- Diagnosed with albuminuria (UACR 30-500 mg/g)
- On insulin injections or pump
- 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
- Controls: T1D subjects without CKD
- Adults, males or females diagnosed with T1D
- Age 18-65 years
- No CKD (eGFR \>90 ml/min/1.73 m2)
- No albuminuria (UACR \<30 mg/g)
- On insulin injections or pump
- 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
- Hemoglobin \<9
- On GLP-1 agonist or DPP4 inhibitor or sodium-glucose co-transporter-2 inhibitors use within 30 days
- pregnancy or plans to become pregnant
- On steroids
- Diagnosed with cancer, immunosuppression/autoimmune conditions
- Reported heavy alcohol use or recreational drug use
- Any condition which jeopardizes patient safety or affects monocytes at physician's discretion
Where
- Cleveland, Ohio
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 8, 2026 · Source of record for eligibility and locations