Status:
NOT_YET_RECRUITING
Continuous Glucose Monitoring (CGM) in an Underserved Population
Lead Sponsor:
Tulane University
Collaborating Sponsors:
Abbott
Conditions:
Diabetes
Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The investigators aim is to conduct a randomized clinical trial in an underserved population who are either uninsured or on Medicaid and taking at least one injection of insulin daily. The investigato...
Detailed Description
This study is a randomized open label trial with study participants being randomized to either a continuous glucose monitoring group (intervention) or a self-monitoring group (control) after a period ...
Eligibility Criteria
Inclusion
- Age 18-75 years
- Type 2 diabetes mellitus
- HbA1C ≥ 7.5%
- At least on 1 insulin injection therapy daily
- Patients established with primary care clinic or endocrinology clinic or diabetes clinics in the New Orleans and surrounding areas
- Patients with Medicaid or free care or uninsured
- Patients must be able to speak and understand English and be capable of providing informed consent to participate in the study
Exclusion
- Type 1 diabetes mellitus
- Currently on CGM or using insulin pump
- Advanced renal disease or Estimated Glomerular Filtration Rate (eGFR) \<40
- Serious co-morbidities which in the investigator's opinion, will make it challenging for patients to participate
- The patient has been diagnosed with end-stage renal disease, is on dialysis, or has had a kidney transplant, Hemoglobinopathies, iron therapy or other condition that interferes with HbA1c measurement
- Pregnant
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT07135531
Start Date
November 1 2025
End Date
March 1 2027
Last Update
October 28 2025
Active Locations (1)
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1
University Medical Center
New Orleans, Louisiana, United States, 70112