Continuous Glucose Monitoring (CGM) in an Underserved Population
Recruiting · NCT07135531 · Interventional (participants receive a specific treatment) · Lead sponsor: Tulane University
View the official record on ClinicalTrials.gov →Interventions studied
Continuous Glucose Monitoring (CGM)
What this trial is about
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 investigators believe that this study will lead to considerable alleviation of health disparities and provide better care for an underserved population. This will be a pilot study to evaluate the feasibility of such a trial in this population before doing a larger multicenter trial.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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
Where it is running
1 location listed across 1 US state.
- University Medical Center - New Orleans, Louisiana, United States