Continuous glucose monitoring for adults with type 2 diabetes in underserved communities
Continuous Glucose Monitoring in an Underserved Population: Impact on Glucose Control, Patient Reported Outcomes, Healthcare Utilization, and Long Term Complications
This project will test whether giving continuous glucose monitors to uninsured or Medicaid-insured adults with type 2 diabetes who take daily insulin helps them manage their blood sugar better than standard fingerstick monitoring.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Tulane University Academic / other |
| Locations | 1 site (New Orleans, Louisiana) |
| Trial ID | NCT07135531 on ClinicalTrials.gov |
What this trial studies
This is a randomized, open-label pilot comparing continuous glucose monitoring (CGM) versus standard self-monitoring in underserved adults with type 2 diabetes on daily insulin. After a two-week run-in, participants are randomized to the CGM group or the self-monitoring group and all receive diabetes education, with six months of follow-up. Participants in the control group may opt to wear a CGM for three months after the six-month follow-up. The pilot will test feasibility and provide preliminary data on glycemic outcomes to inform a larger multicenter trial.
Who should consider this trial
Good fit: Adults 18–75 years with type 2 diabetes, HbA1c ≥ 7.5%, taking at least one insulin injection daily, covered by Medicaid or uninsured and established with local clinics in the New Orleans area who can consent in English.
Not a fit: People with type 1 diabetes, current CGM or insulin pump users, those with advanced kidney disease (eGFR <40), pregnant patients, or those unable to attend local clinic visits are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, CGM could improve blood sugar control and reduce diabetes-related disparities among uninsured and Medicaid patients.
How similar studies have performed: Randomized trials in insulin-treated type 2 diabetes have demonstrated improved glycemic control with CGM, but few have focused specifically on uninsured or Medicaid populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
New Orleans, Louisiana
- University Medical Center — New Orleans, Louisiana, United States (Recruiting)
Study contacts
- Principal investigator: Shaveta Gupta, MD — Tulane University
- Study coordinator: Neha Upadhyay, BDS,MPH
- Email: nupadhyay@tulane.edu
- Phone: 5049889803
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.