NCT07135531NARecruiting

Continuous Glucose Monitoring (CGM) in an Underserved Population

Tulane University

Start Date

3/19/2026

Completion Date

7/1/2027

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 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.

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 of two-week run-in and followed for 6 months. All participants regardless of assignment will be provided diabetes education. Participants randomized to the self-monitoring group will be given an opportunity to wear the CGM sensor for 3 months at the conclusion of the 6-month follow-up as an optional follow-up.

Eligibility Criteria

Age Range: 18 years to 75 years

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

Interventions

DEVICE

Continuous Glucose Monitoring (CGM)

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Conditions

DiabetesDiabetes MellitusDiabetes Type 2

Locations

University Medical Center

New Orleans, Louisiana 70112

United States