Continuous Glucose Monitoring (CGM) in an Underserved Population

Last updated: May 3, 2026
Sponsor: Tulane University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Mellitus, Type 2

Diabetic Neuropathy

Diabetic Retinopathy

Treatment

Continuous Glucose Monitoring (CGM)

Clinical Study ID

NCT07135531
2024-1872
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 diabetesclinics 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 providinginformed consent to participate in the study

Exclusion

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 challengingfor patients to participate

  • The patient has been diagnosed with end-stage renal disease, is on dialysis, or hashad a kidney transplant, Hemoglobinopathies, iron therapy or other condition thatinterferes with HbA1c measurement

  • Pregnant

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Continuous Glucose Monitoring (CGM)
Phase:
Study Start date:
March 19, 2026
Estimated Completion Date:
July 31, 2027

Study 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.

Connect with a study center

  • University Medical Center

    New Orleans, Louisiana 70112
    United States

    Active - Recruiting

  • University Medical Center

    New Orleans 4335045, Louisiana 4331987 70112
    United States

    Site Not Available

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