Continuous Glucose Monitoring (CGM) in an Underserved Population

Part of paid clinical trials in New Orleans, Louisiana.

Sponsor
Tulane University
Study ID
NCT07135531
Status
Recruiting
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Conditions

  • Diabetes
  • Diabetes Mellitus
  • Diabetes Type 2

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Continuous Glucose Monitoring (CGM) — DEVICE
    Continuous glucose monitors will be placed subcutaneously every 14 days.

Study Details

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.

Key Dates

Start date
Mar 19, 2026
Status verified
May 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

Arms

  • Placebo Comparator: Self-Monitoring of Blood Glucose (SMBG)
    The study participants will be randomized to the self-monitoring group (control) after a period of two-week run-in and followed for 6 months. They 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.
  • Active Comparator: Continuous Glucose Monitoring (CGM)
    The study participants will be randomized to the continuous glucose monitoring group (intervention).

Primary Outcome Measure

Change in Glycated hemoglobin (HbA1c) between baseline and 6-month visits for both groups [ Time Frame: Baseline, 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University Medical CenterNew OrleansLouisiana70112
Neha Upadhyay, BDS,MPH
[email protected]
504-988-9803
Ayitevi Agbodji, MD,MPH&TM
[email protected]
504-988-9839
Shaveta Gupta, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University Medical Center· New Orleans, LA

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