Actively Recruiting
Continuous Glucose Monitoring in an Underserved Population: Impact on Glucose Control, Patient Reported Outcomes, Healthcare Utilization, and Long Term Complications
Led by Tulane University · Updated on 2026-05-05
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
T
Tulane University
Lead Sponsor
A
Abbott
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a randomized clinical trial to study continuous glucose monitoring (CGM) in adults with type 2 diabetes who are either uninsured or on Medicaid and use at least one daily insulin injection. The goal is to address health disparities and improve care for this underserved population. This pilot study will test the feasibility of a larger multicenter trial. Participants will be randomly assigned to either use continuous glucose monitoring devices, which are placed under the skin every 14 days, or continue with self-monitoring of blood glucose after a two-week run-in period. Both groups will receive diabetes education. Those in the self-monitoring group can optionally use the CGM device for three months after the six-month follow-up period. During the study, participant glucose control will be measured by changes in HbA1c and time spent in target glucose range over six months. Researchers will also track episodes of low blood sugar. Participants will be followed for six months, with assessments at the start and end of this period, and optional CGM use thereafter. The study team will monitor health outcomes, patient-reported experiences, and healthcare usage throughout the trial.
CONDITIONS
Brief Title
Continuous Glucose Monitoring (CGM) in an Underserved Population
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years
- Diagnosed with type 2 diabetes mellitus
- HbA1c level of 7.5% or higher
- Receiving at least one insulin injection daily
- Established patient at primary care, endocrinology, or diabetes clinics in New Orleans or surrounding areas
- Have Medicaid, free care, or are uninsured
- Able to speak and understand English and provide informed consent
You will not qualify if you...
- Diagnosed with type 1 diabetes mellitus
- Currently using continuous glucose monitoring or insulin pump
- Advanced kidney disease or estimated glomerular filtration rate (eGFR) less than 40
- Serious other medical conditions making participation difficult
- Diagnosed with end-stage renal disease, on dialysis, or had a kidney transplant
- Conditions interfering with HbA1c measurement such as hemoglobinopathies or iron therapy
- Pregnant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants undergo a two-week run-in period before randomization.
Visits as needed during run-in period
Duration - 6 months
Participants are randomized to either continuous glucose monitoring or self-monitoring of blood glucose and receive diabetes education.
Visits at baseline and 6 months for assessments
Duration - 3 months
Participants in the self-monitoring group may wear the continuous glucose monitoring sensor for 3 months after the 6-month follow-up.
Visits as needed during optional follow-up
Trial Site Locations
Total: 1 location
1
University Medical Center
New Orleans, Louisiana, United States, 70112
Actively Recruiting
Research Team
N
Neha Upadhyay, BDS,MPH
A
Ayitevi Agbodji, MD,MPH&TM
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
PREVENTION
Number of Arms
2
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