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NCT Number: NCT07135531

Continuous Glucose Monitoring (CGM) in an Underserved Population

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.

Recruiting

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous glucose monitoring (CGM)

Device

Continuous glucose monitors will be placed subcutaneously every 14 days.

Primary outcomes

  1. Change in Glycated hemoglobin (HbA1c) between baseline and 6-month visits for both groups

    Time frame: Baseline, 6 months

    The investigators will take blood samples at baseline and at the 6 months visit to measure the HbA1c levels. Change in the level of HbA1c at 6 months will be compared between the 2 groups to assess the outcome.

Secondary outcomes

  1. Change in Time in Range (TIR)

    Time frame: Baseline, 6 months

    TIR is a percentage of time that a person with diabetes spends within their target blood glucose range. The investigators will review the data from the CGM devices and assess if there are any changes in the TIR between the 2 groups at baseline and at 6 months. The higher the percentage is for TIR, the better the blood glucose control is for patients.

  2. Change in documented hypoglycemia <70 mg/ dl and severe hypoglycemia - <54 mg/dl

    Time frame: Baseline, 6 months

    The investigators will measure the change in documented hypoglycemia and severe hypoglycemia in patients in both groups at baseline and at 6 months. The lower the numbers of the hypoglycemia incidences, the better the outcome is.

    Documented hypoglycemia and severe hypoglycemia will be measured as a percentage of time that a person with diabetes below their target blood glucose range.

Study contacts

Contact information is provided by the study sponsor or research team.

Ayitevi Agbodji, MD,MPH&TM

CONTACT

[email protected]

504-988-9839

Neha Upadhyay, BDS,MPH

CONTACT

[email protected]

5049889803

Sponsors and collaborators

Lead sponsor

Tulane University

Other

Collaborators

  • Abbott

Registry information

Official study title

Continuous Glucose Monitoring in an Underserved Population: Impact on Glucose Control, Patient Reported Outcomes, Healthcare Utilization, and Long Term Complications

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 22, 2025
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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