Continuous Glucose Monitoring (CGM) in an Underserved Population

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus; Diabetes; Diabetes Type 2
• Intervention / Treatment: Device: Continuous Glucose Monitoring (CGM)

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Neha Upadhyay, BDS,MPH; Phone Number: 5049889803; Email: nupadhyay@tulane.edu
• Study Contact Backup: Name: Ayitevi Agbodji, MD,MPH&TM; Phone Number: 504-988-9839; Email: aagbodji@tulane.edu

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Recruiting
      • University Medical Center
      • Contact: Ayitevi Agbodji, MD,MPH&TM; Phone Number: 504-988-9839; Email: aagbodji@tulane.edu
      • Contact: Neha Upadhyay, BDS,MPH; Phone Number: 504-988-9803; Email: nupadhyay@tulane.edu
      • Principal Investigator: Shaveta Gupta, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: Continuous Glucose Monitoring (CGM); Continuous glucose monitors will be placed subcutaneously every 14 days.
Active Comparator: Continuous Glucose Monitoring (CGM); The study participants will be randomized to the continuous glucose monitoring group (intervention).	Device: Continuous Glucose Monitoring (CGM); Continuous glucose monitors will be placed subcutaneously every 14 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Glycated hemoglobin (HbA1c) between baseline and 6-month visits for both groups	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.	Baseline, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Time in Range (TIR)	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.	Baseline, 6 months
Change in documented hypoglycemia <70 mg/ dl and severe hypoglycemia - <54 mg/dl	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.	Baseline, 6 months

Collaborators and Investigators

• Sponsor: Tulane University
• Collaborators: Abbott
• Investigators: Principal Investigator: Shaveta Gupta, MD, Tulane University

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: August 14, 2025
• First Submitted That Met QC Criteria: August 14, 2025
• First Posted (Actual): August 22, 2025

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: May 3, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Continuous glucose monitoring; Medicaid; Uninsured; Underinsured
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Diabetes Mellitus; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Blood Chemical Analysis; Clinical Chemistry Tests; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Continuous Glucose Monitoring
• Other Study ID Numbers: 2024-1872

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes