Continuous Glucose Monitoring (CGM) in an Underserved Population

NCT07135531 | Recruiting FDA Device

• 1 other identifier: 2024-1872
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes; Diabetes Mellitus; Diabetes Type 2

Keywords

Medicaid; Underinsured; Continuous glucose monitoring; Uninsured

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Time in Range (TIR)

  Baseline, 6 months

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

  Baseline, 6 months

Study Arms (2)

Self-Monitoring of Blood Glucose (SMBG)

PLACEBO COMPARATOR

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 Monitoring (CGM)

ACTIVE COMPARATOR

The study participants will be randomized to the continuous glucose monitoring group (intervention).

Device: Continuous Glucose Monitoring (CGM)

Interventions

Continuous Glucose Monitoring (CGM) DEVICE

Continuous glucose monitors will be placed subcutaneously every 14 days.

Continuous Glucose Monitoring (CGM); Self-Monitoring of Blood Glucose (SMBG)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tulane University: lead
• Abbott: collaborator

Study Sites (1)

University Medical Center

New Orleans, Louisiana, 70112, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Shaveta Gupta, MD

  Tulane University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neha Upadhyay, BDS,MPH

CONTACT

5049889803; nupadhyay@tulane.edu

Ayitevi Agbodji, MD,MPH&TM

CONTACT

504-988-9839; aagbodji@tulane.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 22, 2025
• Study Start: March 19, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)