Recruiting

Observational Study

Sponsor:

Tulane University

Code:

NCT07135531

Conditions

Diabetes

Diabetes Mellitus

Diabetes Type 2

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Continuous Glucose Monitoring (CGM)

Study Details

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

Study ID

NCT07135531

Start date

Mar 19, 2026

Status verified date

May, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

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).

Interventions

Continuous Glucose Monitoring (CGM)

Continuous glucose monitors will be placed subcutaneously every 14 days.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Neha Upadhyay, BDS,MPH

5049889803nupadhyay@tulane.edu

Ayitevi Agbodji, MD,MPH&TM

504-988-9839aagbodji@tulane.edu

Locations

University Medical Center

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Neha Upadhyay, BDS,MPH

504-988-9803nupadhyay@tulane.edu

Ayitevi Agbodji, MD,MPH&TM

504-988-9839aagbodji@tulane.edu

Principal Investigator:

Shaveta Gupta, MD

More Information

Sponsor

Tulane University

Last update posted

May 5, 2026

Last verified

May, 2026

Keywords

  • Medicaid
  • Underinsured
  • Continuous glucose monitoring
  • Uninsured

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Tulane University on 2026-05-05.