Continuous Glucose Monitoring (CGM) in an Underserved Population

Tulane University

Status: Not yet enrolling

Conditions: Diabetes; Diabetes Mellitus; Diabetes Type 2

Treatments: Device: Continuous Glucose Monitoring (CGM)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07135531

2024-1872

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups, including a placebo group

Self-Monitoring of Blood Glucose (SMBG)

Placebo Comparator group

Description:

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.

Treatment:

Device: Continuous Glucose Monitoring (CGM)

Continuous Glucose Monitoring (CGM)

Active Comparator group

Description:

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

Treatment:

Device: Continuous Glucose Monitoring (CGM)