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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 months, 3 months
  • Procedures mentioned: Injections

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This small study tests whether a larger study of continuous glucose monitoring (CGM), which tracks blood sugar throughout the day, can be done. It is for adults with type 2 diabetes who take insulin daily and have Medicaid, get free care, or have no health insurance.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are 18 to 75 years old.
  • Have type 2 diabetes.
  • Have an HbA1c of 7.5% or higher. This test measures average blood sugar over the past few months.
  • Take at least one insulin shot each day.
  • Already get care at a primary care, hormone care, or diabetes clinic in New Orleans or nearby areas.
  • Have Medicaid, get free care, or have no health insurance.
  • Can speak and understand English and can give informed consent, meaning you understand the study and agree to join.

Who can't join

  • Have type 1 diabetes.
  • Already use a continuous glucose monitor or an insulin pump.
  • Have advanced kidney disease or an eGFR below 40. This test shows how well your kidneys filter blood.
  • Have other serious health problems that the study doctor thinks would make it hard to take part.
  • Have kidney failure, receive dialysis (treatment to filter the blood), or have had a kidney transplant.
  • Have a blood disorder affecting hemoglobin, take iron treatment, or have another condition that affects the HbA1c test.
  • Are pregnant.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

LA