Continuous Glucose Monitoring (CGM) in an Underserved Population
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Continuous Glucose Monitoring (CGM).
- Who it may be relevant to
- Registry conditions: Diabetes, Diabetes Mellitus, Diabetes Type 2. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Continuous Glucose Monitoring in an Underserved Population: Impact on Glucose Control, Patient Reported Outcomes, Healthcare Utilization, and Long Term Complications
Overview
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.
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.
Interventions
- Device Continuous Glucose Monitoring (CGM)
Continuous glucose monitors will be placed subcutaneously every 14 days.
Primary outcome measures
- Change in Glycated hemoglobin (HbA1c) between baseline and 6-month visits for both groups [Time frame: Baseline, 6 months]
Secondary outcome measures (2)
- Change in Time in Range (TIR) [Time frame: Baseline, 6 months]
- Change in documented hypoglycemia <70 mg/ dl and severe hypoglycemia - <54 mg/dl [Time frame: Baseline, 6 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- University Medical Center — New Orleans
Identifiers
NCT: NCT07135531 · 2024-1872