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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
50
Continuous glucose monitors will be placed subcutaneously every 14 days.
University Medical Center
New Orleans, Louisiana, United States
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.
Time frame: Baseline, 6 months
Change in Time in Range (TIR)
TIR is a percentage of time that a person with diabetes spends within their target blood glucose range. The investigators will review the data from the CGM devices and assess if there are any changes in the TIR between the 2 groups at baseline and at 6 months. The higher the percentage is for TIR, the better the blood glucose control is for patients.
Time frame: Baseline, 6 months
Change in documented hypoglycemia <70 mg/ dl and severe hypoglycemia - <54 mg/dl
The investigators will measure the change in documented hypoglycemia and severe hypoglycemia in patients in both groups at baseline and at 6 months. The lower the numbers of the hypoglycemia incidences, the better the outcome is. Documented hypoglycemia and severe hypoglycemia will be measured as a percentage of time that a person with diabetes below their target blood glucose range.
Time frame: Baseline, 6 months
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