Diabetes, Diabetes Mellitus, Diabetes Type 2
Conditions
Keywords
Medicaid, Underinsured, Continuous glucose monitoring, Uninsured
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.
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
DEVICEContinuous Glucose Monitoring (CGM)
Continuous glucose monitors will be placed subcutaneously every 14 days.
Sponsors
Tulane University
Abbott
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glycated hemoglobin (HbA1c) between baseline and 6-month visits for both groups | Baseline, 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Time in Range (TIR) | Baseline, 6 months | 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. |
| Change in documented hypoglycemia <70 mg/ dl and severe hypoglycemia - <54 mg/dl | Baseline, 6 months | 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. |
Countries
United States
Contacts
CONTACTNeha Upadhyay, BDS,MPH
CONTACTAyitevi Agbodji, MD,MPH&TM
PRINCIPAL_INVESTIGATORShaveta Gupta, MD
Tulane University
Outcome results
None listed