CGMs for All: Studying the Impact of Expanding CGM Access
Yale University
Summary
This non-blinded, non-randomized pre-post study will examine the impact of providing CGM sensors free of charge to adult patients of Fair Haven Community Health Care with poorly controlled type 2 diabetes on glycemic control and quality of life.
Description
This study will enroll adult patients with type 2 diabetes and A1c of 8.0 or greater despite long-term use of insulin who are underinsured and under-resourced , meaning they are unable to reasonably afford CGM sensors. The participants will be chosen from among the panels of three providers. This study aims to determine whether providing CGMs free of charge to patients with poorly controlled diabetes who could not otherwise afford them positively impacts their glycemic control and quality of life. FHCHC's clinicians will identify adult patients from their panel with type 2 diabetes and poor…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Diagnosed with type 2 diabetes mellitus * A1c greater than or equal to 8.0 within two weeks of the time of enrollment * On insulin for at least one year +/- other antihyperglycemics * Ability and willingness to wear CGM for 14-day periods throughout the trial period * Ability and willingness to comply with provider-directed adjustments to medication regimen * Inability to afford CGM sensors A note on Vulnerable Pop…
Interventions
- DeviceContinuous Glucose Monitor (CGM)
The first CGM sensor will be applied as directed during the first visit with a brief training by staff. Participant will be instructed to remove and replace the device every 14 days for the remainder of the 3-month trial period. Participant will also be instructed to scan the sensor three times daily. Compliance may be tracked via remote accessing of the blood glucose log on the online FreeStyle portal. CGM models used will include the Abbott FreeStyle Libre 2 and 3 and Dexcom G5, G6 and G7.
Location
- Fair Haven Community Health Care (FHCHC)New Haven, Connecticut