Continuous Glucose Monitors (CGMs) for All: Studying the Impact of Expanding CGM Access

Launched by YALE UNIVERSITY · Oct 22, 2024

Keywords

ClinConnect Summary

This clinical trial, titled "Continuous Glucose Monitors (CGMs) for All," is studying how providing free continuous glucose monitors (CGMs) can help adults with poorly controlled type 2 diabetes. The goal is to see if using CGMs improves blood sugar levels and the overall quality of life for these patients. Participants will be recruited from Fair Haven Community Health Care, where many patients face economic challenges, and the findings aim to directly benefit this population.

To be eligible for the trial, participants must be adults diagnosed with type 2 diabetes and have a blood sugar level (measured by a test called A1c) of 8.0 or higher. They should have been using insulin for at least a year and be willing to wear a CGM for two-week periods during the study. Participants must also agree to follow their doctor's guidance on any medication changes. Those who cannot afford CGM sensors are particularly encouraged to join. Throughout the study, participants can expect support from the research team and the opportunity to learn more about managing their diabetes.

Gender

ALL

Eligibility criteria

• 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 Populations: Many of FHCHC's patients are economically disadvantaged and of minority backgrounds; the clinic's patient base may be considered to constitute a vulnerable population. As such, recruitment and enrollment will be conducted within a vulnerable population. The nature of the study requires this, and the results are intended to directly benefit this population through the potential for improved glycemic control and quality of life.
• Exclusion Criteria:
• • Insulin naïve
• • Diabetic ketoacidosis (DKA) in previous 6 months
• • End-Stage Renal Disease (ESRD)
• • Contraindications to CGM use
• • Active insurance plan that would provide enough of a subsidy for participant to feasibly purchase CGM sensors
• • Pregnancy