Continuous Glucose Monitors (CGMs) for All: Studying the Impact of Expanding CGM Access
Recruiting now · Not applicable
Conditions studied: Diabetes, Type 2 Diabetes, Type 2 Diabetes Mellitus - Poor Control
In brief
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.
Key facts
- Study ID
- NCT06658067
- Run by
- Yale University
- People needed
- 17
- Starts
- 2024-11-12
- Expected to finish
- 2026-06-01
- Last updated by the study team
- 2025-12-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Fair Haven Community Health Care (FHCHC) — New Haven, Connecticut, United States (enrolling)
Full record on ClinicalTrials.gov
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