Continuous Glucose Monitors (CGMs) for All: Studying the Impact of Expanding CGM Access
Recruiting · NCT06658067 · Interventional (participants receive a specific treatment) · Lead sponsor: Yale University
View the official record on ClinicalTrials.gov →Interventions studied
Continuous Glucose Monitor (CGM)
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- Fair Haven Community Health Care (FHCHC) - New Haven, Connecticut, United States