Providing free continuous glucose monitors to improve diabetes management
CGMs for All: Studying the Impact of Expanding CGM Access
This study is testing if giving free continuous glucose monitors to adults with poorly controlled type 2 diabetes can help them manage their blood sugar better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 17 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT06658067 on ClinicalTrials.gov |
What this trial studies
This study examines the effects of providing continuous glucose monitors (CGMs) at no cost to adult patients with poorly controlled type 2 diabetes. Participants will be selected from Fair Haven Community Health Care and must have an A1c of 8.0 or greater while being unable to afford CGM sensors. The study will assess changes in glycemic control and quality of life over a 12-week period, with follow-up visits to adjust medication based on CGM data. The goal is to determine if access to CGMs can improve health outcomes for economically disadvantaged patients.
Who should consider this trial
Good fit: Ideal candidates are adults with type 2 diabetes, an A1c of 8.0 or greater, and who are unable to afford continuous glucose monitors.
Not a fit: Patients who have well-controlled diabetes or those who can afford CGM sensors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly enhance glycemic control and quality of life for patients with type 2 diabetes who currently lack access to necessary monitoring tools.
How similar studies have performed: Other studies have shown positive outcomes with similar interventions, indicating that providing CGMs can improve diabetes management in underserved populations.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New Haven, Connecticut
- Fair Haven Community Health Care (FHCHC) — New Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Kasia Lipska, MD MHS — Yale University
- Study coordinator: Justin A Dower, MD
- Email: justin.dower@yale.edu
- Phone: (973) 901-4431
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.