Providing free continuous glucose monitors to improve diabetes management

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.