Understanding blood sugar control in patients with Left Ventricular Assist Devices

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 observational study aims to evaluate the effectiveness of hemoglobin A1c as a measure of glycemic control in patients with Left Ventricular Assist Devices (LVADs). Researchers will compare A1c levels with continuous glucose monitor (CGM) readings to determine if CGM provides better insights into blood sugar management. The study will involve patients who have been implanted with contemporary LVADs and have a diagnosis of type 2 diabetes. By utilizing the Freestyle Libre 3 CGM, the study seeks to improve blood sugar control and minimize episodes of hypoglycemia.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Prior implantation of contemporary, centrifugal flow LVAD (HeartWare or HeartMate 3) at any time after 2010
* Diagnosis of type II diabetes mellitus
* Any antihyperglycemic regimen
* Greater than 3 months out from LVAD implantation
* Capable of utilizing smartphone device for LibreLink app for uploading glycemic data
* Patients may be enrolled who have preexisting CGM in place.

Exclusion Criteria:

* Type I diabetics
* Unable to return at 3 month evaluation
* Unwillingness to participate

Where it's running

• Mayo Clinic in Rochester
  Rochester, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Andrew Rosenbaum, MD — Mayo Clinic
• Study coordinator: Sarah Schettle, PA-C
• Email: Schettle.Sarah@mayo.edu
• Phone: (507) 293-1375

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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.