Actively Recruiting
GLYcemic Control Evaluation by Continuous Glucose Monitor Compared With a1C in Left Ventricular Assist Device-supported Patients (GLYCEM1C-LVAD)
Led by Mayo Clinic · Updated on 2026-05-08
20
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the accuracy of hemoglobin A1c, a common blood sugar control measurement over three months, in patients with implanted Left Ventricular Assist Devices (LVADs). The study aims to compare A1c results with continuous glucose monitoring (CGM) data to see if A1c is a reliable indicator for this group. Additionally, the trial will explore whether CGM use can improve blood sugar control and reduce low blood sugar episodes in patients with type 2 diabetes and LVAD support. Participants diagnosed with type 2 diabetes and supported by a contemporary centrifugal flow LVAD will receive a Freestyle Libre 3 CGM device. They will use this device to monitor blood glucose continuously over about three months. Data from the CGM will be uploaded weekly via the LibreLink smartphone app for review by diabetes-trained providers. Based on these results, diet and medication adjustments may be made to manage blood sugar levels and prevent hypoglycemia or severe hyperglycemia. During the study, participants will have their average glucose levels measured by CGM, hemoglobin A1c, and fructosamine lab tests at three months. Researchers will track changes in antihyperglycemic medications and episodes of hypoglycemic unawareness. Participants must be able to use a smartphone app and attend a follow-up evaluation at three months. The study will monitor glucose control and treatment effects during this period, providing close consultation and support throughout.
CONDITIONS
Brief Title
A Study of Glycemic Control in Left Ventricular Assist
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- More than 3 months have passed since LVAD implantation
- Able to use a smartphone device for the LibreLink app to upload glucose data
- Patients may already have a continuous glucose monitor in place
You will not qualify if you...
- Diagnosis of type I diabetes mellitus
- Unable to return for the 3-month evaluation
- Unwilling to participate in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 3 months
Participants are provided a Freestyle Libre 3 Continuous Glucose Monitor (CGM) to monitor blood glucose levels throughout the study. CGM data will be uploaded weekly for review and consultation with a diabetes-trained provider to adjust diet and medication therapy as needed.
Weekly visits (virtual or in-person) for data upload and consultation
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
S
Sarah Schettle, PA-C
A
Andrew Rosenbaum, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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