RecruitingNCT05933161

A Study of Glycemic Control in Left Ventricular Assist

GLYcemic Control Evaluation by Continuous Glucose Monitor Compared With a1C in Left Ventricular Assist Device-supported Patients (GLYCEM1C-LVAD)

Sponsor

Mayo Clinic

Enrollment

20 participants

Start Date

Nov 10, 2023

Study Type

OBSERVATIONAL

Conditions

Hyperglycemia Hypoglycemia Type 2 Diabetes Mellitus

Summary

The study is being conducted to understand if the hemoglobin A1c, a measurement of control of blood sugars over a 3-month time, is valid in patients with Left Ventricular Assist Devices (LVADs) in place. To understand whether it is an adequate measurement, the investigators will compare the A1c to results from a continuous glucose monitor (CGM) measurement of blood sugars. By monitoring blood sugars continuously, the investigators will also assess whether they can get better control of blood sugars with a CGM, including avoiding low blood sugars.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how well blood sugar (glucose) is controlled in people who have a heart pump implant (called an LVAD — left ventricular assist device) and also have type 2 diabetes. Researchers will use a small wearable sensor (continuous glucose monitor) to track blood sugar levels over time. **You may be eligible if...** - You have had a centrifugal-flow heart pump (HeartWare or HeartMate 3) implanted after 2010 - You have type 2 diabetes - You are more than 3 months past your heart pump surgery - You are able to use a smartphone app to upload glucose data - You are on any diabetes medication **You may NOT be eligible if...** - You have type 1 diabetes - You are unable to return for a 3-month follow-up visit - You are unwilling to participate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEFreestyle Libre 3 Continuous Glucose Monitor (CGM)

Subjects will be provided a Freestyle Libre 3 CGM for monitoring of blood glucose levels throughout participation in the study (approximately 3 months). CGM data will be uploaded to the LibreLink app on a weekly basis for review of glucose control and consultation with a diabetes-trained provider for any values outside of normal ranges. Adjustments to diet and medication therapy (antihyperglycemic therapy) will be made during consultations to improve episodes of hypoglycemia or severe hyperglycemia that were observed.

Locations(1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

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NCT05933161

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