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)
Mayo Clinic
20 participants
Nov 10, 2023
OBSERVATIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria3
- Type I diabetics
- Unable to return at 3 month evaluation
- Unwillingness to participate
Interventions
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05933161