A Study of Glycemic Control in Left Ventricular Assist
Recruiting · NCT05933161 · Observational (researchers observe without assigning treatment) · Lead sponsor: Mayo Clinic
View the official record on ClinicalTrials.gov →Interventions studied
Freestyle Libre 3 Continuous Glucose Monitor (CGM)
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 is running
1 location listed across 1 US state.
- Mayo Clinic in Rochester - Rochester, Minnesota, United States