A Study of Glycemic Control in Left Ventricular Assist (GLYCEM1C-LVAD)

Mayo Clinic

Status: Enrolling

Conditions: Hypoglycemia; Hyperglycemia; Type 2 Diabetes Mellitus

Treatments: Device: Freestyle Libre 3 Continuous Glucose Monitor (CGM)

Study type: Observational

Funder types: Other

Identifiers

NCT05933161

22-011965

Details and patient eligibility

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 1 patient group

Left Ventricular Assist Device (LVAD) supported Type 2 Diabetes Mellitus (T2DM) Subjects

Description:

Subjects diagnosed with T2DM who have a LVAD will be provided a Freestyle Libre 3 CGM.

Treatment:

Device: Freestyle Libre 3 Continuous Glucose Monitor (CGM)