20 Participants Needed

A Study of Glycemic Control in Left Ventricular Assist

(GLYCEM1C-LVAD Trial)

SS
AR
Overseen ByAndrew Rosenbaum, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Mayo Clinic
Must be taking: Antihyperglycemics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Research Team

AR

Andrew Rosenbaum, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

Prior implantation of contemporary, centrifugal flow LVAD (HeartWare or HeartMate 3) at any time after 2010
Greater than 3 months out from LVAD implantation
Diagnosis of type II diabetes mellitus
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Freestyle Libre 3 CGM to monitor blood sugar levels continuously and compare with hemoglobin A1c over a 3-month period

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adjustments to antihyperglycemic agents

4 weeks

Treatment Details

Participant Groups
1Treatment groups
Experimental Treatment
Group I: Left Ventricular Assist Device (LVAD) supported Type 2 Diabetes Mellitus (T2DM) SubjectsExperimental Treatment1 Intervention
Subjects diagnosed with T2DM who have a LVAD will be provided a Freestyle Libre 3 CGM.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+
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