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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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for people with type 2 diabetes who have a left ventricular assist device (LVAD), a pump that helps the heart move blood. It compares A1c, a blood test that tracks average blood sugar over 3 months, with readings from a continuous glucose monitor (CGM). It also checks whether using a CGM can help control blood sugar and avoid low blood sugar.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a HeartWare or HeartMate 3 LVAD placed after 2010.
  • Have type 2 diabetes.
  • Use any treatment plan to lower blood sugar.
  • Had the LVAD placed more than 3 months ago.
  • Can use the LibreLink app on a smartphone to upload blood sugar readings.
  • You may join if you already use a CGM, a device that tracks blood sugar throughout the day.

Who can't join

  • Have type 1 diabetes.
  • Cannot return for the 3-month checkup.
  • Do not want to take part.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

MN