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Glycemic Control in Left Ventricular Assist Devices (LVADs)

This observational study is looking at how well a common blood sugar test, hemoglobin A1c, works for people with Type 2 Diabetes Mellitus who also have a Left Ventricular Assist Device (LVAD) implanted. Researchers want to see if A1c accurately reflects blood sugar levels in these patients. You might be able to join if you are an adult with Type 2 Diabetes, have had an LVAD (HeartWare or HeartMate 3) implanted after 2010, and can use a smartphone app. The study will compare A1c results with readings from a Freestyle Libre 3 Continuous Glucose Monitor (CGM) to see if continuous monitoring can help improve blood sugar control and prevent low blood sugars. This study is currently unclear on its recruitment status and plans to enroll 20 participants.

Study design
This is an observational study with no specified phase, planning to enroll 20 participants. It will compare different ways of measuring blood sugar control.
What's involved
You will use a Freestyle Libre 3 Continuous Glucose Monitor (CGM) for about 3 months. You will also need to upload CGM data weekly using the LibreLink app on your smartphone.
Compensation
Not stated in the trial record.
Follow-up
Your average glucose values will be measured at 3 months, and estimated average glucose (eAG) values based on A1c and fructosamine will also be measured at 3 months.

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NCT05933161

A Study of Glycemic Control in Left Ventricular Assist

Recruiting
Not specifiedAges 18+Observational
Mayo Clinic
~20 participants
Updated 2026-05-08 on ClinicalTrials.gov
What's tested:Freestyle Libre 3 Continuous Glucose Monitor (CGM)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Average glucose values based on continuous glucose monitoring
Measured over 3 months
+2 more outcomes measured

Conditions

Type 2 Diabetes Mellitus
Hyperglycemia
Hypoglycemia

Explore related trials

Type 2 Diabetes Mellitus

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Andrew Rosenbaum, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Sarah Schettle, PA-C
[email protected]
(507) 293-1375
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Type I diabetics
Unable to return at 3 month evaluation
Unwillingness to participate

What this trial measures

  • Average glucose values based on continuous glucose monitoring3 months

    Average level of blood sugar reported in mg/dL obtained via the Freestyle Libre 3 CGM over a 3 month period.

  • Estimated average glucose (eAG) values based on hemoglobin-A1c lab values3 months

    Estimated average level of blood sugar reported in mg/dL based on conversion of hemoglobin-A1c lab values (eAG=28.7\*A1C - 46.7) collected at the 3-month visit.

  • Estimated average glucose (eAG) values based on fructosamine lab values3 months

    Estimated average level of blood sugar reported in mg/dL based on conversion of fructosamine lab values (eAG= 28.7\*(0.017 x fructosamine + 1.61) - 46.7) collected at the 3-month visit.