A Study of Glycemic Control in Left Ventricular Assist

NCT ID: NCT05933161

Last Updated: 2025-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-10

Study Completion Date

2026-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus Hyperglycemia Hypoglycemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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

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

Freestyle Libre 3 Continuous Glucose Monitor (CGM)

Intervention Type DEVICE

Subjects will be provided a Freestyle Libre 3 CGM for monitoring of blood glucose levels throughout participation in the study (approximately 3 months). CGM data will be uploaded to the LibreLink app on a weekly basis for review of glucose control and consultation with a diabetes-trained provider for any values outside of normal ranges. Adjustments to diet and medication therapy (antihyperglycemic therapy) will be made during consultations to improve episodes of hypoglycemia or severe hyperglycemia that were observed.

Interventions

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Freestyle Libre 3 Continuous Glucose Monitor (CGM)

Subjects will be provided a Freestyle Libre 3 CGM for monitoring of blood glucose levels throughout participation in the study (approximately 3 months). CGM data will be uploaded to the LibreLink app on a weekly basis for review of glucose control and consultation with a diabetes-trained provider for any values outside of normal ranges. Adjustments to diet and medication therapy (antihyperglycemic therapy) will be made during consultations to improve episodes of hypoglycemia or severe hyperglycemia that were observed.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Andrew N Rosenbaum

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrew Rosenbaum, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sarah Schettle, PA-C

Role: CONTACT

(507) 293-1375

Andrew Rosenbaum, MD

Role: CONTACT

(507) 284-0783

Facility Contacts

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Sarah Schettle, PA-C

Role: primary

(507) 293-1375

Andrew Rosenbaum, MD

Role: backup

(507) 284-0783

Other Identifiers

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22-011965

Identifier Type: -

Identifier Source: org_study_id

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