RECRUITING

A Study of Glycemic Control in Left Ventricular Assist

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

GLYcemic Control Evaluation by Continuous Glucose Monitor Compared With a1C in Left Ventricular Assist Device-supported Patients (GLYCEM1C-LVAD)

Quick Facts

Study Start:2023-11-10
Study Completion:2025-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05933161

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Prior implantation of contemporary, centrifugal flow LVAD (HeartWare or HeartMate 3) at any time after 2010
  2. * Diagnosis of type II diabetes mellitus
  3. * Any antihyperglycemic regimen
  4. * Greater than 3 months out from LVAD implantation
  5. * Capable of utilizing smartphone device for LibreLink app for uploading glycemic data
  6. * Patients may be enrolled who have preexisting CGM in place.
  1. * Type I diabetics
  2. * Unable to return at 3 month evaluation
  3. * Unwillingness to participate

Contacts and Locations

Study Contact

Sarah Schettle, PA-C
CONTACT
(507) 293-1375
Schettle.Sarah@mayo.edu
Andrew Rosenbaum, MD
CONTACT
(507) 284-0783
Rosenbaum.Andrew@mayo.edu

Principal Investigator

Andrew Rosenbaum, MD
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Andrew Rosenbaum, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-10
Study Completion Date2025-07

Study Record Updates

Study Start Date2023-11-10
Study Completion Date2025-07

Terms related to this study

Keywords Provided by Researchers

  • Left Ventricular Assist Device (LVAD)

Additional Relevant MeSH Terms

  • Type 2 Diabetes Mellitus
  • Hyperglycemia
  • Hypoglycemia