A Study of Glycemic Control in Left Ventricular Assist

NCT05933161 | Recruiting

• 1 other identifier: 22-011965
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus; Hyperglycemia; Hypoglycemia

Keywords

Left Ventricular Assist Device (LVAD)

Outcome Measures

Primary Outcomes (3)

• Average glucose values based on continuous glucose monitoring

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

  3 months

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

  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.

  3 months

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

  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.

  3 months

Secondary Outcomes (2)

• Number of adjustments of antihyperglycemic agents

  3 months

• Number of hypoglycemic unawareness episodes

  3 months

Study Arms (1)

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.

Device: Freestyle Libre 3 Continuous Glucose Monitor (CGM)

Interventions

Freestyle Libre 3 Continuous Glucose Monitor (CGM) 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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects diagnosed with Type 2 Diabetes Mellitus who have a Left Ventricular Assist Device (LVAD) will be recruited from the LVAD clinic at Mayo Clinic in Rochester, MN.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hyperglycemia; Hypoglycemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Andrew Rosenbaum, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Schettle, PA-C

CONTACT

(507) 293-1375; Schettle.Sarah@mayo.edu

Andrew Rosenbaum, MD

CONTACT

(507) 284-0783; Rosenbaum.Andrew@mayo.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 28, 2023
• First Posted: July 6, 2023
• Study Start: November 10, 2023
• Primary Completion: April 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)