Recruiting

A1c vs. CGM

Sponsor:

Mayo Clinic

Code:

NCT05933161

Conditions

Type 2 Diabetes Mellitus

Hyperglycemia

Hypoglycemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Freestyle Libre 3 Continuous Glucose Monitor (CGM)

Study Details

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

Study ID

NCT05933161

Start date

Nov 10, 2023

Status verified date

May, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Average glucose values based on continuous glucose monitoring [ Time Frame: 3 months ]
  • Estimated average glucose (eAG) values based on hemoglobin-A1c lab values [ Time Frame: 3 months ]
  • Estimated average glucose (eAG) values based on fructosamine lab values [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Sarah Schettle, PA-C

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

Andrew Rosenbaum, MD

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

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Sarah Schettle, PA-C

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

Andrew Rosenbaum, MD

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

Principal Investigator:

Andrew Rosenbaum, MD

More Information

Sponsor

Mayo Clinic

Last update posted

May 8, 2026

Last verified

May, 2026

Keywords

  • Left Ventricular Assist Device (LVAD)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-05-08.