A Study of Glycemic Control in Left Ventricular Assist

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT05933161
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Nov 10, 2023
Status verified
May 2026
Primary completion
Apr 30, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
20 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Average glucose values based on continuous glucose monitoring [ Time Frame: 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Sarah Schettle, PA-C
[email protected]
(507) 293-1375
Andrew Rosenbaum, MD
[email protected]
(507) 284-0783
Andrew Rosenbaum, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Rochester, MN

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Type 2 diabetes
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By research site
Mayo Clinic in Rochester· Rochester, MN

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