NCT05933161 A Study of Glycemic Control in Left Ventricular Assist
| NCT ID | NCT05933161 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Type 2 Diabetes Mellitus |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-11-10 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2023-11-10 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Andrew Rosenbaum, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT05933161 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Type 2 Diabetes Mellitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05933161 currently recruiting?
Yes, NCT05933161 is actively recruiting participants. Contact the research team at Schettle.Sarah@mayo.edu for enrollment information.
Where is the NCT05933161 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT05933161 clinical trial?
NCT05933161 is sponsored by Mayo Clinic. The principal investigator is Andrew Rosenbaum, MD at Mayo Clinic. The trial plans to enroll 20 participants.
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