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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Minnesota
Mayo Clinic in Rochester
RECRUITING
Rochester
Contact Information
Primary
Sarah Schettle, PA-C
Schettle.Sarah@mayo.edu
(507) 293-1375
Backup
Andrew Rosenbaum, MD
Rosenbaum.Andrew@mayo.edu
(507) 284-0783
Time Frame
Start Date: 2023-11-10
Estimated Completion Date: 2027-07
Participants
Target number of participants: 20
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic

This content was sourced from clinicaltrials.gov