Understanding blood sugar control in patients with Left Ventricular Assist Devices
GLYcemic Control Evaluation by Continuous Glucose Monitor Compared With a1C in Left Ventricular Assist Device-supported Patients (GLYCEM1C-LVAD)
This study is trying to see if using a continuous glucose monitor gives better information about blood sugar control than traditional blood tests for people with Left Ventricular Assist Devices and type 2 diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT05933161 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of hemoglobin A1c as a measure of glycemic control in patients with Left Ventricular Assist Devices (LVADs). Researchers will compare A1c levels with continuous glucose monitor (CGM) readings to determine if CGM provides better insights into blood sugar management. The study will involve patients who have been implanted with contemporary LVADs and have a diagnosis of type 2 diabetes. By utilizing the Freestyle Libre 3 CGM, the study seeks to improve blood sugar control and minimize episodes of hypoglycemia.
Who should consider this trial
Good fit: Ideal candidates include individuals with type 2 diabetes who have undergone LVAD implantation and are capable of using a smartphone for data upload.
Not a fit: Patients with type 1 diabetes or those unable to participate in follow-up evaluations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved blood sugar management strategies for patients with LVADs and type 2 diabetes.
How similar studies have performed: Other studies have explored glycemic control in diabetic patients, but this specific approach in the context of LVADs is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Andrew Rosenbaum, MD — Mayo Clinic
- Study coordinator: Sarah Schettle, PA-C
- Email: Schettle.Sarah@mayo.edu
- Phone: (507) 293-1375
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.