Freestyle Libre 3 CGM for Diabetes
(GLYCEM1C-LVAD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if tracking blood sugar over three months with hemoglobin A1c accurately reflects levels in people with Left Ventricular Assist Devices (LVADs). Researchers will compare this method with continuous glucose monitoring (CGM) to assess whether CGM provides better blood sugar control and helps prevent low blood sugar episodes. The trial seeks participants with type 2 diabetes who have had an LVAD implanted after 2010 and can use a smartphone app to track their blood sugar data. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance diabetes management for LVAD patients.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. It mentions that any antihyperglycemic regimen (medications to lower blood sugar) is allowed, so you may be able to continue your current diabetes medications.
What prior data suggests that this method is safe for patients with LVADs?
Research has shown that managing diabetes in patients with Left Ventricular Assist Devices (LVADs) presents challenges. Patients with diabetes and LVADs face a higher risk of stroke compared to those without diabetes. This combination may also hinder heart recovery and increase the likelihood of complications.
However, SGLT2 inhibitors, a type of diabetes medication, have shown positive results in these patients. These medications have been associated with fewer deaths and hospital visits, as well as reduced heart failure issues and strokes.
Overall, despite the challenges, certain treatments can enhance the safety of LVADs for patients with diabetes.12345Why are researchers excited about this trial?
Researchers are excited about using the Freestyle Libre 3 continuous glucose monitor (CGM) for patients with Type 2 Diabetes Mellitus (T2DM) who also have a Left Ventricular Assist Device (LVAD). Unlike traditional methods that require regular finger-prick blood tests, this CGM offers a more convenient and pain-free way to continuously track glucose levels in real-time. This can lead to better glycemic control without the hassle of constant manual monitoring. The potential for improved quality of life and more precise management of diabetes in these patients is what makes this approach particularly promising.
What evidence suggests that using a CGM is effective for managing blood sugars in patients with LVADs?
This trial will focus on subjects diagnosed with Type 2 Diabetes Mellitus (T2DM) who have a Left Ventricular Assist Device (LVAD). Participants will receive a Freestyle Libre 3 continuous glucose monitor (CGM) to help manage blood sugar levels. Research has shown that using a CGM can aid in controlling blood sugar, which is crucial as diabetes can worsen outcomes for people with LVADs. Studies have found that diabetic patients face a higher risk of complications and slower recovery after receiving an LVAD. However, effective blood sugar management can improve heart function and overall health. By comparing hemoglobin A1c, which measures long-term blood sugar, with real-time CGM data, researchers aim to find the best way to manage diabetes in these patients.16789
Who Is on the Research Team?
Andrew Rosenbaum, MD
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants use the Freestyle Libre 3 CGM to monitor blood sugar levels continuously and compare with hemoglobin A1c over a 3-month period
Follow-up
Participants are monitored for safety and effectiveness after treatment, including adjustments to antihyperglycemic agents
What Are the Treatments Tested in This Trial?
Interventions
- Freestyle Libre 3 Continuous Glucose Monitor (CGM)
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Subjects diagnosed with T2DM who have a LVAD will be provided a Freestyle Libre 3 CGM.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
Citations
Impact of Diabetes Mellitus on Outcomes in Patients with Left ...
Patients with DM have higher rates of hypertension, dyslipidemia, peripheral vascular disease, and renal dysfunction, posing challenges to LVAD management.
Diabetes and Outcomes After Left Ventricular Assist Device ...
Patients with diabetes have poorer outcomes after surgery in general. In this study, we assess the impact of diabetes on outcomes after left ventricular assist ...
Influence of Diabetes Mellitus on Outcomes in Patients ...
During follow-up, 32 diabetic patients (33%) and 15 nondiabetic patients (16%) died after LVAD implantation. Cumulative probability of death was ...
Left Ventricular Assist Device-Mediated Cardiac Recovery
DM appears to negatively affect functional cardiac improvement on LVAD support and effective glycemic control seems to be beneficial.
Outcomes of Left Ventricular Assist Device Implantation as ...
Patients supported with LVAD had significantly improved 1-year survival, from 25% to 52%, providing >2-fold survival benefit over maximal medical therapy.
Diabetes Mellitus and Outcomes in Patients Supported with ...
Our analysis suggests that diabetic patients receiving LVADs are at an increased risk of stroke when compared to non-diabetic patients. Furthermore, the risk of ...
Impact of Diabetes and Glycemia on Cardiac Improvement ...
Type 2 diabetes and pre‐LVAD glycemia modify the potential for functional cardiac improvement and the risk for adverse events on LVAD support.
Long-Term Use of a Left Ventricular Assist Device for End- ...
The Kaplan–Meier estimates of survival at one year were 52 percent in the device group and 25 percent in the medical-therapy group (P=0.002) and at two years ...
SGLT2 inhibitors and cardiovascular outcomes in patients ...
SGLT2i use in LVAD patients reduced all-cause death by 43% and hospitalization by 38%. · SGLT2i use was linked to fewer heart failure exacerbations, strokes, and ...
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