A Study of Glycemic Control in Left Ventricular Assist
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Freestyle Libre 3 Continuous Glucose Monitor (CGM).
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes Mellitus, Hyperglycemia, Hypoglycemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
GLYcemic Control Evaluation by Continuous Glucose Monitor Compared With a1C in Left Ventricular Assist Device-supported Patients (GLYCEM1C-LVAD)
Overview
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.
Interventions
- Device Freestyle Libre 3 Continuous Glucose Monitor (CGM)
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 hyperglyce
Primary outcome measures
- Average glucose values based on continuous glucose monitoring [Time frame: 3 months]
- Estimated average glucose (eAG) values based on hemoglobin-A1c lab values [Time frame: 3 months]
- Estimated average glucose (eAG) values based on fructosamine lab values [Time frame: 3 months]
Secondary outcome measures (2)
- Number of adjustments of antihyperglycemic agents [Time frame: 3 months]
- Number of hypoglycemic unawareness episodes [Time frame: 3 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT05933161 · 22-011965