A Study of Glycemic Control in Left Ventricular Assist

Type 2 Diabetes Mellitus Clinical Trial

— GLYCEM1C-LVAD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05933161
• Other study ID #: 22-011965
• Status: Recruiting
• Start date: November 10, 2023
• Est. completion date: July 2025

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: Sarah Schettle, PA-C
• Phone: (507) 293-1375
• Email: Schettle.Sarah[@]mayo.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Hyperglycemia
• Hypoglycemia
• Type 2 Diabetes Mellitus

Intervention

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 hyperglycemia that were observed.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average glucose values based on continuous glucose monitoring	Average level of blood sugar reported in mg/dL obtained via the Freestyle Libre 3 CGM over a 3 month period.	3 months
Primary	Estimated average glucose (eAG) values based on hemoglobin-A1c lab values	Estimated average level of blood sugar reported in mg/dL based on conversion of hemoglobin-A1c lab values (eAG=28.7*A1C - 46.7) collected at the 3-month visit.	3 months
Primary	Estimated average glucose (eAG) values based on fructosamine lab values	Estimated average level of blood sugar reported in mg/dL based on conversion of fructosamine lab values (eAG= 28.7*(0.017 x fructosamine + 1.61) - 46.7) collected at the 3-month visit.	3 months
Secondary	Number of adjustments of antihyperglycemic agents	Number of adjustments made to diet and medication therapy based on consultation from a trained diabetes specialist to improve episodes of hypoglycemia or severe hyperglycemia following review of glucose levels obtained via the Freestyle Libre 3 CGM.	3 months
Secondary	Number of hypoglycemic unawareness episodes	Number of hypoglycemia unawareness episodes defined as periods where subjects did not know that they had low blood sugar according to Freestyle Libre 3 CGM generated alerts.	3 months