A Study of Glycemic Control in Left Ventricular Assist

Recruiting

• Conditions: Hypoglycemia; Hyperglycemia; Type 2 Diabetes Mellitus
• Interventions: Device: Freestyle Libre 3 Continuous Glucose Monitor (CGM)

• Registration Number: NCT05933161
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2023-06-28
• Study First Submitted QC: 2023-06-28
• Study First Posted: 2023-07-06
• Study Start: 2023-11-10
• Status Verified: 2024-03
• Last Update Submitted: 2024-04-08
• Last Update Posted: 2024-04-09
• Primary Completion: 2025-04
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

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Exclusion Criteria

• Type I diabetics
• Unable to return at 3 month evaluation
• Unwillingness to participate

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Left Ventricular Assist Device (LVAD) supported Type 2 Diabetes Mellitus (T2DM) Subjects	Freestyle Libre 3 Continuous Glucose Monitor (CGM)	Subjects diagnosed with T2DM who have a LVAD will be provided a Freestyle Libre 3 CGM.

Primary Outcome Measures

Name	Time	Method
Average glucose values based on continuous glucose monitoring	3 months	Average level of blood sugar reported in mg/dL obtained via the Freestyle Libre 3 CGM over a 3 month period.
Estimated average glucose (eAG) values based on fructosamine lab values	3 months	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.
Estimated average glucose (eAG) values based on hemoglobin-A1c lab values	3 months	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.

Secondary Outcome Measures

Name	Time	Method
Number of hypoglycemic unawareness episodes	3 months	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.
Number of adjustments of antihyperglycemic agents	3 months	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States