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NCT Number: NCT05933161

A Study of Glycemic Control in Left Ventricular Assist

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperglycemia Hypoglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Freestyle Libre 3 Continuous Glucose Monitor (CGM)

Device

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.

Primary outcomes

  1. Average glucose values based on continuous glucose monitoring

    Time frame: 3 months

    Average level of blood sugar reported in mg/dL obtained via the Freestyle Libre 3 CGM over a 3 month period.

  2. Estimated average glucose (eAG) values based on hemoglobin-A1c lab values

    Time frame: 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.

  3. Estimated average glucose (eAG) values based on fructosamine lab values

    Time frame: 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.

Secondary outcomes

  1. Number of adjustments of antihyperglycemic agents

    Time frame: 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.

  2. Number of hypoglycemic unawareness episodes

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrew Rosenbaum, MD

CONTACT

[email protected]

(507) 284-0783

Sarah Schettle, PA-C

CONTACT

[email protected]

(507) 293-1375

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Acronym: GLYCEM1C-LVAD

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jul 6, 2023
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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