A Study of Glycemic Control in Left Ventricular Assist
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Type I diabetics
Unable to return at 3 month evaluation
Unwillingness to participate
Trial population
Subjects diagnosed with Type 2 Diabetes Mellitus who have a Left Ventricular Assist Device (LVAD) will be recruited from the LVAD clinic at Mayo Clinic in Rochester, MN.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Freestyle Libre 3 Continuous Glucose Monitor (CGM)
DeviceSubjects 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Left Ventricular Assist Device (LVAD) supported Type 2 Diabetes Mellitus (T2DM) Subjects1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
3 months2
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.
Time frame
3 months3
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.
Time frame
3 monthsSecondary outcomes
1
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.
Time frame
3 months2
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.
Time frame
3 monthsSponsors and contacts
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Source ClinicalTrials.gov