Hyperglycemia, Hypoglycemia, Type 2 Diabetes Mellitus
Conditions
Keywords
Left Ventricular Assist Device (LVAD)
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.
Interventions
DEVICEFreestyle 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.
Sponsors
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Contacts
CONTACTSarah Schettle, PA-C
CONTACTAndrew Rosenbaum, MD
PRINCIPAL_INVESTIGATORAndrew Rosenbaum, MD
Mayo Clinic
Outcome results
None listed