Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Left Ventricular Assist Device (LVAD) supported Type 2 Diabetes Mellitus (T2DM) Subjects | Subjects diagnosed with T2DM who have a LVAD will be provided a Freestyle Libre 3 CGM. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Schettle, PA-C | Contact | (507) 293-1375 | Schettle.Sarah@mayo.edu | |
| Andrew Rosenbaum, MD | Contact | (507) 284-0783 | Rosenbaum.Andrew@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Andrew Rosenbaum, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D006943 | Hyperglycemia |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 |
| D004700 | Endocrine System Diseases |