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The purposes of this study is to study if CGMs worn in the postoperative ICU or non-ICU hospital setting have adequate accuracy for blood glucose monitoring when compared to point-of-care (POC) capillary glucometers.
Eligible patients will be approached by research staff either preoperatively or on the first 5 days post-surgery and offered to be enrolled. If agreed to participate, they will be fitted with a blinded CGM monitor (Dexcom G6 PRO) as soon as they are awake and alert after the surgery. They will continue to have their blood glucose check as usual in the ICU and on surgical floors with POC glucometers. On discharge, or at the end of the first CGM sensor life, the sensor will be removed and sensor data will be analyzed. CGM data will be compared with Point-of-Care blood glucose monitoring obtained in the hospital.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CGM Patients | Experimental | Subjects with diabetes mellitus or medication induced diabetes that have been admitted to the hospital after a surgery for organ transplantation or scheduled for organ transplant surgery will be fitted with a CGM monitor to monitor glucose levels during hospitalization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Glucose Monitor (CGM) | Device | A device that measures blood sugar levels every 1-5 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| CGM accuracy | Measured by the mean absolute relative difference (MARD), calculated between matched pairs of POC (point of care) glucose monitors and the closest CGM reading. MARD will be summarized as mean (standard deviation) or median (range) for glucose readings <70g/dl, >180g/dl, >250g/dl respectively. | From date of enrollment and until discharge from the hospital up to 30 days. |
| Measure | Description | Time Frame |
|---|---|---|
| CGM recorded hypoglycemia episodes | The incidence and duration of hypoglycemic episodes | From date of enrollment and until discharge from the hospital up to 30 days. |
| CGM recorded hyperglycemia episodes |
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Inclusion Criteria:
Exclusion Criteria:
Patients with skin lesions at the application site that may interfere with placement of the sensor.
Patients with known allergy to medical grade adhesive.
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| Name | Affiliation | Role |
|---|---|---|
| Adrian Dumitrascu, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Jacksonville | Florida | 32224 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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The incidence of hyperglycemic episodes
| From date of enrollment and until discharge from the hospital up to 30 days. |