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 purpose of this study is to measure differences in diabetes control with the use of continuous glucose monitor (CGM) and diabetes education compared with standard of care for glucose monitoring (glucometer checks) and diabetes education in participants with diabetes mellitus receiving therapy with insulin and being admitted to Mayo Clinic Advanced Care at Home Program (ACH).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous Glucose Monitoring | Experimental | Subjects admitted to the Advanced Care at Home program (home hospital) will have the continuous glucose monitor sensor placed for up to 10 days to monitor and dose insulin. |
|
| Control Arm (Standard of Care) | No Intervention | Subjects admitted to the Advanced Care at Home program (home hospital) will continue with standard of care glucose monitoring (capillary glucose levels checked via glucometer), insulin dosing, and DM treatment during the 10 day period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Glucose Monitor Dexcom G6 PRO | Device | Connected to a smart phone that transmits continuous glucose monitoring data in real time to Advanced Care at Home Command Center for monitoring. |
| Measure | Description | Time Frame |
|---|---|---|
| Time in Range | Percentage of time with continuous glucose monitor values within 70-180 mg/dl | 10 days |
| Mean daily glucose | Mean daily glucose level (mg/dl) | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of hypoglycemia episodes | Number of episodes with blood glucose below 70 mg/dl measured via point of care testing (POCT) and Continuous Glucose Monitor (CGM) | 10 days |
| Mean absolute relative difference (MARD) variation with Oxygen saturation. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Adrian Dumitrascu, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Recruiting | Jacksonville | Florida | 32224 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Measured in percentage |
| 10 days |
| Mean absolute relative difference (MARD) variation with Daily hemoglobin. | Measured in grams per deciliter (g/dl) | 10 days |
| Mean absolute relative difference (MARD) variation with Glomerular filtration rate (GFR) | Measured in ml/min | 10 days |
| Mean absolute relative difference (MARD) variation with Arterial blood pressure | Measured in millimeters of mercury (mmHg) | 10 days |
| Percentage of subjects to continue use of continuous glucose monitor | Percentage of subjects will using continuous glucose monitor at 40 days post enrollment | 40 days |