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The purpose of this research is to prove that data generated by your real-time personal continuous glucose monitors CGMs brought in the hospital at the time of hospitalization can be monitored and safely used to guide insulin therapy aiming to improve glycemic control and to diminish the hypoglycemia and hyperglycemia episodes without negatively affecting patients' satisfaction, providers and your nurses satisfaction with how glucose is monitored and treated in the hospital.
This study will be a single center, randomized, unblinded, prospective, crossover, 2 arm, pilot study. The study will compare the glucose control in hospitalized patients with diabetes mellitus on insulin therapy and wearing a personal CGM when the CGM data will be continuously accessed versus glucose control for hospitalized patients not having the CGM data continuously accessed and receiving inpatient standard of care for diabetes mellitus.
Population:
Adult patients with diagnosis of diabetes mellitus, receiving subcutaneous insulin therapy in the hospital or in the home hospital program - Advanced Care at Home Program (ACH) and wearing a personal real time CGM at the time of admission.
Eligible subjects will be identified and will be approached for enrollment in person by the research coordinators. After enrollment they will be randomized in 2 arms: intervention and control arms.
Both intervention and control arm subjects:
Control Arm subjects:
Intervention Arm subjects:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | patients admitted to the hospital wearing a CGM with data not monitored in real time |
|
| Monitored | Experimental | patients admitted to the hospital wearing a CGM with data monitored in real time |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Real time CGM data monitoring | Device | CGM data will be monitored in real time during daytime in the hospital. Alerts about high and low glucose levels will be communicated to patient's nurse and treating providers. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in mean glucose levels between subjects in intervention vs control group | Difference in mean glucose levels between subjects in intervention vs control group | From admission date to discharge date up to 8 weeks. |
| Difference in Time in Range (time spent with CGM values between 70-180 mg/dl) between subjects in intervention and control cohorts | Difference in Time in Range (time spent with CGM values between 70-180 mg/dl) between subjects in intervention and control cohorts | From admission date to discharge date up to 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Time Below Range <54 mg/dl and Time Below Range <70 mg/dl between subjects in intervention and control cohorts | Difference in Time Below Range <54 mg/dl and Time Below Range <70 mg/dl between subjects in intervention and control cohorts | From admission date to discharge date up to 8 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adrian G Dumitrascu, MD | Contact | 9049532000 | dumitrascu.adrian@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Adrian G Dumitrascu, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Recruiting | Jacksonville | Florida | 32224 | United States |
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| Insulin dose adjustment based on glucometer and CGM glucose data trends | Device | Insulin dose will be modulate based on glucometer values and previous day glucose trends as recorded on CGM. |
|
| Share CGM data on admission and on discharge from the hospital | Device | Record 14 days' worth of CGM data prior to admission and all CGM data recorded during the hospitalization at the time of discharge from the hospital |
|
| Difference in Time Above Rance >180 mg/dl and Time Above Rance >250 mg/dl between subjects in intervention and control cohorts. |
Difference in Time Above Rance >180 mg/dl and Time Above Rance >250 mg/dl between subjects in intervention and control cohorts. |
| From admission date to discharge date up to 8 weeks. |
| Measure subjects perceived satisfaction with CGM inpatient monitoring | Percentage of subjects satisfied or very satisfied with inpatient CGM monitoring | At the time of discharge date assessed up to 8 weeks. |
| 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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