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This is an investigator initiated prospective, randomized controlled trial which aims to compare two groups of patients with either type 2 or steroid-induced diabetes who are discharged with insulin. The intervention group will use the Libre 3 Plus continuous glucose monitoring (CGM) system at discharge, while the control group will use blinded CGM and fingerstick monitoring. Both the intervention and control groups will wear the sensor for 28 days post discharge and participate in telehealth diabetes management visits. The target enrollment for the study is 65 participants and participants are expected to be in the study for up to 35 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Libre 3 Plus continuous glucose monitoring (CGM) system | Experimental | use of unmasked continuous glucose monitoring |
|
| Blinded CGM and fingerstick monitoring | Active Comparator | Self-monitoring blood glucose (SMBG)+masked CGM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Libre 3 Plus continuous glucose monitoring (CGM) system | Device | Use of unmasked CGM after discharge |
|
| Measure | Description | Time Frame |
|---|---|---|
| time in range 70-180 mg/dl | percent time in range for last 10 days of study | Day 20-30 |
| Measure | Description | Time Frame |
|---|---|---|
| 30 day time in range | Overall 30 day time in range | Day 30 |
| Percent time >180mg/dL | percent time in range on day 30 | Day 30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sophie Baum | Contact | 212-241-7173 | sophie.baum@mssm.edu |
| Name | Affiliation | Role |
|---|---|---|
| Grenye O'Malley, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10035 | United States |
Dates tied to admission which is identifying
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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randomized control trial
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| Blinded Continuous Glucose Monitoring | Device | Masked CGM |
|
| Finger stick | Behavioral | Self-monitoring blood glucose |
|
| Percent time >250mg/dL | percent time in range on day 30 | Day 30 |
| Percent time <70mg/dL | percent time in range on day 30 | Day 30 |
| Percent time <54mg/dL | percent time in range on day 30 | Day 30 |
| D004700 | Endocrine System Diseases |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |