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| Name | Class |
|---|---|
| DexCom, Inc. | INDUSTRY |
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Several observational studies have shown that uncontrolled hyperglycemia in hospitalized patients in the non-critical care, non-Intensive Care Unit (non-ICU) setting is associated with prolonged length of stay, increased mortality and an increased incidence of infections. Randomized clinical trials in both the critical and the non-ICU settings have shown that by improving glucose control there is a decrease in the incidence of infections, length of stay and inpatient health care costs.
Continuous glucose monitoring (CGM) systems have evolved as useful devices providing excellent clinical care in patients with Diabetes Mellitus (DM). These systems detect glucose in subcutaneous interstitial fluid using a glucose sensor that transmits glucose measurements to a receiving device that reads out average glucose levels every couple of minutes.
In this clinical trial the investigators propose to examine the clinical use of CGM in hospitalized patients with Diabetes Mellitus type 2 (DM2). CGM use may improve glucometric values and clinical outcomes in hospitalized individuals with Diabetes Mellitus type 2 (DM2).
We use CGM devices to monitor but also to transmit glucose values wirelessly to monitoring devices that are in the nursing station. Half of the participants are placed on Real Time CGM (alarms turned on) and half of them are placed on blinded CGM values (alarms turned off). Nursing staff will be notified when glucose is <85 mg/dl , in order to treat and potentially prevent a potential hypoglycemic episode.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous glucose Monitoring and Point of Care blood glucose | Active Comparator | Hospitalized patients with Diabetes Mellitus type 2 (DM2) managed with Continuous glucose monitoring (CGM) and Point of Care (POC) Finger sticks blood glucose |
|
| Point of Care (POC) blood glucose | Placebo Comparator | Hospitalized Diabetes Mellitus type 2 (DM2) patients managed with Point of Care (POC) blood glucose only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous glucose Monitoring (CGM) device and Point of Care (POC) blood glucose | Device | Testing Blood Glucose levels with Continuous glucose Monitoring (CGM) device and Point of Care (POC) blood glucose |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Time Spent in Hyperglycemia > 180 mg/dL | Through study completion, during hospital stay, an average of 1 week | |
| Percentage of Time Spent in Significant Hyperglycemia (>300 mg/dL) | Through study completion, during hospital stay, an average of 1 week | |
| Number of Participants With Hypoglycemic Events (< 70mg/dL) | Through study completion, during hospital stay, an average of 1 week |
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Inclusion Criteria:
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baltimore VA Medical Center | Baltimore | Maryland | 21201 | United States |
Only de-identified data are going to be shared.
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| ID | Title | Description |
|---|---|---|
| FG000 | Continuous Glucose Monitoring and Point of Care Blood Glucose | Hospitalized patients with Diabetes Mellitus type 2 (DM2) managed with Continuous glucose monitoring (CGM) and Point of Care (POC) Finger sticks blood glucose Continuous glucose Monitoring (CGM) device and Point of Care (POC) blood glucose: Testing Blood Glucose levels with Continuous glucose Monitoring (CGM) device and Point of Care (POC) blood glucose |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 25, 2018 |
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| Point of Care (POC) blood glucose | Other | Testing Blood Glucose levels with Point of Care (POC) blood glucose |
|
| FG001 | Point of Care (POC) Blood Glucose | Hospitalized Diabetes Mellitus type 2 (DM2) patients managed with Point of Care (POC) blood glucose only Point of Care (POC) blood glucose: Testing Blood Glucose levels with Point of Care (POC) blood glucose |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Continuous Glucose Monitoring and Point of Care Blood Glucose | Hospitalized patients with Diabetes Mellitus type 2 (DM2) managed with Continuous glucose monitoring (CGM) and Point of Care (POC) Finger sticks blood glucose Continuous glucose Monitoring (CGM) device and Point of Care (POC) blood glucose: Testing Blood Glucose levels with Continuous glucose Monitoring (CGM) device and Point of Care (POC) blood glucose |
| BG001 | Point of Care (POC) Blood Glucose | Hospitalized Diabetes Mellitus type 2 (DM2) patients managed with Point of Care (POC) blood glucose only Point of Care (POC) blood glucose: Testing Blood Glucose levels with Point of Care (POC) blood glucose |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| A1c, % | Mean | Standard Deviation | % of glycated hemoglobin |
| |||||||||||||||
| DM duration | Mean | Standard Deviation | years |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Time Spent in Hyperglycemia > 180 mg/dL | Posted | Mean | Standard Deviation | percentage of time spent > 180mg/dL | Through study completion, during hospital stay, an average of 1 week |
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| ||||||||||||||||||||||||||||||
| Primary | Percentage of Time Spent in Significant Hyperglycemia (>300 mg/dL) | Posted | Mean | Standard Deviation | percent of time spent > 300mg/dL | Through study completion, during hospital stay, an average of 1 week |
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| Primary | Number of Participants With Hypoglycemic Events (< 70mg/dL) | Posted | Count of Participants | Participants | Through study completion, during hospital stay, an average of 1 week |
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Adverse events collected from the patient enrollment to the end of patient hospitalization, an average of 5 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Continuous Glucose Monitoring and Point of Care Blood Glucose | Hospitalized patients with Diabetes Mellitus type 2 (DM2) managed with Continuous glucose monitoring (CGM) and Point of Care (POC) Finger sticks blood glucose Continuous glucose Monitoring (CGM) device and Point of Care (POC) blood glucose: Testing Blood Glucose levels with Continuous glucose Monitoring (CGM) device and Point of Care (POC) blood glucose | 0 | 6 | 0 | 6 | 2 | 6 |
| EG001 | Point of Care (POC) Blood Glucose | Hospitalized Diabetes Mellitus type 2 (DM2) patients managed with Point of Care (POC) blood glucose only Point of Care (POC) blood glucose: Testing Blood Glucose levels with Point of Care (POC) blood glucose | 0 | 7 | 0 | 7 | 0 | 7 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transferred to ICU (for non study-related reasons) | Infections and infestations | Non-systematic Assessment | Patient developed dry gangrene and was transferred to ICU related to osteomyelitis, not the CGM in our study. |
| |
| Bleeding at site of the CGM insertion | Blood and lymphatic system disorders | Non-systematic Assessment | Minor bleeding at the site of CGM insertion |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ilias (Elias) Spanakis | Veterans Affairs Medical Center | (617) 319-9731 | ispanakis@som.umaryland.edu |
| Apr 25, 2021 |
| Prot_SAP_000.pdf |
| 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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| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| D013525 | Surgical Instruments |
| D019095 | Point-of-Care Systems |
| D001786 | Blood Glucose |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
| D006751 | Hospital Information Systems |
| D006739 | Hospital Administration |
| D058016 | Health Facility Administration |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
| D008331 | Management Information Systems |
| D010346 | Patient Care Management |
| D005947 | Glucose |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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