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To demonstrate that a focused Emergency Department (ED) intervention for uncontrolled hyperglycemia enables safe and effective glycemic management and reduces emergency room re-visits. We assessed hypoglycemia BG < 60mg/dL; change in mean blood glucose and A1C, and ED revisits for hyperglycemia.
Patients with BG > 200mg/dL presenting to an urban tertiary care hospital ED were enrolled in a 4 week prospective intervention with historic self-controls. Subjects returned at 12-72 hours, 2 and 4 weeks. Diabetes medications (including sulfonylureas, metformin and/or insulin) were initiated and/or adjusted at each visit using the intervention algorithm per presenting blood glucose and prior diabetes medications. Survival skills self-management education and navigation to outpatient services were provided.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetes education and medication management | Other | All enrolled patients received the intervention. There was no comparative arm. The analysis was done as pre and post. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antihyperglycemic medication guideline for management of uncontrolled hyperglycemia presenting to the ED using metformin, sulfonylurea and/or insulin | Drug | Diabetes medications (including sulfonylureas, metformin and/or insulin) were initiated and/or adjusted at each visit using the intervention algorithm per presenting blood glucose and prior diabetes medications. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Hypoglycemia Events (Blood Glucose < 60mg/dL) Within 24 Hours of Baseline Visit | Total Number of hypoglycemic events defined as Blood Glucose < 60 within 24 hours of index emergency room visit (baseline) | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Blood Glucose From Time of Presentation to Emergency Room to End of Intervention 30 Days From Baseline | Mean difference in of blood glucose in mg/dl between baseline mean BG and end of intervention mean BG 30 days from baseline | 30 days |
| Change in Hemoglobin A1C From Baseline to End of Intervention at 30 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle F Magee, MD, MBBCh | Medstar Diabetes and Research Institutes, Georgetown University School of Medicine. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Diabetes Education and Medication Management | All enrolled patients received the intervention. There was no comparative arm. The analysis was done as pre and post. Antihyperglycemic medication guideline for management of uncontrolled hyperglycemia presenting to the ED using metformin, sulfonylurea and/or insulin: Diabetes medications (including sulfonylureas, metformin and/or insulin) were initiated and/or adjusted at each visit using the intervention algorithm per presenting blood glucose and prior diabetes medications. Diabetes survival skills self-management education: Survival skills DSME based upon current JCAHO and ADA joint recommendations for persons with diabetes prior to discharge to the outpatient setting was initiated in the ED and continued at the follow-up encounters. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Diabetes survival skills self-management education | Behavioral | Survival skills DSME based upon current JCAHO and ADA joint recommendations for persons with diabetes prior to discharge to the outpatient setting was initiated in the ED and continued at the follow-up encounters. |
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difference between mean hemoglobin A1C at baseline and mean Hemoglobin A1C to end of intervention |
| 30 days |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | All enrolled patients received the intervention. There was no comparative arm. The analysis was done as pre and post. Antihyperglycemic medication guideline for management of uncontrolled hyperglycemia presenting to the ED using metformin, sulfonylurea and/or insulin: Diabetes medications (including sulfonylureas, metformin and/or insulin) were initiated and/or adjusted at each visit using the intervention algorithm per presenting blood glucose and prior diabetes medications. Diabetes survival skills self-management education: Survival skills DSME based upon current JCAHO and ADA joint recommendations for persons with diabetes prior to discharge to the outpatient setting was initiated in the ED and continued at the follow-up encounters. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | Total Number of Hypoglycemia Events (Blood Glucose < 60mg/dL) Within 24 Hours of Baseline Visit | Total Number of hypoglycemic events defined as Blood Glucose < 60 within 24 hours of index emergency room visit (baseline) | Posted | Number | events | 24 hours |
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| Secondary | Change in Mean Blood Glucose From Time of Presentation to Emergency Room to End of Intervention 30 Days From Baseline | Mean difference in of blood glucose in mg/dl between baseline mean BG and end of intervention mean BG 30 days from baseline | This data was only available for 51 patients therefore only 51 patients' results were analyzed. | Posted | Mean | Standard Deviation | mg/dl | 30 days |
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| ||||||||||||||||||||||||||
| Secondary | Change in Hemoglobin A1C From Baseline to End of Intervention at 30 Days | difference between mean hemoglobin A1C at baseline and mean Hemoglobin A1C to end of intervention | Only 46 patients had a baseline and end of intervention A1C available therefore only 46 participants are included in the data | Posted | Mean | Standard Deviation | percentage of hemoglobin A1C | 30 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 | Intervention | All enrolled patients received the intervention. There was no comparative arm. The analysis was done as pre and post. Antihyperglycemic medication guideline for management of uncontrolled hyperglycemia presenting to the ED using metformin, sulfonylurea and/or insulin: Diabetes medications (including sulfonylureas, metformin and/or insulin) were initiated and/or adjusted at each visit using the intervention algorithm per presenting blood glucose and prior diabetes medications. Diabetes survival skills self-management education: Survival skills DSME based upon current JCAHO and ADA joint recommendations for persons with diabetes prior to discharge to the outpatient setting was initiated in the ED and continued at the follow-up encounters. | 0 | 86 | 0 | 86 | 14 | 86 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycemia | Endocrine disorders | Blood sugar less then 70 mg/dl |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Michelle Magee | MedStar Health Research Institute | 2028772383 | michelle.f.magee@medstar.net |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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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