Stop Emergency Room Visits for Hyperglycemia Project - District of Columbia (DC)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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STEP-DC: Stop Emergency Room Visits for Uncontrolled Hyperglycemia Project in the District of Columbia

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Antihyperglycemic medication guideline for management of uncontrolled hyperglycemia presenting to the ED using metformin, sulfonylurea and/or insulin
* Behavioral: Diabetes survival skills self-management education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Type 2 Diabetes Mellitus, random BG > 200 mg/dL, willing and able to provide informed consent and to participate in diabetes self-management education (DSME) stable for discharge from the ED once hyperglycemia treatment initiated. Exclusion Criteria: type 1 Diabetes Mellitus, diabetic ketoacidosis or hyperosmolar non-ketotic state, concomitant treatment with glucocorticoids (other than stable maintenance dose therapy), cognitive or physical impairment preventing participation in DSME unwillingness or inability to provide consent and/or attend follow-up visits.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Diabetes education and medication management<br>All enrolled patients received the intervention. There was no comparative arm. The analysis was done as pre and post. | Drug: Antihyperglycemic medication guideline for management of uncontrolled hyperglycemia presenting to the ED using metformin, sulfonylurea and/or insulin<br>* 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.<br>Behavioral: Diabetes survival skills self-management education<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | difference between mean hemoglobin A1C at baseline and mean Hemoglobin A1C to end of intervention | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes mellitus, Uncontrolled hyperglycemia, Emergency Department