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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: 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

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Washington Hospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Diabetes education and medication management; 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; 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.; Behavioral: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medstar Health Research Institute
• Investigators: Principal Investigator: Michelle F Magee, MD, MBBCh, Medstar Diabetes and Research Institutes, Georgetown University School of Medicine.

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): November 1, 2008
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: December 14, 2009
• First Submitted That Met QC Criteria: December 14, 2009
• First Posted (Estimate): December 16, 2009

Study Record Updates

• Last Update Posted (Actual): October 5, 2020
• Last Update Submitted That Met QC Criteria: September 11, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Emergency Department; Type 2 diabetes mellitus; Uncontrolled hyperglycemia
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Disease Attributes; Hyperglycemia; Diabetes Mellitus; Diabetes Mellitus, Type 2; Emergencies; Physiological Effects of Drugs; Hypoglycemic Agents; Metformin
• Other Study ID Numbers: 2007-268