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

This study has been completed.
Sponsor:
Collaborator:
District of Columbia Department of Health
Information provided by:
Medstar Research Institute
ClinicalTrials.gov Identifier:
NCT01033773
First received: December 14, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Type 2 Diabetes Mellitus
 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

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: STEP-DC: Stop Emergency Room Visits for Uncontrolled Hyperglycemia Project in the District of Columbia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medstar Research Institute:

Primary Outcome Measures:
  • Hypoglycemia (blood glucose < 60mg/dL) following index emergency department visit for uncontrolled hyperglycemia [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in mean Blood glucose from time of presentation to Emergency room to end of intervention. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Reduction in emergency dept visits for uncontrolled hyperglycemia. [ Time Frame: 6mos pre- and post-intervention ] [ Designated as safety issue: Yes ]

Enrollment: 86
Study Start Date: September 2007
Study Completion Date: January 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01033773

Locations
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Medstar Research Institute
District of Columbia Department of Health
Investigators
Principal Investigator: Michelle F Magee, MD, MBBCh Medstar Diabetes and Research Institutes, Georgetown University School of Medicine.
  More Information

No publications provided

Responsible Party: Michelle F. Magee, MD, Medstar Diabetes and Research Institutes
ClinicalTrials.gov Identifier: NCT01033773     History of Changes
Other Study ID Numbers: 2007-268
Study First Received: December 14, 2009
Last Updated: December 14, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Medstar Research Institute:
Type 2 diabetes mellitus
Uncontrolled hyperglycemia
Emergency Department

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Emergencies
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Disease Attributes
Pathologic Processes
Insulin
Hypoglycemic Agents
Metformin
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013