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OpenTrials
Completed

NCT Number: NCT01033773

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Disease Attributes Emergencies Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Total Number of Hypoglycemia Events (Blood Glucose < 60mg/dL) Within 24 Hours of Baseline Visit

    Time frame: 24 hours

    Total Number of hypoglycemic events defined as Blood Glucose < 60 within 24 hours of index emergency room visit (baseline)

Secondary outcomes

  1. Change in Mean Blood Glucose From Time of Presentation to Emergency Room to End of Intervention 30 Days From Baseline

    Time frame: 30 days

    Mean difference in of blood glucose in mg/dl between baseline mean BG and end of intervention mean BG 30 days from baseline

  2. Change in Hemoglobin A1C From Baseline to End of Intervention at 30 Days

    Time frame: 30 days

    difference between mean hemoglobin A1C at baseline and mean Hemoglobin A1C to end of intervention

Sponsors and collaborators

Lead sponsor

Medstar Health Research Institute

Other

Registry information

Official study title

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

Acronym: STEP-DC

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Dec 16, 2009
Registry last updated
Oct 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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