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

Type 2 Diabetes Mellitus Clinical Trial

— STEP-DC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01033773
• Other study ID #: 2007-268
• Status: Completed
• Phase: N/A
• Start date: September 2007
• Est. completion date: January 2009

Study information

• Verified date: September 2020
• Source: Medstar Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: January 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Emergencies
• Hyperglycemia
• Type 2 Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Medstar Health Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	24 hours
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	30 days
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	30 days