Trial | NCT01033773  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Intervention/Treatment

    insulin human sitagliptin sufonylurea ...

  • Study Participants

    86
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.
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 Started
Sep 30
2007
Primary Completion
Nov 30
2008
Study Completion
Jan 31
2009
Results Posted
Oct 05
2020
Last Update
Oct 05
2020

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.

Diabetes education and medication management Other

All enrolled patients received the intervention. There was no comparative arm. The analysis was done as pre and post.

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.

Summary

Intervention

All Events

Event Type Organ System Event Term Intervention

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)

Intervention

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

Intervention

Mean BG at baseline

356.0
mg/dl (Mean)
Standard Deviation: 110

Mean BG at end of intervention

183.0
mg/dl (Mean)
Standard Deviation: 103

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

Intervention

Mean baseline A1C

12.0
percentage of hemoglobin A1C (Mean)
Standard Deviation: 1.5

Mean end of intervention A1C

11.6
percentage of hemoglobin A1C (Mean)
Standard Deviation: 1.6

Age, Customized

Race (NIH/OMB)

Sex: Female, Male

Overall Study

Diabetes Education and Medication Management