Back to resultsStop Emergency Room Visits for Hyperglycemia Project - District of Columbia (DC) (STEP-DC)
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Antihyperglycemic medication guideline for management of uncontrolled hyperglycemia presenting to the ED using metformin, sulfonylurea and/or insulin
Diabetes survival skills self-management education
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Type 2 diabetes mellitus, Uncontrolled hyperglycemia, Emergency Department
Eligibility 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.
Sites / Locations
- Washington Hospital Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Diabetes education and medication management
Arm Description
All enrolled patients received the intervention. There was no comparative arm. The analysis was done as pre and post.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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
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
Full Information
NCT ID
NCT01033773
First Posted
December 14, 2009
Last Updated
September 11, 2020
Sponsor
Medstar Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT01033773
Brief Title
Stop Emergency Room Visits for Hyperglycemia Project - District of Columbia (DC)
Acronym
STEP-DC
Official Title
STEP-DC: Stop Emergency Room Visits for Uncontrolled Hyperglycemia Project in the District of Columbia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medstar Health Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Type 2 diabetes mellitus, Uncontrolled hyperglycemia, Emergency Department
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diabetes education and medication management
Arm Type
Other
Arm Description
All enrolled patients received the intervention. There was no comparative arm. The analysis was done as pre and post.
Intervention Type
Drug
Intervention Name(s)
Antihyperglycemic medication guideline for management of uncontrolled hyperglycemia presenting to the ED using metformin, sulfonylurea and/or insulin
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Diabetes survival skills self-management education
Intervention Description
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 Outcome Measure Information:
Title
Total Number of Hypoglycemia Events (Blood Glucose < 60mg/dL) Within 24 Hours of Baseline Visit
Description
Total Number of hypoglycemic events defined as Blood Glucose < 60 within 24 hours of index emergency room visit (baseline)
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Change in Mean Blood Glucose From Time of Presentation to Emergency Room to End of Intervention 30 Days From Baseline
Description
Mean difference in of blood glucose in mg/dl between baseline mean BG and end of intervention mean BG 30 days from baseline
Time Frame
30 days
Title
Change in Hemoglobin A1C From Baseline to End of Intervention at 30 Days
Description
difference between mean hemoglobin A1C at baseline and mean Hemoglobin A1C to end of intervention
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle F Magee, MD, MBBCh
Organizational Affiliation
Medstar Diabetes and Research Institutes, Georgetown University School of Medicine.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Stop Emergency Room Visits for Hyperglycemia Project - District of Columbia (DC)
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