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

• Sponsor: Medstar Health Research Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT01033773
• Collaborator: (none)
• Enrollment: 86
• Location: 1
• Arm: 1
• Duration (Months): 16
• Patients Per Site Per Month: 5.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
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	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 86 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: STEP-DC: Stop Emergency Room Visits for Uncontrolled Hyperglycemia Project in the District of Columbia
• Study Start Date: Sep 1, 2007
• Actual Primary Completion Date: Nov 1, 2008
• Actual Study Completion Date: Jan 1, 2009

Arms and Interventions

Arm

Intervention/Treatment

Other: Diabetes education and medication management All enrolled patients received the intervention. There was no comparative arm. The analysis was done as pre and post.

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.

Outcome Measures

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Washington Hospital Center	Washington	District of Columbia	United States	20010

Sponsors and Collaborators

• Medstar Health Research Institute

Investigators

• Principal Investigator: Michelle F Magee, MD, MBBCh, Medstar Diabetes and Research Institutes, Georgetown University School of Medicine.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michelle Magee, Director, MedStar Diabetes Institute, Medstar Health Research Institute
• ClinicalTrials.gov Identifier: NCT01033773
• Other Study ID Numbers: 2007-268
• First Posted: Dec 16, 2009
• Last Update Posted: Oct 5, 2020
• Last Verified: Sep 1, 2020

• Keywords provided by Michelle Magee, Director, MedStar Diabetes Institute, Medstar Health Research Institute: Type 2 diabetes mellitus; Uncontrolled hyperglycemia; Emergency Department
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hyperglycemia; Emergencies; Metformin; Hypoglycemic Agents

Study Results

Participant Flow

Arm/Group Title	Diabetes Education and Medication Management
Arm/Group Description	All enrolled patients received the intervention. There was no comparative arm. The analysis was done as pre and post. 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. 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.
Period Title: Overall Study
STARTED	86
COMPLETED	51
NOT COMPLETED	35

Baseline Characteristics

Arm/Group Title	Intervention
Arm/Group Description	All enrolled patients received the intervention. There was no comparative arm. The analysis was done as pre and post. 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. 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.
Overall Participants	86
Age, Customized (Count of Participants)
Age 18-44	28 32.6%
Age 45-64	51 59.3%
Age 65 and older	7 8.1%
Sex: Female, Male (Count of Participants)
Female	42 48.8%
Male	44 51.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	76 88.4%
White	4 4.7%
More than one race	0 0%
Unknown or Not Reported	6 7%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention
Arm/Group Description	All enrolled patients received the intervention. There was no comparative arm. The analysis was done as pre and post. 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. 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.
Measure Participants	86
Number [events]	0

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

This data was only available for 51 patients therefore only 51 patients' results were analyzed.

Arm/Group Title	Intervention
Arm/Group Description	All enrolled patients received the intervention. There was no comparative arm. The analysis was done as pre and post. 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. 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.
Measure Participants	51
Mean BG at baseline	356 (110)
Mean BG at end of intervention	183 (103)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Only 46 patients had a baseline and end of intervention A1C available therefore only 46 participants are included in the data

Arm/Group Title	Intervention
Arm/Group Description	All enrolled patients received the intervention. There was no comparative arm. The analysis was done as pre and post. 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. 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.
Measure Participants	46
Mean baseline A1C	12.0 (1.5)
Mean end of intervention A1C	11.6 (1.6)

Adverse Events

Arm/Group Title	Intervention
Arm/Group Description	All enrolled patients received the intervention. There was no comparative arm. The analysis was done as pre and post. 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. 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.
All Cause Mortality
	Intervention
	Affected / at Risk (%)	# Events
Total	0/86 (0%)
Serious Adverse Events
	Intervention
	Affected / at Risk (%)	# Events
Total	0/86 (0%)
Other (Not Including Serious) Adverse Events
	Intervention
	Affected / at Risk (%)	# Events
Total	14/86 (16.3%)
Endocrine disorders
Hypoglycemia	14/86 (16.3%)	26

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.