NCT01033773

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Sep 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 16, 2009

Completed
10.8 years until next milestone

Results Posted

Study results publicly available

October 5, 2020

Completed
Last Updated

October 5, 2020

Status Verified

September 1, 2020

Enrollment Period

1.2 years

First QC Date

December 14, 2009

Results QC Date

August 13, 2020

Last Update Submit

September 11, 2020

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes mellitusUncontrolled hyperglycemiaEmergency Department

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

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

    30 days

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

    30 days

Study Arms (1)

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.

Drug: Antihyperglycemic medication guideline for management of uncontrolled hyperglycemia presenting to the ED using metformin, sulfonylurea and/or insulinBehavioral: Diabetes survival skills self-management education

Interventions

Antihyperglycemic medication guideline for management of uncontrolled hyperglycemia presenting to the ED using metformin, sulfonylurea and/or insulinDRUG

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 education and medication management
Diabetes survival skills self-management educationBEHAVIORAL

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington Hospital Center

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

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Emergencies

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr Michelle Magee
Organization
MedStar Health Research Institute
michelle.f.magee@medstar.net
2028772383

Study Officials

  • Michelle F Magee, MD, MBBCh

    Medstar Diabetes and Research Institutes, Georgetown University School of Medicine.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, MedStar Diabetes Institute

Study Record Dates

First Submitted

December 14, 2009

First Posted

December 16, 2009

Study Start

September 1, 2007

Primary Completion

November 1, 2008

Study Completion

January 1, 2009

Last Updated

October 5, 2020

Results First Posted

October 5, 2020

Record last verified: 2020-09

Locations

US(1)