NCT02478190

Brief Summary

Emergency Department (ED) patients with severe hyperglycemia will be randomized to two treatment goals: discharge glucose less than 600 mg/dL or less than 350 mg/dL. Randomization is stratified by whether the chief complaint is "High Blood Sugar" in the electronic medical record or other.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable

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

June 1, 2015

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 23, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 21, 2018

Status Verified

March 1, 2018

Enrollment Period

2.5 years

First QC Date

June 17, 2015

Last Update Submit

March 20, 2018

Conditions

HyperglycemiaDiabetes MellitusComplications of Diabetes MellitusDiabetes-Related ComplicationsDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • ED Length of Stay

    Time elapsed from when the patient is roomed until the time the MD places discharge order, by review of the Electronic Medical record by a blinded abstractor.

    This outcome measure is defined as the amount of time elapsed between when the patient is roomed, and when a discharge order is placed, during a single ED encounter, which is generally less than 4 hours.

Secondary Outcomes (3)

  • Iatrogenic hypoglycemia

    The patient will be followed during a single ED encounter, which is generally less than 4 hours.

  • Return ED visit for hyperglycemia and hospital admission for any reason, excluding trauma

    7 days

  • Return ED visit for any reason

    7 days

Study Arms (2)

Tight control

EXPERIMENTAL

Patients in this arm will have a treatment glucose value at ED discharge of 350 mg/dL or lower.

Other: Tight control: goal glucose 350 mg/dL or lower

Loose control

EXPERIMENTAL

Patients in this arm will have a treatment glucose value at ED discharge of 600 mg/dL or lower.

Other: Loose control: goal glucose 600 mg/dL or lower

Interventions

Tight control: goal glucose 350 mg/dL or lowerOTHER

Goal glucose at discharge will be 350 mg/dL or less.

Tight control
Loose control: goal glucose 600 mg/dL or lowerOTHER

Goal glucose at discharge will be 600 mg/dL or less.

Loose control

Eligibility Criteria

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

You may qualify if:

  • Glucose of more than 400mg/dL but less than 600 mg/dL at any point in the ED
  • Working phone number and willing to discuss health status at 7-10 days via phone

You may not qualify if:

  • Plan for hospital admission
  • Already received insulin during the ED stay
  • Type 1 diabetes
  • Less than 18 years old
  • Non-English speaking
  • Altered mental status or encephalopathy (unable to provide informed consent)
  • DKA, as determined clinically by the treating physician, without a lab requirement.
  • Critically ill, as determined by the treating physician.
  • Unable to provide informed consent
  • Prisoners
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Related Publications (1)

  • Driver BE, Klein LR, Cole JB, Prekker ME, Fagerstrom ET, Miner JR. Comparison of two glycemic discharge goals in ED patients with hyperglycemia, a randomized trial. Am J Emerg Med. 2019 Jul;37(7):1295-1300. doi: 10.1016/j.ajem.2018.09.053. Epub 2018 Oct 5.

    PMID: 30316635DERIVED

MeSH Terms

Conditions

HyperglycemiaDiabetes MellitusDiabetes ComplicationsDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Brian Driver, MD

    HCMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 17, 2015

First Posted

June 23, 2015

Study Start

June 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

March 21, 2018

Record last verified: 2018-03

Locations

US(1)