ED Management of Severe Hyperglycemia: A Clinical Trial

ED Management of Severe Hyperglycemia: An Open-Label Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Hyperglycemia; Diabetes Mellitus, Type 2; Diabetes Mellitus; Complications of Diabetes Mellitus; Diabetes-Related Complications
• Intervention / Treatment: Other: Tight control: goal glucose 350 mg/dL or lower; Other: Loose control: goal glucose 600 mg/dL or lower

Detailed Description

It is common practice to provide insulin and/or intravenous (IV) fluids to lower glucose levels prior to discharge in patients that present with hyperglycemia. There is, however, no data supporting this practice.

A recent retrospective observational cohort study (HSR# 12-3497) of 567 ED patients with severe hyperglycemia demonstrated no association between discharge glucose levels and short-term adverse outcomes at 7 days (return ED visits, diabetic ketoacidosis (DKA), hospitalization, and death).

There were no other short-term adverse outcomes associated with the degree of glycemic control. Less than 1% of patients developed DKA at 7 days. No patients died.

As this was a retrospective study, the conclusions that can be drawn are limited by the lack of randomization and control; it is necessary to conduct a randomized controlled trial to quantify how much time is expended caring for these patients, and gather safety data.

This is important because much time and money is focused on glucose reduction, which may not change short-term outcomes. Furthermore, in retrospective analysis approximately 1.5% of patients receiving therapy for hyperglycemia developed iatrogenic hypoglycemia during the ED stay.

To detect a difference in length of stay by 60 minutes (Standard deviation is 100 minutes) with an p=0.05 and b=0.8, enrollment of 45 patients per group will be required, with a total enrollment of 90 patients. Enrollment will stop when 45 patients in each group have been contacted in follow-up.

This study will only include patients who are discharged from the ED. Patients who are enrolled and then eventually admitted to the hospital will be tabulated but excluded from the length of stay analysis.

Statistical analysis will be completed for the primary outcome with a Mann-Whitney U test, assuming the data will not be normally distributed. Secondary outcomes will be compared with chi-squared testing. A secondary regression model will be formed, based on covariates that could influence ED length of stay, such as amount of diagnostic testing completed.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin County Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tight control; 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; Goal glucose at discharge will be 350 mg/dL or less.
Experimental: Loose control; 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; Goal glucose at discharge will be 600 mg/dL or less.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Iatrogenic hypoglycemia	Rate of iatrogenic hypoglycemia in both groups, defined as: glucose <60 or glucose less than 100 mg/dL and symptoms of hypoglycemia that resolved with food/drink, or any use of IV dextrose 50%, glucagon, or oral glucose tabs/gel	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	Composite outcome of rate of repeat ED visit for hyperglycemia or hospital admission for any reason, excluding trauma admission. ED visit for hyperglycemia defined as: chief complaint of hyperglycemia, chief complaint of polyuria, polydipsia, fatigue, blurry vision, or malaise and found to have blood glucose more than 250 mg/dL, primary ED diagnosis of hyperglycemia, or ED or hospital diagnosis of DKA or hyperosmolar syndrome.	7 days
Return ED visit for any reason	Each patient will be assessed via chart review and telephone follow up to see if they visited an ED for any reason during the 7 day time frame. Rates of ED visits for any reason at 7 days will be compared between the two treatment arms.	7 days

Collaborators and Investigators

• Sponsor: Hennepin Healthcare Research Institute
• Investigators: Principal Investigator: Brian Driver, MD, HCMC

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: June 17, 2015
• First Submitted That Met QC Criteria: June 18, 2015
• First Posted (Estimate): June 23, 2015

Study Record Updates

• Last Update Posted (Actual): March 21, 2018
• Last Update Submitted That Met QC Criteria: March 20, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Complications
• Other Study ID Numbers: 15-3931