ED Management of Severe Hyperglycemia: A Clinical Trial

NCT ID: NCT02478190

Last Updated: 2018-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2017-12-31

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.

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.

Conditions

Hyperglycemia; Diabetes Mellitus; Complications of Diabetes Mellitus; Diabetes-Related Complications; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Tight control

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

Group Type: EXPERIMENTAL

Tight control: goal glucose 350 mg/dL or lower

Intervention Type: OTHER

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

Loose control

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

Group Type: EXPERIMENTAL

Loose control: goal glucose 600 mg/dL or lower

Intervention Type: OTHER

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

Interventions

Tight control: goal glucose 350 mg/dL or lower

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

Intervention Type: OTHER

Loose control: goal glucose 600 mg/dL or lower

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hennepin Healthcare Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Brian Driver

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brian Driver, MD

Role: PRINCIPAL_INVESTIGATOR

HCMC

Locations

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30316635 (View on PubMed)

Other Identifiers

15-3931

Identifier Type: -

Identifier Source: org_study_id