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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02478190
Other study ID # 15-3931
Secondary ID
Status Completed
Phase N/A
First received June 17, 2015
Last updated March 20, 2018
Start date June 2015
Est. completion date December 2017

Study information

Verified date March 2018
Source Minneapolis Medical Research Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Other:
Tight control: goal glucose 350 mg/dL or lower
Goal glucose at discharge will be 350 mg/dL or less.
Loose control: goal glucose 600 mg/dL or lower
Goal glucose at discharge will be 600 mg/dL or less.

Locations

Country Name City State
United States Hennepin County Medical Center Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Minneapolis Medical Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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.
Secondary 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
Secondary 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
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