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Subcutaneous Aspart Insulin to Treat Diabetic Ketoacidosis (DKA) and Beta-Hydroxybutyrate Testing in DKA

Information source: Rush University Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetic Ketoacidosis

Intervention: Insulin (Aspart Insulin [Novolog], Regular Insulin) (Drug)

Phase: N/A

Status: Completed

Sponsored by: Rush University Medical Center

Official(s) and/or principal investigator(s):
Rema A Gupta, MD, Principal Investigator, Affiliation: Rush University Medical Center
David Baldwin, MD, Principal Investigator, Affiliation: Rush University Medical Center

Summary

The purpose of this study is to determine whether insulin administered by a subcutaneous injection is effective in the treatment of a diabetic crisis and to determine if beta-hydroxybutyrate is useful to monitor during treatment of a diabetic crisis.

Clinical Details

Official title: Subcutaneous Aspart Insulin and Point of Care Beta Hydroxybutyrate Testing: A New Paradigm for the Management of Diabetic Ketoacidosis

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Hours to resolution of ketoacidosis as defined as beta-hydroxybutyrate <0.6

Hours to achieve blood glucose less than 200mg/dl

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: age 18 or older

- venous pH < 7. 3 or arterial < 7. 35

- at least 2 of the following 3:

1. serum HCO3 < 18/anion gap > 16 2. serum glucose > 300 mg/dl 3. serum acetone positive Exclusion Criteria:

- pregnant

- less than age 18

Locations and Contacts

Rush University Medical Center, Chicago, Illinois 60612, United States
Additional Information

Starting date: January 2005
Last updated: August 14, 2012

Page last updated: August 23, 2015

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