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OpenTrials
Completed

NCT Number: NCT00920725

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

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.

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Key information

Conditions

Diabetic Ketoacidosis Acid-Base Imbalance Acidosis Diabetes Complications Diabetes Mellitus Endocrine System Diseases Ketosis Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

age 18 or older

  • venous pH < 7.3 or arterial < 7.35
  • at least 2 of the following 3:
  • serum HCO3 < 18/anion gap > 16
  • serum glucose > 300 mg/dl
  • serum acetone positive

Exclusion criteria

  • pregnant
  • less than age 18

Treatment and study plan

Insulin (Aspart Insulin [Novolog], Regular Insulin)

Drug

Aspart Insulin 0.2units/sq q 2 hours

Regular Insulin 0.1units/kg/hr intravenous

Aspart Insulin 0.1 units/kg/hr intravenous

Primary outcomes

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

    Time frame: q 2 hours

  2. Hours to achieve blood glucose less than 200mg/dl

    Time frame: q 1 hour

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Collaborators

  • Novo Nordisk A/S

Registry information

Official study title

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

Acronym: DKA

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Jun 15, 2009
Registry last updated
Aug 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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