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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00920725

Acronym

DKA

Enrollment

Registered

2009-06-15

Start date

2005-01-31

Completion date

2007-12-31

Last updated

2012-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Ketoacidosis

Keywords

DKA

Brief 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.

Interventions

DRUGInsulin (Aspart Insulin [Novolog], Regular Insulin)

Aspart Insulin 0.2units/sq q 2 hours Regular Insulin 0.1units/kg/hr intravenous Aspart Insulin 0.1 units/kg/hr intravenous

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Hours to resolution of ketoacidosis as defined as beta-hydroxybutyrate <0.6	q 2 hours
Hours to achieve blood glucose less than 200mg/dl	q 1 hour

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026