Early Subcutaneous Insulin Glargine Plus Standard of Care for Treatment of Diabetic Ketoacidosis

NCT02930044 | Completed

• 1 other identifier: HP-00070969
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether adult DKA patients who present to the emergency department treated with early subcutaneous long acting insulin versus standard care receive a shorter total duration of intravenous (IV) insulin infusion.

Conditions

Diabetic Ketoacidosis

Keywords

Emergency department; Insulin; Adult

Outcome Measures

Primary Outcomes (1)

• Duration of intravenous insulin infusion

  Measured in minutes from starting insulin infusion

  up to 10 months

Secondary Outcomes (7)

• Time to resolution of high serum glucose (hyperglycemia)

  up to 10 months

• Time to closure of anion gap

  up to 10 months

• Time to correction of bicarbonate

  up to 10 months

• Time to correction of serum pH

  up to 10 months

• Total duration of hospital stay

  up to 10 months

Study Arms (2)

Early glargine dose

EXPERIMENTAL

Subcutaneous insulin glargine will be administered within two hours of starting the IV insulin infusion.

Other: Early administration of subcutaneous insulin glargine dose; Other: IV insulin infusion; Drug: IV fluid repletion

Standard therapy

PLACEBO COMPARATOR

Retrospective arm that received standard insulin therapy for treatment of DKA

Other: IV insulin infusion; Drug: IV fluid repletion

Interventions

Early administration of subcutaneous insulin glargine dose OTHER

DKA patients in the prospective intervention arm will receive subcutaneous glargine within two hours of starting their intravenous insulin infusion. The dose of glargine is 0.3 units/kg with a maximum dose of 30 units.

Early glargine dose

IV insulin infusion OTHER

All patients will receive the standard of care which is a protocol based continuous insulin infusion

Early glargine dose; Standard therapy

IV fluid repletion DRUG

0.9% NaCl or Plasmalyte A will be initiated as a continuous infusion for volume repletion. Fluids will be switched to contain potassium if serum potassium is less than 3.3 mEq/L. Fluids will be switched to contain dextrose if the serum glucose is less than 250 mg/dL.

Early glargine dose; Standard therapy

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Bicarbonate \<18 mg/dL
• Anion gap \>16
• Blood glucose \>250 mg/dL
• Ketonemia or ketonuria

You may not qualify if:

• Pregnant women
• Refused consent
• Patient left ED against medical advice

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Medical Center

Baltimore, Maryland, 21217, United States

Location

MeSH Terms

Conditions

Diabetic Ketoacidosis; Emergencies; Insulin Resistance

Condition Hierarchy (Ancestors)

Ketosis; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders

Study Officials

• George C Willis, MD

  Director of Undergraduate Medical Education

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD FACEP, Director of Undergraduate Medical Education

Study Record Dates

• First Submitted: September 14, 2016
• First Posted: October 11, 2016
• Study Start: October 1, 2016
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: April 1, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)