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

Prospective Comparison of Early Subcutaneous Insulin Glargine Plus Standard of Care Versus Standard of Care for Treatment of Diabetic Ketoacidosis in the Emergency Department

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Ketoacidosis
• Intervention / Treatment: Other: Early administration of subcutaneous insulin glargine dose; Other: IV insulin infusion; Drug: IV fluid repletion

Detailed Description

Specific Aims: To evaluate the impact of early administration of subcutaneous glargine versus standard care on time of insulin infusion in DKA patients and other secondary outcomes listed in this application.

Methods: DKA patients enrolled in this study will receive the long acting glargine dose (0.3 units/kg with a maximum dose of 30 units) within two hours after initiation the IV insulin infusion. Besides timing of the glargine dose, no other changes in standard patient care will occur in those patients enrolled in this study, the same labs will be collected and the insulin infusion will be titrated using the same hospital protocol algorithm.

Patients enrolled in the prospective arm will be compared with the retrospective control group, which received standard insulin therapy (subcutaneous insulin glargine administered at least 2 to 3 hours prior to termination of the insulin infusion). There will be 18 patients in this group selected in reverse chronological order from our pre-specified date range of 8/1/2014 to 7/31/2016.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21217
      • University of Maryland Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 87 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early glargine dose; Subcutaneous insulin glargine will be administered within two hours of starting the IV insulin infusion.	Other: Early administration of subcutaneous insulin glargine dose; 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.; Other: IV insulin infusion; All patients will receive the standard of care which is a protocol based continuous insulin infusion; Drug: IV fluid repletion; 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.
Placebo Comparator: Standard therapy; Retrospective arm that received standard insulin therapy for treatment of DKA	Other: IV insulin infusion; All patients will receive the standard of care which is a protocol based continuous insulin infusion; Drug: IV fluid repletion; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of intravenous insulin infusion	Measured in minutes from starting insulin infusion	up to 10 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to resolution of high serum glucose (hyperglycemia)	Measured in minutes from starting insulin infusion	up to 10 months
Time to closure of anion gap	Measured in minutes from starting insulin infusion	up to 10 months
Time to correction of bicarbonate	Measured by serum bicarbonate	up to 10 months
Time to correction of serum pH	Measured by pH on venous blood gas	up to 10 months
Total duration of hospital stay	Measured in days	up to 10 months
Return of DKA within 24 hours	Indicated by presence of diagnostic criteria within 24 hours of starting insulin infusion	up to 10 months
Incidence of low serum glucose (hypoglycemia) within 24 hours	Measure by serum glucose.	up to 10 months

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Investigators: Principal Investigator: George C Willis, MD, Director of Undergraduate Medical Education

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Actual): November 1, 2021
• Study Completion (Actual): November 1, 2021

Study Registration Dates

• First Submitted: September 14, 2016
• First Submitted That Met QC Criteria: October 8, 2016
• First Posted (Estimate): October 11, 2016

Study Record Updates

• Last Update Posted (Actual): April 1, 2022
• Last Update Submitted That Met QC Criteria: March 19, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Insulin; Adult; Emergency department
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Acid-Base Imbalance; Acidosis; Ketosis; Diabetic Ketoacidosis; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Glargine
• Other Study ID Numbers: HP-00070969

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Individual subject results will not be shared with those involved in the prospective arm.