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

Diabetic Ketoacidosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02930044
• Other study ID #: HP-00070969
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: November 1, 2021

Study information

• Verified date: March 2022
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 1, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Acidosis
• Diabetic Ketoacidosis
• Ketosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Maryland Medical Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

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