NCT02930044

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Diabetic Ketoacidosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-10-01
• Primary completion: 2021-11-01
• Completion: 2021-11-01
• First posted: 2016-10-11
• Last updated: 2022-04-01

Locations

1 site across 1 country: United States