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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Departm

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.

Detailed Summary:

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.


Sponsor: University of Maryland

Current Primary Outcome: Duration of intravenous insulin infusion [ Time Frame: up to 10 months ]

Measured in minutes from starting insulin infusion


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: University of Maryland

Dates:
Date Received: September 14, 2016
Date Started: October 2016
Date Completion: June 2017
Last Updated: November 28, 2016
Last Verified: November 2016