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.
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
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
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.
All patients will receive the standard of care which is a protocol based continuous insulin infusion
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.
University of Maryland Medical Center
Baltimore, Maryland, United States
Duration of intravenous insulin infusion
Measured in minutes from starting insulin infusion
Time frame: up to 10 months
Time to resolution of high serum glucose (hyperglycemia)
Measured in minutes from starting insulin infusion
Time frame: up to 10 months
Time to closure of anion gap
Measured in minutes from starting insulin infusion
Time frame: up to 10 months
Time to correction of bicarbonate
Measured by serum bicarbonate
Time frame: up to 10 months
Time to correction of serum pH
Measured by pH on venous blood gas
Time frame: up to 10 months
Total duration of hospital stay
Measured in days
Time frame: up to 10 months
Return of DKA within 24 hours
Indicated by presence of diagnostic criteria within 24 hours of starting insulin infusion
Time frame: up to 10 months
Incidence of low serum glucose (hypoglycemia) within 24 hours
Measure by serum glucose.
Time frame: up to 10 months
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