Early Basal Insulin Administration in Adult Diabetic Ketoacidosis Management
The transition from IV Insulin Infusion (IVII) to Subcutaneous Long-acting insulin injections in Diabetic Ketoacidosis (DKA) management frequently results in rebound hyperglycemia, particularly if there are high insulin requirements that can adversely affect the DKA recovery, increase Length Of Stay (LOS), morbidity, and mortality. Investigators propose a prospective, open-label, intervention, non-randomized, controlled study to test the hypothesis that an insulin glargine dose of 0.4 Units/kg early administered (within four hours) of IVII initiation in DKA management in adult would be effective and safe in shortening the time to anion gap closure comparing to the standard practice.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
39
A dose of insulin glargine, 0.4 unit/kg, will be given within 4 hours from initiating the IV Insulin Infusion
A historical retrospective control group for the adult patients admitted to the same ICU with a diagnosis of DKA and received insulin glargine after anion gap closure.
Continuous weight based IV insulin infusion as per Cleveland Clinic DKA Protocol
Cleveland Clinic Fairview Hospital
Cleveland, Ohio, United States
Time to Anion Gap Closure
Measured in hours from starting insulin infusion till anion gap ≤ 12 milliequivalent/Liter (mEq/L)
Time frame: Participants monitored from hospital admission to discharge, an average of 5 days
Hospital Length of Stay
The time, in days, from the patient admission to the hospital till discharge
Time frame: Participants monitored from hospital admission to discharge, an average of 5 days
ICU Length of Stay
The time, in hours, from the patient admission to the ICU till transfer to regular nursing floor
Time frame: Participants monitored from hospital admission to discharge, an average of 5 days
Total IV Insulin Infusion Dose
the total amount of insulin infusion, by International Unit, has been received by the patient during the DKA treatment
Time frame: Participants monitored from hospital admission to discharge, an average of 5 days
Incidence of Transitional Failure
Defined as the recurrence of DKA (BG ≥ 250 mg/dl, Anion Gap \> 12 milliequivalent/Liter (mEq/L), and positive Ketones in serum or urine) after initial IV insulin infusion (IVII) discontinuation within 24 hours and requiring re-initiating the IVII
Time frame: up to 24 hours after IVII discontinuation
Incidence of Hyperglycemia
Incidence of hyperglycemia (\> 180 mg/dL) after IVII discontinuation
Time frame: up to 24 hours after initial Insulin Glargine dose
Incidence of Hypoglycemia
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The IV fluid and electrolytes replacement will be left to the treating physician's discretion. IV fluid to contain dextrose to keep Target Blood Glucose 150 - 200 mg/dl during the DKA management and 140 - 180 mg/dl after DKA resolution.
Incidence of hypoglycemia (defined as ≤ 70 mg/dL, \<54 mg/dL, \<40 mg/dl) after IVII discontinuation
Time frame: up to 24 hours after initial Insulin Glargine dose