Clinical Trial: Effectiveness of Subcutaneous Glargine On The Time To Closure of The Anion Gap in Patients Presenting to the Emergency Department With Diabetic Keto-acidosis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effectiveness of Subcutaneous Glargine On The Time To Closure of The Anion Gap in Patients Presenting to the Emergency Department With Diabetic Keto-acidosis: A Pilot Stud

Brief Summary: To determine if co-administration of subcutaneous (SQ)Insulin glargine in combination with intravenous (IV) insulin decreases the time to resolution of ketoacidosis and requirement for ICU admission compared to IV insulin with delayed administration of SQ glargine for the treatment of diabetic ketoacidosis (DKA).

Detailed Summary:
Sponsor: The University of Texas Health Science Center, Houston

Current Primary Outcome: Time to Anion Gap Closure [ Time Frame: Participants monitored from hospital admission to discharge, an average of 4 days ]

Anion Gap is a measure of acidosis that results from decompensated Diabetes Mellitus. Acidosis is the result of the body being unable to utilize glucose for energy production and instead uses fatty acid metabolism resulting in ketone formation. Anion Gap is a surrogate measure for the level of ketones resulting in the excess acid production. Results reported are adjusted for initial anion gap, etiology of diabetic ketoacidosis, and comorbidities.


Original Primary Outcome: Time to Anion Gap Closure [ Time Frame: Monitored from hospital admission to discharge ]

Anion Gap is a measure of acidosis that results from decompensated Diabetes Mellitus. Acidosis is the result of the body being unable to utilize glucose for energy production and instead uses fatty acid metabolism resulting in ketone formation. Anion Gap is a surrogate measure for the level of ketones resulting in the excess acid production.


Current Secondary Outcome:

  • Number of Participants Admitted to the ICU [ Time Frame: Participants followed for the duration of the Emergency Department stay, an expected average of 12 hours ]
    The goal was to determine if the amount of patients admitted to the ICU could be reduced by providing more efficient resolution of the critical condition which is the acidosis.
  • Intensive Care Unit Length of Stay [ Time Frame: Participants monitored from hospital admission to discharge, an average of 4 days ]
    Determine the amount of time patient is admitted to the intensive care unit with the goal of assessing if more efficient correction of the acidosis results in decreased time in the intensive care unit for the patients.
  • Hospital Length of Stay [ Time Frame: Participants monitored from hospital admission to discharge, an average of 4 days ]
    Hospital length of stay was determined to assess whether a more efficient correction of the acidosis will result in decreased time that the patient is admitted to the hospital. Results reported are adjusted for age, hospital site, and etiology of diabetic ketoacidosis.
  • Number of Participants Who Developed Hypoglycemia [ Time Frame: Participants monitored during the 24 hours after anion gap closure ]

    To determine whether it is safe to administer both IV and subcutaneous insulin, it is important to assure that patient's glucose does not drop to critically low level and lead to adverse events. Hypoglycemia was defined as less than or equal to 60mg/dL during 24 hours after anion gap closure.

    Anion Gap is a measure of acidosis that results from decompensated Diabetes Mellitus. Acidosis is the result of the body being unable to utilize glucose for energy production and instead uses fatty acid metabolism resulting in ketone formation. Anion Gap is a surrogate measure for the level of ketones resulting in the excess acid production.



Original Secondary Outcome:

  • Rate of ICU admission [ Time Frame: Participants will followed for the duration of the Emergency Department stay, an expected average of 12 hours ]
    The goal was to determine if we could reduce the amount of patients admitted to the ICU by providing more efficient resolution of the critical condition which is the acidosis.
  • Intensive Care Unit Length of Stay [ Time Frame: Participants will followed for the duration of the hospital stay, an expected average of 7 days ]
    Determine the amount of time patient is admitted to the intensive care unit with the goal of assessing if more efficient correction of the acidosis results in decreased time in the intensive care unit for the patients.
  • Hospital Length of Stay [ Time Frame: Participants will followed for the duration of the hospital stay, an expected average of 7 days ]
    Hospital length of stay was determined to assess whether a more efficient correction of the acidosis will result in decreased time that the patient is admitted to the hospital.
  • Rate of hypoglycemia [ Time Frame: Participants will followed for the duration of the hospital stay, an expected average of 7 days ]
    To determine whether it is safe to administer both IV and subcutaneous insulin, it is important to assure that patient's glucose does not drop to critically low level and lead to adverse events.


Information By: The University of Texas Health Science Center, Houston

Dates:
Date Received: November 20, 2013
Date Started: November 2012
Date Completion:
Last Updated: April 10, 2017
Last Verified: April 2017