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

Overview

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).

Full Title of Study: “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 Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: April 2013

Interventions

  • Drug: Insulin Glargine
  • Drug: Regular Insulin

Arms, Groups and Cohorts

  • Experimental: Insulin Glargine plus Regular Insulin
    • Patient’s with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring, with the addition of subcutaneous Insulin Glargine within 2 hours of diagnosis.
  • Active Comparator: Control – Regular Insulin
    • Patient’s with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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.

Participating in This Clinical Trial

Inclusion Criteria

  • Age >18 years – Blood Glucose >200 – potential of hydrogen (pH) < 7.3 – Bicarbonate < 18 – Ketonemia or Ketonuria – Anion Gap > or = 16 Exclusion Criteria:

  • Age < 18 years – Pregnant – End state renal disease (ESRD) – Prisoners – Patients in shock or requiring emergency surgery – Those unwilling to consent for the trial – Allergic to Insulin Glargine

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The University of Texas Health Science Center, Houston
  • Provider of Information About this Clinical Study
    • Principal Investigator: Pratik B Doshi, Assistant Professor – The University of Texas Health Science Center, Houston
  • Overall Official(s)
    • Pratik B Doshi, MD, Principal Investigator, The University of Texas Health Science Center, Houston

References

Shankar V, Haque A, Churchwell KB, Russell W. Insulin glargine supplementation during early management phase of diabetic ketoacidosis in children. Intensive Care Med. 2007 Jul;33(7):1173-1178. doi: 10.1007/s00134-007-0674-3. Epub 2007 May 17.

Citations Reporting on Results

Doshi P, Potter AJ, De Los Santos D, Banuelos R, Darger BF, Chathampally Y. Prospective randomized trial of insulin glargine in acute management of diabetic ketoacidosis in the emergency department: a pilot study. Acad Emerg Med. 2015 Jun;22(6):657-62. doi: 10.1111/acem.12673. Epub 2015 May 25.

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