Clinical trial NCT02006342: Effectiveness of Subcutaneous Glargine On The Time To Closure of The Anion Gap in Patients Presenting to the Emergency Department With Diabetic Keto-acidosis
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 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Ketoacidosis
Keywords: Diabetes Mellitus
Diabetic Ketoacidosis
Insulin Glargine
Anion gap
Metabolic acidosis
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2013-12-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Time to Anion Gap Closure
timeFrame: Participants monitored from hospital admission to discharge, an average of 4 days
Secondary outcomes:
measure: Number of Participants Admitted to the ICU
timeFrame: Participants followed for the duration of the Emergency Department stay, an expected average of 12 hours
measure: Intensive Care Unit Length of Stay
timeFrame: Participants monitored from hospital admission to discharge, an average of 4 days
measure: Hospital Length of Stay
timeFrame: Participants monitored from hospital admission to discharge, an average of 4 days
measure: Number of Participants Who Developed Hypoglycemia
timeFrame: Participants monitored during the 24 hours after anion gap closure
Other outcomes:
Locations:
city: Houston
country: United States
facility: Lyndon B Johnson Hospital
state: Texas
city: Houston
country: United States
facility: Memorial Herman Hospital-Texas Medical Center
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Pratik B Doshi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.