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

Diabetic Ketoacidosis Clinical Trial

— GT-COG  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02006342
• Other study ID #: HSC-MS-12-0535
• Status: Completed
• Phase: N/A
• First received: November 20, 2013
• Last updated: December 4, 2013
• Start date: November 2012
• Est. completion date: April 2013

Study information

• Verified date: December 2013
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 DKA.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >18 years

• Blood Glucose >200

• pH < 7.3

• Bicarbonate < 18

• Ketonemia or Ketonuria

• Anion Gap > or = 16

Exclusion Criteria:

• Age < 18 years

• Pregnant

• ESRD

• Prisoners

• Patients in shock or requiring emergency surgery

• Those unwilling to consent for the trial

• Allergic to Insulin Glargine

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acidosis
• Diabetic Ketoacidosis

Intervention

Drug:
• Insulin Glargine

• Regular Insulin

Locations

Country	Name	City	State
United States	Lyndon B Johnson Hospital	Houston	Texas
United States	Memorial Herman Hospital-Texas Medical Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

References & Publications (1)

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):1173-8. Epub 2007 May 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to 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.	Monitored from hospital admission to discharge	No
Secondary	Rate of ICU admission	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.	Participants will followed for the duration of the Emergency Department stay, an expected average of 12 hours	No
Secondary	Intensive care unit Length of Stay	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.	Participants will followed for the duration of the hospital stay, an expected average of 7 days	No
Secondary	Hospital Length of stay	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.	Participants will followed for the duration of the hospital stay, an expected average of 7 days	No
Secondary	Rate of hypoglycemia	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.	Participants will followed for the duration of the hospital stay, an expected average of 7 days	Yes