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

Primary Purpose

Diabetic Ketoacidosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Insulin Glargine
Regular Insulin
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Ketoacidosis focused on measuring Diabetes Mellitus, Diabetic Ketoacidosis, Insulin Glargine, Anion gap, Metabolic acidosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lyndon B Johnson Hospital
  • Memorial Herman Hospital-Texas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Insulin Glargine plus Regular Insulin

Control - Regular Insulin

Arm Description

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.

Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.

Outcomes

Primary Outcome Measures

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. Results reported are adjusted for initial anion gap, etiology of diabetic ketoacidosis, and comorbidities.

Secondary Outcome Measures

Number of Participants Admitted to the ICU
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
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
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
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.

Full Information

First Posted
November 20, 2013
Last Updated
April 10, 2017
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT02006342
Brief 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
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Ketoacidosis
Keywords
Diabetes Mellitus, Diabetic Ketoacidosis, Insulin Glargine, Anion gap, Metabolic acidosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Insulin Glargine plus Regular Insulin
Arm Type
Experimental
Arm Description
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.
Arm Title
Control - Regular Insulin
Arm Type
Active Comparator
Arm Description
Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.
Intervention Type
Drug
Intervention Name(s)
Insulin Glargine
Other Intervention Name(s)
Lantus Insulin
Intervention Type
Drug
Intervention Name(s)
Regular Insulin
Primary Outcome Measure Information:
Title
Time to Anion Gap Closure
Description
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.
Time Frame
Participants monitored from hospital admission to discharge, an average of 4 days
Secondary Outcome Measure Information:
Title
Number of Participants Admitted to the ICU
Description
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.
Time Frame
Participants followed for the duration of the Emergency Department stay, an expected average of 12 hours
Title
Intensive Care Unit Length of Stay
Description
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.
Time Frame
Participants monitored from hospital admission to discharge, an average of 4 days
Title
Hospital Length of Stay
Description
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.
Time Frame
Participants monitored from hospital admission to discharge, an average of 4 days
Title
Number of Participants Who Developed Hypoglycemia
Description
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.
Time Frame
Participants monitored during the 24 hours after anion gap closure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pratik B Doshi, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lyndon B Johnson Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77026
Country
United States
Facility Name
Memorial Herman Hospital-Texas Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17508198
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.
Results Reference
background
PubMed Identifier
26013711
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.
Results Reference
result

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

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