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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pratik B Doshi, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT02006342
First received: November 20, 2013
Last updated: April 10, 2017
Last verified: April 2017
  Purpose
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).

Condition Intervention
Diabetic Ketoacidosis Drug: Insulin Glargine Drug: Regular Insulin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Participant
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pratik B Doshi, The University of Texas Health Science Center, Houston:

Primary Outcome 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 Outcome 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.



Enrollment: 40
Study Start Date: November 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Insulin Glargine
Other Name: Lantus Insulin
Drug: Regular Insulin
Active Comparator: Control - Regular Insulin
Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.
Drug: Regular Insulin

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02006342

Locations
United States, Texas
Lyndon B Johnson Hospital
Houston, Texas, United States, 77026
Memorial Herman Hospital-Texas Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Pratik B Doshi, MD The University of Texas Health Science Center, Houston
  More Information

Publications:
Responsible Party: Pratik B Doshi, Assistant Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02006342     History of Changes
Other Study ID Numbers: HSC-MS-12-0535
Study First Received: November 20, 2013
Results First Received: April 10, 2017
Last Updated: April 10, 2017

Keywords provided by Pratik B Doshi, The University of Texas Health Science Center, Houston:
Diabetes Mellitus
Diabetic Ketoacidosis
Insulin Glargine
Anion gap
Metabolic acidosis

Additional relevant MeSH terms:
Diabetic Ketoacidosis
Emergencies
Acidosis
Ketosis
Disease Attributes
Pathologic Processes
Acid-Base Imbalance
Metabolic Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Diabetes Complications
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 25, 2017