Trial record 4 of 15 for:    "Diabetic Ketoacidosis"

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: December 4, 2013
Last verified: December 2013
  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 DKA.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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 The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Time to anion gap closure [ Time Frame: Monitored from hospital admission to discharge ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Rate of ICU admission [ Time Frame: Participants will followed for the duration of the Emergency Department stay, an expected average of 12 hours ] [ Designated as safety issue: No ]
    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.

  • Intensive care unit Length of Stay [ Time Frame: Participants will followed for the duration of the hospital stay, an expected average of 7 days ] [ Designated as safety issue: No ]
    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 will followed for the duration of the hospital stay, an expected average of 7 days ] [ Designated as safety issue: No ]
    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.

  • Rate of hypoglycemia [ Time Frame: Participants will followed for the duration of the hospital stay, an expected average of 7 days ] [ Designated as safety issue: Yes ]
    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.


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: Experimental
Patient's with Diabetic Ketoacidosis receiving standard of care treatment with 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
Patient's with Diabetic Ketoacidosis receiving standard of care treatment with insulin drip, IV fluids and close monitoring.
Drug: Regular Insulin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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
Memorial Herman Hospital-Texas Medical Center
Houston, Texas, United States, 77030
Lyndon B Johnson Hospital
Houston, Texas, United States, 77026
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
Last Updated: December 4, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Diabetic Ketoacidosis
Acidosis
Ketosis
Acid-Base Imbalance
Metabolic Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Diabetes Complications
Endocrine System Diseases
Insulin, Globin Zinc
Glargine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014