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Completed

NCT Number: 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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lyndon B Johnson Hospital, Houston, Texas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

insulin glargine

Drug

Other names: Lantus Insulin

Regular insulin

Drug

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study 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

Acronym: GT-COG

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 10, 2013
Registry last updated
May 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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