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

Not Applicable

Completed

• Conditions: Diabetic Ketoacidosis
• Interventions: Drug: Insulin Glargine; Drug: Regular Insulin

• Registration Number: NCT02006342
• Lead Sponsor: The University of Texas Health Science Center, Houston

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Study First Submitted: 2013-11-20
• Study First Submitted QC: 2013-12-04
• Study First Posted: 2013-12-10
• Status Verified: 2017-04
• Results First Submitted: 2017-04-10
• Results First Submitted QC: 2017-04-10
• Last Update Submitted: 2017-04-10
• Results First Posted: 2017-05-16
• Last Update Posted: 2017-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Age >18 years
• Blood Glucose >200
• potential of hydrogen (pH) < 7.3
• Bicarbonate < 18
• Ketonemia or Ketonuria
• Anion Gap > or = 16

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Insulin Glargine plus Regular Insulin	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.
Control - Regular Insulin	Regular Insulin	Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.
Insulin Glargine plus Regular Insulin	Insulin Glargine	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.

Primary Outcome Measures

Name	Time	Method
Time to Anion Gap Closure	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

Name	Time	Method
Number of Participants Admitted to the ICU	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	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	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	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.

Trial Locations

Locations (2)

Memorial Herman Hospital-Texas Medical Center; 🇺🇸 Houston, Texas, United States

Lyndon B Johnson Hospital; 🇺🇸 Houston, Texas, United States