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

Study Overview
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Brief Summary
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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).

Official Title
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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: A Pilot Study

Conditions
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Diabetic Ketoacidosis

Intervention / Treatment
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* Drug: Insulin Glargine
* Drug: Regular Insulin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insulin Glargine plus Regular Insulin<br>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<br> <br> * Other names: Lantus Insulin;Drug: Regular Insulin<br> <br> |
| Active Comparator: Control - Regular Insulin<br>Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring. | Drug: Regular Insulin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Participants monitored from hospital admission to discharge, an average of 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Participants followed for the duration of the Emergency Department stay, an expected average of 12 hours | 
| 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. | Participants monitored from hospital admission to discharge, an average of 4 days | 
| 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. | Participants monitored from hospital admission to discharge, an average of 4 days | 
| 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. | Participants monitored during the 24 hours after anion gap closure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Diabetic Ketoacidosis, Insulin Glargine, Anion gap, Metabolic acidosis