Early Subcutaneous Insulin Glargine Plus Standard of Care for Treatment of Diabetic Ketoacidosis

Study Overview
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Brief Summary
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The purpose of this study is to determine whether adult DKA patients who present to the emergency department treated with early subcutaneous long acting insulin versus standard care receive a shorter total duration of intravenous (IV) insulin infusion.

Detailed Description
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Specific Aims: To evaluate the impact of early administration of subcutaneous glargine versus standard care on time of insulin infusion in DKA patients and other secondary outcomes listed in this application. Methods: DKA patients enrolled in this study will receive the long acting glargine dose (0.3 units/kg with a maximum dose of 30 units) within two hours after initiation the IV insulin infusion. Besides timing of the glargine dose, no other changes in standard patient care will occur in those patients enrolled in this study, the same labs will be collected and the insulin infusion will be titrated using the same hospital protocol algorithm. Patients enrolled in the prospective arm will be compared with the retrospective control group, which received standard insulin therapy (subcutaneous insulin glargine administered at least 2 to 3 hours prior to termination of the insulin infusion). There will be 18 patients in this group selected in reverse chronological order from our pre-specified date range of 8/1/2014 to 7/31/2016.

Official Title
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Prospective Comparison of Early Subcutaneous Insulin Glargine Plus Standard of Care Versus Standard of Care for Treatment of Diabetic Ketoacidosis in the Emergency Department

Conditions
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Diabetic Ketoacidosis

Intervention / Treatment
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* Other: Early administration of subcutaneous insulin glargine dose
* Other: IV insulin infusion
* Drug: IV fluid repletion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Bicarbonate <18 mg/dL Anion gap >16 Blood glucose >250 mg/dL Ketonemia or ketonuria Exclusion Criteria: Pregnant women Refused consent Patient left ED against medical advice

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early glargine dose<br>Subcutaneous insulin glargine will be administered within two hours of starting the IV insulin infusion. | Other: Early administration of subcutaneous insulin glargine dose<br>* DKA patients in the prospective intervention arm will receive subcutaneous glargine within two hours of starting their intravenous insulin infusion. The dose of glargine is 0.3 units/kg with a maximum dose of 30 units.<br>Other: IV insulin infusion<br>* All patients will receive the standard of care which is a protocol based continuous insulin infusion<br>Drug: IV fluid repletion<br>* 0.9% NaCl or Plasmalyte A will be initiated as a continuous infusion for volume repletion. Fluids will be switched to contain potassium if serum potassium is less than 3.3 mEq/L. Fluids will be switched to contain dextrose if the serum glucose is less than 250 mg/dL.<br>|
| Placebo Comparator: Standard therapy<br>Retrospective arm that received standard insulin therapy for treatment of DKA | Other: IV insulin infusion<br>* All patients will receive the standard of care which is a protocol based continuous insulin infusion<br>Drug: IV fluid repletion<br>* 0.9% NaCl or Plasmalyte A will be initiated as a continuous infusion for volume repletion. Fluids will be switched to contain potassium if serum potassium is less than 3.3 mEq/L. Fluids will be switched to contain dextrose if the serum glucose is less than 250 mg/dL.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of intravenous insulin infusion | Measured in minutes from starting insulin infusion | up to 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to resolution of high serum glucose (hyperglycemia) | Measured in minutes from starting insulin infusion | up to 10 months | 
| Time to closure of anion gap | Measured in minutes from starting insulin infusion | up to 10 months | 
| Time to correction of bicarbonate | Measured by serum bicarbonate | up to 10 months | 
| Time to correction of serum pH | Measured by pH on venous blood gas | up to 10 months | 
| Total duration of hospital stay | Measured in days | up to 10 months | 
| Return of DKA within 24 hours | Indicated by presence of diagnostic criteria within 24 hours of starting insulin infusion | up to 10 months | 
| Incidence of low serum glucose (hypoglycemia) within 24 hours | Measure by serum glucose. | up to 10 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Emergency department, Insulin, Adult