Early Administration of Long-acting Insulin Treatment of Diabetic Ketoacidosis in Pediatric Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
The management goals of diabetic ketoacidosis (DKA) in the pediatric type 1 diabetes (T1DM) population are fluid and electrolyte repletion, insulin administration, and correction of acidosis in order to stabilize the patient. Traditionally, a rapid-acting insulin IV infusion is begun immediately and continued until the acidosis is corrected and hyperglycemia normalized. Once the acidosis is corrected, patients are able to be transitioned to a subcutaneous insulin regimen. The role that a subcutaneous long-acting insulin such as glargine has in the acute treatment of DKA has not been extensively studied. While giving glargine during the treatment of DKA is becoming more common place, few studies have examined the potential risks and benefits of its use. This study will investigate the effects of early administration of glargine during DKA in patients with newly diagnosed TIDM. The design of this study is a prospective, double-blind study of children ages 2-21 who are admitted to the hospital in DKA with a diagnosis of T1DM. The control group will receive all traditional methods of treatment for DKA, including a placebo subcutaneous injection. The study group will receive the same treatment, but will be supplemented with a subcutaneous glargine injection.

Official Title
-----------------
Early Administration of Long-acting Insulin Glargine for the Treatment of Diabetic Ketoacidosis in Pediatric Type 1 Diabetes: A Randomized Double Blind Trial

Conditions
-----------------
Diabetes Mellitus, Type 1, Diabetic Ketoacidosis

Intervention / Treatment
-----------------
* Drug: Glargine
* Drug: IV insulin
* Other: Electrolyte Correction
* Other: Correction of Fluid Loss


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: T1DM Hyperglycemia >200 mg/dl Bicarbonate ≤ 15 mmol/L pH < 7.3 Ketonemia Ketonuria Glucosuria Admission to PICU (Pediatric Intensive Care Unit) Ages 1-21 years Exclusion Criteria: Patients who received glargine within the last 24 hours Patients with sepsis

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control Group<br>The control group will receive all traditional methods of treatment for DKA including iv insulin, correction of fluid loss, and electrolyte correction, including a placebo subcutaneous injection. | Drug: IV insulin<br>* The intravenous infusion of insulin at a weight-based fixed rate until ketosis has subsided.<br>Other: Electrolyte Correction<br>* If the potassium level is greater than 6 mEq/L, do not administer potassium supplement. If the potassium level is 4.5-6 mEq/L, administer 10 mEq/h of potassium chloride. If the potassium level is 3-4.5 mEq/L, administer 20 mEq/h of potassium chloride.<br>Other: Correction of Fluid Loss<br>* Initial correction of fluid loss is either by isotonic sodium chloride solution or by lactated Ringer solution. The recommended schedule for restoring fluids is as follows: Administer 1-3 L during the first hour. Administer 1 L during the second hour. Administer 1 L during the following 2 hours Administer 1 L every 4 hours, depending on the degree of dehydration and central venous pressure readings<br>|
| Experimental: Treatment Group<br>The study group will receive the same treatment including iv insulin, correction of fluid loss, and electrolyte correction, but will be supplemented with a subcutaneous glargine injection. | Drug: Glargine<br>* The control group will receive all traditional methods of treatment for DKA, including a placebo subcutaneous injection. The study group will receive the same treatment, but will be supplemented with a subcutaneous glargine injection.<br>* Other names: Lantus;Drug: IV insulin<br>* The intravenous infusion of insulin at a weight-based fixed rate until ketosis has subsided.<br>Other: Electrolyte Correction<br>* If the potassium level is greater than 6 mEq/L, do not administer potassium supplement. If the potassium level is 4.5-6 mEq/L, administer 10 mEq/h of potassium chloride. If the potassium level is 3-4.5 mEq/L, administer 20 mEq/h of potassium chloride.<br>Other: Correction of Fluid Loss<br>* Initial correction of fluid loss is either by isotonic sodium chloride solution or by lactated Ringer solution. The recommended schedule for restoring fluids is as follows: Administer 1-3 L during the first hour. Administer 1 L during the second hour. Administer 1 L during the following 2 hours Administer 1 L every 4 hours, depending on the degree of dehydration and central venous pressure readings<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose |  | Within 3 hrs of arrival | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose | checking for changes in levels after intervention initiation | 4 hours after intervention initiation | 
| blood pH |  | within 3 hours of arrival | 
| blood pH | checking for changes in levels after intervention initiation | 4 hours after intervention initiation | 
| blood bicarbonate level |  | Within 3 hrs of arrival | 
| blood bicarbonate level | checking for changes in levels after intervention initiation | 4 hours after intervention initiation | 
| Urinalysis for levels of ketones & glucosuria |  | Within 3 hrs of arrival | 
| Urinalysis for levels of ketones & glucosuria | checking for changes in levels after intervention initiation | 4 hours after intervention initiation |