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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
17
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.
The intravenous infusion of insulin at a weight-based fixed rate until ketosis has subsided.
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.
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
Children's @ Erlanger
Chattanooga, Tennessee, United States
Blood glucose
Time frame: Within 3 hrs of arrival
Blood glucose
checking for changes in levels after intervention initiation
Time frame: 4 hours after intervention initiation
blood pH
Time frame: within 3 hours of arrival
blood pH
checking for changes in levels after intervention initiation
Time frame: 4 hours after intervention initiation
blood bicarbonate level
Time frame: Within 3 hrs of arrival
blood bicarbonate level
checking for changes in levels after intervention initiation
Time frame: 4 hours after intervention initiation
Urinalysis for levels of ketones & glucosuria
Time frame: Within 3 hrs of arrival
Urinalysis for levels of ketones & glucosuria
checking for changes in levels after intervention initiation
Time frame: 4 hours after intervention initiation
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