Clinical Trial: Early Administration of Long-acting Insulin Treatment of Diabetic Ketoacidosis in Pediatric New-onset Type 1 Diabetes

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief Summary:

The management goals of diabetic ketoacidosis (DKA) in the pediatric new-onset 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 new 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.


Detailed Summary:
Sponsor: Chattanooga-Hamilton County Hospital Authority

Current Primary Outcome: Blood glucose [ Time Frame: Within 3 hrs of arrival ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Blood glucose [ Time Frame: 4 hours after intervention intiation ]
    checking for changes in levels after intervention initation
  • blood pH [ Time Frame: within 3 hours of arrival ]
  • blood pH [ Time Frame: 4 hours after intervention intiation ]
    checking for changes in levels after intervention initation
  • blood bicarbonate level [ Time Frame: Within 3 hrs of arrival ]
  • blood bicarbonate level [ Time Frame: 4 hours after intervention intiation ]
    checking for changes in levels after intervention initation
  • Urinalysis for levels of ketones & glucosuria [ Time Frame: Within 3 hrs of arrival ]
  • Urinalysis for levels of ketones & glucosuria [ Time Frame: 4 hours after intervention intiation ]
    checking for changes in levels after intervention initation


Original Secondary Outcome: Same as current

Information By: Chattanooga-Hamilton County Hospital Authority

Dates:
Date Received: September 9, 2015
Date Started: November 2015
Date Completion:
Last Updated: September 11, 2015
Last Verified: September 2015