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

• Status: Terminated
• Trial end date: 2019-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chattanooga-Hamilton County Hospital Authority
• Treatments: Insulin; Insulin Glargine; Insulin, Globin Zinc; Insulin, Long-Acting

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