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

Not Applicable

Terminated

• Conditions: Diabetes Mellitus, Type 1; Diabetic Ketoacidosis
• Interventions: Drug: Glargine; Drug: IV insulin; Other: Electrolyte Correction; Other: Correction of Fluid Loss

• Registration Number: NCT02548494
• Lead Sponsor: Chattanooga-Hamilton County Hospital Authority

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-09
• Study First Submitted QC: 2015-09-11
• Study First Posted: 2015-09-14
• Study Start: 2015-11
• Primary Completion: 2019-02-01
• Study Completion: 2019-02-01
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-21
• Last Update Posted: 2020-09-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	IV insulin	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.
Control Group	Electrolyte Correction	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.
Control Group	IV insulin	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.
Control Group	Correction of Fluid Loss	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.
Treatment Group	Electrolyte Correction	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.
Treatment Group	Correction of Fluid Loss	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.
Treatment Group	Glargine	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.

Primary Outcome Measures

Name	Time	Method
Blood glucose	Within 3 hrs of arrival

Secondary Outcome Measures

Name	Time	Method
Blood glucose	4 hours after intervention initiation	checking for changes in levels after intervention initiation
blood pH	4 hours after intervention initiation	checking for changes in levels after intervention initiation
blood bicarbonate level	4 hours after intervention initiation	checking for changes in levels after intervention initiation
Urinalysis for levels of ketones & glucosuria	4 hours after intervention initiation	checking for changes in levels after intervention initiation

Trial Locations

Locations (1)

Children's @ Erlanger; 🇺🇸 Chattanooga, Tennessee, United States