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

Chattanooga-Hamilton County Hospital Authority

Status: Terminated

Conditions: Diabetes Mellitus, Type 1; Diabetic Ketoacidosis

Treatments: Drug: IV insulin; Other: Correction of Fluid Loss; Drug: Glargine; Other: Electrolyte Correction

Study type: Interventional

Funder types: Other

Identifiers

NCT02548494

15-Lantus

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 1 to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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17 participants in 2 patient groups, including a placebo group

Control Group

Placebo Comparator group

Description:

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:

Other: Correction of Fluid Loss

Drug: IV insulin

Other: Electrolyte Correction

Treatment Group

Experimental group

Description:

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:

Other: Correction of Fluid Loss

Drug: IV insulin

Drug: Glargine

Other: Electrolyte Correction