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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2019-02-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 1 Diabetic Ketoacidosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Control Group

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.

Group Type PLACEBO_COMPARATOR

IV insulin

Intervention Type DRUG

The intravenous infusion of insulin at a weight-based fixed rate until ketosis has subsided.

Electrolyte Correction

Intervention Type OTHER

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.

Correction of Fluid Loss

Intervention Type OTHER

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

Treatment Group

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.

Group Type EXPERIMENTAL

Glargine

Intervention Type DRUG

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.

IV insulin

Intervention Type DRUG

The intravenous infusion of insulin at a weight-based fixed rate until ketosis has subsided.

Electrolyte Correction

Intervention Type OTHER

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.

Correction of Fluid Loss

Intervention Type OTHER

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

Interventions

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Glargine

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.

Intervention Type DRUG

IV insulin

The intravenous infusion of insulin at a weight-based fixed rate until ketosis has subsided.

Intervention Type DRUG

Electrolyte Correction

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.

Intervention Type OTHER

Correction of Fluid Loss

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

Intervention Type OTHER

Other Intervention Names

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Lantus

Eligibility Criteria

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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