Early Administration of Long-acting Insulin Treatment of Diabetic Ketoacidosis in Pediatric Type 1 Diabetes
| Status: | Recruiting |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 1 - 21 |
| Updated: | 2/2/2019 |
| Start Date: | November 2015 |
| End Date: | December 1, 2023 |
| Contact: | Rita Shridharani, MD |
| Email: | rita.shridharani@erlanger.org |
| Phone: | 423-778-5521 |
Early Administration of Long-acting Insulin Glargine for the Treatment of Diabetic Ketoacidosis in Pediatric Type 1 Diabetes: A Randomized Double Blind Trial
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.
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.
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
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