Early Administration of Long-acting Insulin Glargine for the Treatment of Diabetic Ketoacidosis in Pediatric Type 1 Diabetes: A Randomized Double Blind Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Blood glucose
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Year 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients who received glargine within the last 24 hours
- •Patients with sepsis
研究组 & 干预措施
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.
干预措施: IV insulin (Drug)
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.
干预措施: Electrolyte Correction (Other)
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.
干预措施: Correction of Fluid Loss (Other)
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.
干预措施: Glargine (Drug)
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.
干预措施: IV insulin (Drug)
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.
干预措施: Electrolyte Correction (Other)
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.
干预措施: Correction of Fluid Loss (Other)
结局指标
主要结局
Blood glucose
时间窗: Within 3 hrs of arrival
次要结局
- Blood glucose(4 hours after intervention initiation)
- blood pH(4 hours after intervention initiation)
- blood bicarbonate level(4 hours after intervention initiation)
- Urinalysis for levels of ketones & glucosuria(4 hours after intervention initiation)
研究者
Rita Shridharani
Dr. Shridharani
Chattanooga-Hamilton County Hospital Authority