Prospective Comparison of Early Subcutaneous Insulin Glargine Plus Standard of Care Versus Standard of Care for Treatment of Diabetic Ketoacidosis in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Duration of intravenous insulin infusion
研究概览
简要总结
The purpose of this study is to determine whether adult DKA patients who present to the emergency department treated with early subcutaneous long acting insulin versus standard care receive a shorter total duration of intravenous (IV) insulin infusion.
详细描述
Specific Aims: To evaluate the impact of early administration of subcutaneous glargine versus standard care on time of insulin infusion in DKA patients and other secondary outcomes listed in this application.
Methods: DKA patients enrolled in this study will receive the long acting glargine dose (0.3 units/kg with a maximum dose of 30 units) within two hours after initiation the IV insulin infusion. Besides timing of the glargine dose, no other changes in standard patient care will occur in those patients enrolled in this study, the same labs will be collected and the insulin infusion will be titrated using the same hospital protocol algorithm.
Patients enrolled in the prospective arm will be compared with the retrospective control group, which received standard insulin therapy (subcutaneous insulin glargine administered at least 2 to 3 hours prior to termination of the insulin infusion). There will be 18 patients in this group selected in reverse chronological order from our pre-specified date range of 8/1/2014 to 7/31/2016.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bicarbonate <18 mg/dL
- •Anion gap >16
- •Blood glucose >250 mg/dL
- •Ketonemia or ketonuria
排除标准
- •Pregnant women
- •Refused consent
- •Patient left ED against medical advice
研究组 & 干预措施
Early glargine dose
Subcutaneous insulin glargine will be administered within two hours of starting the IV insulin infusion.
干预措施: Early administration of subcutaneous insulin glargine dose (Other)
Early glargine dose
Subcutaneous insulin glargine will be administered within two hours of starting the IV insulin infusion.
干预措施: IV insulin infusion (Other)
Early glargine dose
Subcutaneous insulin glargine will be administered within two hours of starting the IV insulin infusion.
干预措施: IV fluid repletion (Drug)
Standard therapy
Retrospective arm that received standard insulin therapy for treatment of DKA
干预措施: IV insulin infusion (Other)
Standard therapy
Retrospective arm that received standard insulin therapy for treatment of DKA
干预措施: IV fluid repletion (Drug)
结局指标
主要结局
Duration of intravenous insulin infusion
时间窗: up to 10 months
Measured in minutes from starting insulin infusion
次要结局
- Time to closure of anion gap(up to 10 months)
- Time to resolution of high serum glucose (hyperglycemia)(up to 10 months)
- Time to correction of bicarbonate(up to 10 months)
- Time to correction of serum pH(up to 10 months)
- Total duration of hospital stay(up to 10 months)
- Return of DKA within 24 hours(up to 10 months)
- Incidence of low serum glucose (hypoglycemia) within 24 hours(up to 10 months)
研究者
George Willis
MD FACEP, Director of Undergraduate Medical Education
University of Maryland, Baltimore