Management of Hyperglycemia in the Emergency Room: A Randomized Clinical Trial of a Subcutaneous Insulin Aspart Protocol Coupled With Rapid Initiation of Basal Bolus Insulin Prior to Hospital Admission Versus Usual Care
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Hospital Length of Stay
研究概览
简要总结
This study will examine two questions: 1. Whether insulin treatment of high blood sugar in patients with diabetes while they are in the emergency room will improve how quickly they recover from illness if they need to be hospitalized. 2. Whether immediately beginning long lasting insulin detemir in patients with diabetes when they are admitted to hospital from the emergency room will improve how quickly they recover from the illness which necessitated hospitalization.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years
- •History of type 2 diabetes mellitus for at least 3 months
- •Prior therapy with dietary management, oral agents, or insulin
- •Non child-bearing potential or a negative urine pregnancy test
- •Initial blood glucose in ER > 200 mg/dl
排除标准
- •Subsequent finding of diabetic ketoacidosis or hyperosmolar non-ketotic syndrome after initial evaluation.
- •Patients with critical illness suspected to require intensive care unit admission or direct surgical intervention.
- •History of current drug or alcohol abuse.
- •History of current mental illness
- •Inability to give informed consent
- •Female patients who are pregnant or are breast feeding
- •Patients who have clinically significant liver disease with AST/ALT (aspartate transaminase/alanine transaminase) > 3 times the upper range of normal
- •Patients currently treated with dialysis
研究组 & 干预措施
aspart detemir
these subjects will be treated with insulin aspart every 2 hours if blood glucose is more than 200 mg/dl during their ER evaluation. If they are admitted to hospital then they will receive a weight-based dose of insulin detemir immediately prior to admission and then every 24 hours thereafter combined with mealtime doses of insulin aspart if they are eating.
干预措施: insulin aspart (Drug)
aspart detemir
these subjects will be treated with insulin aspart every 2 hours if blood glucose is more than 200 mg/dl during their ER evaluation. If they are admitted to hospital then they will receive a weight-based dose of insulin detemir immediately prior to admission and then every 24 hours thereafter combined with mealtime doses of insulin aspart if they are eating.
干预措施: insulin detemir (Drug)
结局指标
主要结局
Hospital Length of Stay
时间窗: from hospital admission to hospital discharge
hospital length of stay in days
次要结局
- Average Blood Glucose During the Hospital Admission(from admission to discharge)
- Frequency of Hypoglycemia(from hospital admission to discharge)
- Frequency of Hypoglycemia During Emergency Room Therapy With Insulin(from emergency room admission to discharge)
- Efficacy of Blood Glucose Lowering During the Emergency Room Stay(from emergency room admission to discharge)