Inpatient Diabetes on Corticosteroids
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Mean POC Glucose Level Between Groups
研究概览
简要总结
Despite a significant problem with out-of-control glucose levels in patients with diabetes receiving corticosteroids for a variety of illnesses, there are no published protocols addressing how to adequately treat corticosteroid-induced hyperglycemia. Investigators propose to test a protocol using scheduled dosing of NPH (Neutral protamine Hagedorn) insulin for inpatients with diabetes receiving corticosteroids. NPH insulin action is ideally timed to counteract corticosteroid-induced hyperglycemia, and the dose is added to the patient's usual insulin regimen and timed to correspond to the corticosteroid dosing regimen. Investigators will prospectively enroll eligible consented patients with diabetes who are receiving corticosteroids as part of their treatment in a large county hospital, will randomize them to intervention or control groups, and will monitor their glucose levels during their inpatient stay. The protocol will demonstrate improved control of glucose levels with minimal risk of hypoglycemia, and will provide a practical and readily implementable protocol using NPH insulin as therapy for corticosteroid-induced diabetes.
详细描述
As above.
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prior history of diabetes
- •Able to provide informed consent
- •Receiving corticosteroids while hospitalized of greater than 10 mg/d prednisone or the equivalent of dexamethasone or methylprednisolone
- •Expect to be hospitalized for 48 hours
排除标准
- •Renal failure with GFR (glomerular filtration rate) < 30 ml/min/1.73m2
- •ALT (alanine aminotransferase) > 2 times upper normal for laboratory
研究组 & 干预措施
NPH with steroid dose
Receive NPH with each corticosteroid dose during the study duration (2-5 days).
Low dose corticosteroids High dose corticosteroids Eating and 6a-8p 0.15 units NPH/kg 0.3 units NPH/kg NPO(nothing by mouth) or 8p-6a 0.1 units NPH/kg 0.2 units NPH/kg
干预措施: NPH (Drug)
NPH with steroid dose
Receive NPH with each corticosteroid dose during the study duration (2-5 days).
Low dose corticosteroids High dose corticosteroids Eating and 6a-8p 0.15 units NPH/kg 0.3 units NPH/kg NPO(nothing by mouth) or 8p-6a 0.1 units NPH/kg 0.2 units NPH/kg
干预措施: Correction Factor (Drug)
Control - Background and correction insulin
Receive usual care with background insulin and correction factor for duration of study (2-5 days)
干预措施: Correction Factor (Drug)
结局指标
主要结局
Mean POC Glucose Level Between Groups
时间窗: Assessed from enrollment to discharge or enrollment to day five.
Primary outcome measure was mean blood glucose levels measured pre-meal and at bedtime in study patients and controls for the duration of the intervention. Values shown are the overall mean point of care blood glucose.
次要结局
- Episodes of Hypoglycemia Between NPH and Control Groups(Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention. Values shown represent cumulative episodes of hypoglycemia per group.)