STEP-DC: Stop Emergency Room Visits for Uncontrolled Hyperglycemia Project in the District of Columbia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Total Number of Hypoglycemia Events (Blood Glucose < 60mg/dL) Within 24 Hours of Baseline Visit
研究概览
简要总结
To demonstrate that a focused Emergency Department (ED) intervention for uncontrolled hyperglycemia enables safe and effective glycemic management and reduces emergency room re-visits. We assessed hypoglycemia BG < 60mg/dL; change in mean blood glucose and A1C, and ED revisits for hyperglycemia.
详细描述
Patients with BG > 200mg/dL presenting to an urban tertiary care hospital ED were enrolled in a 4 week prospective intervention with historic self-controls. Subjects returned at 12-72 hours, 2 and 4 weeks. Diabetes medications (including sulfonylureas, metformin and/or insulin) were initiated and/or adjusted at each visit using the intervention algorithm per presenting blood glucose and prior diabetes medications. Survival skills self-management education and navigation to outpatient services were provided.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Type 2 Diabetes Mellitus,
- •random BG > 200 mg/dL,
- •willing and able to provide informed consent and to participate in diabetes self-management education (DSME)
- •stable for discharge from the ED once hyperglycemia treatment initiated.
排除标准
- •type 1 Diabetes Mellitus,
- •diabetic ketoacidosis or hyperosmolar non-ketotic state,
- •concomitant treatment with glucocorticoids (other than stable maintenance dose therapy),
- •cognitive or physical impairment preventing participation in DSME
- •unwillingness or inability to provide consent and/or attend follow-up visits.
研究组 & 干预措施
Diabetes education and medication management
All enrolled patients received the intervention. There was no comparative arm. The analysis was done as pre and post.
干预措施: Antihyperglycemic medication guideline for management of uncontrolled hyperglycemia presenting to the ED using metformin, sulfonylurea and/or insulin (Drug)
Diabetes education and medication management
All enrolled patients received the intervention. There was no comparative arm. The analysis was done as pre and post.
干预措施: Diabetes survival skills self-management education (Behavioral)
结局指标
主要结局
Total Number of Hypoglycemia Events (Blood Glucose < 60mg/dL) Within 24 Hours of Baseline Visit
时间窗: 24 hours
Total Number of hypoglycemic events defined as Blood Glucose \< 60 within 24 hours of index emergency room visit (baseline)
次要结局
- Change in Hemoglobin A1C From Baseline to End of Intervention at 30 Days(30 days)
- Change in Mean Blood Glucose From Time of Presentation to Emergency Room to End of Intervention 30 Days From Baseline(30 days)
研究者
Michelle Magee
Director, MedStar Diabetes Institute
Medstar Health Research Institute