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临床试验/NCT01033773
NCT01033773
已完成
不适用

STEP-DC: Stop Emergency Room Visits for Uncontrolled Hyperglycemia Project in the District of Columbia

Medstar Health Research Institute1 个研究点 分布在 1 个国家目标入组 86 人2007年9月

概览

阶段
不适用
干预措施
Antihyperglycemic medication guideline for management of uncontrolled hyperglycemia presenting to the ED using metformin, sulfonylurea and/or insulin
疾病 / 适应症
Type 2 Diabetes Mellitus
发起方
Medstar Health Research Institute
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
状态
已完成
最后更新
5年前

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.

注册库
clinicaltrials.gov
开始日期
2007年9月
结束日期
2009年1月
最后更新
5年前
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

发起方
Medstar Health Research Institute
责任方
Principal Investigator
主要研究者

Michelle Magee

Director, MedStar Diabetes Institute

Medstar Health Research Institute

入排标准

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

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

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)

研究点 (1)

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