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临床试验/NCT02904512
NCT02904512已完成不适用

Inpatient Diabetes Mellitus (DM) Management With Continuous Glucose Monitoring Devices, a Pilot Study.

University of Maryland, Baltimore2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2016年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
2
主要终点
Number of Participants With Hypoglycemic Events (< 70mg/dL)

研究概览

简要总结

Several observational studies have shown that uncontrolled hyperglycemia in hospitalized patients in the non-critical care, non-Intensive Care Unit (non-ICU) setting is associated with prolonged length of stay, increased mortality and an increased incidence of infections. Randomized clinical trials in both the critical and the non-ICU settings have shown that by improving glucose control there is a decrease in the incidence of infections, length of stay and inpatient health care costs.

Continuous glucose monitoring (CGM) systems have evolved as useful devices providing excellent clinical care in patients with Diabetes Mellitus (DM). These systems detect glucose in subcutaneous interstitial fluid using a glucose sensor that transmits glucose measurements to a receiving device that reads out average glucose levels every couple of minutes.

In this clinical trial the investigators propose to examine the clinical use of CGM in hospitalized patients with Diabetes Mellitus type 2 (DM2). CGM use may improve glucometric values and clinical outcomes in hospitalized individuals with Diabetes Mellitus type 2 (DM2).

We use CGM devices to monitor but also to transmit glucose values wirelessly to monitoring devices that are in the nursing station. Half of the participants are placed on Real Time CGM (alarms turned on) and half of them are placed on blinded CGM values (alarms turned off). Nursing staff will be notified when glucose is <85 mg/dl , in order to treat and potentially prevent a potential hypoglycemic episode.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • History of Diabetes Mellitus type 2 (DM2) on insulin
  • Exclusion Criteria
  • Patients that are expected to require a hospital stay ≤3 days
  • Pregnant patients
  • Subjects that have significant hyperglycemia or Diabetic Ketoacidosis (DKA) that requires treatment with intravenous insulin infusion
  • Patients receiving glucocorticosteroids in doses (equivalent) to ≥ 20 mg of hydrocortisone/day
  • Any mental condition rendering the subject incapable of understanding the objectives and potential consequences of the study
  • Patients that need hospitalization in the critical care (ICU) setting.
  • History of Diabetes Mellitus type 1 (DM1)

排除标准

  • 未提供

结局指标

主要结局

Number of Participants With Hypoglycemic Events (< 70mg/dL)

时间窗: Through study completion, during hospital stay, an average of 1 week

Percentage of Time Spent in Significant Hyperglycemia (>300 mg/dL)

时间窗: Through study completion, during hospital stay, an average of 1 week

Percentage of Time Spent in Hyperglycemia > 180 mg/dL

时间窗: Through study completion, during hospital stay, an average of 1 week

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ilias Spanakis

MD

University of Maryland, Baltimore

研究点 (2)

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