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临床试验/NCT04533945
NCT04533945已完成不适用

The Feasibility of Using the FreeStyle Libre Flash Glucose Monitoring System During the Transition of Care (TOC) From Inpatient to Outpatient in Persons With Type 2 Diabetes (T2D) Using Basal/Bolus Insulin

Northwell Health1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年3月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Change in Hemoglobin A1C (HbA1C)

研究概览

简要总结

Using the Libre during the TOC with persons with T2D will improve patient glucose monitoring and satisfaction, which can potentially lead to an improvement in glycemic control and hospital utilization. This study aims to assess this with inpatients using insulin.

详细描述

Integrating the use of the Libre during the TOC will improve patient glucose monitoring and satisfaction, which can potentially lead to an improvement in glycemic control and hospital utilization. Inpatients admitted to the medical-surgical units would be considered based on the inclusion and exclusion criteria. If the patient qualifies they would be consented to participate in the trial. In addition they would be given a script for refills. Primary outcome is change in HbA1c and secondary outcomes at baseline and 90 days include satisfaction, number of ED/inpatient visits, completion of follow-up appointment, and duration of CGM use.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

  • •Persons with T2DM
  • •Persons on atleast 3 injections of insulin/day
  • •Persons whose insurance will cover the device

排除标准

  • •Persons with adhesive allergy
  • •Pregnant women
  • •Persons with CKD 4/5 or on dialysis

研究组 & 干预措施

FreeStyle Libre Device

Other

Inpatients admitted to the medical-surgical units that are eligible for the trial will have the FreeStyle Libre device will be placed by the inpatient diabetes team at the discharge and glucose log will be obtained in 2 weeks followed by Hba1c in 3 months.

干预措施: FreeStyle Libre (Device)

结局指标

主要结局

Change in Hemoglobin A1C (HbA1C)

时间窗: 90 days

Change in HbA1c

次要结局

  • Satisfaction with device assessed by the FreeStyle Libre Telephone Questionnaire(90 days)
  • Incidence of patients that complete of follow-up appointment(90 days)
  • Number of ED/inpatient visits(90 days)
  • Duration of CGM use(90 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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