Continuous Glucose Monitoring in the Hospital to Aid in Care and Improve Transition of Care to Outpatient
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Changes in care
研究概览
简要总结
A pilot study using the FreeStyle Libre to assess its potential benefits in patients with diabetes starting when they are inpatients and continuing during the transition of care to the outpatient setting to see if diabetes care can be improved after discharge.
This study is designed to address the following questions:
- How do the glucose readings from FreeStyle Libre Pro compare to our inpatient glucometer system? Is the system is accurate enough to use for clinical decision making?
- How often does the additional continuous glucose data change inpatient care?
- Does this technology work with inpatient nursing workflow?
- Does leaving the patch on at discharge and reading in the office improve transition of care?
- Does reading the patch after discharge in the office improve follow-up care?
详细描述
Continuous glucose monitoring checks blood glucose continuously. This allows the patient and provider to see what the glucose does between finger stick measurements. The FreeStyle Libre, is a sensor patch that can continuously measure glucose for up to two weeks.
Objectives To see if new continuous glucose technology can 1) Improve glucose management in the hospital compared to finger sticks 4-5 times per day. 2) Help with glucose control during transition of care from hospital to home and follow-up in the office The main hypothesis of this study is if the additional glucose information improves diabetes care for patients in the hospital and after the transition to home.
Background The FreeStyle Libre Pro was recently approved by the FDA. It is a patch applied to the skin with glucose containing sensing technology that will record the subcutaneous blood continuously for up to 2 weeks. It has the potential to reduce the number of painful glucose checks done by pricking the finger. It is currently approved for use in the office.
Study Method A pilot using the FreeStyle Libre to assess its potential benefits in patients with diabetes starting when they are inpatients and continuing during the transition of care to the outpatient setting to see if diabetes care can be improved after discharge. To our knowledge, there are currently no studies on using CGM to help the transition of care.
Protocol Outline
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
- •Inpatients on insulin therapy 18 years and older on insulin with glucose testing 4-5 times per day
- •Patient able to sign informed consent.
排除标准
- •Patient unable to give informed consent
- •Critically ill patients will not be started in the CGM patch, but he patch will not be removed if transferred to ICU.
- •Patients currently on acetaminophen
- •Currently on diathermy treatments
- •Currently on vitamin C
- •Patient is sensitive to the adhesive or develops significant skin irritation.
- •Treatment for dehydration
结局指标
主要结局
Changes in care
时间窗: 2 weeks
Each day a clinician from the Diabetes Service sees a patient in the hospital or office setting after discharge, they will download the information in the sensor patch. The clinician will note on the data collection sheet if the additional information changed the care compared to the information available from the hospital and patient glucose testing.
次要结局
- Accuracy of device(2 weeks)
研究者
Anne Webster, APN
APN
Methodist Medical Center of Illinois