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临床试验 NCT04430608 (CGM-ISO) 针对糖尿病，新冠病毒2019，感染目前已完成。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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卡片视图
Remote Continues Glucose Monitoring During the COVID-19 Pandemic in Quarantined Hospitalized Patients (CGM-ISO) 64 随机化 远程参与
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临床试验NCT04430608 (CGM-ISO)是一项针对糖尿病，新冠病毒2019，感染的干预性研究试验，试验状态为已完成。试验开始于2020年5月25日，共计划招募64名患者。该研究由Nordsjaellands Hospital主导，已于2021年4月25日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2024年4月5日。
简要概括
This is a randomized controlled trial of isolated patients with diabetes admitted to Nordsjællands Hospital with or without COVID-19-pneumonia. A continuous glucose monitoring (CGM) based system with transmission of glucose data to a central system is used for remote monitoring of glucose levels and compared to standard finger-prick glucose. Blinded (to patients) CGM is mounted in the finger-prick group.
详细描述
Epidemics and pandemics are a constant threat to health care systems globally. This stresses the importance of preparedness for a large amount of hospitalized quarantined patients in isolation, with the extra challenges it brings. The COVID-19 pandemic challenges the Danish health care system in many aspects: An increased number of citizens are expected to be admitted to hospital due to COVID-19 infected pneumonia an...显示更多
官方标题
Remote Glucose Monitoring of Patients With Diabetes Quarantined During the COVID-19 Pandemic - a Hospital-Based Randomized Controlled Trial of the Effect of Remote Continuous Glucose Monitoring Compared to Usual Glucose Monitoring
疾病
糖尿病新冠病毒2019感染出版物
关于此临床试验发表的科学文章和研究论文：其他研究标识符
- CGM-ISO
- H-20025305
NCT编号
实际开始日期
2020-05-25
最近更新发布
2024-04-05
预计完成日期
2021-04-25
计划入组人数
64
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
已完成
关键词
endocrinology
diabetes
quarentine
isolation
CGM
diabetes
quarentine
isolation
CGM
主要目的
其他
分配方式
随机
干预模型
平行
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
其他Fingerprick glucose Standard care with fingerprick glucose + blinded CGM stratification on COVID-19 status | Dexcom G6 The investigational device is a CGM Dexcom G6. The Dexcom G6 System is intended to replace fingerstick blood glucose testing for diabetes treatment decisions. The device-system consists of a sensor, the Dexcom G6 device/sender, and connects to a smart device like a cellphone. The Dexcom G6 CGM system is probably the most precise system on the market and with no need for daily calibration with finger prick glucose. Th...显示更多 |
实验性Open continous glucose monitoring (CGM) Standard care with fingerprick glucose + un-blinded CGM stratification on COVID-19 status | Dexcom G6 The investigational device is a CGM Dexcom G6. The Dexcom G6 System is intended to replace fingerstick blood glucose testing for diabetes treatment decisions. The device-system consists of a sensor, the Dexcom G6 device/sender, and connects to a smart device like a cellphone. The Dexcom G6 CGM system is probably the most precise system on the market and with no need for daily calibration with finger prick glucose. Th...显示更多 |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Time In Range (TIR) for blood glucose | TIR is presented in percent of time in which the participants' glucose values are in different glucose ranges. | 1-2 weeks |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Saved patient-personnel contacts related to blood glucose measurements. | Saved patient-personnel contacts related to blood glucose measurements, incl. time healthcare providers spent on diabetes related tasks and PPE related tasks, during the patients' hospitalization. | 1-2 weeks |
Glucose variations during hospitalization | Additional glucose outcomes based on data from Dexcom G6 are for example Time Above Range (TAR), Time Below Range (TBR), average glucose, variance in glucose (CV), etc. | 1-2 weeks |
Blood glucose lowering interventions | That is: Tablet-based and insulin-based regimens and number of times that sliding scale insulin (including dose of insulin) has been administered for each patient. | 1-2 weeks |
CGM sensor performance | Number of techincal errors during the sensors lifetime. | 1-2 weeks |
Course of hospital stay. | Hospital death (yes/no), length of stay at hospital, need for respiratory support (yes/no) and intensive care (yes/no), recovered vs. fatal (death within 60 days from admission). | 1-2 weeks |
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
- Hospitalized with confirmed COVID-19 infection by real-time PCR or another validated method OR hospitalized with a non-COVID-19 diagnosis AND in isolation at time of inclusion.
- A documented clinically relevant history of diabetes or newly discovered during hospitalization.
- Written informed consent obtained before any trial related procedures are performed.
- Male or female aged over 18 years of age.
- Must be able to communicate with the study personnel.
- The subject must be willing and able to comply with trial protocol.
1. Known hypersensitivity to the band-aid of the Dexcom G6 sensors
Nordsjaellands Hospital没有联系数据。
1 位于 1 个国家/地区的研究中心
Nordsjællands Hospital, Hillerød, 3400, Denmark