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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Time In Range (TIR) for blood glucose
研究概览
简要总结
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 and this will demand extra workforce resources, extra use of protective equipment (gowns, masks, gloves, etc) and extra time used for taking protective equipment on and off. In concert these extra demands will drain the health care system and any initiative to reduce these challenges is needed.
In this randomized controlled trial, isolated patients with diabetes will be randomized to either standard care fingerprick glucose + blinded CGM or Dexcom G6 only.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •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.
排除标准
- •1. Known hypersensitivity to the band-aid of the Dexcom G6 sensors
结局指标
主要结局
Time In Range (TIR) for blood glucose
时间窗: 1-2 weeks
TIR is presented in percent of time in which the participants' glucose values are in different glucose ranges.
次要结局
- Glucose variations during hospitalization(1-2 weeks)
- Saved patient-personnel contacts related to blood glucose measurements.(1-2 weeks)
- Blood glucose lowering interventions(1-2 weeks)
- CGM sensor performance(1-2 weeks)
- Course of hospital stay.(1-2 weeks)