Implementation of Networked Continuous Glucose Monitoring With Telemetry Within the Intensive Care Unit (ICU-TeleCGM)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Phase 1: Eligible participants that consent to participate.
研究概览
简要总结
The aim of this observational study is to assess safety and implementation of continuous glucose monitors within the Intensive Care Unit. The Dexcom G7 is a continuous glucose monitoring system that shows blood glucose values in real-time and includes alarms if the glucose is very low or high.
详细描述
Aim: To assess safety and implementation of networked CGM with ViewsEMR® telemetry within ICU.
The study will be conducted in a two-stage process:
- Phase 1: A single arm (non-randomised) unmasked feasibility study with adjunctive use of networked CGM using the Dexcom G7 system and ViewsEMR® telemetry. This phase will be conducted at a single site at Imperial College Healthcare NHS Trust (ICHNT).
- Phase 2: A randomised, parallel-group pilot study with adjunctive use of networked CGM using the Dexcom G7 system and ViewsEMR® telemetry compared to standard of care. This phase will be conducted at three hospitals within the same site: ICHNT (St Mary's Hospital, Charing Cross Hospital and Hammersmith Hospital). The study will be conducted at Imperial College Healthcare NHS Trust in people with hyperglycaemia on admission to ICU requiring insulin.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Age >18years inclusive
- •Hyperglycaemia requiring insulin therapy (subcutaneous injection or intravenous insulin) during admission on ICU
- •Admission to ICU within 48hours
排除标准
- •Known significant allergy to tape/ adhesives
- •Imminent death or anticipated length of stay <24hours
- •Women who are pregnant
- •Imminent extracorporeal membrane oxygenation (ECMO)
- •Requirement for therapeutic temperature control (i.e. cooling) post cardiac arrest
研究组 & 干预措施
Adjunctive use of continuous glucose monitoring (Dexcom G7) with telemetry (ViewsEMR/CampViews®)
Adjunctive use of continuous glucose monitoring (Dexcom G7) with telemetry (ViewsEMR/CampViews®)
干预措施: Dexcom G7 (Device)
Adjunctive use of continuous glucose monitoring (Dexcom G7) with telemetry (ViewsEMR/CampViews®)
Adjunctive use of continuous glucose monitoring (Dexcom G7) with telemetry (ViewsEMR/CampViews®)
干预措施: ViewsEMR telemetry (Device)
Usual care + masked Dexcom G7
Use of continuous glucose monitoring (Dexcom G7) without telemetry (ViewsEMR/CampViews®)
干预措施: Dexcom G7 (Device)
结局指标
主要结局
Phase 1: Eligible participants that consent to participate.
时间窗: Throughout Phase 1 study period, up to 6 months
Percentage of eligible participants that consent to participate, including the percentage enrolled through participant informed consent, via personal consultee, and via nominated consultee.
Phase 1: Time from admission to ICU to initiation of CGM
时间窗: From admission to ICU to initiation of CGM, up to 48 hours
Time in minutes from admission to ICU to initiation of CGM
Phase 1: Time from consent to initiation of CGM
时间窗: From enrollment to the end of intervention at 10 days
Time from consent to initiation of CGM
Phase 1: Percentage of CGM data availability for each participant
时间窗: From enrollment to the end of intervention at 10 days
Percentage of CGM data availability for each participant
Phase 1: Percentage of participants successfully set-up on telemetry (ViewsEMR ®)
时间窗: From enrollment to the end of intervention at 10 days
Percentage of participants successfully set-up on telemetry (ViewsEMR ®)
Phase 1: Number of premature sensor failures per participant (defined as <70% of anticipated use)
时间窗: From enrollment to the end of intervention at 10 days
Number of premature sensor failures per participant (defined as \<70% of anticipated use)
Phase 1: Number and type of adverse events related to CGM use (e.g., skin irritation, device malfunction)
时间窗: From enrollment to the end of intervention at 10 days
Number and type of adverse events related to CGM use (e.g., skin irritation, device malfunction)
Phase 1: Proportion of participants completing the study
时间窗: Throughout Phase 1 study period, up to 6 months
Proportion of participants completing the study
Phase 1: Proportion of nursing staff completing study survey
时间窗: Throughout Phase 1 study period, up to 6 months
Proportion of nursing staff completing study survey
Phase 2: Number of episodes of hypoglycaemia per participant
时间窗: Throughout Phase 2, up to 30 days
Number of episodes of hypoglycaemia per participant (defined as \<3.9mmol/L for 15minutes)
次要结局
- Phase 1: Safety Outcomes(From enrollment to the end of intervention, up to 10 days)