NCT04879693Unknown不适用
Effectiveness and Safety of the Dexcom G6 Continuous Glucose Monitoring System in Non-Critically Ill Patients in the Inpatient Setting
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- DexCom, Inc.
- 入组人数
- 250
- 主要终点
- System Performance
研究概览
简要总结
Effectiveness and Safety of the Dexcom G6 Continuous Glucose Monitoring System in Non-Critically Ill Patients in the Inpatient Setting
详细描述
To assess the performance of the CGM System in comparison to a blood glucose comparator method in non-critically ill hospitalized patients who need glucose control.
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
盲法说明
All systems worn will be blinded. All sensor insertions will be performed at the clinic by subjects and/or caregivers.
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age and older
- •Admitted to the hospital in a non-ICU bed or once transferred out of ICU
- •Anticipate at least 48 hours of hospital stay
- •On treatment for glucose control.
- •Willingness to complete the study.
- •Willingness to wear up to 3 CGM systems simultaneously. Two in the abdomen and one on the back of the arm or one on each arm and one on the abdomen.
- •Subject and/or caretaker are able to speak, read, and write English
排除标准
- •Presence of extensive skin changes/diseases at sensor wear site(s) that preclude wearing the sensor(s) on normal skin (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis)
- •Currently in an intensive care unit (ICU) of the following type (does not apply to participants placed in an ICU bed due to space issues in the non-ICU areas)
- •Known allergy to medical-grade adhesives
- •Pregnancy, demonstrated by a positive test (for subjects of childbearing potential)
- •Women admitted to give birth or any other admission related to pregnancy
- •Patients receiving Hydroxyurea
- •Bleeding disorder
- •Participants that are currently being treated for malignancies, cancer
- •Participant that are hospitalized to receive an organ transplant
- •Require a Magnetic Resonance Imaging (MRI) scan
- •End stage renal disease and currently managed by dialysis or anticipating initiating dialysis during the study wear period
- •Current participation in another investigational study protocol (If a subject has recently completed participation in another drug study, the subject must have completed that study at least 7 days prior to being enrolled in this study.)
- •Any condition that, in the opinion of the Investigator, would interfere with their participation in the trial or pose an excessive risk to study staff (e.g., known history of hepatitis B or C)
研究组 & 干预措施
Hospitalized Patients
Experimental
To assess performance of CGM compared to comparator measurement.
干预措施: Continuous Glucose Monitoring System (Device)
结局指标
主要结局
System Performance
时间窗: Up to 10 days
Assess the performance of the CGM System in comparison to a blood glucose comparator method in non-critically ill hospitalized patients who need glucose control.
次要结局
未报告次要终点
研究者
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