NCT06838819尚未招募不适用
Evaluation of Accuracy of Medtronic Simplera™ CGM in Patients on Icodextrin-containing Peritoneal Dialysis Regimens
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Elaine Chow
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Mean absolute relative difference (MARD)
研究概览
简要总结
Assessment of performance (precision and accuracy) of Simplera™ CGM as compared with a gold standard reference laboratory method (YSI glucose) in diabetes patients on peritoneal dialysis with icodextrin
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 or 2 diabetes mellitus for at least 3 months
- •On continuous ambulatory peritoneal dialysis (CAPD) or APD for at least 2 months
- •On icodextrin PD solutions for at least 1 month or planned for switching to icodextrin PD solutions within 3 months of screening
- •Male or female age ≥ 18 years old and ≤ 75 year old.
- •Women who are not pregnant, lactating or planning a pregnancy during their participation in the clinical study.
- •Willingness, ability and commitment to comply with the testing, procedure and follow-up outlined in this protocol including (but not limited to) frequency of clinic visits and use of pre-specified glucose monitoring devices.
- •Willingness to abstain from swimming during their participation in the measurement phase.
- •In the opinion of the investigator, absence of any physical limitations, addictive diseases, or underlying medical conditions (including mental health) that may preclude the patient from being a good study candidate.
- •Written informed consent to participate in the study provided by the patient.
排除标准
- •Poorly controlled diabetes mellitus with HbA1c>11%
- •Peritonitis within 1 month of screening
- •Planned for switching to hemodialysis or living donor transplant in the future 1 month
- •Currently pregnant, as demonstrated by a positive pregnancy test at screening for women of reproductive potential
- •Any active acute or chronic disease or condition that, in the opinion of the investigator, might interfere with the performance of this study.
- •Any active acute or chronic infectious disease that, in the opinion of the investigator, would pose an excessive risk to study staff.
- •Current use or recent exposure to any medication that in the opinion of the investigator could have an influence on the patient's ability to participate in this study or on the performance of the test device.
- •Extensive skin changes/diseases that preclude wearing the required number of devices on normal skin at the proposed application sites (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis).
- •Have a known allergy to medical-grade adhesives, or known hypersensitivity to any of the products used in the study.
- •Blood donation of more than 500 ml within the last three months
- •Currently participating in another investigational study protocol where the testing or results may interfere with study compliance, diagnostic results, or data collection.
- •Has a MRI scan, CT scan, or diathermy scheduled during the proposed study participation.
- •An identified protected vulnerable patient (including but not limited to those in detention, or a prisoner).
- •Women of reproductive potential who are unwilling to adopt contraceptive measures during the study period
- •Patients with history of pacemaker and prosthesis implantation.
- •Continuous use of real-time CGM for personal diabetes management in the three months prior to screening (sensor use >80% of time)
结局指标
主要结局
Mean absolute relative difference (MARD)
时间窗: 5 minutes
MARD of sensor versus YSI glucose
次要结局
- Median absolute relative difference (MedARD)(5 minutes)
- Consensus Error grid analysis(5 minutes)
- Percent accuracy(5 minutes)
- Hypoglycemia detection rates(15 minutes)
- Hyperglycemia detection rates(15 minutes)
- User satisfaction(2 weeks)
- Correlation between CGM metrics, HbA1c and fructosamine(2 weeks)
- Correlation between CGM metrics and SMBG(2 weeks)
研究者
Elaine Chow
Clinical Associate Professor
Chinese University of Hong Kong
研究点 (1)
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