Kidney Disease Sweat Sensor Patch for Early Diagnosis and Remote MonIToring
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 52
- 主要终点
- Incidence of adverse events related to the wearable device
研究概览
简要总结
Chronic kidney disease (CKD) affects over 10% of the global population, leading to significant morbidity, mortality, and economic burden. Early detection is crucial for preventing disease progression and complications; however, awareness and diagnosis of CKD remain alarmingly low. Current methods rely on blood or urine analysis, which are invasive and require specialized facilities. The KERMIT patch aims to address this gap by providing a wearable lab-on-a-chip device capable of measuring key biomarkers from sweat non-invasively. This innovation has the potential to revolutionize CKD diagnosis, particularly in remote or underserved areas.
The KERMIT patch integrates functional printed biosensors, a high-frequency electrochemical microchip, and a sustainable microfluidic system. Sensors are fabricated using carbon inks and 2D materials, enabling immunodetection and non-enzymatic sensing of creatinine, urea, and cystatin C. Preliminary tests evaluated detection limits, skin compatibility, and carbon footprint.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Adults aged ≥18 years with stable CKD, defined as:
- •eGFR < 60 mL/min/1.73 m², or
- •eGFR ≥ 60 mL/min/1.73 m² with documented evidence of kidney damage (persistent albuminuria, structural abnormalities on imaging or histology, or genetic kidney disease).
排除标准
- •Any signs of dermal infections, open wounds, or skin irritation.
- •Significant variations in eGFR in the last two months, defined as any absolute change (either increase or decline) in eGFR of >10 mL/min/1.73m2 ;
- •Patients with a functioning kidney graft;
- •Patients receiving immunosuppression treatment;
- •Patients with kidney stones;
- •Patients with uncontrolled hypertension (a systolic blood pressure (SBP) >150 mmHg and/or diastolic blood pressure (DBP) >90 mmHg with measurements taken under standardized conditions (e.g after a 5-minute seated rest, using validated equipment);
- •Patients receiving drugs reported to affect serum levels of creatinine and cystatin-c without affecting kidney function (i.e. cimetidine, trimethoprim, and fibrates);
- •Known allergy to pilocarpine,
- •Glaucoma;
- •Patients with metal implants;
- •Pregnancy;
- •Active malignancy;
- •Low life expectancy (<6 months) according to investigators judgement
结局指标
主要结局
Incidence of adverse events related to the wearable device
时间窗: Day 1 (up to 1 hour post-device removal)
Assess the number and severity of adverse events related to the use of the wearable sweat-sensing device, including skin irritation, discomfort, or allergic reactions. Unit of Measure: Number of events, graded by severity (mild, moderate, severe)
Creatinine concentration in sweat
时间窗: Day 1 (includes screening, device application, and sample analysis)
Estimate the concentration of creatinine in sweat and assess its diagnostic accuracy in differentiating CKD patients with reduced kidney function (eGFR \< 60 mL/min/1.73 m²) from those with preserved kidney function (eGFR ≥ 60 mL/min/1.73 m² but with documented kidney damage). Unit of Measure: µmol/L
Urea concentration in sweat
时间窗: Day 1 (includes screening, device application, and sample analysis)
Estimate the concentration of urea in sweat and assess its diagnostic accuracy in differentiating CKD patients with reduced kidney function (eGFR \< 60 mL/min/1.73 m²) from those with preserved kidney function (eGFR ≥ 60 mL/min/1.73 m² but with documented kidney damage). Unit of Measure: mmol/L
次要结局
未报告次要终点
研究者
Evangelia Ntounousi
Ass. Prof. of Nephrology, Head of Nephrology Department
University of Ioannina