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| ID | Type | Description | Link |
|---|---|---|---|
| Horizon Europe EIC programme | Other Grant/Funding Number | Horizon Europe EIC programme |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CKD with eGFR < 60 mL/min/1.73 m² | Other | CKD patients with reduced kidney function (eGFR < 60 mL/min/1.73 m²), and |
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| CKD with eGFR ≥ 60 mL/min/1.73 m²) | Other | CKD patients with preserved kidney function (eGFR ≥ 60 mL/min/1.73 m²) but with documented evidence of kidney damage (e.g., albuminuria, structural or genetic abnormalities). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KERMIT dermal patch | Device | The KERMIT patch is a non-invasive, wearable device designed to collect sweat and measure concentrations of kidney function biomarkers, including creatinine, urea, and cystatin C. The patch integrates printed biosensors and a microfluidic system for electrochemical detection. It is applied to the skin for a short duration (typically <1 hour), with pilocarpine stimulation. This study evaluates the patch's performance in differentiating between CKD patients with reduced versus preserved renal function. |
| Measure | Description | Time Frame |
|---|---|---|
| Creatinine concentration in sweat | 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 | Day 1 (includes screening, device application, and sample analysis) |
| Urea concentration in sweat | 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 | Day 1 (includes screening, device application, and sample analysis) |
| Incidence of adverse events related to the wearable device | 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) | Day 1 (up to 1 hour post-device removal) |
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Inclusion Criteria:
Adults aged ≥18 years with stable CKD, defined as:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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This is a non-randomized, parallel assignment interventional study designed to evaluate the diagnostic performance and safety of an experimental wearable sweat-sensing device. The study includes two parallel arms based on kidney function:
All participants will undergo a single application of the wearable device, which non-invasively collects sweat to quantify kidney biomarkers.
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| KERMIT dermal patch | Device | The KERMIT patch is a non-invasive, wearable device designed to collect sweat and measure concentrations of kidney function biomarkers, including creatinine, urea, and cystatin C. The patch integrates printed biosensors and a microfluidic system for electrochemical detection. It is applied to the skin for a short duration (typically <1 hour), with pilocarpine stimulation. This study evaluates the patch's performance in differentiating between CKD patients with reduced versus preserved renal function. |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |