The Validity of a Novel Diabetes Diagnostic Device and Its Feasibility as Metabolic Syndrome Diagnostic One. [TREARS STUDIES II]
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 258
- 主要终点
- Diagnostic accuracy of self-sampled earwax glucose for diabetes and glucose intolerance detection
研究概览
简要总结
Trears Biomarkers: A New Way to Manage Chronic Diseases
Trears Biomarkers are changing how we care for chronic diseases by focusing on patients' needs. People with chronic conditions often experience long-lasting changes in their bodies that typical tests do not accurately capture because they mostly measure short-term levels. These tests can be inconvenient, as patients frequently must travel to clinics, and some methods, like using needles, can be painful.
The Trears device, on the other hand, is easy and safe for people to use at home. It lets patients take their earwax samples, which they can send to the lab by regular mail, avoiding the hassle of mailing blood samples. This device could even make diagnosing diabetes more accurate.
Trears Biomarkers also investigates whether measuring sodium (salt) levels in earwax may be more reliable than a single blood pressure check and more straightforward than using a 24-hour blood pressure monitor. The aim is to enhance the diagnosis of all primary chronic conditions associated with Metabolic Syndrome (MetS), including diabetes, high cholesterol, obesity, and high blood pressure. These conditions are increasingly prevalent and already impact many people worldwide. With just one use, the Trears "multiplex" device could confirm a diagnosis typically requiring multiple tests.
Long-term lifestyle changes, like a healthy diet and regular exercise, work better than many drugs for treating MetS. Since the Trears device measures levels that change over time, it can give doctors a better picture of what's happening in a patient's body, allowing for more personalised recommendations. For instance, providing specific dietary advice could be more effective than simply prescribing medication, as it may lead to more lasting improvements in weight and blood pressure.
The device's design makes it accessible for home use, including by post, as earwax's natural bacteriostatic properties help preserve sample quality during mailing. In this study, we will test how effectively the Trears device works for diagnosing different types of diabetes and whether it can accurately track long-term levels of MetS markers. The device's new "multiplex" version might also support future point-of-care (POC) testing, allowing for the quick and convenient measurement of all MetS markers. We will consider how lifestyle factors - such as regular earplug use - might affect sample quality, ensuring the technology remains accurate and inclusive across diverse users. If necessary, we will introduce any potential changes in the Trears device design and/or marketing strategy after carefully considering feedback from our patients and their families, as outlined in Trears's mandate. Additionally, we will conduct an economic analysis to determine whether introducing the Trears device to a broader audience is financially sensible and essential. This will strengthen our position when launching our revolutionary technology in a conservative market.
详细描述
Title
The Validity of a Novel Diabetes Diagnostic Device and its Feasibility as Metabolic Syndrome Diagnostic One.
[TREARS STUDIES II] Herane-Vives, Andres1,2,3
- Visiting Lecturer; Institute of Cognitive Neuroscience; Clinical, Educational & Health Psychology Department; Faculty of Brain Disease; University College London Alexandra House; 17-19 Queen Square; Bloomsbury; London; UK.
- Visiting Lecturer; Affective Disorders Research Group, Centre for Affective Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.
- Trears Biomarkers Ltd, Founder & CEO, General Adult Psychiatrist Consultant, London, UK.
Abstract
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •i.People older than 35 years old ii.First-degree relative [parents or siblings] with diabetes. iii.Latin [Chilean] nationality iv.Women with a previous history of gestational diabetes or delivering a macrosomic (>9lb) baby v.Overweight or obese [BMI greater than or equal to 25 kg/m2] vi.Physical inactivity (no work-, transport-, or recreation-related physical activity in a typical week) vii.BP ≥130 and/or ≥80 mm Hg or use of antihypertensive medication viii.Self-reported diagnosis of prediabetes IFG, IGT or borderline diabetes. ix.Self-reported history of CVD: myocardial infarction, coronary heart disease, or stroke.
- •x.HDL-cholesterol < 35 mg/dL, triglycerides > 250 mg/dL, or lipid-lowering medication use xi.Women with polycystic ovarian syndrome xii.People with conditions associated with insulin resistance, such as acanthosis nigricansxiii.
- •Have non-alcoholic fatty liver disease.
排除标准
- •Participants with any ear disease, including external or internal otitis; Meniere syndrome or any form of dizziness; vertigo; malformation of the external ear; tinnitus; impacted earwax; current or previously perforated eardrums; individuals with tubes in their ears or who have had mastoid surgery; hearing loss or deafness, due to excess earwax production.
- •Asian ethnicity or intellectual disabilities due to their differences in the type and amount and type of earwax, respectively (Nussinovitch et al., 2004b; Pata et al., 2003).
- •This study will exclude people with very high blood glucose (blood sugar) levels [greater than or equal to 200 mg/dl] or with classic symptoms of high blood glucose.
- •Individuals with extreme ages under 18 years of age and over 75 years due to their different physiological responses and higher risk profiles.
- •Any conditions that might result in a significant change in glycemia, such as diseases requiring steroid therapy or pregnancy plans during the study period, will be exclusionary.
- •Any conditions that might result in a significant change in BP, such as diseases requiring steroid therapy or pregnancy plans during the study period, will be exclusionary.
- •Any conditions that might result in a significant change in BMI, such as plans for pregnancy during the study period, will be exclusionary.
- •Participants with hemoglobinopathies, anaemia, reticulocytosis, blood loss, transfusions, chronic renal or liver disease, high-dose vitamin C, or erythropoietin treatment (Nathan et al., 2007) will also be excluded (Nathan et al., 2007; Weatherall, 2011).
- •Individuals with a phobia of needles
- •Presence of infection or acute metabolic complications of diabetes, such as ketoacidosis or hyperosmolar state (coma).
- •Individuals with existing cardiovascular conditions (e.g., coronary artery disease, heart failure, arrhythmias) may be at increased risk of adverse events (e.g., arrhythmias, hypertensive crises) during salt and fat loading.
- •Individuals with morbid obesity (e.g., BMI > 40 kg/m²) if not safely manageable within the study protocols.
- •Current or heavy smokers, e.g. 20 or more cigarettes per day, due to the cardiovascular and metabolic impact of tobacco.
- •Individuals who abuse alcohol or any illicit substance due to their potential impact on liver and kidney function, electrolyte balance, and blood pressure regulation.
- •Participants adhering to strict dietary regimens (e.g., ketogenic diet, vegetarianism) may have atypical metabolic responses to high-fat and high-salt intake.
- •Individuals with existing renal diseases, e.g. Chronic Kidney Disease (CKD) stages 3-5 (eGFR <60 mL/min/1.73m²), history of acute kidney injury, nephrotic syndrome or significant proteinuria.
- •Individuals with recent illness or hospitalisation.
- •Current users of loop diuretics, thiazides, or potassium-sparing diuretics. insulin or oral hypoglycaemic agents, statins and other lipid-lowering drugs
- •Individuals with polypharmacy will also be excluded, including steroids or any medication that may affect sodium secretion and/or excretion in tablets, creams, or aerosols.
- •Allergy to medical grade adhesive or isopropyl alcohol used to prepare the skin.
- •Presence of skin lesions, scarring, redness, infection, or oedema at sensor application sites.
- •Individuals with Inflammatory Bowel Disease (Crohn's disease, ulcerative colitis), history of bariatric surgery within the past year, severe malabsorption syndromes, hepatitis, type 1 or Type 2 Diabetes Mellitus requiring insulin therapy, hyperaldosteronism or Addison's disease, thyroid disorders (e.g.,hyperthyroidism, hypothyroidism) not adequately controlled.
- •Use of non-steroidal anti-inflammatory drugs (NSAIDs) regularly.
- •The presence of any other condition is considered to warrant exclusion.
结局指标
主要结局
Diagnostic accuracy of self-sampled earwax glucose for diabetes and glucose intolerance detection
时间窗: Baseline sampling with reference tests conducted within a ±5-day window
This primary outcome assesses the sensitivity and specificity of self-sampled earwax glucose levels, measured in a central lab, in identifying individuals with diabetes and glucose intolerance. These will be compared against standard diagnostic methods including the Oral Glucose Tolerance Test (OGTT), HbA1c, capillary POC glucose, and Continuous Glucose Monitoring (CGM) across a 90-day period. Diagnostic performance metrics (sensitivity, specificity, PPV, NPV) will be calculated. The hypothesis is that earwax glucose will yield ≥85% sensitivity and ≥90% specificity compared to OGTT, with variability \<5% and higher predictive accuracy than HbA1c.
次要结局
- Correlation between earwax sodium concentration and chronic blood pressure(Single sampling at baseline; blood pressure history from past 3 months)