Development of Hand Held Breath Acetone Monitor for Control of Type 1 Diabetes

糖尿病是21世纪最具挑战性的健康问题之一，是大多数高收入国家的主要死亡原因。有大量证据表明，在许多经济发展中国家，这是一种流行病。据估计，全球有3.66亿人患有糖尿病，每年花费4650亿美元（占全球医疗保健支出的11%），而且发病率正在上升。血糖升高，即高血糖，在不受控制的糖尿病中很常见，随着时间的推移，会导致身体许多系统的进行性衰竭，尤其是神经和血管，这可能导致严重的、使人衰弱的溃疡，甚至可能导致截肢。糖尿病有两种类型：1。1型（占糖尿病总人数的10%）：胰岛素分泌不足，通过定期检测血糖水平（每天3~10次）和胰岛素治疗。类型2：胰岛素产生不足或使用无效，由生活方式改变和药物控制。有证据表明，通过定期监测良好的血糖控制对糖尿病，特别是1型糖尿病的治疗至关重要。然而，目前的血糖监测仪是有创的，患者通过手指刺血，这是痛苦和不方便的，特别是对儿童来说，是患者依从性差和自我管理欠佳的原因之一。无创血糖监测仪将为改善自我管理提供动力，尤其是儿童。OMD正在为1型糖尿病患者开发一种手持无创呼吸丙酮监测仪，旨在通过测量呼吸丙酮水平来检测血糖水平。有明确的证据表明，诊断为1型糖尿病的患者呼吸丙酮的变化与血糖之间存在相关性[3,4,5]。这项技术已经在实验室进行了测试，以便下一个发展阶段——微型化——可以继续进行。该项目计划在2012年第四季度开发出预生产原型，准备在2013年用于临床试验

Diabetes is one of the most challenging health problems in the 21st century, being a leadingcause of death in most high-income countries. There is substantial evidence that it is anepidemic in many economically developing countries. It is estimated that 366m people havediabetes globally costing $465bn pa (11% of global healthcare expenditure) and the incidenceis increasing[1].Raised blood sugar, Hyperglycaemia, is common in uncontrolled diabetes and over time leadsto progressive failure of a number of the body’s systems, especially nerves and blood vesselswhich can lead to severe and debilitating ulcers and potentially limb amputation.There are two types of diabetes:1. Type 1 (10% of diabetic popn): the absence of insulin production, managed by regulartesting of blood glucose levels (3~10 times daily) and insulin administration.2. Type 2: insufficient production of, or ineffective use of, insulin, managed by lifestylechanges and drugs.There is evidence that good control of blood glucose by regular monitoring is essential in themanagement of diabetes, especially Type 1[2]. However, current blood glucose monitors areinvasive, the patient extracts blood by a finger prick, which is painful and inconvenientespecially for children, and is one of the causes of poor patient compliance and sub optimalself-management. A non-invasive blood glucose monitor would provide the incentive forimproved self-management especially in children.OMD is developing a hand held non-invasive breath acetone monitor for Type 1 diabetics,designed to test blood glucose levels by measuring breath acetone levels. There is clearevidence of a correlation between the changes breath acetone and blood glucose in diagnosedType 1 diabetics[3,4,5]. The technology has been tested in the laboratory such that the nextdevelopment stage, miniaturisation, can proceed. The project plan is to develop a preproductionprototype by Q4 2012 ready for use in clinical trials in 2013