Continuous Monitoring of Glycemic Oscillations in Interstitial Fluid

连续监测间质液中的血糖波动

• 批准号: 7926546
• 负责人: John P. Willis
• 金额: $ 19.12万
• 依托单位: ULTRADIAN DIAGNOSTICS, LLC
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-08-09 至 2011-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7926546
• 关键词: Algorithms; Artificial Pancreas; Belief; Beta Cell; Biological Models; Biosensor; Blood; Cardiovascular system; Cell Surface Receptors; Cell membrane; Cells; Characteristics; Chronic; Clinical; Clinical Research; Complications of Diabetes Mellitus; Coupled; Data; Defect; Dermis; Development; Diabetes Mellitus; Diagnosis; Diagnostic; Diet; Environment; Evaluation; Exhibits; Family suidae; Frequencies; Gene Expression; Glucose; Glycolysis; Government; Healthcare Systems; Human; Hybrids; Hypoglycemia; In Vitro; Individual; Insulin; Insulin Resistance; Insulin-Dependent Diabetes Mellitus; Intercellular Fluid; Intervention; Kinetics; Lead; Life; Life Style; Link; Marketing; Measures; Medical; Methods; Modeling; Monitor; Mutation; Needles; Noise; Non-Insulin-Dependent Diabetes Mellitus; Onset of illness; Outcome; Pancreas; Patients; Pattern; Pattern Recognition; Periodicity; Persons; Physicians; Population; Preventive; Preventive Medicine; Protocols documentation; Publishing; Reporting; Research; SLC2A1 gene; Screening procedure; Series; Signal Transduction; Staging; Surface; Suspension substance; Suspensions; Symptoms; System; Technology; Therapeutic Intervention; Time; Time Series Analysis; Universities; Yeasts; base; cost; extracellular; glucose metabolism; glucose monitor; glucose transport; human subject protection; in vitro Model; in vivo; in vivo Model; mathematical model; patient population; public health relevance; receptor; tool; trend; type I and type II diabetes

DESCRIPTION (provided by applicant): To date, the use of marketed continuous glucose monitoring systems (CGMs) are limited to glucose trend analysis by patients with insulin-dependent type 1 and type 2 diabetes. Accuracy limitations, particularly in the hypoglycemic range, and low signal-to-noise ratio have precluded expansion of this promising technology into screening applications to identify early signs of diabetes, prior to clinical onset of disease, so preventive measures may be taken. The proposed research is focused on developing an in vitro model of glycemic oscillations in yeast using a combined yeast-biosensor hybrid. The information derived from this model will be used to determine if manifestations of glycemic oscillations can be measured and characterized within the interstitial fluid (ISF) of humans. So far, the phenomenon of in vivo interstitial fluid glycemic oscillations has not been reported. Preliminary in vivo interstitial fluid glucose data, measured in the dermis of swine, revealed an oscillatory phenomenon that may be indicative of intracellular glycolysis. Included in the Specific Aims is the development of an in vitro yeast-biosensor hybrid system that models the in vivo ISF environment. This unique hybrid, continuous glucose monitoring system will be used to develop a model of glycemic oscillations in yeast. Data from the in vitro model will be used to develop pattern recognition algorithms to characterize in vivo ISF oscillations specific to type 1 and type 2 diabetes. Successful completion of the proposed research will provide advances in continuous glucose monitoring technology that have the potential to resolve inaccuracy issues encountered by patients using CGMs. It is our belief the proposed research will break-down technical barriers that preclude the use of this technology as a stand-alone system with expanded utility for screening and preventative applications that may bring the artificial pancreas on step closer to reality. PUBLIC HEALTH RELEVANCE: The potential for continuous glucose monitoring systems (CGMs) to detect glycemic oscillations in interstitial fluid will advance the use of this technology into the realm of preventative medicine by providing an inexpensive screening tool, capable of identifying people with abnormal glucose metabolism long before overt clinical symptoms are apparent. The outcomes of the proposed research will allow physicians to intervene early in the progression of diabetes symptoms with low cost diet and lifestyle changes as opposed to high cost therapeutic intervention. Early stage intervention will have a significant impact on reducing the over $200 billion annual cost to the US healthcare system to treat the chronic complications of diabetes.

描述（由申请人提供）：迄今为止，市售的连续血糖监测系统（CGM）的使用仅限于胰岛素依赖性1型和2型糖尿病患者的血糖趋势分析。准确性的限制，特别是在低血糖范围内，以及低信噪比，阻碍了这种有前景的技术扩展到筛查应用，以在疾病临床发作之前识别糖尿病的早期迹象，因此可以采取预防措施。拟议的研究重点是使用酵母-生物传感器混合体开发酵母血糖振荡的体外模型。从该模型获得的信息将用于确定是否可以测量和表征人类间质液（ISF）内的血糖波动表现。迄今为止，体内间质液血糖振荡现象尚未见报道。在猪真皮中测量的初步体内间质液葡萄糖数据揭示了可能表明细胞内糖酵解的振荡现象。具体目标包括开发体外酵母-生物传感器混合系统，模拟体内 ISF 环境。这种独特的混合连续血糖监测系统将用于开发酵母血糖波动模型。来自体外模型的数据将用于开发模式识别算法，以表征 1 型和 2 型糖尿病特有的体内 ISF 振荡。拟议研究的成功完成将推动连续血糖监测技术的进步，有可能解决使用 CGM 的患者遇到的不准确问题。我们相信，拟议的研究将打破阻碍该技术作为独立系统使用的技术障碍，并扩大筛查和预防应用的效用，从而使人工胰腺更接近现实。 公共健康相关性：连续血糖监测系统（CGM）检测间质液中血糖波动的潜力将通过提供一种廉价的筛查工具将这项技术的使用推进到预防医学领域，该工具能够在明显的临床症状出现之前识别出糖代谢异常的人。拟议研究的结果将使医生能够通过低成本的饮食和生活方式的改变来早期干预糖尿病症状的进展，而不是高成本的治疗干预。早期干预将对减少美国医疗系统每年超过 2000 亿美元的糖尿病慢性并发症治疗费用产生重大影响。

项目成果

Pilot study of a prototype minimally invasive intradermal continuous glucose monitor.

原型微创皮内连续血糖监测仪的初步研究。

• DOI: 10.1177/193229681200600627
• 发表时间: 2012
• 期刊: Journal of diabetes science and technology
• 影响因子: 5
• 作者: Weinstock,RuthS;Bristol,Suzan;Armenia,Andrew;Gesswein,AChris;Bequette,BWayne;Willis,JohnP
• 通讯作者: Willis,JohnP