Continuous glucose monitoring in critically ill patients

危重病人的持续血糖监测

• 批准号: 6777760
• 负责人: RINAT O. ESENALIEV
• 金额: $ 30.58万
• 依托单位: UNIVERSITY OF TEXAS MED BR GALVESTON
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-03-01 至 2007-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6777760
• 关键词: bioimaging /biomedical imaging; biomedical equipment development; biosensor device; biotechnology; blood glucose; blood tests; clinical biomedical equipment; clinical research; comprehensive care; critical care; diabetes mellitus; glucose clamp technique; human morbidity; human mortality; human subject; hyperglycemia; insulin sensitivity /resistance; laboratory rabbit; light scattering; medical complication; noninvasive diagnosis; optical tomography; oral mucosa; patient care management; skin; swine

DESCRIPTION (provided by applicant): In both nondiabetic and diabetic patients, hyperglycemia and insulin resistance commonly complicate critical illness. Even moderate hyperglycemia, at levels that conventionally have not been treated acutely with insulin because of the risk of inducing hypoglycemia, contributes to morbidity and mortality. A recent randomized clinical trial in critically ill patients demonstrated that intensive insulin therapy to tightly control blood glucose concentration (80 - 110 mg/dL) substantially reduced morbidity and mortality by more than 40% (from 8.0% to 4.6%) but was associated with a 5.0% incidence of severe hypoglycemia (glucose concentration < 40 mg/dL). Therefore, in critically ill patients, continuous glucose monitoring, ideally noninvasive, would be invaluable to guide insulin infusion to both control hyperglycemia and avoid hypoglycemia. For this purpose, optical coherence tomography (OCT) based on low-coherence interferometry, a high-resolution optical technique that sensitively detects photons coherently scattered from tissue, is highly promising. We have developed a novel, OCT-based glucose sensor that precisely, continuously and noninvasively measures the decrease of tissue light scattering that linearly accompanies increases of blood glucose concentration. During the past two years, supported by an NIDDK R-21 grant under the PA-99-036 ("Pilot and Feasibility Program in Diabetes Endocrinology and Metabolism"), we performed preliminary animal and clinical studies of the novel glucose sensor. Our studies demonstrated: 1) a sharp and linear decrease of the OCT signal slope in skin and oral mucosa as blood glucose concentration increased; and 2) substantial improvement of accuracy of the OCT signal slope measurement by optimizing the dimensions of the probed tissue area. The goals of the proposed project are: (1) to further refine the glucose sensor in animal studies; and (2) to validate the resulting sensor in clinical studies in normal subjects and critically ill patients. Successful implementation of the project will produce a continuous, noninvasive, and accurate glucose sensor that will substantively contribute to reduced mortality and morbidity in critically ill patients.

描述（由申请人提供）：在非糖尿病患者和糖尿病患者中，高血糖和胰岛素抵抗通常都使重症疾病复杂化。即使是中度高血糖，由于诱发低血糖的风险，在常规上没有用胰岛素急性治疗的水平有助于发病率和死亡率。最近在重症患者中进行的一项随机临床试验表明，严格控制血糖浓度（80-110 mg/dL）的强化胰岛素治疗实质上将发病率和死亡率降低了40％以上（从8.0％到4.6％），但与严重低血糖症的发生率为5.0％有关。因此，在重症患者中，理想情况下，连续葡萄糖监测（理想情况下是无创的）是无价的，可以指导胰岛素输注以控制高血糖并避免低血糖。为此，基于低稳态干涉仪的光学相干断层扫描（OCT）是一种高分辨率的光学技术，敏感地检测到从组织中相干散布的光子，非常有前途。我们已经开发了一种新型的基于OCT的葡萄糖传感器，该传感器精确，连续和无创测量的组织光散射的减少，伴随着血糖浓度的增加。在过去的两年中，在PA-99-036下的NIDDK R-21赠款的支持下（“糖尿病内分泌学和代谢的试验和可行性计划”），我们对新型葡萄糖传感器进行了初步动物和临床研究。我们的研究表明：1）随着血糖浓度的增加，皮肤和口服粘膜中OCT信号斜率的急剧下降； 2）通过优化探测的组织面积的尺寸，可以实质性提高OCT信号斜率测量的精度。拟议项目的目标是：（1）进一步完善动物研究中的葡萄糖传感器； （2）在正常受试者和重症患者的临床研究中验证所得传感器。该项目的成功实施将产生连续，无创和准确的葡萄糖传感器，该传感器将实质上有助于降低重症患者的死亡率和发病率。