Non-invasive Glucose Measurement Using Laser Technology
Condition: Oral Glucose Tolerance Test
Study type: Observational

Summary: 
      This study is to evaluate the capability of Raman spectroscopy as a non-invasive method for
      monitoring concentrations of glucose by illuminating a small spot on the skin, collecting and
      analyzing the return light. The glucose measurements obtained by Raman Spectroscopy are
      correlated with those obtained using YSI glucose analyzer and ACCUCHECK instruments.
    

Detailed description: 
      Diabetes mellitus (DM), caused by impairment in the glucose metabolism is a worldwide
      epidemic. It is projected that by the year 2035 there will be approximately 592 million
      diabetic patients. Blood glucose (BG) levels are finely regulated by insulin secretion and
      any defects in the secretion or function can lead to DM. As no well-established medical
      intervention for DM has been known till date, continuous monitoring of BG is the only way to
      avoid secondary metabolic complications such as strokes, heart attacks, high blood pressure,
      blindness and coma. Diagnosis and therapeutic monitoring of diabetes requires direct
      measurement of plasma (or blood) glucose. Measurement of the fasting glucose level is the
      preferred test for diagnosis of diabetes in children and non-pregnant adults, while the oral
      glucose tolerance test (OGTT) is the preferred method of diagnosis for gestational diabetes.
      In addition, patients with an established diagnosis of insulin-dependent diabetes (all type-I
      and many type-II) require frequent glucose measurements for therapeutic monitoring. Emergence
      of hand-held glucose sensors have enabled patients with the ability to self-monitor the BG
      level. The frequent monitoring requires small blood sample (<1 µL) obtained by a
      "finger-pricking" and electrochemical sensing using a portable 'glucometer'. However the
      procedure is inconvenient, results in poor patient compliance and lacks in providing real
      time information about concentration changes. Regardless of the clinical test performed,
      withdrawal of blood or interstitial fluid is currently required for measurement of BG levels.

      The proposed study is based on preliminary research supported by the MIT Laser Biomedical
      Research Center (LBRC), and promising results obtained with spectroscopic measurement of
      blood glucose in the laboratory, in an experimental animal model, and in a small cohort of
      human subject volunteers. In order to make non-invasive glucose measurement a viable clinical
      technology, however, a methodological implementation and validation from bench to bedside is
      required. In the application, we propose to accomplish this goal by means of a
      carefully-designed translational research study employing specifically-designed
      instrumentation and methods for pre-clinical validation and early clinical studies in human
      subjects. These studies will incrementally increase in data complexity, culminating in a
      clinical study in human subjects, as well as a non-invasive, spectroscopic glucose tolerance
      test as an alternative to OGTT.
    

Intervention name(s): Blood glucose measurement
Intervention type(s): Device
Intervention description(s): Device used to measure blood glucose levels
Other intervention name(s): Raman Spectroscopy BLOOD GLUCOSE LEVEL MEASUREMENT
Observational model: Other
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        All races and ethnicity
      
Biospecimen description: 
      Blood samples
    
Keywords: Blood glucose; non-invasive; Raman spectroscopy