Spectrophon LTD Glucometry Monitor Accuracy
Condition: Glucose Metabolism Disorders; Diabetes Mellitus
MeSH terms: Metabolic Diseases; Glucose Metabolism Disorders
Study type: Observational [Patient Registry]

Summary: 
      Diabetes mellitus (or diabetes) is a chronic, metabolic disease characterized by elevated
      levels of blood glucose. Patients with diabetes need to monitor their blood glucose level
      several times a day to control their medical state. Modern biosensors have become a promising
      solution for non-invasive blood glucose measurements. This study aims to validate the
      efficacy and the accuracy of Glucometry Monitor (NIGM) developed by Spectrophon LTD
      incorporated in smart watches.

      Method Participants will use Spectrophon biosensors to non-invasively estimate the level of
      glucose in blood. Blood will also be collected and the glucose level will be checked with
      commercially available blood glucose analyzers . All sets of data will be compared to
      estimate the accuracy of measurements of Spectrophon NIGM
    

Detailed description: 
      Diabetes is a chronic, life-long disease that represents a major public health challenge at a
      world level (Matthews et al 1985). It is important to note that diabetes is common among
      mentally ill patients, especially among patients with schizophrenia that are treated with new
      generation antipsychotic drugs (Nielsen et al 2010, Vancampfort et al 2016).

      To maintain blood glucose level homeostasis, repeated blood glucose testing is needed. The
      vast majorities of currently available methods for blood glucose testing are invasive and
      cause discomfort for patients. However, biosensors have recently become a promising solution
      for non-invasive glucose blood testing (Bandodkar et al 2014; Zhang et al 2015). Spectrophon
      LTD has developed a technology that allows measurement of even the smallest amounts of
      various compounds contained in sweat. Using unique algorithm developed by Spectrophon LTD,
      these data provides the possibility of evaluating the levels of chemicals in the bloodstream.
      Based on this technology, Spectrophone LTD has developed a glucometer biosensor that is able
      to non-invasively detect the blood glucose level. This glucometer biosensor can be easily
      incorporated into most commercially available smartwatches. Development of this technology
      will allow real-time, non-invasive measurement of blood glucose level and will dramatically
      facilitate effective treatment of diabetes. In addition, this technology will enable
      monitoring of glucose levels in patients with mental disorders that will facilitate the early
      detection of metabolic syndrome.

      Study Design: this naturalistic study will examine the accuracy of Spectrophon NIGM
      incorporated in smart watch Samsung Gear S2 that non-invasively and indirectly detect the
      level of glucose in human blood. The study will be held in Maale Carmel Mental Health Center
      (MCMHC). Adult participants (n=200) will be recruited for the study from the staff of MCMHC
      (including doctors, nurses and administrative workers; no psychiatric in-patients will be
      recruited for the study). In parallel to glucose measurements with NIGM, blood will be
      collected and the glucose level will be checked using commercially available blood glucose
      analyzers.

      The participants will be able to select between two options for blood collection:

      The first option: intravenous cannula (Venflon) will be inserted in cubital vein and blood
      will be collected twice in the beginning and at the end of the procedure (within 1-3 hours)
      and checked for the glucose level with commercially available blood glucose analyzers.

      The second option: The blood will be collected twice from the cubital vein at the beginning
      and at the end of the procedure (within 1-3 hours) and checked for the glucose level using
      commercially available blood glucose analyzers .

      The measurements will be performed twice: before meal (subject should be in fasting state)
      and after meal with one hour interval between two measurements.

      The results of the measurements of the NIGM will be compared to the results obtained from
      commercially available blood glucose analyzers.

      The application automatically saves every measurement into archive. To better control the
      process, the manual fixation of data obtained by NIGM is performed.
    

Intervention name(s): Spectrophon Glucometry Monitor; YSI 2300 Stat Plus
Intervention type(s): Device; Device
Intervention description(s): Wearable smartwatch with integrated non-invasive glucose detection system; Reference commercial glucometer
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Israeli and non-israeli citizens of age 18-75.
      
Keywords: Spectrophon; Glucose; Biosensor; Non-invasive testing