Validation Study for the Alertgy Non-invasive Continuous Glucose Monitor (ANICGM)
Condition: Type 2 Diabetes
Study type: Interventional

Summary: 
      Diabetes mellitus (DM) affects 30 million people in the United States. To achieve glucose
      control, most patients are prescribed glucose meters by their physicians. Obtaining glucose
      levels in this manner necessitates cleaning the fingers, attaching a lancet to a device (or
      simply using a lancet if a device is not available), pricking the finger with a lancet,
      placing a drop blood on a strip, and awaiting the readout that results after some chemical
      reactions. Thereafter, the lancet has to be disposed of in a safe receptacle and the finger
      has to be blotted to stop the blood from oozing.

      The anxiety, pain, and tedious process have led researchers to develop other means of
      checking glucose levels. There are now continuous glucose monitoring systems (CGMS) that
      entail inserting a subcutaneous sensor that sends readings through a transmitter. These CGMs
      may or may not need calibration with a fingerstick glucose reading, and the subcutaneous
      sensor still has to be changed every 10 -14 days.

      The Alertgy non-invasive continuous glucose monitor (ANICGM) is a device that does not entail
      any subcutaneous insertion of a sensor. It is strapped on to the wrist, and glucose readings
      are given based on subcutaneous signals. In 2001, a non-invasive device called Glucowatch
      Biographer was introduced that also involved subcutaneous signals without needing a
      subcutaneous insertion. However, for various reasons such as long calibration period and
      reading inaccuracies, the product did not take off. The ANICGM is a promising device that
      might overcome the limitations of existing and previous methods of non-invasive glucose
      measurement.
    

Detailed description: 
      The ANICGM uses a weak electromagnetic field generated by its wrist band sensor to look into
      the body to produce a spectrum that provides a measurement of blood glucose present in the
      wrist area of the body. The core sensing technology used is dielectric spectroscopy, and has
      been shown capable of measuring blood glucose, non-invasively, in a laboratory environment.
      The system uses proprietary and patented dielectric materials and signal processing to
      enhance performance in both selectivity and sensitivity for blood glucose measurement.

      Much like how a MRI uses a strong magnetic field and its interaction with the body to create
      a picture of what is inside, the ANICGM uses a safe weak low frequency radiofrequency field
      to take a picture of a person's chemical spectrum, some of it specific only to blood glucose.

      The device sends and receives back signals from the wrist area that are used to generate a
      dielectric spectrum once every 6 seconds. The POC BG using the Accuchek Inform II will be
      used to provide calibration values for the ANICGM every 5 minutes in mg/dL, during the
      calibration process. The POC BG levels will be entered into the Alertgy laptop and a
      proprietary calibration program will be used to analyze the spectral data collected and will
      generate a calibration algorithm.
    

Intervention name(s): Alertgy non-invasive continuous glucose monitoring device (ANICGM)
Intervention type(s): Device
Intervention description(s): Alertgy non-invasive continuous glucose monitoring device (ANICGM)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: glucose monitor