Validation Study for the Alertgy Non-invasive Continuous Glucose Monitor (ANICGM)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Validation Study for the Alertgy Non-invasive Continuous Glucose Monitor

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Device: Alertgy non-invasive continuous glucose monitoring device (ANICGM)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes on diet or on pharmacologic treatment for diabetes Hemoglobin A1c between 7.5 - 10.0% Age 18 - 75 years old Exclusion Criteria: Patients taking prandial insulin Fasting blood glucose by fingerstick of < 70 mg/dL or >250 mg/dL Pregnancy End stage renal disease Decompensated or acute heart failure Medications that may cause false readings with glucose meters: acetaminophen, ascorbic acid, dopamine, maltodextrin, mannitol Conditions that limit the ANICGM such as lesions on the forearms Other conditions that the investigator deems will affect the conduct of the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ANICGM<br>non-invasive continuous glucose monitoring device | Device: Alertgy non-invasive continuous glucose monitoring device (ANICGM)<br>* Alertgy non-invasive continuous glucose monitoring device (ANICGM)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Absolute Relative Difference (MARD) of Glucose Values Between the ANICGM and FDA-approved Glucose Monitoring Device | Hypothesis is that ANICGM device will perform similarly as other blood glucose monitoring devices Mean absolute relative difference (MARD) is computed by taking the arithmetic mean of the absolute relative differences between the ANICGM system measures and the reference standard FS BG, which serves as the denominator of the calculation. The MARD is expressed as a percentage, and a lower MARD signifies better concordance between the two measurements. | 2 time points taken over 2 separate days respectively, over a span of up to 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glucose monitor