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This web site is about a new technology found in diabetes management. I propose a new device to prove the evidence that this new technology is working.

Nowadays there are two categories of electronic devices to help with glycaemic self control: invasive instruments and non-invasive ones. 

Invasive  instruments.

This kind of devices are the mostly used and, consequently the mostly tested. They only need to be periodically calibrated. Their working principle is the fact that glucose concentration changes the ability of one blood drop to reflect the light.

Non-invasive instruments.

This kind of devices are the newest ones and, consequently the less tested. They usually need to be frequently calibrated. Their working principles are based almost completely on the following two technologies:

1) A first technology uses the principle that glucose concentration changes some parameters in a ray of light which is reflected by the eyes.

2) A second technology uses the principle that glucose concentration in the skin changes the electrical properties (electric resistance) of the skin itself.

The substantial advantage with this second category instruments is that they don't need blood at all, and they represent a very direct way to have a continuous glycaemic monitoring.

Many companies rise and fall every day because it is very tempting the fact that every year the number of people with diabetes increases at a very high rate; but, on the other hand it is also very hard to make these new technologies working good.  

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The project I've been involved since 1997 is to develop and produce a new non-invasive glucose meter.

The main problems I had to face in this project are the following:

Ø      the interference of electrical noise;

Ø      the reproducibility of the measure;

Ø      the positioning of the sensor.

These problems are the same for everyone who wants to realize such devices. The most promising technology used in new non-invasive glucose meters, I think, is the detection of the electrical resistance of the skin and the association to the glucose concentration in blood. In this case there seems to be a high degree of noise resistance of the device. But the reproducibility of this measure is quite affected by the fact that the sensor must be positioned and then the machine must be set-up. This procedure of initialisation which seems to be necessary to the device to work good is no longer valid if the sensor changes its position. In this case how can a patient be sure whether the sensor changes position or not? This means that this device is not adapt to work during the night; but what happens during the day? They say that if the sensor is good placed, there is a certain percentage of good measure which is close to the 50%… but how can a patient be sure of what to do? The first question I would make is : Am I in the right 50% or in the wrong 50%?

I’ve developed a new technology for these instruments and I have two working devices that are suitable to understand how can be faced each of the upper problems with this new technology.

Each of the two devices must be applied to the ear, in fact there is a relationship between some specific physical parameter detectable just internally the ear and the blood glucose levels.

The first instrument is composed by:

Ø      a sensor head that is quite insensible to noises;

Ø      a pc to visualize the situation;

This first instrument is suitable just for an initial survey. While it’s very much insensible to electrical noise it lacks of a good positioning, which is important if we want to reach a good and repetitive measure. When the measure starts it’s evident (and it's possible to feel it) that maybe the device is making some mistakes, instead of a good measure! After many measurements in a single patient I’ve found a position of compromise and completed a table of values, taken in always this position, but in different glycaemic situations. At the end of these tests I had always the same bad sensation to make some mistakes, and this is the reason why I personally never would use a sensor working at a 50% success rate.

The second instrument is composed by:

Ø      a quite smaller sensor head;  

Ø      an electronic pre-amplifier and signal conditioner;  

Ø      a pc to visualize the situation;

The matter with the first-type instrument was the positioning of the sensor head, that is the most common problem of the latest non-invasive instruments.

So I’ve made the second-type instrument to better face the problem with  the positioning. In fact, the behaviour of this instruments is just to compensate the bad positioning. In this case there is another table and a further calculation (by hand, at the moment) to reach the good measure.

In this case I didn’t care of the noise-resistance (and this device is quite delicate with electrical noise). This new system is quite more reactive to the changing of the glycaemic values: it can appreciate the changing of the glucose concentration in blood with only a  delay of 15-30 seconds.

The next steps:

The next step (to do…) will surely be to build up a new instrument which sums the good characteristics of the two upper systems.

Since the device is not capable to give a numeric result (as a standard instrument gives) in automatic, the software must be upgraded in this direction.

Since there is not a filter in the software right now, to avoid electrical noise it could be useful to build up one.

Since these devices have been tested only in one patient, it could be reasonable to start with a wide ranged campaign of tests.

For what I can imagine, it would be easy to realize this device even in cellular phones or palmtop and when there is something wrong it would ring or vibrate…

Since the sensor is hand-made, it is surely important that it is engineered. Maybe, and I say maybe, it can be build up with a wireless technology…

This could be an improvement because the positioning must be in the ear.

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I would like to make a partnership with some investors and/or big companies and/or small companies to produce and to sell the new non-invasive glucose meter.

 

I can see some different situations and consequently different roles of me in this project. The basis is that my contribute is the new technology and the device to prove it’s working. I can also contribute in telling the skills I’ve learned in making the tests. I can see the following possibilities:

 

1)  A big investor is interested in the project. My position could be to give the whole material (and eventually my technical ‘abilities’) at a one time price, because I suppose that the Master of this project will agree in buy a thing and to be the only one: he will decide who, when, why… and I suppose that I won’t be in the plan.

2)  A big factory is interested in the project. My position could be to give the whole material at a one initial price and my technical ‘abilities’ in a collaboration where I’m a freelance technician with a salary (even with a forfait solution).

3)  A small factory is interested in the project. My position can be different because with a little investment I think the results will be poor! I can just give the whole material at a symbolic cipher and hope that something will be done. I’ll try to help, but I think it will be a lost of time.

4)  This project could be carried on by a “self made team of researchers” who agree to put together their skills to reach the same target; You know… no-profit! This is a situation in which I would ask who will face the expences?

If anyone wants to give some good advices, please go to the contact and send me any suggestions. Please, don't be too direct with me, because I don't know if I will reach the goals of such an ambitious project; but maybe I can stimulate the researchers and anyone who can reach this target.

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My name is :                                       Stefano

My surname is:                                   Fornaciari

I live in:                                                via Luxemburg n.22

Town:                                                  Rubiera (R.E.) Italy

CAP :                                                   42048

mailto:                                                 ste_x_forn@yahoo.it

Tel./Fax.:                                             +39 0522 261897

Cell. phone:                                          +39 3488447716  

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