SMSI® Glucose Sensor
Frequently Asked Questions

How big is the sensor?
At present, the sensor implant is the size and shape of a small cold-capsule (see picture of sensor above, right); it is cylindrical with hemi-spherical ends. The current version is a little more than half an inch long and less than a quarter of an inch in diameter. Future product releases are targeted to be the size of a grain of rice.

Where will the sensor be located?
We expect the sensor to be used in the lower forearm (with a wristwatch reader such as the one pictured above, left) or in the abdomen (with a pager-like reader).

How will the sensor be placed under the skin?
A physician will apply local anesthetic to the implantation site and then insert the sensor through a trocar (large bore needle). No sutures should be necessary.

How long would the sensor last before being replaced?
The Company is targeting an initial indication of 6 months of use before replacement. Long term, the usable lifetime may be increased to one year.

How will the sensor be removed?
The sensor will be removed either using a trocar or through a small incision.

If the sensor is not in a blood vessel, how can it measure blood sugar levels?
The sensor will not measure blood glucose directly, but instead will be in contact with interstitial fluid (ISF). Studies have shown that ISF glucose correlates well with blood glucose, and therefore can be a useful diagnostic measurement.

Will foreign body response be a problem?
When a foreign object is inside the body, one way the immune system responds is to "wall off" the object in a fibrotic layer. Theoretically, fibrotic encapsulation could affect the performance of the glucose sensor. However, based on animal tests done so far, we are optimistic that we have an effective solution for fibrotic encapsulation.

How often will glucose measurements be taken?
We are targeting an automatic measurement interval of as little as every 2 minutes.

When will it be available to the public?
Availability depends upon successful completion of clinical trials and approvals from the proper government regulatory authorities. The testing and approval process will take several years.


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The Regulatory Approval Process

 

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