Hypoglycemia (also called an insulin reaction) occurs when blood glucose level falls too low, also resulting in a shortage of glucose in the brain (neuroglycopenia). During periods with brain glucose shortage, the function of the neurons is affected, altering the brain function and behavior. Hypoglycemia is, with good reason, feared by all insulin treated diabetics, due to the fact that it has some dramatic short-term effects, including shaking, sweating, nausea, inability to concentrate, cramps, unconsciousness, permanent brain damage or even death. Hypoglycemia can be caused by a number of factors: too much insulin, not enough food, too much exercise, eating late, or eating too little carbohydrates. In short, it happens when insulin and blood glucose are out of balance. Hypoglycemia can come abruptly and without warning. This can have serious consequences for the patient, especially if the timing is bad, for example, if the patient is driving a car. This can result in a number of derived effects such as third party person and property damage and constant social restrictions as a consequence of awkward or aggressive behavior. The number of severe hypoglycemia related incidents is estimated to be 50,000 per day, and explains death in 2-4% of insulin treated diabetics. The distribution of these severe attacks is uneven, and depends on the patients’ individual ability to sense the approach of hypoglycemia. Though all diabetics can be exposed to hypoglycemia, most cases will be registered in the 25% of the insulin users, normally categorized as the group with “unawareness” to hypoglycemia. The diabetics with unawareness are unable to sense and react to an upcoming hypoglycaemic event.
hyposafe™ SubQ is the name of a new technology designed to detect and alert diabetics of hypoglycemia. Tests have shown that the human brain, which lives primarily on glucose, begins to demonstrate recognizable electric patterns approximately 20 minutes before hypoglycemia. By continuous measurement of the electrical activity within the brain (via EEG ), hypoglycemia can be detected, and the diabetic alerted before the situation becomes critical. When alerted, the diabetic can take the necessary action required to avoid hypoglycemia from occurring and thereafter adjust his/her glucose level to the appropriate interval.
hyposafe™ SubQ is a device that is implanted under the diabetic’s skin on the side of the head. The device is implanted in the sub cutis layer, only a few millimeters below the skin, making the implant procedure rather simple. The implantation consists of the insertion of a 5 cm long, 0.5mm diameter electrode with a coin sized device attached to the end. The implant procedure takes 15-30 minutes and is performed under local anesthesia. The device can remain implanted for more than 10 years (depending on regulatory approval). The implanted part is soft and small and does not create inconvenience to the user. When implanted, there are no physical elements passing through the skin and the use of bandage/plaster is not required. Thus, there is no risk of infection or allergic reactions. Furthermore, as the device is hidden under the skin, it has low implications for the users chosen lifestyle.
hyposafe™ SubQ works because it uses the brain directly as a biosensor, measuring changes in EEG signals, monitoring for signs of hypoglycemia. By using EEG signals as the measuring principle there is a direct correlation between oncoming hypoglycemia and the signal that is measured. In this way, the measurement principle is not affected by delays and other unintended transition functions. Basing the measurement principle on the EEG signal further enhances robustness due to the fact that no calibration is required to identify the characteristic hypoglycemia pattern.
The technology developed by UNEEG™ medical has 5 major benefits that will greatly enhance the lives of insulin treated diabetics:
1) Provides a genuine protection against hypoglycemia by:
a. Ensuring the detection of all hypoglycemia events – this is possible due to the fact that the brain always emits a characteristic and recognizable EEG pattern, prior to the onset of hypoglycemia. This means that the user can feel secure that the device will alert before hypoglycemia arrives.
b. Provides alarms in time to react – our testing has demonstrated that by measuring EEG, hypoglycemia can be detected 10-20 minutes before the cognitive state starts to deteriorate. Receiving this warning gives the patient time to take positive steps to avoid hypoglycemia.
c. Does not stress the user with false positive alerts – the EEG measurement principle is very robust with respect to source of external interference, which creates an optimal signal for interpretation. Furthermore, the mathematical model used in the analysis is strong enough to ensure that we avoidance incorrect conclusions. This means that the user is not unnecessarily stressed by false positive alerts.
2) Does not require calibration – The measuring principle is based on changes in the EEG (delta) and doesn’t require a fixed reference value. This means that once implanted, the device does not need readjustments, despite individual differences in EEG.
3) Has no replacement parts – the internal device is based on electrical signals, and has therefore no moving parts or chemical reactions that can reduce the performance of the device. This means that once implanted, the device does not require maintenance.
4) Does not compromise the comfort of the user – as the device is hidden under the skin of the patient, there is no skin penetration and no risk of infection. This allows the user to engage in whatever lifestyle that the user wishes, without having to constantly take the device into account.
5) Is a simple, cheap and long lasting solution – the device is based on known and simple technologies, thus making the device relatively cheap to produce. The absence of mechanical and chemical components reduces the need for continual maintenance. Furthermore, the device is expected to have a lifetime of more than 10 years. This means that the device is very robust.