80-LB: At Home, Monitoring Device for Prevention and Interception of Diabetic Ketoacidosis Events in Children

Diabetic ketoacidosis (DKA) is often the first sign of type 1 diabetes (T1D) , especially in those children under the age of 3, with 55-100% of those in this age range diagnosed in DKA. Furthermore, 10-12% of children diagnosed with Stage 3 T1D are 3 or less, highlighting a critical need to identify those children at highest risk of a potentially life threatening DKA event at diagnosis. Commercially available urine analysis strips are not easily used with young children, so a simpler solution is urgently needed for early detection of DKA. In order to change the T1D diagnosis and treatment paradigm, we have developed a non-invasive monitoring solution that integrates into a child’s everyday routine and can alert caretakers real time when some of the early indicators of diabetes and DKA arise. The solution comprises of a single use sensing pad and a reusable Bluetooth® connected device which together fit into standard diapers. The pad collects urine and saturates two specialized colorimetric biosensor membranes which react with glucose and ketones. The device detects sufficient saturation of the biosensors and at a prescribed optimal time point, takes a reading via a photodetector to quantify the color change. Data is then sent to a mobile app which converts the readings to glucose & ketone levels using an algorithm. It sends alerts to the child’s caregiver if values indicate a threshold limit of ketones have been met, which can be early signs of diabetes or DKA. The data captured by the device can be stored and analyzed over time, so caregivers and healthcare providers may know days or weeks in advance if their child is headed toward diabetes, hoping to fend off a DKA event. This feature may provide an earlier and less precipitous diagnosis and treatment, rather than experiencing a life-threatening emergency. This at home, mobile smart monitoring solution provides a practical solution for at-home, real-time monitoring of urine glucose and ketones in young children at risk of developing T1D.