Tempo Health and award-winning Dutch health clinic Diabeter are working together to retrieve and analyze biosensor data from young Type I Diabetes Mellitus patients. The resulting analysis of this high-level observational pilot should provide new insights and correlations between the various data, and provide the foundation for the creation of new tools to optimize treatment of the disease.
Traditional treatment of Diabetes Mellitus is done by monitoring glucose levels at least four times per day and to respond by injecting insulin-based on the measured value, and finally a calculation based on guesses as to the amount of carbohydrates in meals. A growing number of patients have started to use an insulin pump, which drips a ‘basal’ amount of insulin into the body. These users still must calculate and initiate the ‘bolus’ injections during mealtime and before sleep.
The majority of patients under the care of the Diabeter clinic have an insulin pump as well as a Continuous Glucose Monitor (CGM), which constantly monitors glucose levels. Ideally, this provides far better insight in the varying glucose levels throughout the day; however, it does not alleviate the user from manual monitoring actions, and the need to validate CGM values and calibrate the CGM itself.
Most CGMs and pumps have interfaces to websites of the manufacturers, where users can evaluate their values, and, share these with their doctors.
For the last five years at Diabeter, the standard practice is a therapy regime where the doctors use uploaded data to instantly advise the patients as to the optimal pump settings for the next days. The results have been impressive and gained attention from diabetes research and practice doctors world-wide, although Diabeter still believes that there is room for improvement.
Ultimately, a fully “closed-loop” system where measurements trigger automatic dosage activities would ease the burden on the patient substantially.
Monitored glucose levels are the (delayed) result of a wide range of variables. Some of these variables can now be monitored with the latest developments in sensor technology and the application of advanced data analysis. This is where Tempo Health has become a critical component of this research.
Tempo Health has selected a new patch that contains 15 biosensors that are monitoring body functions in real time, and transports this data wirelessly, and in real-time, through the user’s smartphone. These biosensors measure values like heart rate, skin temperature, stress, activities/steps, sleep, respiration, posture, etc.
Combined with the data from the glucose monitors and pumps, Tempo Health’s data analysis should provide insights that change in glucose levels can be attributed to, triggered by or influenced by one or a combination of the data from these biosensors. For example, if the heart rate and/or stress level increases without a corresponding activity, like walking or exercising, it may indicate another change within the body that is materially relevant to blood glucose levels.
This is what the Diabeter and Tempo Health teams will investigate in the pilot. The pilot will equip a group of 24 children with different current treatment plans for diabetes for about two weeks with biosensor patches. These children are already comfortable working with their CGMs and insulin pumps.
No investigation like this has ever been conducted and there are great expectations from the medical teams and scientists involved.