American researchers have developed a system that automatically treats type 1 diabetes without the need for needles and finger pricks. In this system, a wearable insulin pump and a small sensor enable any smartphone to become a "digital pancreas," which can deliver insulin when needed and monitor blood sugar levels in an effortless and automatic manner.
The new system joins the ranks of other solutions developed for treating type 1 diabetes.
The "digital pancreas" has been in the works since 2006. Lead researcher Boris Kovatchev said the system doesn't only work but it can also effectively run using a smartphone. Kovatchev is the director of the Center for Diabetes Technology at the University of Virginia.
How It Works
The small blood sugar sensor can be worn on the abdomen, arm or leg. The wireless sensor monitors the blood sugar level every 5 minutes and sends a report to an accompanying smartphone app.
An algorithm in the smartphone app then analyzes the received data. If the patient needs insulin, the app will send a signal to the wearable insulin pump, which can be hooked on the patient's clothes.
The discreet device injects insulin into the blood through very fine needles. The system provides a very inconspicuous way of administering insulin without the need for syringes.
"If it is working, you do not know that it is there," said Francis Doyle III, Harvard's Paulson School of Engineering and Applied Sciences dean. Doyle and Kovatchev collaborated on the development of the new "closed-loop" system.
In a conventional insulin administration, knowing just how much insulin is needed is tricky. Kovatchev's original algorithm is similar with traditional diabetes management strategies in that it aims to maintain the blood glucose level at a precise target number. Using the algorithm in an automatic system means the app needs to change levels many times depending on the data sent by the sensor.
To address this potential problem, Doyle and his team improved Kovatchev's algorithm so that instead of targeting specific numbers, the new algorithm targets specific "zones" for healthy blood sugar levels. The new algorithm is easier to hit and maintain, enabling the system to adjust to each patient's insulin sensitivity and healthy sugar levels.
Clinical Trials
The U.S. National Institutes of Health gave the new system a $12.6 million grant. Together with the U.S. Food and Drug Administration, the research team will take the new system through two final phases of clinical tests in several clinics around the country and in France, Netherlands and Italy this year.
The first six-month clinical trial will test the system's efficacy and safety on 240 patients using Kovatchev's original algorithm and design. Out of the original 240 participants, 180 patients will undergo the second phase which will last another six months. The second phase will involve the improved algorithm developed by Doyle.
Similar to a home thermostat, the new system aims to automatically detect and adjust based on the pre-set targets. Doyle said there are about 1.25 million people who are living with type 1 diabetes. The team's goal is to provide a new system to help manage the disease automatically and effortlessly.
