Release date: 2013-07-04
Researchers report that the first smartphone-based wearable artificial insulin platform has passed early feasibility testing in a realistic setting.
“In the total possible time from opening to closing, this closed loop system under study can work correctly in 98% of the time, exceeding the 80% of the primary endpoint set at the beginning,†at the annual American Diabetes Association meeting. Dr. Boris Kovatchev of the University of Virginia in Charlottesville and colleagues said.
However, there is still a way to go before the artificial pancreas is ready for clinical use. When the system is working properly, only 80% of the time at night, blood sugar levels can be controlled in the target range of 70 ~ 180 mg / dL.
"We still have a lot of problems, we need more insulin, and the system still needs improvement. But we have come a long way; the older generation of sensors are not working, they will only shut down," co-author, California Dr. Howard Zisser of the University of Barbara said. “From last year to this year, we have improved, so we now have a good way to control insulin release every minute at night to reduce the onset of hypoglycemia.†As a diabetes assistant, the system includes a sensor placed under the skin (measuring interstitial Blood glucose concentration), which transmits information to the receiver. After the information is processed, the signal is transmitted to the control center, which is commanded by the control center to output the insulin.
In this study, 20 patients with type 1 diabetes were tested not only in hospitals or clinics. Accompanied by the researchers, they went to the field or at the restaurant while putting on the equipment. A continuous blood glucose monitoring/pumping system (DexcomSeven Plus/Omnipod) was placed in each subject and connected to the smartphone system. The patient operated the system through the Diabetes Assistant user interface (in the open loop mode for the first 14 hours of the study). After another 28h, they switched to closed loop monitoring.
The researchers remotely monitor patients via a diabetes assistant connected to 3G or WiFi and can seek help on the website. “The graphical user interface has proven to be reliable and well understood by the subject. All subjects can easily navigate through the commands in the open and closed loop modes of operation to view continuous glucose monitoring and insulin information, managing diet Or adjust the diet as needed,†the researchers wrote. The important thing is that participants are free to move. One of the subjects used the hotel's treadmills, one riding a bicycle, one walking to a nearby museum, and five even hanging a bag outside the bathroom. The total duration of the appropriate system communication function is 807.5h (274h open loop, 533.5h closed loop), which is equivalent to 97.7% of the total possible time from start to shutdown. No serious adverse events or system failures have occurred. Since the blood glucose level was lower than 60 mg/dL, there were 6 treatments for carbohydrates, and an average of 0.17 adverse events occurred every 24 hours. At the same time, 3 patients developed mild ketosis, which was quickly and successfully cured by subcutaneous injection of insulin.
"In combination with real-time remote monitoring, the system enables the implementation of a large, critical trial that will establish an artificial pancreas as a viable mainstream treatment strategy for type 1 diabetes." Daniel Gordin (Medical Doctor, DMSC, Central Hospital, University of Helsinki, Finland) Commenting on the results, the development of artificial pancreas "has really improved over the past five to ten years. In the past, we used to use laptops to deliver information, and now we are using mobile phones."
Source: Kexun
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