For people living with type 1 diabetes, a constant process of monitoring and adjusting blood sugar levels is required. A change may be on the horizon, though. A bionic pancreas trialled among 30 adults has been very well-received by the participants, and has been approved by the US Food and Drug Administration (FDA) for three transitional outpatient studies over the next 18 months.
People with type 1 diabetes are unable to produce insulin, a hormone that is required to control the level of sugar in the bloodstream. As a result, blood sugar levels can vary dramatically, causing potential damage to body organs when too high, or confusion and loss of consciousness when too low.
The device comprises a sensor inserted under the skin that relays hormone level data to a monitoring device, which in turn sends the information wirelessly to an app on the user's smartphone. Based on the data, which is provided every five minutes, the app calculates required dosages of insulin or glucagon to maintain optimal blood sugar levels and communicates the information to two corresponding hormone infusion pumps worn by the patient.
The bionic pancreas has been developed by associate professor of biomedical engineering at Boston University Dr. Edward Damiano, and assistant professor at Harvard Medical School Dr. Steven Russell. To date, it has been trialled with diabetic pigs and in three hospital-based feasibility studies amongst adults and adolescents over 24-48 hour periods. The upcoming studies will allow the device to be tested by participants in real-world scenarios with decreasing amounts of supervision.
The first study will test the device's performance for five continuous days. Twenty adults with type 1 diabetes will use it between 7am and 11pm, during which time they will have access to a 3 sq mi area near Massachusetts General Hospital (MGH). Accompanying nurses will check the participants' blood sugar levels every two hours to ensure the device is working. Participants will sleep at a hotel, where their blood sugar levels will continue to be monitored throughout the night. The results will be compared to a corresponding five-day period during which the participants will be at home under their own care without the device.
A second study will be carried out using 16 boys and 16 girls with type 1 diabetes, testing the device's performance for six days against a further six days of the participants' usual care routine. The third study will be carried out amongst 50 to 60 further participants with type 1 diabetes who are also medical professionals. They will wear the device for two weeks at home and monitor a comparative two-week period without the device.
Should the transitional trials be successful, a more developed version of the bionic pancreas, based on results and feedback from the previous trials, will be put through its paces in multi-center pivotal trials during 2015. The device will be a single, dual-chamber insulin and glucagon pump, without the need for being paired with a smartphone app. It will be tested in hundreds of participants with type 1 diabetes over a six-month period, with the results compared against participants in a control group using their usual care routine.
If all goes well, Damiano hopes that the bionic pancreas will gain FDA approval and be rolled out by 2017, when his son, who has type 1 diabetes, is expected to start higher education.