Currently, patients suffering from Type-1 diabetes are required to use two systems, one for glucose monitoring and other for insulin delivery. The contemporary insulin delivery methods have to account for the extreme unpredictability of insulin needs. For example, the amount of insulin needed can vary largely depending on factors like amount of exercise, stress levels, food intake, menstruation, and exposure to viruses. With the mismanagement of dosing regimen, the non-adherence rates of insulin administration and the risks of life-threatening hyper and hypoglycaemia are gradually increasing. These cases of improper glucose control can lead to vision problems, heart disease, coma, and even death; so, patients with type 1 diabetes need to monitor their blood glucose levels frequently.
Although type 1 diabetes mellitus accounts for only 5%–10% of all diabetes cases, its prevalence continues to increase worldwide, and it has severe long-term implications. The incidences of T1DM is rising by 3% every year and at present over 90,000 children are affected in Europe alone. Nearly 80,000 new children are diagnosed to have T1DM every year. This increase in the incidence along with improved access to insulin and better survival rates, has provided the companies operating in this segment an opportunity to capitalize on, by providing a technology which is more efficient, convenient, user-friendly and relieves the patient from all the complications involved with conventional insulin delivery systems.
Therefore, a device that repeatedly monitors blood glucose levels, and administers insulin accordingly, is an ideal tool to treat the disease state. Now with the development of Artificial Pancreas Device System, which is an automated blood glucose level maintenance system the patient is free from the tedious process involved.
The Artificial Pancreas system also offers an alternative to transplantation of new beta cells (the cells in the pancreas that produce insulin) into diabetic patients. This is another new treatment option that researchers are looking into, but there have been mixed results and the surgery places a heavy burden on immune system.
Significant milestones in moving the artificial pancreas system from laboratory to unsupervised free-living settings have been achieved in the past decade. Researchers will soon commence one of the largest-ever long-term clinical trials of a closed-loop glucose monitoring system. With $12.7 million backing from the National Institutes of Health (NIH), the system developed by a team of researchers from University of Virginia (UVA) School of Medicine will be tested in 240 patients at 9 sites in the USA and Europe. In association with other institutional partners, the two six-month trials have begun earlier this year.
Recent Updates on Artificial Pancreas System Development:
International Diabetes Closed Loop
A new version of DiA’s hybrid closed loop algorithm that can run on a pump or on a smartphone app is being developed for commercial purpose. Its clinical trials have started in Jan 2016
Tandem is currently developing a predictive low glucose suspend and Hypoglycemia-Hyperglycemia minimizer algorithms for its t: slim insulin delivery pump using Dexcom CGM as glucose sensor. Its clinical trial began in Jan 2016.
Medtronic has developed MiniMed 670G pump with built-in closed loop algorithm using Enlite 3 CGM Sensor. It has been submitted for FDA approval at the end of June 2016 and is expected to be launched by April 2017.
Beta Bionics has been developing a dual chambered pump with built-in algorithm, named Bionic Pancreas iLet device using Dexcom CGM sensor. Its pivotal trial is set to start in mid-2017 and be ready for FDA submission by the end of 2017.
Bigfoot biomedical is using the former Asante pump body and reusable Bluetooth-enabled controller with built-in algorithm and Dexcom CGM sensor for developing its Artificial Pancreas System model. The pivotal study will commence in first half of 2017 and FDA submission by end of 2017.
Animas pump with built-in Hypoglycemia-Hyperglycemia Minimizer algorithm using Dexcom CGM sensor is being developed at Bayer Healthcare. The clinical study has already begun in Jan 2016 and is expected to be launched by end of 2018
Insulet has equipped its Omnipod insulin delivery system with hybrid closed loop algorithm. It had also developed a mobile app to communicate with the pod. Its first clinical trials will start later this year (2016).
Many firms in the healthcare industry want to capitalize on this niche opportunity present in the diabetes sector. While emerging countries offer untapped markets with huge potential, products like Artificial Pancreas with technological and cost implications are better served as a mainstream product in first world nations. The generally high medical expenditure of people and the existing technological infrastructure together makes these demographics the stronghold for future technologies.
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