Diabetes mellitus, commonly known as diabetes, is a condition characterized by high blood glucose. In a healthy individual, blood glucose is regulated by insulin, a hormone that is produced by the beta cells of the pancreatic islets. When blood glucose levels are not regulated, the individual is at risk of short-term health emergencies such as hypo- and hyper glycemia. Long-term complications of diabetes include neuropathy, blindness, or even non-healing wounds that often result in amputation. Diabetes is a very expensive disease, where 90% of the costs are due to the side effects of the disease. As such, it is important to develop technologies to improve blood glucose management, such as frequent blood glucose monitoring.
In individuals with type 1 diabetes, their insulin secreting cells are systematically destroyed by the body's immune system. Today, the majority of Type 1 diabetics utilize technologies such as glucose test strips and insulin pens to ensure the management of their blood glucose levels. These are invasive technologies where the individual must break their skin to draw blood for blood glucose testing and to inject insulin into their body.
The next wave of devices for diabetes management is wearable insulin pumps and continuous glucose monitors (CGM). These devices are already in use today and uptake is increasing. The devices remove a significant number of pain points from current technologies. For example, CGMs, a $2.6 billion market in 2018, are inserted once every few weeks and provide almost continuous feedback on glucose levels. This improves the tracking of blood glucose levels and decreases the number of times an individual must prick their fingers. One direction that technology is moving towards is the artificial pancreas - CGMs and insulin pumps communicate with each other to automatically modulate blood glucose.
To learn more about the ongoing disruption in the technology landscape for diabetes management, please refer to the IDTechEx report: Technologies for Diabetes Management 2019-2029: Technology, Players and Forecasts.
However, a more direct approach to treat type 1 diabetes is to replace the beta cells. Patients can certainly receive pancreatic islet transplants, but the innovation lies in cell therapy devices. These devices enclose the insulin-secreting cells in a protective pouch to protect them from attack from the immune system. The pouch also traps the cells for easy monitoring and retrieval while allowing the insulin to diffuse out. Such a system is a significant improvement on today's methods of diabetes management. Already there are several companies in this space, including ViaCyte, Sernova Corporation, Betalin Therapeutics, Semma Therapeutics, and Sigilon Therapeutics.
ViaCyte and Sernova are the apparent leaders of this pack of companies, both having initiated at least Phase I/II clinical trials of their cell therapy devices. ViaCyte is a few years ahead of Sernova - ViaCyte already have 2-year safety results for their cell pouch at a sub-therapeutic dose, while Sernova have only begun their clinical testing this April. Semma Therapeutics have announced plans to initiate clinical trials in 2020.
Already, Sernova have presented interim results at the World Congress of the International Pancreas and Islet Transplant Association in Lyon, France this July, and have showed that patients implanted with their cell therapy pouch benefitted from a 87.5% reduction in hypoglycemic events compared to baseline and weight loss of 12% of total body weight.
All of this is very promising for patients with Type 1 diabetes, who hopefully within the next 10 years, can see their daily lives completely transformed from multiple fingerstick tests and insulin injections a day to occasional insulin pump and CGM changes to implanted insulin-secreting cell therapy devices.
To learn more about tissue engineering technologies such as cell encapsulation devices, please refer to the IDTechEx report: Technologies for Diabetes Management 2019-2029: Technology, Players and Forecasts.
Top image: ViaCyte