At this point an artificial pancreas is only a concept rather than a clinical reality.
A small implantable device, an artificial pancreas would continuously monitor blood-sugar levels and release insulin as needed in patients with Type 1 diabetics. It would do everything the real pancreas in the body does. Current technologies in the U.S., such as blood-glucose meters, continuous-glucose monitors, insulin pumps, and new insulins are continuously being upgraded, but are not yet at the stage where they can fully replace a functional pancreas.
But progress has been made toward making the concept a reality.
Johnson & Johnson's Animas
Johnson & Johnson's (NYSE:JNJ) Animas unit leads the way, its external device currently the subject of a second feasibility study.
The Phase 1 trial tested a closed-loop system that would predict a rise or fall in blood glucose and adjust the insulin delivery accordingly. The monitor, from Dexcom Inc., (NASDAQ:DXCM) was approved by the FDA last fall. Dexcom's latest model is the G4 platinum monitor: it sits almost flat on the skin.
Some people complain the setup is cumbersome. But a lot of advances have been made. A few years back, a refrigerator sized computer was part of the setup, later it was replaced by a backpack, and today the monitor is the size of a smart phone. Surely it could be made even smaller, making implantation an option.
By the end of the study, researchers were pleased to discover the algorithm worked: it was successfully able to predict a rise and fall in glucose above or below the preset thresholds, and send messages to the pump to increase, decrease, or resume insulin infusion accordingly.
Animas' device is designed to mimic the body's natural method of regulating sugar levels. So, instead of just reacting to jumps and drops, it works in tandem with the body, reading vital signs to predict the rise and fall of blood glucose levels and administering its insulin accordingly, much like the real pancreas.
J&J is hardly the only contestant in the race to bring an artificial pancreas to market, but, as Animas Chief Medical Officer Henry Anhalt points out, the Animas device is unique because it is predictive. It forecasts changes in glucose levels and adjusts insulin infusion actively before the pump needs to be suspended altogether.
This sets it apart from Medtronic's (NYSE:MDT) device, which Anhalt says is a "reactive system" that stops insulin infusion when glucose levels hit a certain threshold.
In 2012 Johnson & Johnson diabetes care sales, which includes drugs and devices, were $2.6 billion, a decrease of 1.4% versus the prior year.
Johnson & Johnson's LifeScan subsidiary is a leader in hand-held, electronic blood glucose monitoring systems and test strips for people with diabetes to use in the home or for bedside monitoring in hospitals. The company has manufacturing facilities in the US, Puerto Rico, and the UK, and employs more than 2,500 people.
LifeScan pioneered blood glucose monitoring with the introduction of OneTouch technology, which eliminated wiping and timing procedures. The OneTouch product line comprises blood glucose meters, test strips, blood sampling devices, and diabetes management software.
In 2006 LifeScan acquired Animas, an insulin delivery company, which gave LifeScan an entry into the fast-growing insulin delivery pump market.
Combining Animas' insulin delivery systems and LifeScan's glucose monitoring systems in 2008 allowed the company to launch the OneTouch Ping Glucose Management System. Glucose Ping is claimed to be the first full-feature insulin pump that wirelessly communicates with a blood glucose meter.
Medtronic has been a pioneer in artificial pancreas systems and developed the first closed loop product, Paradigm Veo, which automatically suspends insulin delivery if the sensor glucose value is equal to or below the low threshold value, potentially limiting episodes of hypoglycemia, which can cause seizures and blackouts.
The pump was approved in Europe in 2009 and is commercially available outside the U.S. Medtronic is conducting a Phase 3 trial in order to obtain US approval.
The JDRF (formerly known as the Juvenile Diabetes Research Foundation) is partnering with Medtronic to advance the company's next-generation continuous glucose monitors.
The goal is to accelerate the development of Medtronic's novel redundant sensor system, which combines two unique sensing technologies in one device.
The redundant sensor system will combine an electrochemical sensor, scientifically referred to as a glucose oxidase sensor, and the commonly used technology, an optical sensor. The two sensors combined function as a "check and balance," providing redundancy, which ensures a safer and more reliable glucose measurement.
Medtronic's diabetes business accounted for $1.5 billion, or 9%, of the company's $16 billion total revenue in 2012.
Type 1 diabetes
In type 1 diabetes, the body does not produce insulin.
Insulin is a hormone that is needed to convert sugar, starches, and other food into energy needed for daily life. Five percent of people with diabetes have this form of the disease.
Type 1 diabetes is usually diagnosed in children and young adults. For that reason it was previously known as juvenile diabetes.
Type 1 diabetes is a relentless, vicious, and expensive autoimmune disease. Remedies effective in controlling Type 2 diabetes, like eating reasonably, losing weight, and exercising, will not help Type 1 patients.
The big difference is the pancreas in Type 2 patients still functions, while in sufferers of Type 1 it does not. People with Type 1 must test their blood glucose levels by pricking their fingers or using a CGM (continuous glucose monitor). Insulin is then administered accordingly via shots or an insulin pump, multiple times throughout the day for a patient's entire life.
The foundation JDRF has been working with most of the device manufacturers on the artificial pancreas project, like J&J Animas, Medtronic, Tandem, and others. Since its founding in 1970, JDRF has awarded more than $1.5 billion to Type 1 diabetes research and more than 80 percent of JDRF's expenditures directly support research and research-related education.
The object of the artificial pancreas project is to develop a first-generation, partially automated system. While not yet fully automated, this "hypoglycemia-hyperglycemia minimizer" system would represent a significant step forward in diabetes management, and could provide immediate benefits in blood sugar control by minimizing dangerous highs and lows.
It is a first step on the path towards a fully automated artificial pancreas system.
Three companies are frontrunners in the race toward a device resembling an artificial pancreas: Johnson & Johnson, Medtronic and the privately held, San Diego based Tandem Diabetes Care.
The first to commercialize a major advance in the convenience of treatment for the country's more than 1 million patients with Type 1 diabetes will likely reap a hefty windfall. As Medtronic Diabetes CMO Francine Kaufman said: "The end of the rainbow is some automated device that will be able to come close to normalizing glucose."
Some observers are pessimistic about the chances of the artificial pancreas project because of the technical difficulties it faces and the FDA's strict approach to diabetes related approvals.
But the project could yield numerous benefits even if the original goal is not attained: faster acting insulin would help all who take insulin and better gadgets could benefit all who pump insulin.
Every improvement in technology that limits the risks of fluctuating sugar levels in the blood could improve the life of patients afflicted with this relentless disease, and the companies and their investors that produce the improvements will be well rewarded.