The first version of an artificial pancreas - a potentially revolutionary way to manage insulin delivery in people with type 1 diabetes - may be available in as little as four years.
The Juvenile Diabetes Research Foundation (JDRF) announced that it's partnering with Johnson & Johnson's insulin pump division, Animas Corp, to begin development of the first artificial pancreas system.
The goal is to have a prototype ready for regulatory review in about four years.
Sophisticated computer algorithms
This device would combine existing pump therapy and continuous glucose monitoring (CGM) technology with sophisticated computer algorithms to help prevent dangerous, potentially life-threatening low blood sugar levels, as well as to help prevent complication-inducing high blood sugar levels.
"The artificial pancreas is one of the largest projects we've ever invested in," Alan Lewis, president and CEO of JDRF, said of the non-profit's $8 million (R59 million) investment.
"We're optimistic that it will transform the way people with diabetes manage their blood sugar and reduce the risk of complications while we wait for a cure," Lewis said during a press conference announcing the partnership.
Constant blood sugar checks
The artificial pancreas would primarily benefit people with type 1 diabetes, an autoimmune disorder that destroys the body's ability to manufacture insulin. People with type 1 diabetes must replace that lost insulin through injections, either with shots or by using an insulin pump.
However, it's difficult to know exactly how much insulin you need, and people with diabetes must constantly check their blood sugar to make sure it's not too high or too low. Numerous factors, such as exercise, illness and even stress, can affect blood sugar levels.
"Even the most sophisticated people with diabetes only spend 30% of the time in their blood sugar range, and it's often much less than that," said Aaron Kowalski, research director of the Artificial Pancreas Project at JDRF.
Holy grail of diabetes management
"Whether you have a young child with diabetes or you're an adult with diabetes, it's very difficult. Type 1 is a 24-7, 365-days-a-year job.
“It's a real struggle and folks just want some relief. While our goal at JDRF is to find a cure and walk away, this is important while we wait and it's one of the biggest advances in diabetes management," Kowalski said.
The holy grail of diabetes management, short of a permanent cure, is a system that could take over all of the jobs that people with type 1 diabetes currently do themselves - calculating the impact of food and exercise on insulin levels, as well as adjust for the glucose naturally produced in the body. Experts refer to this as a "closed-loop" system.
‘Step towards perfection’
This initial artificial pancreas system, however, won't be able manage all of those tasks. People with diabetes will still need to input the amount of carbohydrates they're eating so the insulin pump knows how much insulin is needed, and manual blood sugar checks will still be necessary to confirm the CGM readings.
"Trying to mechanically reproduce the human pancreas is going to be very difficult," said Dr Henry Anhalt, a paediatric endocrinologist and medical director at Animas.
“That's why the initial system is going to attempt to prevent serious highs and lows in blood sugar levels. It's a step towards the perfection we're seeking and will significantly improve the quality of life," he said.
Peace of mind
Both Anhalt and Kowalski said the initial system will help give parents and people with diabetes some peace of mind.
"For a parent to be able to get some sleep, knowing a child's blood sugar won't go too high or low, is truly revolutionary," said Anhalt.
Although the exact configuration of the new device hasn't been settled, it will combine an Animas insulin pump with a DexCom CGM system that will wirelessly transmit information to the pump.
The pump will be programmed with sophisticated mathematical algorithms that will instruct it to stop insulin delivery if the CGM senses that the blood sugar levels are dropping, or to increase insulin delivery if the CGM senses that blood sugar levels are rising unexpectedly.
Closed loop system
Of the announcement, Dr Neslihan Gungor, a paediatric endocrinologist at Scott and White Memorial Hospital in Temple, Texas, who is not involved in the project, said, "There is much progress going on, and hopefully we will have that closed loop system someday. And, this gives me hope for the future."
"Every day in our clinic, we ask parents to check so many blood sugars a day and they always have to keep so many factors in mind. How much is my child going to eat? Is he or she going to exercise? What is the current blood sugar?
“If someone could develop an algorithm that could keep all these things in mind, that would be great, and it would make daily life easier," Gungor said. - (Serena Gordon, HealthDay News, January 2010)