The Juvenile Diabetes Research Foundation (JDRF) said last month it was teaming up with U.S. drugmaker Johnson & Johnson’s unit Animas, which makes insulin pumps, and DexCom Inc, which makes continuous glucose monitoring devices, to develop and test an artificial pancreas system in Type 1 diabetics.
In type 1 diabetes, the pancreas does not produce insulin. Insulin is a hormone that is involved in regulating how the body converts sugar (glucose) into energy. People with type 1 diabetes need to take daily insulin shots and carefully monitor their blood glucose levels.
Type 1 diabetes is less common that type 2 diabetes. This type of diabetes can occur at any age, but usually first develops in childhood or adolescence. Type 1 diabetes accounts for 5 – 10% of all diabetes cases.
The Cambridge study, published in The Lancet medical journal on Friday, used devices and sensors from Smiths Medical, a unit of Smiths Group, Abbott Diabetes Care, a unit of Abbott Laboratories, and Medtronic.
The Cambridge study found their device performed better than a conventional pump, which delivers insulin at pre-set rates and which kept blood sugar levels around normal for 40 percent of the time compared with 60 percent for the artificial pancreas.
This is of particular interest to parents of small children. "Many parents are up every night to test their child’s blood sugar, and many live with the fear that their child won’t wake up in the morning," said Aaron j. Kowalski of the juvenile diabetes research foundation, stressing that the device helps lower nighttime hypoglycemic attacks.
Apart from hypoglycemic attacks, insulin stacking — a condition which occurs after children go to bed after eating a large evening meal — was less frequent in children, who used the new device.
"This is an important step forward in managing overnight blood glucose levels as well as in the eventual development of a full ‘artificial pancreas’ which could vastly improve the quality of life for people with type 1 diabetes and reduce the risk of the associated complications," said research manager Victoria King.
JDRF’s Artificial Pancreas Project stands on the cusp of a breakthrough that represents the first step toward dramatically improving the lives of millions of people with type 1 diabetes: an artificial pancreas, an automated system to disperse insulin based on real-time changes in blood sugar levels.
JDRF’s Artificial Pancreas Project brings together JDRF, founded 40 years ago by parents of children with type 1 and today the global leader in setting the agenda for diabetes research worldwide, and academic and business partners to aggressively work to speed the development and approval of automated systems for people with type 1 diabetes.
In early January, 2008, the FDA approved an in silico model of diabetes as a pre-clinical testing tool for closed loop research at the seven JDRF Artificial Pancreas Consortium sites. Functioning as a computer simulator of type 1 diabetes, the software program is housed at the Jaeb Center for Health Research in Tampa, FL, the consortium’s coordinating center; each group will also have a fully functional but scaled-down version of the simulator for local use.
Among its benefits: The simulator will facilitate the development of new control algorithms–the computer programs that interpret continuous glucose sensor data and instruct the pump to dose the proper amount of insulin–by enabling consortium researchers to test and refine artificial pancreas algorithms quickly; it will allow for computer-based algorithm comparisons; and it will eliminate the need for animal testing, allowing investigators to focus instead on in-hospital human clinical trials, which will save significant investments of time and money. Because the simulator is now FDA-approved, the process of receiving regulatory approval for human trials of closed-loop systems will also be faster and more clearly defined.
On a broader scale, because the simulator is equipped with a wide array of tools for precise fine-tuning, it should help to bring promising algorithms closer to perfection–a necessary criterion for seamless communication between continuous glucose monitors (CGMs) and insulin pumps, and ultimately, the development and possible commercialization of a closed-loop artificial pancreas.