Juvenile Diabetes Research Foundation Artificial Pancreas Project

JDRF launched an initiative to help accelerate the availability of an artificial pancreas to people with diabetes.

Situation

Research shows most people with diabetes are not controlling their glucose levels well enough, resulting in devastating complications such as blindness, kidney failure, heart attacks, amputations, seizures, and comas. For example, a study by Bode et. al. published in Diabetes Care found that patients who were intensively managing their disease – measuring their glucose an average of nine times a day – spent less than 30 percent of the day in normal glucose range.

Solution

JDRF launched an initiative to help accelerate the availability of an artificial pancreas to people with diabetes. Initially, an artificial pancreas will be a combination of external devices 1) insulin pumps, already widely available 2) continuous glucose monitors (CGMs); and 3) an algorithm to communicate between the two. Through independent research and advocacy, JDRF intends to accelerate the development, regulatory approval, availability, and acceptance of these technologies.

Better Health & Lower Costs

According to the American Diabetes Association, diabetes-related costs totaled $132 billion nationwide in 2002, and medical expenditures for people with diabetes were 2.4 times higher than for those without diabetes. The landmark Diabetes Control and Complications Trial (DCCT) found better glucose control greatly reduces the risk of costly complications such as blindness, kidney failure, heart attacks, and amputations. Unfortunately, most patients are still not reaching glycemic control targets. Maintaining normal glucose levels helps patients with type 1 diabetes avoid the acute and long-term complications they currently experience, and results of early clinical trials show significant promise for accomplishing this with continuous glucose monitors.

• One study found people using CGM spent 26 percent more time each day in their target glucose range, and significantly less time with hyper and hypoglycemia.1
• Another trial showed that diabetes patients using CGM had a statistically significant drop in HbA1c compared with a control group, and they spent significantly less time below 70 mg/dl and above 190 mg/dl.2
• A third study found patients at all A1c levels spent increased time in target glucose ranges when using CGM.3

JDRF is currently funding another clinical trial in an effort to provide further clinical evidence supporting the use of CGM. This clinical trial will be the largest trial to date, examining diabetes outcomes in approximately 450 patients ages 8 and above.

Continuous glucose monitors are the first step to closing the loop by combining continuous glucose monitors with an insulin-delivery system to develop an artificial pancreas. An artificial pancreas will enable people with diabetes to maintain normal glucose levels by providing the right amount of insulin at the right time just like the pancreas does in non-diabetic individuals.

• A study at Yale showed that type 1 diabetes patients spent more time in normal glucose ranges when using a closed loop system.4

JDRF is currently funding a consortium of researchers worldwide who are working to “close the loop”.

1 Garg S, Zisser H, Schwartz S, et. al., 2006. Improvement in Glycemic Excursions With a Transcutaneous, Real-Time Continuous Glucose Sensor: A randomized controlled trial, Diabetes Care 29:44-50.

2 Deiss D, Bolinder J, Riveline JP, Battelino T, Bosi E, Tubiana-Rufi N, Kerr D, Phillip M. Improved glycemic control in poorly controlled patients with type 1 diabetes using real-time continuous glucose monitoring. Diabetes Care. 2006; 29: 2730-2.

3 Garg S, Jovanovic L. Relationship of fasting and hourly blood glucose levels to HbA1c values: safety, accuracy, and improvements in glucose profiles obtained using a 7-day continuous glucose sensor. Diabetes Care. 2006; 29: 2644-9.

4 Weinzimer SA, Steil GM, Kurtz N, Swan KL, Tamborlane WV. Automated Feedback-Controlled Insulin Delivery in Children with Type 1 Diabetes Mellitus (T1D): A Preliminary Report. 2006. Abstract 431-P. ADA Annual Scientific Sessions.