“The Artificial Pancreas – Taking the Guesswork out of Diabetes”

That is the reality for millions of people living with type 1 diabetes. Before digging in to a savory plate of food before them, people with type 1 diabetes must calculate the number of carbohydrates about to be consumed, and then inject themselves with the right amount of insulin accordingly. Finally they can eat, but once the meal is finished, they must check their blood glucose levels to make sure they did in fact calculate the correct amount of insulin. It can be a tiring ordeal even in the comfort of home, but when going out for dinner, the challenges become even greater. Added difficulties arise in not knowing the carbohydrate count in everything on the plate, and often times in the need to factor in larger than usual portion sizes.  All this adds up to a lot of guesswork, which can potentially lead to dangerous blood glucose fluctuations.

Therein lies one of many important benefits of an artificial pancreas, which could allow people with diabetes a little relief, and time free from having to constantly think about diabetes. The artificial pancreas would automatically replace guesswork with accuracy, allowing people with the disease to be able to simply eat without calculating carbs, and to go to bed feeling protected, without the fear of hypoglycemia (dangerous low blood sugar) should they let their minds take a rest.

A new study, conducted by a team of researchers led by Dr. Roman Hovorka at the University of Cambridge, set out to test algorithms in artificial pancreas devices in order to determine whether they can in fact help ease some of the burden that people with type 1 diabetes face every day.  Published in the online version of British Medical Journal last Friday, two small randomized trials showed that the devices were able to improve blood glucose control as well as reduce the risk of dangerous low blood sugars overnight. Dr. Hovorka, a researcher in JDRF’s Artificial Pancreas Consortium, created two scenarios to determine whether a closed-loop device, using computer algorithms that allow a continuous glucose monitor (CGM) to “talk” to an insulin pump, could regulate blood sugars as well as conventional methods, in the face of diabetes challenges such as exercise, large meals, and sleep. This study was supported by the use of the algorithms developed by Dr. Hovorka in previous JDRF-funded studies.   

The first testing scenario in Dr. Hovorka’s study was designed to mimic “eating in” by giving 12 patients a moderate-sized meal at 7:00 pm. The second scenario recreated “dining out” by giving a different 12 patients a slightly larger meal, eaten later at night (8:30 pm), and included white wine. Each test scenario used an advanced computer algorithm and included control studies using conventional insulin pump settings. In both cases, the algorithm was able to reduce blood glucose variability; it kept patient levels within a safe and normal range for longer periods of time, and patients experienced fewer episodes of hyperglycemia (high blood sugar).

According to the authors, these findings provide further evidence that overnight closed loop delivery can operate safely, effectively, and consistently across different age groups, insulin sensitivities, and lifestyle conditions. Previous studies on artificial pancreas devices and overnight control were conducted successfully in children and adolescents, as well as in pregnant women with type 1 diabetes. 

To date, artificial pancreas systems have been involved in numerous tests. In-patient studies—those conducted in closely-monitored hospital settings—have been successfully completed across the United States and in the U.K. for years. And each new study has brought the systems closer not just to being safe to use, but to significantly improving control of glucose levels compared to traditional methods.

The technology, which would undoubtedly benefit many people who live with type 1 diabetes, is at an exciting and pivotal place on the road toward becoming available to patients. After steady research and testing progress in hospital or in-patient settings, such as the study done by Dr. Hovorka, the research is now ready to transition to more real-life, outpatient settings. Only when closed-loop systems are able to be tested on an outpatient basis, such as in patient homes, will we truly be able to test the safety and benefit for people with type 1 diabetes.

In order to begin that phase of testing, JDRF and its affiliated research centers are awaiting clear and reasonable guidance from the U.S. Food and Drug Administration (FDA). To that end, JDRF has proposed a draft Guidance Document for consideration by FDA, based on recommendations from a clinical panel of experts. It also includes input and review by the American Association of Clinical Endocrinologists (AACE). The document provides clinical testing recommendations for the development of artificial pancreas systems, and will serve as a roadmap for researchers and companies to develop safe and effective artificial pancreas systems. 

Thanks to important work like Dr. Hovorka’s study, we are making great progress in artificial pancreas research. JDRF hopes this progress can continue quickly with the cooperation of FDA, so that people with type 1 diabetes can soon reap the benefits of these innovative systems.