A team of scientists and engineers, led at the Massachusetts General Hospital Diabetes Center by Steven Russell, MD, PhD, have developed and are testing a first-of-its-kind automated device with the potential to revolutionize diabetes treatment. This medical breakthrough is called the bionic pancreas – and it’s closer than ever to making a real world impact on patients.

Imagine living in constant jeopardy, never being able to let your guard down. Patients with type 1 diabetes face this anxiety every day. Because of their condition, they have to remain vigilant about checking their blood sugar and administering insulin, the hormone that lowers blood glucose. Patients need to check their blood sugar often – typically five to ten times a day – or they could face dire health risks. When their blood sugar is low, they need to be especially attentive and check it every 15 minutes.

Steven Russell, MD, PhD, is working with colleagues on a bionic pancreas that could dramatically change the lives of people with type 1 and type 2 diabetes.
Steven Russell, MD, PhD, is working with colleagues on a bionic pancreas that could dramatically change the lives of people with type 1 and type 2 diabetes.

“My patients must constantly be on high alert,” Dr. Russell says. “They frequently have to interrupt what they’re doing – including pulling over when they’re driving – to check their blood sugar. And it’s not unusual for parents of diabetic children to wake up multiple times in the middle of the night to check their child’s blood sugar. Having diabetes can be incredibly stressful.”

A Three-Part Device Provides One Simple Solution

There is no known prevention or cure for type 1 diabetes, which most commonly strikes during childhood. But the bionic pancreas offers great hope for patients and their families because it’s an innovative and effective solution to all of the challenges that individuals with diabetes face. Capable of monitoring blood glucose automatically, calculating the correct amount of insulin or glucagon needed at any particular moment, and administering the hormones that patients need to stay safe and healthy, the bionic pancreas does it all. “The device is wearable, which allows people to work and live their lives,” says Dr. Russell.  “They can exercise and eat as they like without worrying about their blood sugar.”

“My patients must constantly be on high alert,” Dr. Russell says. “Having diabetes is incredibly stressful.”

In order to appreciate the promise of the bionic pancreas, it’s important to understand just how type 1 diabetes wreaks havoc on patients. This autoimmune disease destroys or reduces the ability of the pancreas to produce insulin, a vital hormone that regulates blood sugar. Before the discovery of insulin, type 1 diabetes patients did not live long, as they quickly fell into diabetic coma and then died.

Since insulin became available in 1922, patients have been able to avoid this fate with a difficult-to-maintain regimen of multiple insulin injections each day or infusion of insulin with a pump. The goal is to give just enough insulin to keep the blood sugar near the normal range most of the time. If this is done successfully, patients can avoid long-term health consequences like kidney failure, nerve damage and blindness.

bionic pancreas
While the prototype bionic pancreas has three parts, the final version will be a single unit.

Because it’s very difficult to know the precise amount of the hormone that needs to be administered, it’s easy to take too much insulin – and diabetics often struggle with low blood sugar as a result. This, too, comes with harmful side effects, such as shakiness, sweating, confusion, accidents such as falling or crashing a vehicle, and in severe cases, brain damage or death. “For patients, it’s like walking a tightrope,” explains Dr. Russell. “On one hand, there’s the risk of serious long-term complications if the blood sugar is too high, and on the other end, there’s the risk of severe injury from low blood sugar. Sometimes, they have to rely on family, friends, or bystanders to help them. It’s very frightening.”

In addition, patients with diabetes have a decreased ability to make glucagon, another hormone produced by the pancreas. Glucagon elevates blood glucose, having the opposite effect of insulin. In healthy individuals, the two hormones work together to control blood sugar. But people who have diabetes aren’t able to make hormones when they are needed. “That’s the beauty of the bionic pancreas,” says Dr. Russell. “It’s the perfect device for patients with diabetes. We call it a ‘bihormonal system’ because it replaces both of the key hormones these patients lack – so patients feel better, faster. And it automatically adapts to the insulin needs of individual patients.” According to Dr. Russell, there is no other device for patients with diabetes in the world that is this versatile and powerful, making the bionic pancreas a truly one-of-a-kind invention.

The bionic pancreas is capable of monitoring blood glucose, calculating the correct amount of insulin or glucagon needed, and administering these hormones.

Research and the Role of Philanthropy

Dr. Russell and his Mass General research team are conducting clinical studies to validate the bionic pancreas, and their results have been promising. In recently published studies, the bionic pancreas was reported to lower average blood glucose, reduce the variability in patients’ blood sugar and associated symptoms, reduce the number of instances of low blood sugars, and improve quality of life in both adults and adolescents.

bionic panceas
Kimberly Martin, RN, is delighted with the bionic pancreas she is wearing as part of a clinical trial at Mass General.

“One subject, a man who participated in our research, told me that wearing the device for the clinical study was most emotional experience he’d ever had,” Dr. Russell recalls, “because it gave him hope for the future and the prospect of relief from the demands and risks of diabetes. Having seen what the bionic pancreas is capable of, I cannot wait to be able to offer this system to all of my patients because I know it will change their lives.”

The next step for Dr. Russell and his colleagues is to conduct a much larger research study, which will further validate the positive results from their first studies and will bring the bionic pancreas one step closer to gaining regulatory approval for development and public use. “The future of the bionic pancreas is bright, but the biggest barrier for us is funding,” says Dr. Russell. “Although we’ve had great success with funding for clinical trials, it’s difficult to get grants for further development of the device, which needs to be streamlined and made more robust for general use. We have been fortunate to receive funding from donors who understand our work’s great potential – and we hope to receive much more in order to have a final device developed and approved for patients in 2018.

“Patients who participate in our clinical trials don’t want to take off the bionic pancreas when the study period is over, because it makes life so much easier for them. They beg me to let them keep it forever,” says Dr. Russell. “It’s my mission to make this device available to all patients with diabetes, so they never have to take it off – unless they’re changing the battery.”

To support Dr. Russell and his team’s extraordinary work, please visit their website.