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Artificial Pancreas Could Mean Big Health Improvements for T1D Patients

Artificial Pancreas Could Mean Big Health Improvements for Those with Type 1 Diabetes

The device will automatically monitor blood glucose levels and deliver insulin when appropriate for people age 14 years and older with Type 1 diabetes.

Type 1 diabetes (T1D) is an autoimmune disease that causes a person’s pancreas to stop producing insulin, a hormone needed to get energy from food. The disease can strike both children and adults at any age and, often, symptoms appear suddenly. Its onset has nothing to do with diet or lifestyle, unlike Type 2 diabetes. Though T1D’s causes are not yet entirely understood, scientists believe that both genetic factors and environmental triggers play a role. Unfortunately, there’s currently nothing that can be done to prevent it and there’s no cure.

Currently, managing T1D is a never-ending, difficult task because the body often struggles with even the most diligent efforts to keep blood sugar at normal levels. As a result, even sleeping can be anxiety-filled for people with the disease—that’s often when dangerous low-blood-sugar episodes occur. Simply enjoying a favorite food can require significant insulin-dose planning to avoid high blood sugar and the resulting risks of serious diabetic complications.

While those with T1D rely on insulin therapy to control blood sugar, insulin is not a cure and doesn’t prevent the possibility of serious side effects. Even with intensive disease management, a significant portion of the day is spent with high or low blood-sugar levels, placing those with T1D at risk for devastating complications, including heart attack, stroke, blindness, kidney disease, and amputation.

A “First-of-its-Kind” Device

But there’s good news for those with T1D: Late last year, the U.S. Food & Drug Administration (FDA) approved an artificial pancreas—a first-of-its-kind device. Only the size of a cell phone, it will monitor and treat patients with Type 1 diabetes, also known as juvenile diabetes.
The Medtronic MiniMed 670G is a hybrid closed looped system that will automatically administer or withhold insulin in response to blood glucose measurements, which it takes every five minutes. It is the first FDA-approved device intended to automatically monitor glucose (sugar) and provide appropriate basal insulin doses in people 14 years of age and older with T1D. This technology can provide greater freedom without having to consistently and manually monitor baseline glucose levels and administer insulin.
The system is made up of a sensor to measure blood glucose under the skin; an insulin pump; an infusion patch to deliver insulin from the pump via a catheter inserted into the skin and a computer chip to use data to optimize insulin delivery by the minute. The device is expected to be available this spring.

Derek Rapp, CEO of the Juvenile Diabetes Research Foundation (JDRF), which has spent $116 million on research in the artificial pancreas field added, “This device will mean peace of mind in knowing a person will be in normal blood sugar range a great majority of the time.”

Rapp, who has a college-age son with Type 1 diabetes, said his son, as a child, had to be awakened many times each evening so his finger could be pricked for a blood sample to ensure his blood sugar level was in an acceptable range. If too low, he would be given fruit juice or a snack. If too high, he would be given insulin. “It is a major news event that a system of this kind has been approved—the first time a pump will administer insulin as a result of information it receives from a sensor,” Rapp said.

More Than One Option on the Horizon

Other artificial pancreas projects are moving into the final stages before they become widely available in the next one to two years.

For example, Beta Bionics is working on a device to administer both insulin and glucagon, the hormone that raises blood sugar. With data from a continuous glucose monitor, its algorithm decides which hormone to release and at what amount. “Using both insulin and glucagon allows for tighter control of blood sugar levels,” says CEO Edward Damiano.

Damiano began developing his bionic pancreas after his son was diagnosed with Type 1 diabetes. He told Time magazine he wants the device approved so his son will no longer have to constantly think about managing his disease. His company hopes to begin clinical trials in mid-2017. An insulin-only version could receive FDA approval as early as 2018.

According to Scientific American, one of the largest clinical trials in this field began early this year with 240 patients in the U.S. and Europe. The trials are led by researchers at the University of Virginia and Harvard University, in cooperation with a group of organizations, and will test the safety and effectiveness of a system that integrates an insulin pump, a continuous glucose monitor, and a smartphone. The smartphone relies on an algorithm to analyze blood sugar readings and then instructs the pump on how much insulin to release. The magazine reports that two different algorithms will be tested.

In total, The National Institutes of Health (NIH) has announced it’s funding four last-stage clinical trials of artificial pancreas devices that automate blood sugar control for people with T1D. If the trials go well, each of these groups could seek approval from federal authorities.

“For many people with Type 1 diabetes, the realization of a successful, fully-automated artificial pancreas is a dearly held dream. It signifies a life freer from nightly wake-up calls to check blood glucose or deliver insulin, a life freer from dangerous swings of blood glucose,” said National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Director Dr. Griffin P. Rodgers. “Nearly 100 years since the discovery of insulin, a successful artificial pancreas would mark another huge step toward better health for people with Type 1 diabetes.”

Revolutionary Technology, But Not for Everyone

Barbara Brody, an author specializing in health and wellness issues, reminds those excited about these new devices on the horizon to remember that not everyone with T1D will be able to use an artificial pancreas. You will not be able to use the device if:
• You require fewer than a total of eight (8) doses of insulin per day;
• You’re not willing to perform at least four (4) blood sugar tests per day;
• You are vision or hearing impaired (these systems use digital displays and audible alarms);
• You are pregnant;
• You have kidney disease; or
• You are younger than 14 years of age.
With approximately 1.25 million Americans currently diagnosed with T1D, and an estimated 40,000 people newly diagnosed each year in the U.S., the American Diabetes Association knows that not everyone with this disease will be able to benefit from the artificial pancreas. The organization reminds those with T1D to remember these crucial elements:
• Work closely with your doctor to manage or update your treatment options;
• Understand how different foods affect your blood glucose levels and use that information to develop solid meal plans you can stick to; and
• Connect with others living with diabetes who understand the daily grind of dealing with the various highs and lows (both physical and emotional) of life with diabetes.

If you have any diabetic health concerns, or questions about any healthcare issue, contact the primary care providers at Coastal Carolina Health Care by calling (252) 633-4111 or visiting www.cchchealthcare.com.

(Sources: Juvenile Diabetes Research Foundation (JDRF); CNN; U.S. Food & Drug Administration; Medtronic; Diabetes in Control; Scientific American Magazine; Time Magazine; The National Institutes of Health; and American Diabetes Association.)