First Automated Insulin Delivery Device For Type 1 Diabetes Approved by FDA

A child with type 1 diabetes lives with a large amount of work needed to care for his or her disease.

The daily routine for most kids with type 1 diabetes includes multiple insulin shots, numerous blood sugar checks and analyzing the carbohydrates in every food eaten. Mental focus and motivation are essential and it’s a challenge to maintain the constant effort.

But new technology has the potential to make life easier for these children. The U.S. Food and Drug Administration has approved the first automated insulin delivery device for type 1 diabetes. The device is intended to automatically monitor glucose (sugar) and provide appropriate basal insulin doses in people 14 years of age and older with type 1 diabetes.

The human pancreas naturally supplies a low, continuous rate of insulin, known as basal or background insulin with spurts of insulin released when food is eaten. In patients with type 1 diabetes, the body’s ability to produce insulin is destroyed or severely impaired.

Joel Steelman, M.D., an endocrinologist at Cook Children’s, says this technology is the latest in insulin pump treatment that began to emerge in the 1980s with the promise of more precise insulin dosing and eliminating daily shots.

The old, basic insulin pump has steadily evolved into a smaller, smarter insulin pump. Current progress has allowed the joining of the relative diabetes technology newcomer, the continuous glucose monitor, with an insulin pump – displaying CGM readings on the insulin pump.”

In spite of all these advances in diabetes care technology, there remain two major challenges facing those affected by type 1 diabetes:

1. Daily mental work of diabetes care is not much different in pumping vs. injections.
2. Variability in blood sugars remains even when using a pump and keeping up consistent efforts.

The new diabetes technology holds the promise to shrink these two challenges and help children have more stable blood sugars. The device called a hybrid closed loop system pairs an insulin pump with a continuous glucose monitor (CGM) which has already been done, but contained within the software program of the insulin pump is an “AI co-pilot” that adjusts basal insulin delivery from the pump based on blood sugars detected by CGM.

“We’re getting there,” Dr. Steelman said. “It will only be a matter of time, people are testing devices now, before we achieve an insulin pump device where kids can ‘set and forget it.’”

Dr. Steelman believes the current technology to be a major step in the right direction, but he does see some concerns:

1. More diabetes technology makes a child more visible and obvious to the general population that could result in bullying or discomfort in sharing his or her condition. He said that will be a topic that the pediatrician and the parents will have to address with the patient.
2. It is technology. Computers, smartphones, etc. do break. “We do get lazy and rely on them more than we should sometimes,” Dr. Steelman said. “Kids using the device will need to stay engaged and responsible for their own health. They can’t just rely on the technology.”
3. While a step forward, the hybrid closed loop system still requires counting carbs in food and activating the pump to give boluses of insulin. Also, blood sugar finger prick tests must still be done.
4. According to Dr. Steelman, the equipment is expensive and physicians will have to work closely with insurance companies to find out what is covered for children and be aware of age restrictions.

Once he addresses these issues with the patient family, Dr. Steelman anticipates the Cook Children’s diabetes team will discuss the new technology with interested teens who have demonstrated good basic understanding and practice in their diabetes self-care. He said the staff and patients will need some additional training on the specifics of the technology, but looks forward to the possibilities.

“We already speak with parents about insulin pumps and technology in diabetes care. We have a formal process that we follow on insulin pumps,” Dr. Steelman said. “This technology has the capacity to further improve diabetes control and chip away at the pesky unpredictability in care. I’m especially excited about the positive impact of reducing nighttime low blood sugars.”

About the source

Dr. Joel Steelman grew up a military brat, on the move every three to four years, to a new home, in a different state. Nevertheless, his family roots remained in Texas, where he finished high school and developed a love for writing, working on the school newspaper and yearbook. He attended Texas A&M University both for his undergraduate and medical degrees.

He trained in endocrinology at the University of Colorado Children’s Hospital in Denver. During his tenure in Colorado, where he met his future wife, Dr. Steelman trained at the internationally renowned Barbara Davis Diabetes Center, one of the world’s largest and most esteemed diabetes medical facilities for adults and children, specializing in type 1 diabetes research. Along the way, he discovered another strong research interest in the area of bone disorders, and Dr. Steelman began to treat children with osteogenesis imperfecta, or brittle bone disease-- a rare, crippling malady. After completing his training, Dr. Steelman left the West to enter academic medicine at Vanderbilt Children’s hospital in Nashville, Tennessee. Over the next seven years he focused on research projects and medical education.

The birth of his daughter, in 2005, and the desire to be closer to family, brought Dr. Steelman back home to Texas, and to Cook Children's. Today, he provides endocrine care for children living in the Dallas/Fort Worth metro area, as well as Denton and West Texas. He expanded his practice, after arriving atCook Children's, to include the care of childhood cancer survivors, collaborating with the neuro-oncology program and Life After Cancer programs.