Sansum Diabetes Research Institute reports positive results for first tubeless delivery system for insulin
Terra Thomas, left, and Dr. Kristin Castorino demonstrate the first tubeless delivery system for insulin at the Sansum Diabetes Research Institute.
Sansum Diabetes Research Institute is part of efforts for the first tubeless delivery system for insulin.
FDA approval of the Omnipod was announced last month by the developing corporation, Insulet Corp. The FDA has OK’d the device for those 6 and older with type 1 diabetes.
The waterproof tubeless device sticks to the skin.
The trial of the Omnipod 5 Automated Insulin Delivery System involved 16 research sites across the country, including Sansum Diabetes Research Institute. That’s the Santa Barbara institute founded by Dr. William Sansum, the Santa Barbara physician who became the first doctor in the country to administer insulin.
The institute continues to make history with its work on the Omnipod 5 system, the nation’s first tubeless automated insulin delivery system that integrates with the Dexcom G6 Continuous Glucose Monitoring System and a compatible smartphone to automatically adjust insulin/ In doing so, it helps to protect against highs and lows in blood sugar.
“The study was a single-arm, multicenter, prospective study of a total of 235 participants ages 6 to 70 years old,” Dr. Kristen Castorino, a senior research physician at the institute and a clinical site investigator, told the News-Press.
A two-week standard therapy phase, which was the usual insulin regimen, was followed by three months of automated insulin delivery.
Terra Thomas was among the research patients in the trial at the institute and was impressed with the results.
“The recent FDA approval of the first tubeless automated insulin delivery system, the Omnipod 5 system, has the entire diabetes community buzzing with excitement,” Ms. Thomas, a credentialed health coach and an authority in wellness, told the News-Press. “After wearing the Omnipod 5 system for over two years in research, I can say, without a doubt, I have more ease of access to my well-being because of the system. I very rarely have low glucose events that require my attention wearing this system.”
Dr. Trang Ly, Insulet senior vice president and medical director at Insulet, said, “Omnipod 5 is the most complex and greatest innovation in the history of our company. As the clinical data has shown, Omnipod 5 significantly improves time in range and reduces HbA1c in children, adolescents and adults with type 1 diabetes. It is an undoubtedly life-changing innovation for people with diabetes.”
Omnipod 5 is the first automated insulin delivery system to integrate its algorithm (SmartAdjustTM technology), which communicates with the Dexcom G6 CGM to adjust insulin dosing depending on blood sugar levels and trends, directly into the pod.
Every five minutes, SmartAdjust predicts where glucose will be 60 minutes into the future. The system increases or decreases insulin or pauses delivery according to the user’s customized target.
That protects the user against highs and lows in blood sugar.
“Generally this is intended for people who require insulin (generally type 1),” Dr. Castorino said. “Our body normally increases and decreases insulin secretion in response to the body’s changing blood sugar level. In type 1 diabetes, the body stops producing insulin, and insulin must be injected throughout the day to keep blood sugars stable, but this can be very difficult.
“Artificial Pancreas, or automated insulin delivery systems, aim to mimic our body’s elegant way of keeping blood sugar levels at just the right level for our bodies, especially our brain, liver and kidneys to work,” Dr. Castorino said. “The Omnipod 5 Automated Insulin Delivery System consists of a tubeless insulin pump (pod) with an embedded automated insulin delivery algorithm (Omnipod 5), an interoperable glucose sensor (Dexcom G6), and a mobile app (Omnipod 5 app) on a locked-down Android phone.”
Blood glucose control throughout the day and overnight is a serious challenge for children and adults with type 1 diabetes, and the Omnipod 5 pivotal trial data demonstrated promising results for its clinical research study participants at the Sansum Diabetes Research Institute as well as the other clinical trial sites.
The institute said the data showed that Omnipod 5 can help adults and children significantly improve their diabetes management.
“I am so thankful for this system,” said a parent with a child in the trial. “I have finally been able to sleep better at night with peace of mind that the system will mitigate my child’s hypoglycemia.”
Ms. Thomas told the News-Press that the new system has benefited her life.
“I spend less time in my relationship with my diabetes, so I can spend more time in my relationship with my life, kids, loved ones, career and business,” she said. “It takes care of the cognitive load of the disease.
“People with type 1 Diabetes make on average an additional 150 decisions per day, according to research. The system uses an algorithm (automated insulin delivery), to make decisions,” she explained. “This requires significantly more cognitive energy than a person not living with type 1 diabetes. The Omnipod 5 system is automated insulin delivery, making some of those decisions for me. This reduces the cognitive load of this disease, allowing more (time) for other areas of my life.”
Dr. Castorino said the system is designed to prevent dangers such as severe low blood sugar and diabetic ketoacidosis. “Any technology for diabetes management should aim to reduce the incidence of these occurrences. Severe low blood sugar can be life threatening.
“We try to help in advocating for people with diabetes, wanting companies to meet people’s needs and make life simpler,” Dr. Castorino said. “No one wants technology that makes life more complicated. Diabetes technology should improve the lives of people with diabetes. However, technology can sometimes inadvertently overcomplicate or confuse people with diabetes. It is exciting to see technology such as the Omnipod 5, offer another option to simplify diabetes management so people with diabetes can focus on their life dreams rather than their blood sugar.”
When asked if she has experienced any drawbacks or side effects, Ms. Thomas said, “What is important to note is that no system is perfect. It is nothing that I haven’t experienced. Technology has a learning curve to recognize. Is it a cure, is it perfect? Nope. but in my opinion, it’s the closest (thing) that exists at the moment for a person who wants to think less about their relationship with diabetes and more about their relationship with loved ones, their career, their friends and their life in general.”
One of the most unique things about this technology is that it is tubeless.
“The tubeless option for automated insulin delivery is a hugely anticipated achievement,” Dr. Castorino said. “Many people with diabetes find this better fits their lifestyle. People prefer it for activities like surfing or hiking. It takes a lot of the work out of guessing the right amount of insulin. The system does the adjusting for them.”
“The Omnipod 5 Research Group found that this tubeless automated insulin delivery system was safe and improved diabetes control in people with type 1 diabetes,” Dr. Castorino said. “The system was effective at keeping blood glucose in the target range of 70-180. There was better blood sugar control with more time in the target range.”
“As this is brand new technology, we are not sure yet of the monthly cost but we have every indication that it will be covered by most health insurances,” said Dr. Castorino.
In addition to Dr. Castorino, site investigators for the trial included nurse practitioner Mei Mei Church and Dr. Ashley Thorsell, a research physician and endocrinologist. The institute also recognizes Dr. Jordan Pinsker “for his incredible contribution to diabetes research while at SDRI.”
For more information, go to www.omnipod.com/current-podders/resources/omnipod-5/faqs.
email: kzhender@newspress.com
