Innovation

The Omnipod Horizon artificial pancreas is a groundbreaking medical device that will dramatically improve the lives of patients living with diabetes. It consists of two small wearable devices; a continuous glucose monitor (CGM) combined with an Omnipod insulin delivery device. Both devices communicate with each other to continuously monitor and regulate a patient’s blood glucose levels via automatic insulin delivery. Diabetes is a metabolic disease in which the Pancreas does not function properly and thus the patient’s body cannot produce enough insulin, which then causes elevated levels of glucose in the blood. Approximately 6 percent of the U.S. population has been diagnosed with diabetes, and another 3 percent of U.S. adults are unaware that they have diabetes (1).

In the past, diabetes patients had to manually check their blood glucose levels via a “Finger Prick” throughout their day, and correspondingly give themselves injections of insulin to regulate their blood glucose. That was replaced in the last decade with various electronically assisted systems that helped them test their blood sugar (still via the finger pricks method), but their required insulin doses were administered via a wearable insulin pump that removed the need for the traditional multiple daily injections of insulin. Insulet Corporation views the development of the Omnipod Horizon device as a giant step towards effectively removing the enormous burden on the patient of manually monitoring and regulating their insulin levels throughout their day.

“The Omnipod Horizon came about via research which was done with Endocrinologists and patients to identify the challenges they face daily. The goal is to make the patients' ability to care for their diabetes as stress free as possible. The Omnipod is connected to a continuous glucose meter, and an algorithm has been created to interface the CGM and pod to constantly communicate. The result is a closed loop system with a bolus delivery option for patient to use at their discretion when eating or exercising” said Lindsay.

She went on to say that “there were many individuals involved in the development of this device, such as endocrinologists, clinical diabetes educators, diabetes patients & caregivers, insurance companies, design engineers, R&D staff, clinical testing staff, software developers, as well as internal marketing and regulatory teams.”

Lindsey stated: “Insulet’s corporate mission is to better the lives of patients living with diabetes, the development of the Omnipod insulin delivery device was step one, the final step is to develop the artificial pancreas, to then even further improve the lives of diabetes patients.”

(1) Source: http://content.healthaffairs.org/content/29/2/297.full

Inspiration

The dream of an artificial pancreas has been around as long as the relationship between the diabetic condition and an under-performing pancreas has been understood. Much like other medical advancements, such as pace makers, knee replacements, and smart bionic limbs, the artificial pancreas concept is much the same in its goal of replacing a naturally occurring human body function/part with a synthesized alternative that functions much the same way.

Shortly after Insulet launched their original Omnipod insulin management system back in 2005, they began looking at possible ways to automatically control the delivery of insulin based upon the body’s needs. This would replace the patient having to manually control all aspects of their insulin levels. Lindsay shared that “[t]he purpose for this innovation is to improve the lives of patients with diabetes via improved clinical outcomes and quality of life. As of today the average diabetes patient makes 100 decisions about their self-care daily.” That day-to-day burden on the patients and their caregivers was a huge motivator for this project.

The challenge for Insulet engineers was that following Omnipod's launch back in 2005 they needed continuous blood glucose (CGM) monitoring technology to evolve to a point that they could integrate it with into the envisioned artificial pancreas system. Once the CGM technology did evolve, the next challenge was to design the control algorithm that could calculate insulin doses to maintain a targeted blood glucose level. They then needed to transfer that information to the Omnipod so that it could deliver the necessary dose of insulin to the patient.

Insulet’s medical advisors first began working on the artificial pancreas back in 2010. A clinical product was ready for clinical trials in May of 2016. Based upon the current project time-lines, Omnipod Horizon will be commercially sold in 2019.

Overall impact

Diabetes is a particularly challenging condition for patients as they are required to monitor and adjust their blood glucose levels at all times during the day to ensure the levels are always balanced. To add further complications to that process, everyday things such as eating and exercise can drastically effect those levels and thus requires the patient to plan ahead to account for those factors. Severe hypoglycemia, or diabetic shock, is a serious health risk for anyone with diabetes. It can occur anytime there is an imbalance in the patient’s insulin levels, and can ultimately result in coma and/or death.

The Omnipod Horizon product is currently in clinical trials with an intended commercial launch in 2019. The control algorithm calculates insulin doses based on predicted glucose values to maintain a targeted blood glucose. Omnipod Horizon is designed to assist patients with better control by achieving targeted blood glucose and increasing their time in the ideal euglycemic range. The Omnipod Horizon is currently 6 months into U.S. clinical trials and the system is already assisting patients in reducing glycemic variability and thus lessening the burden of diabetes management.

Business benefit

The benefit to Insulet from the introduction of the Omnipod Horizon artificial pancreas is that it further expands Insulet’s presence and product offering in the industry. “Any insulin pump company that is in the diabetes treatment space will have to have an artificial pancreas in the future to remain a player in the space” said Lindsay, “Our ongoing advantage is that the Omnipod is the only tubeless insulin pump on the market” she went on to say. Many of Insulet’s current competitors utilize insulin pumps that are worn on the patient’s belt, and require tubes and lancet needles embedded in the patient’s skin to deliver the insulin required doses.

Social and environmental benefit

The direct beneficiaries of this innovation are the diabetic patients who will receive improved clinical outcomes and quality of life. However, there is also a benefit to society in the form of a reduced burden on the health-care system. As of 2007, it was estimated that the cost to the U.S. health-care system for the treatment of patients with diabetes was $153M, 7% of the total $2.24 trillion national health expenditure for that year. A technology like Insulet’s artificial pancreas will allow more diabetic patients to more easily monitor and regulate their condition, which should reduce complications and hospitalizations currently associated with mismanagement of diabetes.1

1: http://content.healthaffairs.org/content/29/2/297.full

Interview

Lindsay Philbrick, Senior Director, Marketing at Insulet Corporation