Designing a Closed-Loop Automated Insulin Delivery System: Simplifying Life for People, Including Children, Living With Type 1 Diabetes

Living with type 1 diabetes is difficult. This is especially true for young children and adolescents who are developing—physically, mentally, emotionally, and socially. As every parent knows, raising children is hard enough without the additional burden of managing a relentless disease that requires constant attention and countless decisions each day. It can be exhausting and overwhelming. Accordingly, diabetes distress commonly affects people with diabetes and their loved ones [1].

Insulet intimately understands this. Since our inception nearly 25 years ago, we have focused on simplifying life for people with diabetes, including children. Many of our employees have firsthand experience with type 1 diabetes, either managing it themselves or serving as a caregiver for a child or family member, which gives additional insights and urgency around designing for young patients. Today, Omnipod, our revolutionary tubeless insulin delivery technology, is used by more than 425,000 people with diabetes, helping them live their best lives.

About type 1 diabetes

Type 1 diabetes is an autoimmune disorder in which the body attacks and destroys its own insulin-producing beta cells of the pancreas [2]. Without insulin, blood glucose levels rise, and if left untreated, may lead to dangerous complications [3]. Treatment involves having external insulin administered via injections or pump to support normal metabolic function including glucose levels. If too much insulin is administered, blood glucose drops, which can lead to severe immediate consequences, including death.

According to the American Diabetes Association (ADA), recommended glycemic goals for people with diabetes are to aim to spend at least 70% of the time with glucose levels in the target range of 70–180 mg/dL (known as “time in range (TIR)”), and to aim for an HbA1c level <7% (laboratory blood test measure reflective of average glucose levels over time) [4]. However, goals can vary by individual circumstance (age, other comorbidities, higher risk of hypoglycemia, etc.), underscoring the importance of collaboration with a healthcare provider to personalize therapy goals. Type 1 diabetes often develops earlier in life but can occur at any age [5]. People with type 1 diabetes must take insulin to survive.

Legacy therapies for managing type 1 diabetes

It was known since 1838 that glucose is the key sugar that people with diabetes cannot metabolize. Insulin was discovered in the early 1920s, changing diabetes therapy forever. In the 1970s, biosynthetic insulin was developed and formulated [6]. For approximately 50 years, from the 1920s throughout the 1970s, insulin was administered exclusively via syringe with multiple daily injections, or MDI. Any parent or caregiver who has taken their young children into a pediatrician’s office for a shot knows how traumatic that can be, for everyone involved. Now imagine that scenario 3–7 times each day for young children with diabetes and their parents. Insulin pumps, a medical device typically attached to a person’s belt/waistline that delivers insulin through a tube into an infusion set applied to the abdominal area, were introduced commercially in the 1970s to continuously infuse insulin, approximating the activity of the pancreas [7].

Simplifying life for kids with type 1 diabetes—It’s in our DNA

Headquartered in Acton, Massachusetts, Insulet (NASDAQ: PODD) was founded in 2000 by the father of a young child with type 1 diabetes. Dealing with the challenges of the existing insulin delivery options—multiple daily injections and/or traditional tubed insulin pumps, he believed there had to be a better way to manage his son’s diabetes. He envisioned a wearable, tubeless, disposable insulin pump, sketched it on a napkin during a flight, and Omnipod was born.

“There has to be a better way” is the same foundational belief that inspires and drives life-changing innovation at Insulet today. And we have come a long way from ideating and designing on the back of napkins.

The initial challenge of making Omnipod was fitting all the required technology into a tiny, cost-effective package. Insulin has a narrow therapeutic range and, accordingly, dosing must be accurate. It also had to be “life-proof,” including for kids. Omnipod was envisaged to be worn 24/7, 365 days per year: whether swimming, mixing it up on a playground, or wrestling with a sibling. Eliminating injections and associated fears was another key design goal, so Omnipod required a way to insert a small, flexible tube (known as a cannula) that was hidden from view. The device also had to last long enough so that replacing it was both economical and convenient, requiring enough battery power and insulin capacity for several days. It needed electronics for onboard controls and communications with a remote controller, so that a user could tell the wearable device what to do. And it had to be small enough to adhere comfortably to the skin.

The first two generations of Omnipod were astonishingly successful at achieving the most difficult of these goals. Cost-effective hardware was developed to accurately dose insulin. Methods of sealing the device and adhering it to the skin were developed, as was technology to insert a soft cannula invisibly to the user. All of this was contained in a small, wearable package that could hold three days of insulin and be remote-controlled by a user. The need for multiple daily injections was eliminated!

Notwithstanding these extraordinary successes, there were compromises in the first two generations. The device was small, but still too big. It was costly and difficult to manufacture. And the handheld remote controller wasn’t as user-friendly as we would later make it.

One of my colleagues, who co-led hardware development of the third-generation device in the late 2000s, visited a diabetes camp and saw kids wearing a second-generation Omnipod. The product was still too big and needed to be easier to use. He came back to Insulet committed to helping design a new and better device that would be small enough for our smallest customers. The team also tackled adding an integrated blood glucose meter to the handheld controller to eliminate one item parents would inevitably forget. The result was the modern day Omnipod disposable: small, automatic cannula insertion, reliable, and cost-effective.

After the third generation, innovation targets shifted from hardware to the rest of the experience. Our User Experience team met hundreds of customers while designing the fourth generation, listening to their life stories and needs [8]. Two key needs emerged: a much simpler set of controls and the ability to remotely monitor how children were doing with their insulin therapy.

Development of the Omnipod DASH1 Insulin Management System (Gen 4) began in 2016, setting out to address both requirements [9]. Leveraging the proven Omnipod wearable, Omnipod DASH dramatically simplified the startup and daily use experience. It also allowed customers to upload pump data from the controller, and share that with a remote caregiver through a companion mobile app. For the first time, parents could see what was happening on their child’s Omnipod while the child was at school or playing with friends, which gave caregivers peace of mind when their child was in someone else’s care. This element of the design—focused on adults but for the benefit of pediatric patients highlights the comprehensive approach designers must take with these sophisticated systems.

Starting in 2018, development of Omnipod 5 (Gen 5) began, seeking to break through four additional barriers: 1) connecting Omnipod to a continuous glucose monitor; 2) adding intelligence to the pump to automatically adjust insulin based on glucose values and trends (turning Omnipod into what’s called “an automated insulin delivery system” or AID); 3) automatically uploading data for all users to the cloud via a SIM card; and 4) enabling control of Omnipod by a mobile phone. Once again, the User Experience team met with hundreds of customers to design the simplest possible experience.

As an automated insulin delivery system, Omnipod 5 required extensive clinical testing. I remember one study where we had young children and their parents at a house wearing prototype systems. The kids were eating and jumping—at the same time. Eating raises blood glucose levels while exercising lowers them. I wasn’t yet a parent, so I didn’t fully appreciate that this was normal—kids being kids. We learned a lot from these studies about the challenges and daily demands the system would need to accommodate. We adjusted and kept adjusting throughout clinical development. We ultimately launched Omnipod 5 in February 2022. The feedback from kids and parents/caregivers has been overwhelmingly positive.

Figure 1. Omnipod1 5 automated insulin delivery system. (Copyrighted image used with permission. © 2024 Insulet Corporation. All rights reserved. Insulet, Omnipod and Omnipod 5 are trademarks or registered trademarks of Insulet Corporation in the United States of America and other various jurisdictions and are used with permission.)

Revolutionizing diabetes management

In 2023, its first full year on the U.S. market, the Omnipod 5 AID System (Figure 1) became the most prescribed and most patient preferred system and still is today. It is FDA cleared and CE marked for people with type 1 diabetes ages two years and older. Omnipod 5 consists of two devices.

1. A small Pod (1.53 × 2.05 × 0.57 in.) that a user fills with up to 2 mL (or 200 units) of insulin and places on his/her body.
2. The Omnipod 5 App (installed on either an Insulet-provided controller or on a user’s compatible smartphone).

The Omnipod 5 AID System integrates with a compatible continuous glucose monitor (CGM) sensor. Options vary geographically and currently include Dexcom G6 and Dexcom G7 (Dexcom, San Diego, CA, USA) and the FreeStyle Libre 2 Plus (Abbott Diabetes Care, Alameda, CA, USA).

Both the Pod and the CGM sensor adhere to the body (Pod and sensor worn on same side so devices can “see” one another without body blocking communications, at least 1–3 inches apart depending on sensor) [10] and are in continuous communication with each other. Omnipod’s SmartAdjust technology uses a cutting-edge model predictive control algorithm to compute the insulin dose required by a user. The algorithm projects out 60 minutes where glucose levels are expected to be and automatically increases, decreases or pauses insulin every 5 minutes, based on the user’s customizable target glucose, aiming to help users’ glucose levels stay in range [11].

Users can see their glucose readings and control the system all from their fingertips with the Omnipod 5 App on the Insulet-provided controller or their own compatible smartphone.3

Also, the Omnipod 5 includes a SmartBolus calculator that can automatically incorporate a user’s CGM value and trend, making it quick and easy to calculate and deliver additional insulin (bolus) at mealtimes. Omnipod 5 is the only automated insulin delivery system with this built-in feature.

Cloud connectivity—game changer for therapy, continuous improvement, and innovation

Additionally, Omnipod 5 is connected to the cloud. This provides important benefits for users and their care teams. It also helps Insulet improve product design and customer experience.

One of the typical pain points for users and diabetes care teams is getting data off diabetes devices. With legacy systems, this required physically plugging a pump system into a terminal to download data, and uploading it to a data management platform. All handheld controllers provided by Insulet include a SIM card, which automatically uploads data to the cloud. When the Omnipod 5 App runs on a user’s mobile phone, data is also automatically uploaded. This simplifies office visits and enables easier remote consultations, which can be particularly helpful in the first few weeks after diagnosis.

Importantly, cloud connectivity may also be helping break down prescribing barriers. One of the challenges with legacy pump systems is that they were only prescribed by specialized centers with the expertise required to manage them. In early 2024, more than 20,000 prescribers were prescribing Omnipod, broadening the reach of this important technology.

Insulet also uses anonymized user data to improve and enhance features, improve the automated insulin delivery algorithm, and more. For example, we recently saw an opportunity to enhance the algorithm by adjusting two parameters and offering the opportunity to use a lower setpoint. This future innovation is currently being evaluated in clinical studies. The ability to analyze real world data from Omnipod 5 users contributes to a better user experience that helps Insulet simplify life for people with diabetes and their caregivers.

Form factor: Better design -> Greater useability = Improved efficacy

As noted earlier, dealing with a chronic disease is extremely challenging. It involves some 180 daily decisions, according to researchers [13]. The more burdensome the therapy (irrespective of disease), the less likely a person is going to stay on therapy. So, the connection between ease-of-use and efficacy is powerful and unusually clear in diabetes.

Thanks to the unique Omnipod form factor and the simplicity of Omnipod 5, the user experience is easier than multiple daily injections or tubed pump therapy. Accordingly, once people try Omnipod 5, they rarely go back [14], [15], [16], [17], [18].

Because users stay on therapy, outcomes are better. For people with diabetes, that means staying in range and lowering the incidence of diabetes distress [18], [19]. Omnipod 5 also demonstrated strong performance in clinical trials (Table 1).

Table 1. Omnipod 5 performance in clinical trials.

How can design changes like this be measured for their success in the pediatric population? Notably, for users ages 2–5.9, time in range increased from 57.2 to 68.1% or 2.6 hours per day. Users ages 6–13.9, time in range increased from 52.5% to 68.0% or 3.7 more hours per day [11], [12].

Living with a relentless disease like type 1 diabetes is difficult and can be overwhelming, especially for young children, adolescents, and their families. Any company that intends to succeed with their design here must deeply understand these challenges. Insulet is inspired to simplify life for people with diabetes and their loved ones, and this mission has led us to revolutionize diabetes management with the Omnipod Insulin Management System and flagship product Omnipod 5. A unique, tubeless, wearable, cloud-connected automated insulin delivery system, Omnipod 5 lessens the burden of living with type 1 diabetes and improves lives.

Reference

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