Living your life with type 1 diabetes
Pricking, measuring, injecting: this is everyday life for many people with type 1 diabetes. The autoimmune disease requires constant attention, frequent monitoring, and regular, precise insulin doses. This is because the consequences of too high or too low insulin levels can be life-threatening.
A father’s mission to simplify his son's diabetes care led to a breakthrough in insulin delivery.
- People with type 1 diabetes must constantly monitor blood sugar and administer precise insulin doses to avoid life-threatening complications.
- Ed Damiano developed the iLet Bionic Pancreas to simplify diabetes management for his son, achieving his goal after 20 years.
- The system uses SCHOTT Pharma’s cartridges for precise microdosing, automating insulin delivery.
- The iLet’s adaptive technology may help manage other hormonal disorders in the future.
When his son was diagnosed with diabetes as a baby, Ed Damiano, Professor of Biomedical Engineering at Boston University, came up with an ambitious plan: by the time David goes to university, he should no longer have to think about his illness. Twenty years later, his plan became a reality. With the iLet Bionic Pancreas System, which uses SCHOTT Pharma’s customized cartridges to enable precise microdosing, Ed not only developed an artificial pancreas – he laid the foundation for future automated therapies with sophisticated technology and components.
The young family's life changed abruptly. At just eleven months old, Ed and Toby Damiano's son David was diagnosed with type 1 diabetes. "The first thought was that the only difference between a nightmare and reality is that reality lasts longer. So it was a scary moment," Ed Damiano recalls. The doctors also had no experience in treating such a young child.
The responsibility of fine-tuning every insulin dose – knowing that small mistakes could be life-threatening – weighed heavily on him, making him anxious for his child's future. But not long after the early days of trial and error, Ed began exploring ways to develop, or at least contribute to, a technology that could automatically manage David's blood glucose levels, freeing him from constant worry about his condition.
This was a challenging task. Type 1 diabetes is an autoimmune disease in which the immune system attacks and destroys the insulin-producing beta cells in the pancreas. The hormone insulin plays a crucial role in energy metabolism by transporting glucose from the blood into the body's cells, where it serves as a source of energy. Without insulin, glucose remains in the blood, leading to increased blood sugar levels and dangerous long-term complications. The interplay between insulin and glucose is what makes the treatment of diabetes so difficult, as the levels can fluctuate greatly.
The night risk
For people with type 1 diabetes, resting at night poses particular risks. During sleep, there is the risk of one’s blood sugar level dropping unnoticed—a condition known as nocturnal hypoglycemia. As those affected often do not notice any warning signals such as trembling or sweating during sleep, severe hypoglycemia can have serious consequences and, in extreme cases, be life-threatening.
Ed and Toby remember all too well how worry-filled and nerve-wracking the first few nights of treatment were: "We checked David's blood sugar one to three times every night to make sure he was safe. If his blood sugar was high, we gave him insulin; if it was too low, we gave him juice. He slept through it all and didn't even wake up when we gave him the juice." The little boy learned early on how complex life with diabetes can be.
Prick, measure, hope
Manually measuring blood glucose levels often requires several daily injections.
Historically, patients had to manually measure their blood glucose levels and dose the insulin accordingly, often requiring several daily injections. This type of therapy is undoubtedly challenging as many factors – such as diet, exercise, and stress – have an unpredictable influence on blood glucose levels.
To that end, the correct insulin dosage is one of the biggest challenges in everyday life for people with type 1 diabetes. Finding the balance so that the blood sugar level remains in the optimal range – the so-called "time in range"– is crucial. However, achieving this balance requires experience and constant attention. Errors in dosage can quickly lead to low blood sugar levels (hypoglycemia), or high blood sugar levels (hyperglycemia).
What is type 1 diabetes?
- Type 1 diabetes is an autoimmune disease in which the immune system destroys the insulin-producing cells of the pancreas, resulting in the body’s inability to produce its own insulin..
- The disease often occurs in childhood or adolescence and is incurable. Almost nine million people are affected worldwide..
- Typical symptoms include severe thirst, frequent urination, sudden weight loss and fatigue..
- Without insulin, the body cannot regulate blood sugar, which can lead to serious complications such as ketoacidosis and organ failure if left untreated..
- Treatment requires lifelong insulin therapy, either through injections or insulin pumps, as well as continuous blood glucose monitoring..
- Complications of poor blood sugar control can include long-term cardiovascular disease, kidney damage and blindness..
- The disease presents sufferers with daily challenges, as factors such as diet, exercise and stress constantly influence insulin requirements..
- Type 2 diabetes usually develops in adulthood and is often associated with obesity and lack of exercise. Although the body continues to produce insulin, the cells can no longer use the hormone effectively (insulin resistance). It is not an autoimmune disease like type 1 diabetes.
If blood sugar levels are too high, there is a risk of long-term damage to organs, blood vessels, and nerves. Conversely, low levels can not only result in serious health consequences, it can also be life-threatening. As Ed and Toby can attest, a drop in blood sugar is particularly dangerous at night when the risk of undetected hypoglycemia increases. This is why many diabetics measure their blood sugar several times a day and have to make constant adjustments. The psychological strain can be immense: depressive disorders are twice as common in diabetes patients as in people without diabetes.
"Breakthrough Device" with revolutionizing potential
Ed Damiano did not want to accept the inevitability of the autoimmune disease. Fortunately, he was perfectly positioned to make a lasting difference in the lives of people with type 1 diabetes. As a professor of biomedical engineering at Boston University, he is an expert in both biomedicine and engineering, and he had a unique combination: personal involvement and technical expertise to develop a new system that goes far beyond existing technologies. His goal was an artificial pancreas that automatically doses insulin and glucagon, making daily life safer and easier for those affected, with the potential to revolutionize type 1 diabetes management.
Many patients currently use continuous glucose monitoring systems (CGMs), which measure blood glucose in real time and sound an alarm when critical values are reached. The sensors are usually inserted under the skin and send data continuously, allowing patients to quickly recognize whether their blood glucose level is in the optimal range.
However, CGMs require regular calibration and only measure blood glucose indirectly via the tissue fluid, which can lead to slight deviations. Patients can, for example, indicate how many calories their meal contained or how intensive their sports training was to help determine the values. However, even after years of experience with the disease, these are only estimates.
With paternal love to innovator
Ed Damiano is the co-founder of Beta Bionics. Founded in 2015, the US company, "...which puts people first and serves the entire diabetes community," is based in Irvine, California, and employs around 250 people. Driven by his son, who was diagnosed with type 1 diabetes at 11 months old, Ed is passionate about researching and developing a bihormonal bionic pancreas.Ed has been a Professor of Biomedical Engineering at Boston University since 2004. Prior to that, he was an Assistant Professor of Mechanical Engineering at the University of Illinois. Ed holds a doctorate in applied mechanics and a bachelor's degree in biomedical engineering from Rensselaer Polytechnic Institute, as well as a master's degree in mechanical engineering from Washington University in St. Louis.
Patients also use insulin pumps, which are more precise than syringes, but there is still a risk of hypoglycemia or hyperglycemia as the dose is not fully automated. Although many patients find these devices to be a relief, constant self-monitoring and manual intervention remain an integral part of everyday life.
"What we needed was a new tool," Ed summarizes. So he founded Beta Bionics to develop it. Motivated by the unconditional desire to enable his son to lead a carefree life despite his diabetes, Ed presented the medical world with the iLet Bionic Pancreas, a new medical device, in 2019. This device was intended to eliminate all the weaknesses of existing solutions completely autonomously—a system that even received the rare "Breakthrough Device" award from the US Food and Drug Administration in the same year.
Making life easier
The iLet is a compact, pocket-sized touchscreen device, slightly smaller than an iPhone but about twice as thick.
Instead of relying on manual calculations and interventions, three adaptive closed loop algorithms control 100% of the insulin in real time without patients having to enter calorie values, carbs, workouts, or similar information. Only the body weight has to be entered once at the beginning. The Beta Bionics team developed three algorithms that not only calculate the insulin requirements, but also learn how the patient lives. Over time the iLet can adapt the dosage to the patient’s lifestyle, thus achieving hormone levels in the desired range for longer periods, and more often.
A real breakthrough, as Ed explains: "Most patients are rarely in the optimal glucose level window. The iLet solves this problem by continuously measuring glucose levels and responding immediately. The iLet gives people spontaneity again—they can eat and exercise without having to constantly worry about their blood glucose levels."
Using the iLet requires patients to complete just a few simple steps. Depending on the brand of insulin that the user is prescribed, Beta Bionics sends them a set with empty cartridges and tubes for replacement. Patients can then purchase insulin from a pharmacy and fill the vials themselves. After filling, the cartridge is inserted into the iLet for automatic delivery.
How often the cartridge needs to be changed depends on the individual's insulin requirement, which is determined by body weight and other factors. On average, adults need about 3 milliliters of insulin per week, which corresponds to one cartridge—about 52 cartridges per year. The glass containers are disposable products that can be discarded of after use.
But the iLet is more than just another insulin pump. The automated calculation and delivery of potentially both essential hormones make the device a kind of “bionic pancreas,” as Ed himself refers to it. "The Bionic Pancreas is not a cure for diabetes,” he says, “but it is a bridge to it."
A vision that moves
Ed’s collaboration with SCHOTT Pharma proved crucial to this medical breakthrough. Although his company was initially a small start-up and the project itself seemed risky, SCHOTT Pharma provided support from the very beginning. Ed's vision and his son's personal story were key motivators. "This story really grabbed us at the time," explains Dominique Bauert, Vice President - Head of Sterile Solutions at SCHOTT Pharma. "When Ed Damiano contacted us, the company consisted of just one person—himself."
The mission to create a better life for his son and other people with type 1 diabetes was worth supporting, despite business uncertainty. "I was sitting in his office at the time, and he told me that he was doing this for his son and said: 'I want him to be able to go to university without having to inject insulin every day. My goal in life is to develop a fully functioning solution.' I found that very touching," Dominique recalls of the partnership that began around 2016.
One major challenge for SCHOTT Pharma was customizing product components to fit Beta Bionics' manufacturing processes and adapting SCHOTT's production capabilities to manufacture it. Another was configuring and developing a novel product in parallel to meet sensitive customer requirements.
Project manager for SCHOTT Pharma Arthur Hackbart describes the technical challenges: "We developed a special production setup that included equipment and processes for washing, siliconizing, and crimping the small cartridges that fit into a handy pump device,” he explains. “In particular, a new sophisticated silicone surface and a process to apply it had to be developed and tested to meet the specifications for reduced friction between the plunger and the glass barrel. This enables precise micro-dispensing via plunger movement."
From there, Arthur explains that the team had to challenge and adjust the processes to produce cartridges reliably and in large quantities. “The quality level must be consistently high,” he says. “Adapting the production line to the customer-specific format, washing, and siliconizing the cartridges—all of this is part of the process technology that we developed."
Next milestone: Dual hormone device
iLet users say that they feel more “freedom from their diabetes” by using the insulin-only iLet. The iLet has been approved in the United States since 2023, and is already used by more than 15,000 – but so far only in the U.S.
The next device will be different – it will use insulin and a form of glucagon. Already tested in a clinical trial, the bi-hormonal bionic pancreas can be fitted with two small pumps and thin tubes that deliver insulin and glucagon into the body in parallel. The two tubes are connected to catheters under the skin, through which deliver the hormones directly into the tissue. "This system can contain both insulin and glucagon, the hormones that regulate blood sugar levels, and it automatically doses them according to the body's needs," Ed says proudly. A partnership with Xeris was launched this year to offer glucagon cartridges soon.
In fact, the iLet is the first device for diabetics that can potentially administer both hormones — and the only one that works completely autonomously. However, it is important to note that the dual hormone iLet is not yet available to patients. It has been used in a clinical trial and is still being tested. The dual hormone system must be submitted to the FDA for approval before it can be made commercially available.
In the future, the potential of this technology may not be limited to improving the lives of diabetics. The adaptive algorithm technology and dual-hormone dosing system could be used in the future for other hormonal diseases that require precise and continuous hormone regulation. In other words, the iLet is a versatile solution in the field of medical technology, one that has the potential to not only support people with diabetes, but those with other chronic diseases as well.
For Ed Damiano, however, this outlook is only part of the Beta Bionics success story. After all, he has never lost sight of his most important goal: "What started as a hobby grew into a research project, and finally into the idea of developing an automated system for blood glucose control—a bionic pancreas—that can take care of David when he goes to college," he says. With the iLet, Ed has achieved this goal.
