Do-It-Yourself Diabetes Systems Bring Convenience—And Risk
Dana Lewis, pictured in Mount Vernon in 2017, worked with her engineer husband to design an artificial pancreas system to manage her type 1 diabetes.
For years, a continuous glucose monitor would beep at night if Dana Lewis' blood sugar measured too high or too low. At age 14, she was diagnosed with type 1 diabetes, an autoimmune disease that destroys insulin-producing cells in the pancreas.
The FDA just issued its first warning to the DIY diabetic community, after one patient suffered an accidental insulin overdose.
But being a sound sleeper, the Seattle-based independent researcher, now 30, feared not waking up. That concerned her most when she would run, after which her glucose dropped overnight. Now, she rarely needs a rousing reminder to alert her to out-of-range blood glucose levels.
That's because Lewis and her husband, Scott Leibrand, a network engineer, developed an artificial pancreas system—an algorithm that calculates adjustments to insulin delivery based on data from the continuous glucose monitor and her insulin pump. When the monitor gives a reading, she no longer needs to press a button. The algorithm tells the pump how much insulin to release while she's sleeping.
"Most of the time, it's preventing the frequent occurrences of high or low blood sugars automatically," Lewis explains.
Like other do-it-yourself device innovations, home-designed artificial pancreas systems are not approved by the Food and Drug Administration, so individual users assume any associated risks. Experts recommend that patients consult their doctor before adopting a new self-monitoring approach and to keep the clinician apprised of their progress.
DIY closed-loop systems can be uniquely challenging, according to the FDA. Patients may not fully comprehend how the devices are intended to work or they may fail to recognize the limitations. The systems have not been evaluated under quality control measures and pose risks of inappropriate dosing from the automated algorithm or potential incompatibility with a patient's other medications, says Stephanie Caccomo, an FDA spokeswoman.
Earlier this month, in fact, the FDA issued its first warning to the DIY diabetic community, which includes thousands of users, after one patient suffered an accidental insulin overdose.
Patients who built their own systems from scratch may be more well-versed in the operations, while those who are implementing unapproved designs created by others are less likely to be familiar with their intricacies, she says.
"Malfunctions or misuse of automated-insulin delivery systems can lead to acute complications of hypo- and hyperglycemia that may result in serious injury or death," Caccomo cautions. "FDA provides independent review of complex systems to assess the safety of these nontransparent devices, so that users do not have to be software/hardware designers to get the medical devices they need."
Only one hybrid closed-loop technology—the MiniMed 670G System from Minneapolis-based Medtronic—has been FDA-approved for type 1 use since September 2016. The term "hybrid" indicates that the system is not a fully automatic closed loop; it still requires minimal input from patients, including the need to enter mealtime carbohydrates, manage insulin dosage recommendations, and periodically calibrate the sensor.
Meanwhile, some tech-savvy people with type 1 diabetes have opted to design their own systems. About one-third of the DIY diabetes loopers are children whose parents have built them a closed system, according to Lewis' website.
Lewis began developing her system in 2014, well before Medtronic's device hit the market. "The choice to wait is not a luxury," she says, noting that "diabetes is inherently dangerous," whether an individual relies on a device to inject insulin or administers it with a syringe.
Hybrid closed-loop insulin delivery improves glucose control while decreasing the risk of low blood sugar in patients of various ages with less than optimally controlled type 1 diabetes, according to a study published in The Lancet last October. The multi-center randomized trial, conducted in the United Kingdom and the United States, spanned 12 weeks and included adults, adolescents, and children aged 6 years and older.
"We have compelling data attesting to the benefits of closed-loop systems," says Daniel Finan, research director at JDRF (formerly the Juvenile Diabetes Research Foundation) in New York, a global organization funding the study.
Medtronic's system costs between $6,000 and $9,000. However, end-user pricing varies based on an individual's health plan. It is covered by most insurers, according to the device manufacturer.
To give users more choice, in 2017 JDRF launched the Open Protocol Automated Insulin Delivery Systems initiative to collaborate with the FDA and experts in the do-it-yourself arena. The organization hopes to "forge a new regulatory paradigm," Finan says.
As diabetes management becomes more user-controlled, there is a need for better coordination. "We've had insulin pumps for a very long time, but having sensors that can detect blood sugars in real time is still a very new phenomenon," says Leslie Lam, interim chief in the division of pediatric endocrinology and diabetes at The Children's Hospital at Montefiore in the Bronx, N.Y.
"There's a lag in the integration of this technology," he adds. Innovators are indeed working to bring new products to market, "but on the consumer side, people want that to be here now instead of a year or two later."
The devices aren't foolproof, and mishaps can occur even with very accurate systems. For this reason, there is some reluctance to advocate for universal use in children with type 1 diabetes. Supervision by a parent, school nurse, and sometimes a coach would be a prudent precaution, Lam says.
People engage in "this work because they are either curious about it themselves or not getting the care they need from the health care system, or both."
Remaining aware of blood sugar levels and having a backup plan are essential. "People still need to know how to give injections the old-school way," he says.
To ensure readings are correct on Medtronic's device, users should check their blood sugar with traditional finger pricking at least five or six times per day—before every meal and whenever directed by the system, notes Elena Toschi, an endocrinologist and director of the Young Adult Clinic at Joslin Diabetes Center, an affiliate of Harvard Medical School.
"There can be pump failure and cross-talking failure," she cautions, urging patients not to stop being vigilant because they are using an automated device. "This is still something that can happen; it doesn't eliminate that."
While do-it-yourself devices help promote autonomy and offer convenience, the lack of clinical trial data makes it difficult for clinicians and patients to assess risks versus benefits, says Lisa Eckenwiler, an associate professor in the departments of philosophy and health administration and policy at George Mason University in Fairfax, Va.
"What are the responsibilities of physicians in that context to advise patients?" she questions. Some clinicians foresee the possibility that "down the road, if things go awry" with disease management, that could place them "in a moral quandary."
Whether it's controlling diabetes, obesity, heart disease or asthma, emerging technologies are having a major influence on individuals' abilities to stay on top of their health, says Camille Nebeker, an assistant professor in the School of Medicine at the University of California, San Diego, and founder and director of its Research Center for Optimal Data Ethics.
People engage in "this work because they are either curious about it themselves or not getting the care they need from the health care system, or both," she says. In "citizen science communities," they may partner in participant-led research while gaining access to scientific and technical expertise. Others "may go it alone in solo self-tracking studies or developing do-it-yourself technologies," which raises concerns about whether they are carefully considering potential risks and weighing them against possible benefits.
Dana Lewis admits that "using do-it-yourself systems might not be for everyone. But the advances made in the do-it-yourself community show what's possible for future commercial developments, and give a lot of hope for improved quality of life for those of us living with type 1 diabetes."
How sharing, hearing, and remembering positive stories can help shape our brains for the better
Across cultures and through millennia, human beings have always told stories. Whether it’s a group of boy scouts around a campfire sharing ghost stories or the paleolithic Cro-Magnons etching pictures of bison on cave walls, researchers believe that storytelling has been universal to human beings since the development of language.
But storytelling was more than just a way for our ancestors to pass the time. Researchers believe that storytelling served an important evolutionary purpose, helping humans learn empathy, share important information (such as where predators were or what berries were safe to eat), as well as strengthen social bonds. Quite literally, storytelling has made it possible for the human race to survive.
Today, neuroscientists are discovering that storytelling is just as important now as it was millions of years ago. Particularly in sharing positive stories, humans can more easily form relational bonds, develop a more flexible perspective, and actually grow new brain circuitry that helps us survive. Here’s how.
How sharing stories positively impacts the brain
When human beings share stories, it increases the levels of certain neurochemicals in the brain, neuroscientists have found. In a 2021 study published in Proceedings of the National Academy of Sciences (PNAS), Swedish researchers found that simply hearing a story could make hospitalized children feel better, compared to other hospitalized children who played a riddle game for the same amount of time. In their research, children in the intensive care unit who heard stories for just 30 minutes had higher levels of oxytocin, a hormone that promotes positive feelings and is linked to relaxation, trust, social connectedness, and overall psychological stability. Furthermore, the same children showed lower levels of cortisol, a hormone associated with stress. Afterward, the group of children who heard stories tended to describe their hospital experiences more positively, and even reported lower levels of pain.
Annie Brewster, MD, knows the positive effect of storytelling from personal experience. An assistant professor at Harvard Medical School and the author of The Healing Power of Storytelling: Using Personal Narrative to Navigate Illness, Trauma, and Loss, Brewster started sharing her personal experience with chronic illness after being diagnosed with multiple sclerosis in 2001. In doing so, Brewster says it has enabled her to accept her diagnosis and integrate it into her identity. Brewster believes so much in the power of hearing and sharing stories that in 2013 she founded Health Story Collaborative, a forum for others to share their mental and physical health challenges.“I wanted to hear stories of people who had found ways to move forward in positive ways, in spite of health challenges,” Brewster said. In doing so, Brewster believes people with chronic conditions can “move closer to self-acceptance and self-love.”
While hearing and sharing positive stories has been shown to increase oxytocin and other “feel good” chemicals, simply remembering a positive story has an effect on our brains as well. Mark Hoelterhoff, PhD, a lecturer in clinical psychology at the University of Edinburgh, recalling and “savoring” a positive story, thought, or feedback “begins to create new brain circuitry—a new neural network that’s geared toward looking for the positive,” he says. Over time, other research shows, savoring positive stories or thoughts can literally change the shape of your brain, hard-wiring someone to see things in a more positive light.How stories can change your behavior
In 2009, Paul Zak, PhD, a neuroscientist and professor at Claremont Graduate University, set out to measure how storytelling can actually change human behavior for the better. In his study, Zak wanted to measure the behavioral effects of oxytocin, and did this by showing test subjects two short video clips designed to elicit an emotional response.
In the first video they showed the study participants, a father spoke to the camera about his two-year-old son, Ben, who had been diagnosed with terminal brain cancer. The father told the audience that he struggled to connect with and enjoy Ben, as Ben had only a few months left to live. In the end, the father finds the strength to stay emotionally connected to his son until he dies.
The second video clip, however, was much less emotional. In that clip, the same father and son are shown spending the day at the zoo. Ben is only suggested to have cancer (he is bald from chemotherapy and referred to as a ‘miracle’, but the cancer isn’t mentioned directly). The second story lacked the dramatic narrative arc of the first video.
Zak’s team took blood before and after the participants watched one of the two videos and found that the first story increased the viewers’ cortisol and oxytocin, suggesting that they felt distress over the boy’s diagnosis and empathy toward the boy and his father. The second narrative, however, didn’t increase oxytocin or cortisol at all.
But Zak took the experiment a step further. After the movie clips, his team gave the study participants a chance to share money with a stranger in the lab. The participants who had an increase in cortisol and oxytocin were more likely to donate money generously. The participants who had increased cortisol and oxytocin were also more likely to donate money to a charity that works with children who are ill. Zak also found that the amount of oxytocin that was released was correlated with how much money people felt comfortable giving—in other words, the more oxytocin that was released, the more generous they felt, and the more money they donated.
How storytelling strengthens our bond with others
Sharing, hearing, and remembering stories can be a powerful tool for social change–not only in the way it changes our brain and our behavior, but also because it can positively affect our relationships with other people
Emotional stimulation from telling stories, writes Zak, is the foundation for empathy, and empathy strengthens our relationships with other people. “By knowing someone’s story—where they come from, what they do, and who you might know in common—relationships with strangers are formed.”
But why are these relationships important for humanity? Because human beings can use storytelling to build empathy and form relationships, it enables them to “engage in the kinds of large-scale cooperation that builds massive bridges and sends humans into space,” says Zak.
Storytelling, Zak found, and the oxytocin release that follows, also makes people more sensitive to social cues. This sensitivity not only motivates us to form relationships, but also to engage with other people and offer help, particularly if the other person seems to need help.
But as Zak found in his experiments, the type of storytelling matters when it comes to affecting relationships. Where Zak found that storytelling with a dramatic arc helps release oxytocin and cortisol, enabling people to feel more empathic and generous, other researchers have found that sharing happy stories allows for greater closeness between individuals and speakers. A group of Chinese researchers found that, compared to emotionally-neutral stories, happy stories were more “emotionally contagious.” Test subjects who heard happy stories had greater activation in certain areas of their brains, experienced more significant, positive changes in their mood, and felt a greater sense of closeness between themselves and the speaker.
“This finding suggests that when individuals are happy, they become less self-focused and then feel more intimate with others,” the authors of the study wrote. “Therefore, sharing happiness could strengthen interpersonal bonding.” The researchers went on to say that this could lead to developing better social networks, receiving more social support, and leading more successful social lives.
Since the start of the COVID pandemic, social isolation, loneliness, and resulting mental health issues have only gotten worse. In light of this, it’s safe to say that hearing, sharing, and remembering stories isn’t just something we can do for entertainment. Storytelling has always been central to the human experience, and now more than ever it’s become something crucial for our survival.
Want to know how you can reap the benefits of hearing happy stories? Keep an eye out for Upworthy’s first book, GOOD PEOPLE: Stories from the Best of Humanity, published by National Geographic/Disney, available on September 3, 2024. GOOD PEOPLE is a much-needed trove of life-affirming stories told straight from the heart. Handpicked from Upworthy’s community, these 101 stories speak to the breadth, depth, and beauty of the human experience, reminding us we have a lot more in common than we realize.
A new type of cancer therapy is shrinking deadly brain tumors with just one treatment
MRI scans after a new kind of immunotherapy for brain cancer show remarkable progress in one patient just days after the first treatment.
Few cancers are deadlier than glioblastomas—aggressive and lethal tumors that originate in the brain or spinal cord. Five years after diagnosis, less than five percent of glioblastoma patients are still alive—and more often, glioblastoma patients live just 14 months on average after receiving a diagnosis.
But an ongoing clinical trial at Mass General Cancer Center is giving new hope to glioblastoma patients and their families. The trial, called INCIPIENT, is meant to evaluate the effects of a special type of immune cell, called CAR-T cells, on patients with recurrent glioblastoma.
How CAR-T cell therapy works
CAR-T cell therapy is a type of cancer treatment called immunotherapy, where doctors modify a patient’s own immune system specifically to find and destroy cancer cells. In CAR-T cell therapy, doctors extract the patient’s T-cells, which are immune system cells that help fight off disease—particularly cancer. These T-cells are harvested from the patient and then genetically modified in a lab to produce proteins on their surface called chimeric antigen receptors (thus becoming CAR-T cells), which makes them able to bind to a specific protein on the patient’s cancer cells. Once modified, these CAR-T cells are grown in the lab for several weeks so that they can multiply into an army of millions. When enough cells have been grown, these super-charged T-cells are infused back into the patient where they can then seek out cancer cells, bind to them, and destroy them. CAR-T cell therapies have been approved by the US Food and Drug Administration (FDA) to treat certain types of lymphomas and leukemias, as well as multiple myeloma, but haven’t been approved to treat glioblastomas—yet.
CAR-T cell therapies don’t always work against solid tumors, such as glioblastomas. Because solid tumors contain different kinds of cancer cells, some cells can evade the immune system’s detection even after CAR-T cell therapy, according to a press release from Massachusetts General Hospital. For the INCIPIENT trial, researchers modified the CAR-T cells even further in hopes of making them more effective against solid tumors. These second-generation CAR-T cells (called CARv3-TEAM-E T cells) contain special antibodies that attack EFGR, a protein expressed in the majority of glioblastoma tumors. Unlike other CAR-T cell therapies, these particular CAR-T cells were designed to be directly injected into the patient’s brain.
The INCIPIENT trial results
The INCIPIENT trial involved three patients who were enrolled in the study between March and July 2023. All three patients—a 72-year-old man, a 74-year-old man, and a 57-year-old woman—were treated with chemo and radiation and enrolled in the trial with CAR-T cells after their glioblastoma tumors came back.
The results, which were published earlier this year in the New England Journal of Medicine (NEJM), were called “rapid” and “dramatic” by doctors involved in the trial. After just a single infusion of the CAR-T cells, each patient experienced a significant reduction in their tumor sizes. Just two days after receiving the infusion, the glioblastoma tumor of the 72-year-old man decreased by nearly twenty percent. Just two months later the tumor had shrunk by an astonishing 60 percent, and the change was maintained for more than six months. The most dramatic result was in the 57-year-old female patient, whose tumor shrank nearly completely after just one infusion of the CAR-T cells.
The results of the INCIPIENT trial were unexpected and astonishing—but unfortunately, they were also temporary. For all three patients, the tumors eventually began to grow back regardless of the CAR-T cell infusions. According to the press release from MGH, the medical team is now considering treating each patient with multiple infusions or prefacing each treatment with chemotherapy to prolong the response.
While there is still “more to do,” says co-author of the study neuro-oncologist Dr. Elizabeth Gerstner, the results are still promising. If nothing else, these second-generation CAR-T cell infusions may someday be able to give patients more time than traditional treatments would allow.
“These results are exciting but they are also just the beginning,” says Dr. Marcela Maus, a doctor and professor of medicine at Mass General who was involved in the clinical trial. “They tell us that we are on the right track in pursuing a therapy that has the potential to change the outlook for this intractable disease.”