The first thing Melinda Wedding thinks about when she wakes at 6:15 am is checking her daughter Carson's blood sugar to see if she needs another dose of insulin.
"Type 1 diabetes is constant," Wedding told me. "There's no downtime."
Throughout the day she might look at her watch, which gives her a reading of her daughter's blood sugar, up to 100 times. With that data comes hundreds of decisions about when Carson should eat and how to use her insulin pump. Every night, Wedding wakes up two or three times to check on her daughter's blood levels again.
If Carson misses a dose of insulin — and she sometimes does as she learns to manage her condition — her blood sugar will rise. Over time, that could lead to all sorts of adverse effects, from brain fogs and stomachaches to a coma or kidney failure.
You'd think that a new device called the "artificial pancreas" would be a godsend for someone like her. Designed to make insulin delivery less of a hassle by automating it, the MiniMed 670G by Medtronic was called "revolutionary" and a game changer after the Food and Drug Administration approved it in September.
But families like the Weddings say the device, slated to hit the market in spring 2017, has been incredibly overhyped.
For starters, it isn't a true artificial pancreas — it only automates the delivery of one type of insulin — and patients who use it still have to do a lot to manage their condition. "I hate [the name]," Wedding summed up. "It gives the connotation that the problem is solved, when it's far from solved."
The device also does nothing to fix one of the most pressing problems facing the 1 million people with Type 1 diabetes in America: The cost of insulin is skyrocketing so much that some patients are being forced to cut back on or skip lifesaving doses.
In response, doctors are turning to older, cheaper insulin formulations so patients can afford their medication. "We're trying to teach doctors to use insulins from the 1980s," said Irl Hirsch, a diabetes doctor and researcher at the University of Washington School of Medicine. "As we talk about moving forward with [the new artificial pancreas], the reality is we're going backward."
Having Type 1 diabetes means doing the work the pancreas can't do — manually
Let's pause for a quick review of Type 1 diabetes. In every human body, cells are fueled by glucose, the energy we need to live. To get that glucose, the digestive tract breaks down carbohydrates, such as pasta, candy, or bread. The glucose then travels into the bloodstream — but it needs the hormone insulin, made in the pancreas, to be able to move from the blood into cells.
With Type 1 diabetes, which affects about 5 percent of diabetics in the US, the immune system attacks the insulin-producing cells in the pancreas, leaving the body with little or none of the hormone. Unlike Type 2 diabetes, the onset of Type 1 has nothing to do with diet or lifestyle; its precise cause is still unknown. And it can't be managed with diet and exercise alone, as some cases of Type 2 diabetes can. So people with Type 1 rely on shots or infusions of insulin through needles or pumps.
Some diabetics also use a blood glucose device — like a continuous glucose monitor — to measure their blood sugar levels and figure out how much insulin they need. These devices come with warning systems so patients can tell when their glucose levels are too high or low. (Carson uses one — it's what her mother checks to stay on top of Carson's health.)
So essentially, managing Type 1 diabetes requires patients to continually attend to their blood sugar levels and respond with insulin accordingly. That's why for the past half-century, researchers have been on a quest to develop a device that would automate some of the work a diabetic's pancreas fails to do. They've called this holy grail the "artificial pancreas."
How the new Medtronic device tries to reduce the hassle
The Medtronic system is the first in the US market to come close to that holy grail. The device uses an FDA-approved computer algorithm to respond to feedback from a continuous blood glucose sensor and deliver insulin to the body automatically when it's needed.
Specifically, the system involves an insulin pump with a catheter that infuses the blood with insulin, as well as a glucose sensor. Both devices are typically inserted into the skin around the abdomen. The sensor continuously measures the patient's glucose levels and the pump delivers insulin based on the real-time needs of the user.
"This device is definitely an advance," said Thomas Donner, director of the Johns Hopkins Diabetes Center. According to a major paper on the MiniMed 670G, published in JAMA, patients who used the device for 12 weeks had improved control of their diabetes (better A1C levels, less glucose variability, and no severe low blood glucose or diabetic ketoacidosis, which is a severe complication of diabetes).
"But," Donner added, "this is an incremental advance."
That's because the device isn't actually fully automated.
There are two types of insulin in the body — basal and bolus — and the device only automates the delivery of basal insulin. Often called background insulin, basal is what helps power the body between meals. It keeps the blood sugar steady when people are not eating.
Bolus insulin is what's needed to even out blood glucose levels after a meal. To do the latter, diabetics need to count the amount of carbohydrates they eat and then calibrate their insulin doses to be able to take care of those carbs. With the new "artificial pancreas," patients still have to do that careful counting. They also need to prick their fingers several times a day to get a glucose reading and calibrate the glucose sensor on the device.
Patients also have to worry about pump and sensor errors, Donner said. Sometimes sensors misread blood glucose levels and dose inappropriately, or the technology can fail altogether. "Patients are dependent on these working all the time," he added. But they don't.
"This is not like we've cured diabetes — it is still a pain in the butt," said Stuart Weinzimer, a professor of pediatrics at the Yale University School of Medicine who helped develop the device. "But I would say every time we've had a new invention with diabetes before, we've given people better control of their disease at the cost of more work and more burden. This is the first time we've been able to make an advance in technology that will improve their overall life with diabetes — but with a little less burden and less hassle."
The American Diabetes Association, which has been advocating for better technology to alleviate some of the burden of the around-the-clock diabetes management, also called the device an incremental step. They are looking forward to a system that can provide both bolus and basal insulin "to provide optimal glucose control and independence for people with diabetes."
Many diabetics are skeptical of the new device
For some of the patients I spoke to, the new Medtronic device doesn't go far enough. They said it's too cumbersome and still requires a lot of vigilance on the part of patients. They also felt baffled by the references to the device as an "artificial pancreas."
"I think it's misleading," said Robert Vesco, a 37-year-old Type 1 diabetic who was diagnosed 10 years ago. "The idea of an artificial pancreas suggests something similar to an artificial heart … a fully autonomous device that requires no intervention from the patient. In contrast, this device requires lots of thinking about how much insulin to dose after a meal."
Melinda Wedding agreed. "You still have to do a lot of the mental calculations involved, so it's not fully automated and it's not alleviating a lot of the decisions we make to treat our daughter," she said.
Vesco is not interested in the device for another, more basic reason. Currently, he has to move his insulin pump around his belly every few days to avoid any scar tissue buildup that would hamper the delivery of insulin.
With the artificial pancreas, he'd have another device to poke into his already overtaxed body — a process that's always painful. "I don't think the gains you get [from the new device] are enough to justify sticking an additional thing in your body," he added. When he tried using a glucose sensor in the past, he found it too often delivered inaccurate results or "sometimes it just stopped working." So he's hesitant to rely on this newer technology.
Doctors are already hearing about these frustrations from their patients, said the University of Washington's Irl Hirsch. He believes the MiniMed 670G is a real advance — since the evidence suggests it can improve diabetes management — but he's been having trouble convincing patients of that. The reason: The glucose sensor errors from older devices have left some of his patients skeptical of the new system.
Patients face other obstacles, too, such as affordability and access. Tom Goffe, a patient in Raleigh, North Carolina, said he would be interested in trying the new device but his insurance would require him to wait another three years before being eligible for coverage. (Most insurance schemes mandate that patients only get coverage for a new device when the warranty on the old device runs out, and deductibles can be steep.) "It's like if you own a car; you can't trade in that car for a new one until the warranty expires," he said.
Medtronic hasn't released the price of the new device yet, and it's currently working with insurance payers to determine coverage for patients ahead of the 2017 launch. A Medtronic spokesperson said the manufacturer is offering a discount program for people who sign up early, and that it expects the device to cost between $6,000 and $9,000, based on a patient's payer and benefit plan.
That price may be too high for many diabetics, particularly folks over the age of 65, since Medicare currently doesn't cover continual glucose monitoring technology for this group. As Yale endocrinologist Kasia Lipska put it, "It's not just that the technology itself is not helpful. It might have a wider reach if it was affordable."
Meanwhile, the price of insulin is skyrocketing
If there's still a long way to go when it comes to improving the gadgets that help diabetics manage their condition, there's another even more basic challenge: The price of insulin, the drug used in these devices, has skyrocketed in recent years, making the lifesaving medication unreachable for some.
In the past few years, Sanofi, Eli Lilly, and Novo Nordisk — the three producers of insulin — have all raised their prices for the drug. The result is that while the US represents only 15 percent of the global insulin market, this country generates almost half of the revenue related to insulin.
As Lipska explained, companies justify the cost increases as the price tag that comes with innovation — creating more effective insulin formulations for patients. "The truth is the innovations have been incremental," she said. "These changes have had some benefits for patients. But they have also increased the cost of insulin hugely."
Jing Luo, a researcher at Brigham and Women's Hospital who has been studying insulin pricing trends, also doesn't find the "cost of innovation" argument very convincing. In his research, he says he's come across many examples of the same insulin products that have been continuously available for years without improvements, and yet their price tags have gone up at a much higher rate than inflation.
Instead, he views the story of insulin as yet another example — along with EpiPens and decades-old generic drugs — of companies raising the cost of their products because of the lax regulatory environment around drug pricing in the US. "They are doing it because they can," said Luo, "and it's scary because it happens in all kinds of different drugs and drug classes."
I asked Melinda Wedding what these soaring costs have meant for her family. She's been tracking the changing prices since her daughter was diagnosed:
While prices have surged, this hasn't affected her family directly. Wedding told me she considered herself lucky: With good insurance coverage, her copay hasn't changed much.
But others aren't quite as lucky, Lipska said. "I've been seeing an increasing number of patients over the past few years who are not able to afford their insulin, which is pretty crazy given that insulin has been around about 100 years."
Patients come in to see her, and she'll tell them that their blood sugars are not well-controlled and they need a higher dose of insulin. "Then I hear people say, 'I can't afford to buy more insulin at this point,' and I find out they have been going down on their doses."
She and other diabetes doctors like Hirsch have been advocating for the use of older, cheaper versions of insulin to help keep costs down for patients.
A long way to go before there's a true artificial pancreas — or a cure
While the MiniMed 670G is the first automated insulin delivery device on the market, other devices are in the pipeline — some with even more automation.
A number of the patients I spoke to were excited about the "bionic pancreas," out of Boston University and Massachusetts General Hospital. This device not only automates insulin delivery but can also deliver glucagon, a hormone that helps raise blood glucose levels when they're low. The device is still in clinical trials, but in theory, it would allow for more comprehensive control of blood sugars in patients.
A biotech startup called BigFoot is running clinical trails on its own automated system. Initially designed by a father for his Type 1 diabetic son, it's supposed to offer patients a highly sensitive and easy-to-use glucose sensor and pump and allow for remote monitoring, so, for example, parents would be alerted if anything notable happens with their kids' blood sugar. (Interestingly, the company is taking pains to tell patients the system is not an artificial pancreas.)
When I asked Wedding what she hopes for her daughter, she said, "In the short term, a tubeless closed loop system would be incredible." This would be an insulin pump that takes blood glucose information and tells the pump to raise or lower dosing on its own — no input required from the patient. Other patients spoke of an implantable pump and monitor that didn't need to be poked into their bellies every day.
"In the long term," Wedding added, "the best thing would be a cure."
Researchers are exploring immunotherapies for Type 1 diabetes that would reverse and restore the immune systems of Type 1 diabetes patients, so that they no longer attack the insulin-producing cells in the pancreas. They're also working on stem cell therapies that would implant patients with the insulin-making cells they lack. These therapies wouldn't require gadgets or insulin.
"At the moment, we don't have any grand slams," the Mayo Clinic's Yogish Kudva told me. So diabetics will have to wait, and hope they can afford the 100-year-old drug they rely on as insulin prices soar.