The Long, Long Wait for a Diabetes Cure

I wrote about producer (and T1Der) Lisa Hepner’s new documentary, The Human Trial, when it premiered last month. Yesterday The NY Times ran this beautiful article. I’m posting it below if you can’t use the link.

A documentary captures the desperation and frustration of Type 1 diabetes patients in a clinical trial.

Published Aug. 9, 2022Updated Aug. 10, 2022

Lisa Hepner produced and directed the documentary “The Human Trial” with her husband, Guy Mossman, about people taking part in a clinical trial to treat Type 1 diabetes.
Lisa Hepner produced and directed the documentary “The Human Trial” with her husband, Guy Mossman, about people taking part in a clinical trial to treat Type 1 diabetes.Alex Welsh for The New York Times

Lisa Hepner produced and directed the documentary “The Human Trial” with her husband, Guy Mossman, about people taking part in a clinical trial to treat Type 1 diabetes.Alex Welsh for The New York Times

In the three decades since she was first diagnosed with Type 1 diabetes, Lisa Hepner has clung to a vague promise she often heard from doctors convinced medical science was on the cusp of making her body whole again. “Stay strong,” they would say. “A cure is just five years away.”

But the cure has yet to arrive, and Ms. Hepner, 51, a filmmaker from Los Angeles, remains hobbled by her body’s inability to make insulin, the sugar-regulating hormone produced by the pancreas. “I might look fine to you,” she said, “but I feel crappy 70 percent of the time.”

Staying healthy can be exhausting for many of the 37 million Americans with some form of diabetes. There’s the round-the-clock monitoring of sugar levels; the constant, life-sustaining insulin injections; and the potential threats from diabetes’ diabolical complications: heart disease, blindness, kidney damage and the possibility of losing a gangrenous limb to amputation.

“‘The cure is five years away’ has become a joke in the diabetes community,” Ms. Hepner said. “If it’s so close, then what’s taking so long? And in the meantime, millions of us have died.”

That attenuated sense of hope drove Ms. Hepner to spend nearly a decade following the fortunes of ViaCyte, a small San Diego biotech company working to create what would essentially be an artificial pancreas. If successful, its stem-cell-derived therapy would eliminate the pin-pricks and insulin injections that circumscribe the lives of the 1.5 million Americans with Type 1 diabetes. Vertex Pharmaceuticals, a Boston biotech company developing a similar therapy, has already made significant headway.

Since its theatrical debut in June, “The Human Trial,” the documentary she produced with her husband, Guy Mossman, has electrified the diabetes community, especially those with Type 1, a disease that the uninitiated often conflate with the more common Type 2.

Unlike Type 2, which tends to emerge slowly in adulthood and can sometimes be reversed early on with exercise and dietary changes, Type 1 is an autoimmune disease that often strikes without warning in childhood or adolescence.

Type 1 is also far less prevalent, affecting roughly 10 percent of those with diabetes. A pancreas transplant can cure the disease, but donated organs are in short supply and the surgery carries substantial risks. In most years, only a thousand transplants are done in the United States. To ensure the body does not reject the implanted pancreas, recipients must take immunosuppressant drugs all their lives, making them more susceptible to infections.

Maren Badger, one of the first patients to have experimental cell colonies implanted under her skin, in a scene from the film.
Maren Badger, one of the first patients to have experimental cell colonies implanted under her skin, in a scene from the film.Abramorama

Therapies developed from human embryonic stem cells, many experts say, offer the best hope for a lasting cure. “The Human Trial” offers a rare glimpse into the complexities and challenges of developing new therapies — both for the patients who volunteer for the grueling clinical trials required by the Food and Drug Administration, and for the ViaCyte executives constantly scrambling to raise the money needed to bring a new drug to market. These days, the average cost, including the many failed trials along the way, is a billion dollars.

At a time when the soaring price of insulin and other life-sustaining drugs has tarnished public perceptions of the pharmaceutical industry, the film is also noteworthy for its admiring portrayal of a biotech company whose executives and employees appear genuinely committed to helping humanity. (Limiting the cost of insulin remains politically volatile. On Sunday, during a marathon vote on the Democrats’ climate and health bill, Republicans forced the removal of a provision with a $35 cap on insulin prices for patients with private insurance, though the cap remained in place for Medicare patients.)

“The Human Trial,” which can also be viewed online, has become a rallying cry for Type 1 patients, many of whom believe only greater visibility can unleash the research dollars needed to find a cure.

Those who have seen the film have also been fortified by seeing their own struggles and dashed hopes reflected in the journeys of the film’s two main subjects, Greg Romero and Maren Badger, who became among the first patients to have the experimental cell pouches implanted under their skin.

The despair that drives them to become human guinea pigs can be hard to watch. Mr. Romero — whose father also had the disease, went blind before he was 30 and then died prematurely — confronts his own failing vision while grappling with the pain of diabetes-related nerve damage. “I hate insulin needles, I hate the smell of insulin. I just want this disease to go away,” Mr. Romero, 48, says numbly at one point in the film.

Type 1 can leave patients feeling alienated and alone, in part because of flawed assumptions about the disease. Tim Hone, 30, a medical writer in New York who has been living with Type 1 since he was 15, said friends and acquaintances sometimes suggested that he was responsible for causing his illness. “I’ve had people scold me and say that if I went on a diet and stopped eating Snickers bars I could reverse my disease,” Mr. Hone said.

The stigma often drives people with Type 1 to hide the disease. In his quest to feel “normal” at college, Todd Boudreaux said, he avoided telling friends about his illness, a decision that could have had dangerous ramifications in the event of a seizure brought on by low blood sugar levels.

Greg Romero, one of the subjects in the documentary. “I hate insulin needles, I hate the smell of insulin. I just want this disease to go away,” he said.
Greg Romero, one of the subjects in the documentary. “I hate insulin needles, I hate the smell of insulin. I just want this disease to go away,” he said.Abramorama

“I didn’t want to be defined by my illness, and I didn’t want to be seen as weak, but having Type 1 does make you different and it’s important that everyone around knows so they can help if you have severe low blood sugar,” said Mr. Boudreaux, 35, who lives in Monterey, Calif., and works for the nonprofit group Beyond Type 1.

Ms. Hepner, too, has spent much of her life downplaying the disease, even with her husband, Mr. Mossman. She recalled his confusion early in their relationship when he awoke to find her discombobulated and drenched in sweat, the result of hypoglycemia, or low blood sugar. The more Mr. Mossman, a cinematographer, learned about the disease, the more he pressed her to make the film.

For years, Ms. Hepner stood her ground, worried about drawing unwanted attention to her health. “It’s a competitive world out there and I just didn’t want people to think, ‘Oh, she’s not thinking straight because her blood sugar is high,’” she said.

But over time, the ubiquity of pink-ribbon breast cancer awareness campaigns and highly publicized efforts to cure Alzheimer’s made Ms. Hepner realize her filmmaking skills could change public perceptions of Type 1, a disease that is nearly invisible, in part because many people who have it do not look sick.

She hopes to change other misperceptions, including the notion that diabetes is a relatively inconsequential and “manageable” illness, one that has been popularized by Big Pharma’s feel-good drug television commercials that feature self-assured patients playing tennis and basketball and piloting hot air balloons.

In fact, the industry spends a fraction of its research dollars on finding a cure, with the rest directed toward developing medications and devices that make it easier to live with the disease, according to the Juvenile Diabetes Cure Alliance.

The payoff from those investments is undeniable. For those who can afford them, continuous glucose-monitoring devices can obviate the need for self-administered finger-prick testing, and the machines can be paired with iPhone-size insulin pumps that eliminate much of the guesswork over dosing.

Ms. Hepner with her son Jack in a scene from the film. “We need to stop trying to normalize this disease because, let’s face it, having diabetes isn’t normal,” she said.
Ms. Hepner with her son Jack in a scene from the film. “We need to stop trying to normalize this disease because, let’s face it, having diabetes isn’t normal,” she said.Abramorama

Ms. Hepner has profound appreciation for the wonders of insulin: At one point in the film she pays homage to its inventor, Frederick Banting, during a visit to his home in Canada. But she notes that insulin-dependent diabetes is no picnic. Many people without insurance cannot afford the thousands of dollars it costs annually for the drug, forcing some to skimp and ration. And a miscalculated or ill-timed dose can lead to seizures, unconsciousness and even death. Even with all the advances in care, only about 20 percent of adults with Type 1 are able to maintain healthy blood sugar levels, according to a 2019 study. On one occasion, Ms. Hepner woke up in the I.C.U. after her insulin pump failed.

“We need to stop trying to normalize this disease because, let’s face it, having diabetes isn’t normal,” she said. “It’s the other pandemic, one that killed 6.7 million people last year around the world.”

Despite her frustrations, it would be inaccurate to describe Mr. Hepner and her film as pessimistic. At the risk of giving away too much, “The Human Trial” ends on a hopeful note. And despite a number of near-brushes with bankruptcy, ViaCyte succeeded in gaining the funding to keep the laboratory lights burning.

Then there is more recent news that did not make it into the film. Last month, ViaCyte was acquired by Vertex, the competing biotech company that has been developing its own stem-cell treatment. That treatment has shown early success, and last year the company announced that a retired postal worker who took part in clinical trials had been cured of Type 1 diabetes.

After almost a lifetime of hearing a cure was just around the corner, Dr. Aaron Kowalski, chief executive of the JDRF (Juvenile Diabetes Research Foundation), the world’s biggest funder of Type 1 research, counts himself as an optimist. A dozen more drug companies are pursuing a cure than a decade ago, he said, and the organization this year plans to spend $100 million on cure research. “It’s not a matter of if this will happen, it’s a matter of when,” said Dr. Kowalski, who is a scientist and has had the disease since childhood, as has a younger brother. “Our job is to make sure it happens faster.”

Until that day, he added, people with diabetes, both Type 1 and Type 2, could use a little empathy and understanding.

I can’t control my blood sugar!

This was my blood sugar overnight the other night. Beautiful. Oh, how I wish I could wake up to see this each morning. Yet, this is not usually the case. Some mornings it’s rising like a torpedo, and it could start at 3 or 4 am if that’s when I first awaken during the night.

There is no cause for this beautiful line. It is food, insulin, exercise, mood, stress level, and who knows what else all coming together to create it. Since I eat and exercise similarly, it should look like this every night. But it doesn’t. All to say, you cannot “control” blood sugar.

Still, I thought it pretty enough to post.

Cheaper insulin coming if you’re on Medicare

Seems as though we’ve been hearing about it forever, but it looks like capping insulin at $35/month is about to become true for people on Medicare. The Democrats budget reconciliation package passed the Senate and is off to the Democratic-controlled House for approval.

The bill empowers Medicare to negotiate prices for certain costly medications including insulin. The bill also redesigns Medicare’s Part D drug plans so seniors wouldn’t pay more than $2,000/year for medications bought at the pharmacy. For more details, check here.

Unfortunately, although Democrats put into the bill a cap on insulin at $35/month for those on private insurance as well, Republicans took it out of the bill. For more details on the bill, you can take a look at “What’s in the Manchin-Schumer deal on climate, health care and taxes.”

Lilly’s historic hypoglycemia emergency kit bites the dust

Now that it’s been about a year or so that two new glucagon emergency delivery systems have graced pharmacy shelves (Baqsimi and Gvoke HypoPen), Lilly’s familiar orange Glucagon Emergency kit has gone the way of black and white TVs and record players. Kaput.

Remarkably, in 50 years with type 1 diabetes, I have never used a glucagon rescue product. Somehow, gratefully, I’ve always been able to catch my descending lows while I can still chew and swallow. That said, it’s nice to know we have much easier rescue products should I, or you, ever need one.

Still, it’s historic to say goodbye to a diabetes product that’s been around for so long. And, that’s the good news. More has progressed in the last decade in medicine and devices than the 40 years before it. And for that, I’m eternally grateful.

diaTribe carries the full story, “As Glucagon Options Expand, Lilly Discontinues Emergency Kit.”

Be still my heart, T1D gets recognized

I know it’s been a while my friends. I’ve had a lot going on placing my mom in an assisted living community at the age of 92.

But my friend sent me this photo she took while driving down the road in North Carolina, “Spotted in Topsail Island North Carolina! We honked.”

Nice to be reminded we are not alone.

The Human Trial, a film about the sixth ever embryonic stem cell trial for T1D, out this week

Just got a note from Lisa Hepner, that the film is being shown on Facebook live today (Thursday), 5 pm PT, 8 pm ET. Also featuring an exclusive post-screening panel discussion with the filmmakers and participants.

The presentation of this film is free and accessible to audiences in the US and Canada.

Panel participants include (next time you join this panel !)

Lisa Hepner | Director, Producer

Greg Romero | Film Participant, Patient 2: University of Minnesota

Esther Krofah | Executive Director, Faster Cures, The Milken Institute

Alecia Wesner | Host, Healthy By Design Podcast, Diabetes Advocate

Moderated by Moira McCarthy | Author, Speaker, D-Mom

The Human Trial is a documentary by filmmakers Lisa Hepner, who has type 1 diabetes, and her husband, Guy Mossman. I know Lisa and I know how invested her heart has been in this film for the more than a decade she and Guy have been creating it.

The film follows a handful of people with diabetes who volunteer for a stem cell trial run by Viacyte to cure type 1. Along the way you realize what goes into a trial, the impact it has on those participating and whether or not we really can hope for a cure.

This week, it will be shown in these theaters across the country:

NADI is the natural low carb, low cal delicious drink you need to try

NADI Founder and CEO, Nina Tickaradze, with her kids

The NADI line of “juices” and apple chips is a family operation hiding in plain sight.

Let me start by saying I don’t drink juice and this NADI Wild Rosehip Original juice is not only delicious, but also nutritious, due to what’s in it – rosehips, water and stevia – and what isn’t, anything else.

Juice to me is medicine, 1/2 a glass if I’m having a low. And I don’t drink soda. Regular and diet are both too sweet. My beverages are mostly water, coffee, tea, wine and occasional hot cocoa I make myself.

So I was amazed when I fell in love with this drink. I tripped over it when it was spotlighted on the food and supplements website, Vitacost, only to be frustrated, after I tasted it, that I couldn’t get more. So I contacted NADI’s founder, Nina Tickaradze.

Nina told me they were waiting on more production. Meanwhile I invited her to share the story of how this juice came to be, part of that story includes a social enterprise that offers economic opportunities to refugees from Nina’s home country of Georgia.

All three NADI juices are available by the dozen on their website and you can also see if they’re available in individual bottles at shops near you.

Guest post by Nina Tickaradze, Founder & CEO of NADI

“One of the things many people with Type 1 diabetes miss is having fruit juices in their diets. Most fruit juices have a lot of sugar and carbohydrates, which can lead to unhealthy blood sugar spikes, fatigue and other problems.

Even so-called “healthy” juices that don’t contain added sugar still have high amounts of naturally occurring sugar from the fruits they are made from. As people with hypoglycemia know, one of the best instant fixes for low blood sugar is to drink some apple or orange juice because the sugar goes into their bloodstream almost immediately.

People with diabetes often avoid fruit juices and miss out on the healthy natural vitamins, minerals, antioxidants and other nutrients that are in fruit juices. But NADI Wild Rosehip Original organic fruit juice is low in sugar and carbs so it is a perfect treat for anyone, including anyone with diabetes. It has ZERO sugar, only 2.46 grams of carbohydrates, and just 8 calories per 10-ounce bottle.

Our Wild Rosehip juice is the first and only USDA certified organic rosehip juice in the United States, and it’s made with just three ingredients — filtered water, wild grown organic rosehips that are handpicked, and a tiny bit of organic stevia to round out the flavor. The flavor is pleasantly tart and has dark fruit notes that are plummy and complex.

Rosehips are one of the best naturally occurring sources of Vitamin C, according to the U.S. Department of Agriculture, and can have 20 to 40 times more Vitamin C by weight than citrus fruits like oranges and lemons. They’re also high in antioxidants, polyphenols, bioflavonoids, Vitamin A, Vitamin K, lycopene and many other nutrients.

For centuries, ancient healers used rosehips to promote heart health, blood circulation, soothe upset stomachs and promote wound healing, and there have been numerous clinical trials and studies by the U.S. National Institutes of Health that demonstrate broad benefits of rosehips and potential treatment applications for people who have diabetes, inflammatory disorders, arthritis, obesity and cancer. Rosehip oil is often used for wound and scar healing, and in face creams and lotions.

During World War II, government officials in the United Kingdom encouraged people to forage for wild rosehips and make tonics and syrups to prevent Vitamin C deficiency and scurvy during blockades that prevented fresh citrus from being imported. 

At NADI, we’re advocates for sustainable growing and harvesting techniques, which is why we use rosehips that grow wild and are hand-harvested from rose bushes that grow in the forests of the Caucasus Mountains in the country of Georgia.

NADI is also a social enterprise. We’re proud to create jobs and economic opportunities for refugees who have been displaced by war and had to leave their homes and all their possessions behind when they fled from regional violence. Every purchase of NADI helps refugees learn new skills, raise their families, rebuild their lives and plant the seeds for future generations.

About Nina:

Nina Tickaradze is the Founder & CEO of NADI, LLC, which makes NADI rosehip juices and Happy Hearts dried apple chips. She is originally from the country of Georgia, and immigrated to the state of Georgia in the United States when she was a teenager. In addition to raising her three children, working a day job at a professional services firm and growing NADI, Nina is also the founder of the nonprofit Georgia to Georgia Foundation that promotes cultural and business ties between the two Georgias and she helped establish the Atlanta-Tbilisi Sister City Committee.

Note: I am not being compensated to share this information.

Freestyle Libre version 3

While I use Dexcom G6 and am awaiting G7, hopefully by the end of the year, Freestyle Libre by Abbott is a very strong competitor, and its third iteration has just received FDA approval.

That means those who prefer Freestyle will soon have the world’s smallest, thinnest (pictured above) and very accurate glucose monitor that goes for 14 days. Ain’t nothing wrong with that.

Like Dexcom you can see your readings on a smart phone. Unlike Dexcom, which gives 5 minute readings, Freestyle shows readings every minute. It also claims to have a sub-8% MARD. All I really know is that means it’s pretty darn accurate. It also has alarms and an easy applicator.

At one third the price of competitors, I’d advocate getting one whether you have diabetes or not. I have found that when someone without diabetes wears a glucose monitor, they’re shocked to see how food and exercise affect their blood sugar.

The husband, who doesn’t have diabetes, when wearing my Dexcom for a week, couldn’t get over how his blood sugar rocketed after eating potatoes. This idea that people without diabetes have steady blood sugars all the time is just wrong.

If you want to know more, here’s the press release. Also here’s a review of Dexcom and Freestyle Libre 3 by my friend and expert Scott Strumello over at Scott’s Web Log where he examines diabetes issues in depth. Thank you Scott.

A new study regards healthcare and living long with T1D

Out to dinner with the husband. Notice the syringe and wine cork. Sort of says everything 😉

Day to day diabetes can have its own mind; certainly I recognize patterns, but sometimes I have no idea why my blood sugar is doing what it is doing.

I don’t really worry about this, I know enough to get through it, make a few guesses, ask my endo if necessary, and at some point it all settles down.

That said, I can tell you quite honestly, I do have some uneasy feelings about the future. At 68 years old now, how will it be when I’m 80? What will happen if I start losing my faculties?

So, I was delighted to discover there is a movement to shine a light on those of us living a long time with diabetes, particularly type 1.

The good news is we didn’t used to, so I guess I have to accept that, for now, as my blessing.

Here’s the study I just read about how healthcare can make it easier for us who live into our senior years with type 1 diabetes.