Type 2 diabetes affects nearly a quarter of all Department of Veterans Affairs patients and, with costs associated with the disease climbing, the VA is seeking innovative approaches to treat it.
Among the therapies being considered is a diet and coaching program from Virta Health -- one that combines a low-carbohydrate diet with online support that aims to reverse the disease.
Researchers with the San Francisco-based company say the approach is clinically proven. In one study, 238 of 262 patients who completed the first 10 weeks saw their A1C levels -- the marker that indicates diabetes -- drop by 1%. Their weight fell an average 7%, and their need for medication declined.
A year later, among the 218 patients still enrolled, insulin therapy had been reduced or eliminated in 94% of patients and no patients were taking drugs to lower blood glucose levels.
"We saw diabetes reversal in about 60 percent of people we treated in one year," Anand Parikh, Virta's head of finance, legal and human resources, told Military.com. "I can tell you that ... those results have been sustained after two years. We've seen 12% weight loss, and those results also have been sustained for two years. This is world-changing medicine."
The therapy, which combines a low-carbohydrate, or ketogenic, diet, with round-the-clock personal coaching, monitoring and support, seems so promising that the VA announced a partnership with Virta Health in May to provide treatment to 400 veterans.
With more than 1.5 million VA patients currently being treated for diabetes, the program offers "an approach currently not widely in use at VA," according to officials.
"Many veterans have Type 2 diabetes, and it is strongly linked to obesity, so we are excited to explore Virta Health's approach to tackling this debilitating and costly condition," said VA Secretary Robert Wilkie in a news release.
Those who enroll are promised care for up to one year at no cost to the VA or the veteran participants.
They receive a package of supplies, including a scale that sends data to the company, glucose meter, ketone strips for measuring the body's reaction to the low carb diet, swabs and a blood pressure cuff for some, and instructions on how to use the app that allows the company to monitor biomarker data and adjust advice and diet accordingly.
"For all individuals who are affected by diabetes, this individualized carbohydrate restriction, even if you cannot reverse diabetes for some individuals, like Type 1 diabetes, there is value in getting off the glucose roller coaster," Parikh said.
Still, some physicians and nutrition experts remain skeptical, saying the research presented by the company was not conducted by neutral parties, and the diet itself, which relies heavily on proteins and fats, may be dangerously unhealthy.
In a blog post in late 2017, cardiologist Dr. Joel Kahn, an author and proponent of plant-based -- vegan -- diets, pointed out that the studies supporting Virta Health were conducted by researchers with financial ties to the company or organizations with a vested interest in the program, including the National Dairy Council, the Palm Oil Board and Atkins Nutritionals, the company founded by Dr. Robert Atkins, one of the original proponents of a low-carb diet.
"The quality of this research program published in a e-journal not recognized as a leader, lacking a control group, experiencing a sizable drop-out rate even though of short duration, and having 100% authorship with financial conflicts is of concern," wrote Kahn on Medium.com.
Dr. Neal Barnard, author and president of the Physicians Committee for Responsible Medicine, voiced concerns about the program in a letter sent to Wilkie on April 26. Barnard, also a proponent of the vegan diet who has written several books, including one on reversing diabetes with a plant-based diet, said, "At best, this type of diet may act as a 'Band-Aid' for diabetes."
He argues that, while a ketogenic diet lowers a symptom of diabetes, high blood sugar, it "does not necessarily fix the root cause of the disease."
Barnard said that keto diets slash blood glucose but don't necessarily address fat buildup in muscle and the liver -- fat cells that disrupt insulin signaling. As a proponent of a plant-based diet, he said a low-fat, high-fiber diet can help get patients off insulin in as little as 16 days.
"A plant-based diet is powerful medicine for diabetes. Not only do people following a plant-based diet have a lower risk of diabetes in the first place, this style of eating can help people effectively manage and even reverse the disease," he wrote, adding that vegan diets also have been shown to reduce heart disease and are linked to reduced rates of cancer.
Parikh said criticisms from vegan proponents are unwarranted, since the Virta program can be tailored to any dietary lifestyle. He said that he himself is a patient -- and a vegetarian.
"We are, to a large extent, diet agnostic. We have people in our treatment who are vegans, and we have people who receive a predominant number of their calories from meat," he said. "Vegan, vegetarian, pescatarian, Mediterranean, religious restrictions. We really personalize people's therapy to food restrictions and lifestyles."
The Virta treatment is not easy: It provides less than 30 grams of carbohydrates a day (that's about the amount in one banana or a large apple) and 1.5 grams of protein for every kilogram of weight and fats to the point of feeling satisfied. It limits alcohol intake (something diabetic patients should be doing anyway), and it requires frequent testing and monitoring.
And for individuals outside the VA pilot, it can be expensive. While insurers and covered patients don't have to pay if they don't see results, those without insurance pay a one-time startup fee of $250 followed by $99 a month.
The company hopes its partnership with the VA will help move it toward its goal -- to reverse diabetes in 100 million people by 2025.
"It's particularly important in the veteran population," said Parihk, noting that Type 2 diabetes is more prevalent among veterans than the general civilian population. "It's something that actually can help everyone."
Veterans interested in the program should visit Virta Health.