Don’t call it a cure, but children and adults with Type 1 diabetes may soon get a peaceful night’s sleep and live injection-free lives. A new combination of safe and well-tested drugs already in use for other conditions has been shown to reverse the disease or lessen the dependence on insulin for many people.
The results of three clinical trials by Dr. Eli Lewis and his team at Ben Gurion University of the Negev has Lewis sounding cautious and understandably reluctant to declare it a “cure,” but his research showed that many subjects who were treated within three or four months of diagnosis — and that early treatment is key — no longer needed insulin. The research team also found that patients with a longer history of diabetes 1 were often able to get off of their nighttime insulin.
The research has been so successful that many doctors in the U.S. and Israel are using the drug on an off-label basis in their practices.
“What we found in these three trials is the sooner the better,” Lewis told JTNews while speaking at Stanford University and the Diabetes Technology Society in the Eastern U.S. “Some kids were 4 years old and we also had a 30-year-old. The response was very positive, regardless of the age group as long as it was really early after the diagnosis that the treatment was started. It’s hard to reverse the disease after one or two years.”
However, Lewis said, even the later-diagnosed subjects found some relief from the treatment.
“There was always a slight improvement,” he said. “Even the ones where there was no major change in their glucose levels ended up reaching the nighttime without insulin. If you ask any parent, that is exactly the stressful area.”
Type 1 diabetes occurs when the pancreas produces little or no insulin, a hormone that transports glucose or sugar into cells to produce energy. Nearly 26 million adults and children have Type 1 diabetes in the U.S, and over 200,000 of them are under 20 years old.
Yet despite a 100-year clinical record of using insulin injections to manage glucose, blood-sugar levels remain “dangerously high over 60 percent of the time,” according to BGU researchers.
“They take insulin and go to bed,” said Lewis. “They all stopped taking their nighttime insulin. That’s a huge benefit.”
The drug Lewis used to treat the diabetes, a natural human blood protein called Alpha-1 antitrypsin is primarily used in preventing or slowing the progression of lung disease and decreasing inflammation from smoking, asthma, or respiratory infections. It has been used for years to treat lung conditions such as emphysema.
When combined with a procedure called T-cell depletion, the patient’s immune system did not reject the transplantation of the healthy animal cells in the pancreas.
“Until now, medicine didn’t have anything to offer kids, but this is revolutionary,” Dr. Andy David, Israel’s consul general to the Pacific Northwest, told JTNews from his office in San Francisco. Two of David’s three young children have Type I diabetes.
In one of only a handful of interviews he’s given about his family’s experience with the disease, David, who has been working and living in San Francisco with his family since 2012, was both proud of Israeli scientific contributions and optimistic about the future.
“It’s a Nobel Prize-level discovery,” David said.
David’s oldest child, a boy, was the first to be diagnosed at the age of 5. When his second child, a girl, was diagnosed he began to look for research that might be promising. That’s when he found Lewis’s work.
His children were the first to receive the drug in Israel and he is hoping to find a physician in the United States who will administer a yearly schedule of treatment for his daughter, although he admits the U.S is more conservative medically, which makes such a doctor more difficult to find.
Today, his thriving 8-year-old girl has been completely off insulin injections for three-and-a-half years after receiving Lewis’s drug therapy. She has none of the diabetic symptoms that afflict her older brother, who was too far along in his progression of the disease to benefit from Lewis’s research.
“There are more and more children that are affected by this,” David said. “It makes sense to screen every child once a year or every six months in school. It’s a simple glucose test that takes seven seconds and the answer is immediate.”
Still, though his daughter is symptom-free, there are no guarantees since the research on the correct dosing procedures is ongoing.
“We continue to watch her diet and she will not drink Pepsi or Coke,” David said.