Published on 2 December 2015

A study has been carried out to explore whether an alternative treatment to daily insulin injections could be possible in the future for people with type 1 diabetes.

Researchers in the US from the University of California, Benaroya Research Institute in Seattle, Yale University and KineMed Inc have begun trials to see if creating healthy new cells in people with type 1 diabetes was safe.

People with type 1 diabetes have fewer cells called T-regulators (T-regs), which are involved in stopping the immune system attacking healthy cells, such as the insulin-producing beta cells in the pancreas. Without insulin, people with type 1 diabetes cannot control the levels of sugar in their blood and insulin is required for life, delivered by injection or pump.

As part of the study, researchers found a way to remove the T-reg cells from people's blood and filter out any faulty cells, and then increase the numbers of healthy T-regs so they could inject them back.

Researchers are testing whether type 1 diabetes can be treated without insulin injections

Researchers took a large sample of blood from 16 adults who had recently been diagnosed with type 1 diabetes.

The results from the early trials were recently published in the Science Translational Medicine journal.

Studies of the treated T-regs in the laboratory, before they were put back into people, showed the cells seemed to have recovered their ability to prevent the body from wrongly attacking beta cells. However, it is not known if this continued after they had been injected back into the bloodstream.

None of the people taking part in the study reported any serious side effects caused by the treatment.

In follow-up studies the results showed that some of the T-reg cells remained in the bloodstream for a year after infusion, although most of the cells (about 75%) could no longer be found 90 days after treatment.

The researchers said: “In people with type 1 diabetes, immune cells attack the insulin-producing beta cells of the pancreas. The resulting prolonged increase in blood sugar levels can lead to serious complications including heart disease and kidney failure.”

The researchers now plan to follow these ‘phase 1’ trials with ‘phase II’ tests to continue to test the treatment.

They added that the therapy, when combined with other treatments being developed, “may lead to durable remission and tolerance in this disease setting”.

An NHS Behind the Headlines report on the study said: “These early-stage results show work is underway to find a long-term treatment for type 1 diabetes, which could one day mean people do not have to inject insulin.

“However, that day is a long way off. Headlines suggesting an end to daily injections can unfairly raise people's hopes, leading to disappointment when no such treatment emerges. Bringing a new treatment into use requires at least three stages of trials, from the phase 1 safety trials, to phase 2 studies of efficacy, to larger-scale phase 3 clinical trials, where the treatment is given to large groups of people who may be followed-up for some time. This is usually done with a comparison group to see whether the new treatment performs better than placebo or the established treatment. Many treatments get no further than phase 1.

“The results from this study are encouraging for the researchers, as they allow them to move on to the next phase of study. However, it doesn't mean there are no safety concerns. We need to see whether the treatment is safe and effective when given to large groups of people. Only after successful phase 3 trials can people with type 1 diabetes start to hope for an injection-free future.”

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