Oral insulin may not prevent type 1 diabetes developing but could delay the age of diagnosis in certain individuals.
The theory is that introducing insulin into the body orally may help the body’s immune system to become used to insulin.
The trial involved 560 children with a very high risk of developing type 1 diabetes. Each participant had relatives with at least two autoantibodies, this represents a high likelihood that the children will develop the autoantibodies which increases the risk of developing type 1 diabetes.
The children were recruited for the trial from nine countries, including the UK and countries in North American, Australasia and Europe. The average age of the participants was eight years old at enrolment.
One group of randomly selected children were given oral insulin and the other were given a placebo. The children were observed for an average of 2.7 years and tested for type 1 diabetes every six months with oral glucose tolerance tests.
The number of children developing type 1 diabetes was slightly lower in the group taking oral insulin; 28 per cent of those taking oral insulin developed type 1 compared with 33 per cent in the placebo group. However, the difference was not statistically significant. The difference in time to developing diabetes was also lower in the oral insulin group but not statistically significant.
Statistically significant means that you need a strong enough difference to show, with a strong level of certainty, that the treatment made a difference. In this case, the difference was not strong enough to say with confidence that the treatment made a difference.
However, the researchers found that a group of children that had low insulin secretion at the start of the trial developed type 1 diabetes 2.5 years later than the children with low insulin secretion that took placebo. This provides some hope that some children may be responders to the treatment.
For now, the researchers state that the findings of the current study do not support the use of oral insulin as a preventative measure in type 1 diabetes. The researchers are planning another trial to see if a greater dose of oral insulin would improve the results.
The study is published in the Journal of the American Medical Association (JAMA).

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