From Lawrence, Kansas, USA:
We are interested in the prevention studies that use insulin injections to delay or prevent the onset of diabetes. When is diabetes considered to be prevented? We read in Diabetes Forecast (February 1994, page 16) that preliminary studies were started in 1992. Has a protocol been established for determining when and if a child should stop taking insulin? If not, what is your opinion about when it would be appropriate to end a trial if a child has not developed diabetes and no longer tests positive for antibodies? Should oral insulin or any other preventive strategy be considered if the child is taken off injections?
To answer your question I need to be specific about what is meant by 'prevention.' There is an ongoing trial called DAISY which is attempting to identify the characteristics, particularly in terms of the HLA genetic classification of infants who will later develop Type 1 Diabetes. The logical extension of this study once an 'at risk' group can be more clearly defined is to offer various forms of vaccination, probably with oral insulin or the subcutaneous injection of a special fragment of the insulin molecule. Actual vaccination studies in man have not yet been started.
There is another nation wide trial called DPT-1 (Diabetes Prevention Trial) which is offered to children with a first degree relative who has Type 1 Diabetes and who have a pattern of specific antibodies. In a sense having antibodies means that the autoimmune process has already begun and the person is already diabetic; but what you are hoping to 'prevent' or 'defer' is insulin dependance and the long term complications of diabetes. There are two categories to this trial. One group that have 3 antibodies and the highest chance of getting clinical diabetes are being offered participation in the subcutaneous insulin trial. Those with only two antibodies are offered participation in an oral insulin trial.
The original design of the trial was to ensure that all subjects received three years of intervention and the trial was supposed to end in 1998. However I have been told that numbers have lagged, understandably particularly in the insulin by injection group so that the study will have to be continued for at least another year to get sufficient numbers for statistical evaluation of the results.
I have also been told that after the trial closes those who have been getting subcutaneous insulin will have an opportunity, if they wish, to continue with this intervention. As far as I know there is no protocol for those who at the end of their period in the study may no longer have antibodies. My own entirely personal view would be that if antibodies became undetectable it would be reasonable to suppose that the autoimmune process would not then progress to overt clinical diabetes. The answer to this question is not known however and a compromise might be to repeat antibody testing annually.
Original posting 10 Dec 97
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