As of 12/31/97, 716 patients have been screened through the CHOP GCRC. Results have been returned on 664 patients. To date, 10 patients have tested positive for ICA. Three patients declined further participation. Of the 6 patients who were staged, 3 have entered into the insulin intervention trial and were randomized into the treatment group. All of these patients have started the insulin protocol One patient was ineligible and the other 3 are in process. The intervention protocol for the intermediate risk cohort, the Oral Antigen Protocol, was finalized in May 1996. The protocol was reviewed by IRB and approved on 9/25/96. In this phase of the DPT, patients who are deemed to be at intermediate risk of developing IDDM, (25-50%), will be randomized into either oral treatment or placebo. Similar to the insulin intervention phase, patients will be followed for 3-6 years to monitor the onset of IDDM. Screening of patients is expected to continue for the next 2 years or until the number of patients needed for the protocols is reached. In addition to the patients entered into the DPT through CHOP, there have been several patients from other clinical centers who have used the GCRC for administration of the insulin intervention protocol. It is expected that due to increased recruitment efforts that there will be an increase in use of the GCRC within the next year.
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