CLINICAL TRIAL: SHARED DIABETES TRIAL STUDIES

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. There are an increasing number of studies across the country testing various drugs and other interventions to see if diabetes can be prevented or its progression delayed. Stanford University is involved in some of the studies (separate IRB protocols) because it is a NIH funded center in the Diabetes TrialNet. As such our General Clinical Reasearch Center staff has substanstial experience in conducting the tests used to monitor diabetes progression. As such, the GCRC is occasionally requested to perform some of these tests for subjects enrolled in studies at OTHER sites. One such request as arrived. The parents of child enrolled in a Texas based study do not wish to fly to Texas during the current geopolicitical unrest and request we do a mixed meal tolerance test. I have written this GCRC request a bit more broadly to cover future similar occurrences requiring this and similar tests. Please note that this applicantion is strictly for testing in subjects ALREADY enrolled in the specific protocol elsewhere. We will NOT consent them for the primary trial, this will have been done already. As such, there are no statistical sections or background information. This is essentially a compassionate use protocol.