Supporting data for the Primary analysis of the adaptive study of IL-2 dose frequency on regulatory T cells in type 1 diabetes (DILfrequency)

DILfrequency is a single-center, non-randomised, open-label, response-adaptive study of participants aged 18 to 70 with T1D. The initial learning phase allocated 12 participants to six different predefined dose-frequency regimens. Then, three cohorts of 8 participants were sequentially allocated dose-frequencies, based on repeated interim analyses of all accumulated trial data. The co-primary endpoints were percentage change in Tregs, Teffs and, CD25 (α subunit of IL-2 receptor) expression by Tregs from baseline to the average of the last three values preceding adesleukin administration at steady state. Trial registration ISRCTN40319192 and ClinicalTrials.gov (NCT02265809).The study was approved by the Health Research Authority, National Research Ethics Service, United Kingdom (14/EE/1057). While all obvious personal identifiers have been stripped from the individual-participant-level results, in our view it cannot be anonymised sufficiently to be able to put it into the public domain without risk of participant identification.

Therefore, it cannot be hosted by the University of Cambridge research repository, but is instead available on application to the DILT1D Data Access Committee, contacted via fw211@cam.ac.uk, and on completion of a Data Access Agreement.

The Data Access Committee consists of: the Chief Investigator; the Senior Trial Statistician; and the independent Trial Chair; with additional independent advice from the University of Cambridge School of Clinical Medicine's Information Governance team.

Applications will be judged on the following criteria: 1. Has the application been submitted by bona fide researchers? 2. Is the application's purpose in line with the original aims of the trial, and the consents given? 3. Does the application run the risk of producing information that may allow individual trial participants to be identified, or may prejudice the willingness of participants to join future trials?