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IDS REQUEST FOR DATA ON SUBJECTS WITH TYPE 1 DIABETES FOLLOWED SINCE DIAGNOSIS


The IDS has previously solicited contributions from the diabetes research community to establish standard methods of performing tests. Examples are autoantibody and T cell workshops as well as development of the ICARUS standard for IVGTT measurements.


We are now initiating a similar effort to collect and analyze C-peptide data from type 1 subjects followed prospectively either as part of natural history studies or from CONTROL arms of intervention trials. Data regarding clinical presentation, insulin dose, genetics, antibodies, etc are also requested so that the impact of these variables on C-peptide can be determined.


An excel spreadsheet is provided to serve as a template for providing this information. Missing information should be left blank.


1. The first sheet contains general instructions.


2. The second sheet requests information about specific methods used for certain tests


a. Stimulation tests


Indicate if one or more of these tests were performed. If known, for each test, indicate the trade name of the stimulus used, the dose and method of administration, the time of day the test was performed, what instructions if any were given regarding insulin administration on the day of the test, what restrictions if any were imposed regarding the baseline glucose levels permitted for performing the test (i.e. glucose must be <15 mmol/l).


b. C-peptide measurement details


If known, indicate which antibody was used, what units are being reported, what the detection limit and normal range is of the assay, the CV of the assay in your hands, the % proinsulin determined in the assay, and the source of the standard used. If a kit was used, indicate the name of the kit and whether the entire kit or just kit components were used.


c. HbA1c


Provide data on the normal range of your assay


d. Autoantibody tests


For each test, indicate level of "positive" and sensitivity and specificity results from Workshops if available. For ICA, if not reporting results in JDF units, please indicate level of "positive" and the detection threshold for your assay.


3. The third sheet is for reporting demographic data and clinical presentation.


Indicate a subject number in the first column. Provide information on their clinical presentation, family history, autoantibody and genetic status at presentation.


4. The fourth sheet is for reporting initial and follow-up visits


Indicate the corresponding subject number in the first column, and the visit date in the second column. Please provide all requested information if known for each visit.


SEND RESULTS VIA ATTACHED FILE OR ASK QUESTIONS BY CONTACTING:

CARLA GREENBAUM, VIRGINIA MASON RESEARCH CENTER, SEATTLE WA, USA or 206-515-5231