The ICAN Study

under construction

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	ICAN	SAP
Purpose	To determine if ICAN trained Diabetes Alert Dogs (DADs) could alert to the scent of a low glycemic sample in the presence of normal and blank (control) samples in a controlled environment.
Description	In both studies, 4 separate wheels, containing samples from 4 separate patients were used and dog (Study 1: n=2, Study 2: n=4) replicated the search 2X/wheel. The placement of the samples was based on a pre-specified randomization scheme. Samples were placed in separate cups on a randomization device.  - One cup contained the low sample 3 contained euglycemic samples from the same patient 3 contained gauze w/o samples
Study Design	Each trained DAD (Study 1, n=2  Study 2, n=4) was tested on the same set of patient samples TWICE  (Study 1, k=4  Study 2, k=4) Each study was conducted with a different set of patients.
Method of Sample Capture and Preservation	Samples consisted of gauze squares wiped on the skin (back of the neck and forehead) and placed in a plastic zipper bag. Prior to sealing the zipper bag, the patient exhaled into the bag containing the gauze square.
Testing Participants	The Experiment Room had 5 individuals and 1 dog per trial. 4 individuals were blinded and 1 individual was unblinded to the study Blinded 1 dog handler 2 scorers 1 coordinator Unblinded Signaler Test Subject dog
Participant Roles	Dog Handler (blinded): -led the dog to and from the experiment room and gave the dog a treat for a correct response Scorers (blinded): -recorded the dog name, time, responses and sniffs by the dog Coordinator (blinded): watched the signaler for a correct response and told the dog handler to give the dog a treat upon a correct response Signaler (unblinded): -loaded the Scent Wheel with the patient samples and placed the Scent Wheel on the ground. During the study, the signaler notified the coordinator if the response was correct.
Scent Wheel Design	The Scent Wheel was designed to use 7 identical cups that hid the sample from sight, but allowed the scent to escape. The 7 cups included 1 low glycemic (low) 3 euglycemic (norm) 3 gauze only (blank samples) Each wheel included randomly placed samples from the same patient. The Scent Wheel was placed on the ground and rotated between trials (reps).
Scent Wheel Cleaning Procedures	The scent wheel and sample cups were cleaned before each study and between each trial Sample cups were washed thoroughly w/commercially available dish soap prior to the study commercially available cleaning wipes were used to ensure scent contamination was not present between trials
Testing Protocol	Each replicate had the same patient samples arranged in the same order, but the scent wheel was rotated to a  different orientation. Each replicate lasted a maximum of 30s or until a correct alert by the DAD.
Donor Acquisition Procedure
Terminology