Evaluation of Blood Volume and Perceived Pain During Fingerstick Monitoring of Blood Glucose

Number of subjects in whom valid meter reading was obtained with each device configuration. The primary outcome of a successful lancing is defined as whether or not a technician is able to use the lancing system to yield a blood sample of sufficient volume to yield a valid meter reading.

Time frame: Study Day 1 (Visit 1)

Population: BD/BD33g and Mini/BD33g were included in 4 arms,the Mini/OT28g in 2 arms,and Ultra/OT28g and AC/AC28g in 1 arm. Thus the # of subj evaluated for each device was 246, 246, 124, 63, and 60, resp. Subj were analyzed for blood volume adequacy if they completed the depth setting/volume testing for at least 1 device w/o significant protocol deviation.

In Visit 2 subjects kept the same group assignment they had in Visit 1. Each subject tested 2 of the 3 systems from Visit 1. Up to 6 pairs of lancings were performed in order to obtain 4 evaluable pairs. After each pair of lancing, the subject was asked to record the pain from the 2nd lancing as compared to the first using a 150mm visual analog scale(0mm = same pain, -75mm = max score for less painful than first lancing,+75mm = max score for more painful). A positive value on the scale (and in table below) indicates that the first device in the pair was more painful than the second.

Time frame: Approximately Day 3 (Visit 2)

Population: Of the 234 subjects that completed Visit 2, 229 had evaluable pairs and were included in the analysis for Visit 2. Some of the lancing pairs from several subjects were excluded due to protocol deviations, subject discontinuation or adverse events. Of these 175 subjects were analyzed for this primary outcome.

The subjects who participated in Study Visit 2 kept the same group assignment they had in Study Visit 1. Each subject tested 2 of the 3 systems they experienced during Visit 1. Up to 6 pairs of lancings were performed in order to obtain 4 evaluable pairs. After each pair of lancing, the subject was asked to record the difference in the pain they perceive between two lancing systems using the 150 mm visual analog scale. A positive value on the scale (and in the table below) indicates that the first device in the pair was more painful than the second.

Time frame: Approximately Day 3 (Visit 2)

Population: 61 subjects in this arm completed visit 1 and evaluable data for lancing pain. See further description above.

After each pair of 4 lancings, the subject was asked: Which of the two devices did you find more comfortable, overall? The choices were: first lancing, second lancing or equivalent. The Stated Preference row indicates # of lancing pairs in which one device was preferred over the other device while the 2 rows below indicate the # of pairs in which each device was preferred. First and second device refers to the 1st and 2nd devices identified in column headers, not the device order during testing. The No Preference row includes lancing pairs with preference of equivalent or no answer.

Time frame: Approximately Day 3 (Visit 2)

Population: Comfort was analyzed per lancing pairs. 236 subjects performed up to 4 lancing pairs. 869 pairs were evaluated across the 4 arms. Pairs were excluded if they did not result in a valid meter reading or associated with protocol deviations or had missing comfort data.