Table 2 Data collection measures

Primary outcome measure

Glycosylated hemoglobin A1c

Blood specimens will be obtained at baseline, and at 3, 6, 9, and 12 months.

Secondary outcome measures

Blood pressure measurements

Blood pressure readings will be obtained at baseline and at 3, 6, 9, and 12 months by a trained research assistant using automated blood pressure monitors (OMRON IntelliSense™ HEM-907XL) with the patient seated comfortably for 5 minutes prior to the measurements.

Quality of life

The 12-item Short Form Health Survey (SF-12) [16] is a valid and reliable instrument to measure functional status and will be used to assess quality of life at baseline and at 3, 6, 9, and 12 months. The SF-12 items reproduce at least 90% of the variance in Physical Component Summary-36 and Mental Component Summary-36 scores.

Resource utilization and cost

The perspective of cost will be that of the payer. Previously validated questions on resource utilization will be administered as part of the baseline and at 3, 6, 9, and 12 months.