Table 1.

Schedule of events and data collected throughout study participation period.

Study Procedures	Baseline			Week 12 ± 2 week
Informed consent (eConsent)	X
Eligibility confirmation	X
EHR data entrya	X			Daily through 12 weeks
ePRO deployed (SF-12)	X			X
RWD extracted (daily b)	# subjects	# Records Collected c	# Data fields per record d (source)	# subjects	# Records Collected c	# Data fields per record (source)
Electronic eligibility confirmation	48	48	10	N/A	N/A
Electronic informed consent	48	48	3	N/A	N/A
Demographics	48	48	4	N/A	N/A
Vital sign measurements	48	192	7	N/A	N/A
Co-existing diseases b	48	841	3	20	48	3
Concomitant medications b	48	489	7	41	101	7
HbA1cb	48	94	6	33	33	6
Clinical encounters b	N/A	N/A	N/A	39	133	3
ePRO (SF-12)	48	48	N/A	28	28	N/A
TOTAL (2,151 Records)		1,808			343
TOTAL (10,118 Data Fields)			8,670			1,448

EHR = electronic health record; ePRO = electronic patient-reported outcome; HbA1c = Glycated hemoglobin; NA= Not applicable.

^aEHR data was collected daily as the encounters occurred and data was recorded by the clinical sites in accordance with the assessments performed during the routine clinical care visits.

^bData extracted daily as received from the EHR feeds.

^c1 Record = 1 row of data.

^dNumber of data fields that the site staff would have entered manually subject to source data validation.