Table 1.

Definition of ACCORD microvascular outcomes and their frequency of assessment.

Outcome Category	Outcome	Definition	Assessment Frequency
Composites	Primary	Development of renal failure (initiation of dialysis or ESRD, renal transplantation, or rise of serum creatinine >291.72 micromol/l) or retinal photocoagulation or vitrectomy to treat retinopathy.	Every 4 months
	Secondary	As in primary composite outcome and/or Score of >2.0 on the Michigan Neuropathy Screening Instrument (MNSI).	Every 4 months
Nephropathy	Neph-1	Development of microalbuminuria (defined as urine albumin/creatinine ratio ≥ 30 mg/g).	Annually
	Neph-2	Development of macroalbuminuria (defined as urine albumin/creatinine ratio ≥ 300 mg/g).	Annually
	Neph-3	Development of renal failure (defined as initiation of dialysis or ESRD, or renal transplantation, or rise of serum creatinine >291.72 micromol/l in absence of an acute reversible cause).	Every 4 months
	Neph-4	Doubling of baseline serum creatinine or more than 20 mL/min/1.73 m2 decrease in estimated GFR. (Estimated GFR is based on the 4-variable MDRD GFR equation of Levey et. al.)	Every 4 months
	Neph-5	Development of any of the three conditions Neph-2, Neph-3, or Neph-4 above.	Every 4 months
Diabetic eye complications	Eye-1	Retinal photocoagulation or vitrectomy to treat retinopathy.	Annually
	Eye-2	Eye surgery for cataract extraction.	Annually
	Eye-3	Three-line change in visual acuity (as measured using Log MAR visual acuity chart).	Biannually
	Eye-4	Severe vision loss (as measured by Snellen fraction <20/200).	Biannually
Neuropathy	Neuro-1	New score of >2.0 on the Michigan Neuropathy Screening Instrument (MNSI	Annually
	Neuro-2	New loss of vibratory sensation (tested using 128 Hz tuning fork).	Annually
	Neuro-3	New loss of ankle jerk during Jendrassic maneuver.	Annually
	Neuro-4	New loss of light touch (as measured by 10 gm force monofilament test).	Annually