Table 1.

Igls definition of functional and clinical outcomes for β-cell replacement therapy (6, 7) (joint publication)

β-cell graft functional status	HbA1c, % (mmol/mol)a	Severe hypoglycemia, events per y	Insulin requirements, U·kg-1·d-1	C-peptide	Treatment success
Optimal	≤6.5(48)	None	None	>Baselineb	Yes
Good	<7.0(53)	None	<50% baselinec	>Baselineb	Yes
Marginal	Baseline	<Baselined	≥50% baseline	>Baselineb	Noe
Failure	Baseline	Baselinef	Baseline	Baselineg	No

Baseline, pretransplant assessment (not applicable to total pancreatectomy with islet autotransplantation patients).

^a Mean glucose should be used to provide an estimate of the glycated hemoglobin, termed the glucose management indicator, in the setting of disordered red blood cell life span.

^b Should also be > 0.5 ng/mL (>0.17 nmol/L) fasting or stimulated.

^c Should also be < 0.5 U·kg^-1·d^-1; might include the use of noninsulin antihyperglycemic agents.

^d Should severe hypoglycemia occur following treatment, then continued benefit may require assessment of hypoglycemia awareness, exposure to serious hypoglycemia (<54 mg/dL [3.0 mmol/L]), and/or glycemic variability/lability with demonstration of improvement from baseline.

^e Clinically, benefits of maintaining and monitoring β-cell graft function may outweigh risks of maintaining immunosuppression.

^f If severe hypoglycemia was not present before β-cell replacement therapy, then a return to baseline measures of glycemic control used as the indication for treatment (6, 7) may be consistent with β-cell graft failure.

^g May not be reliable in uremic patients and/or in those patients with evidence of C-peptide production before β-cell replacement therapy.