. Author manuscript; available in PMC: 2019 Mar 8.

Published in final edited form as: Transplantation. 2018 Sep;102(9):1479–1486. doi: 10.1097/TP.0000000000002158

TABLE 3.

Igls definition of functional and clinical outcomes for β-cell replacement therapy

β-cell graft functional status	HbA1c, % (mmol/mol)^a	Severe hypoglycemia, events per year	Insulin requirements, U· kg⁻¹· d⁻¹	C-peptide	Treatment success
Optimal	≤6.5 (48)	None	None	>Baseline^b	Yes
Good	<7.0 (53)	None	<50% Baseline^c	>Baseline^b	Yes
Marginal	Baseline	<Baseline^d	≥50% Baseline	>Baseline^b	No^e
Failure	Baseline	Baseline^f	Baseline	Baseline^g	No

Baseline, pretransplant assessment.

Mean glucose should be used to provide an estimate of the HbA_1c in the setting of marked anemia or administration of dapsone.¹⁰

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

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

Should severe hypoglycemia occur after 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.

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

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 (Table 2) may be consistent with β-cell graft failure.

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