TABLE 2.

Indications and goals for beta cell replacement therapies expressed in relation to various glycemic control measures

Metric	Indicationa	Goal	Ideal
HbA1c, % (mmol/mol)b	>7.5–8.0 (58–64)	<7.0 (53)	≤6.5 (48)
SH, events per yr	One or more	None	None
Clarke or Gold scorec	≥4	<4	0
Time <54 mg/dl (3.0 mmol/l), %d	≥5	<1	0
Glucose SD, mg/dl (mmol/l)e	≥40 (2.2)	<40 (2.2)	NE
Glucose CV, %f	≥30	<30	NE
Time <70 mg/dl (3.9 mmol/l), %g	NE	<5	<5
Time 70 – 180 mg/dl (3.9 – 10 mmol/l), %h	NE	>70	>90
Time >180 mg/dl (10 mmol/l), %i	NE	<20–30	<5

HbA_1c, glycated hemoglobin; SH, severe hypoglycemia; SD, standard deviation; CV, coefficient of variation = mean/SD; NE, not established.

^aTypically more than one measure is used to define indications for β-cell replacement therapy and establish a baseline prior to treatment.

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

^cUsed to assess impaired awareness of hypoglycemia.^14,15

^dUsed to assess exposure to serious, clinically important hypoglycemia,⁴ which can also be defined by frequency of episodes or using the HYPO score.¹¹

^eUsed to assess glycemic variability,¹⁰ which can also be assessed as glycemic lability using the lability index or LI.¹¹

^fUsed for comparison to artificial pancreas systems.³