TABLE 2.

Mean (SE) and proportional change in hypoglycaemic event rates (per participant per 6‐month period) for subgroups of the per‐protocol population (n = 519) ^a

Subgroup	No. of subjects	Hypoglycaemic event rate (per participant per 6‐month period)		Rate ratio (95% CI)
		SMBG phase (Months 1–6)	CGM phase (Months 7–12)
Overall b	519	0.081 (0.016)	0.031 (0.001) c	0.38 (0.19–0.78)
Type of diabetes
T1D	345	0.101 (0.022)	0.038 (0.014)	0.37 (0.17–0.81)
T2D	174	0.040 (0.022)	0.017 (0.013)	0.43 (0.07–2.64)
Method of insulin delivery
CSII	154	0.091 (0.028)	0.071 (0.032)	0.79 (0.30–2.07)
MDI	365	0.077 (0.020)	0.014 (0.006)	0.18 (0.07–0.44)
Baseline HbA1c
<53 mmol/mol (<7.0%)	122	0.090 (0.035)	0.008 (0.008)	0.09 (0.02–0.42)
53–58 mmol/mol (7.0%–7.5%)	97	0.062 (0.029)	0.031 (0.023)	0.50 (0.10–2.48)
60–64 mmol/mol (7.6%–8.0%)	79	0.051 (0.040)	0.063 (0.052)	1.25 (0.19–8.07)
65–75 mmol/mol (8.1%–9.0%)	110	0.109 (0.039)	0.027 (0.016)	0.25 (0.07–0.96)
76–86 mmol/mol (9.1%–10.0%)	59	0.136 (0.066)	0.051 (0.029)	0.38 (0.09–1.50)
>86 mmol/mol (>10%)	52	0.019 (0.019)	0.019 (0.019)	1.00 (0.06–15.99)
History of hypoglycaemia and/or DKA in the 6 months prior to enrolment
Yes	38	0.368 (0.127)	0.079 (0.044)	0.21 (0.08–0.61)
No	481	0.058 (0.014)	0.027 (0.011)	0.46 (0.20–1.09)
Age (years)
18–25	40	0.050 (0.035)	0.025 (0.025)	0.50 (0.13–2.00)
26–64	352	0.065 (0.018)	0.023 (0.009)	0.35 (0.13–0.90)
>64	127	0.134 (0.041)	0.055 (0.034)	0.41 (0.13–1.32)
Hypoglycaemia awareness d
Impaired (Gold ≥ 4)	169	0.107 (0.037)	0.036 (0.017)	0.33 (0.12–0.96)
Intact (Gold < 4)	347	0.069 (0.016)	0.029 (0.013)	0.42 (0.16–1.06)

^a Includes all events, whether RT‐CGM was worn or not.

^b The overall event rate while participants wore the RT‐CGM was 0.027 (0.010).

^c p = 0.005 for superiority versus SMBG phase.

^d Gold scores were not available from three participants.