Table 1.

Efficacy of the flash glucose monitoring system versus self-monitoring of blood glucose in the REPLACE open-label randomized controlled trial and extension study in patients with type 2 diabetes mellitus

Randomized controlled trial	Outcome (FGMS vs. SMBG) [N = 149 vs. N = 75]		P value
Overall population (6 months)	Mean change from baseline in HbA1c:	− 0.29 ± 0.07 vs. − 0.31 ± 0.09%	P = 0.8222
Subgroup analyses (6 months)
Age
< 65 years	Mean change from baseline in HbA1c:	− 0.53 ± 0.09 vs. − 0.20 ± 0.12%	P = 0.0301
≥ 65 years		− 0.05 ± 0.10 vs. − 0.49 ± 0.13%	P = 0.0081
Time spent in hypoglycemia [h/day]: mean change from baseline
Glucose < 70 mg/dL	Between-group difference:	− 43% [mean ± SE − 0.47 ± 0.13]	P = 0.0006
Glucose < 55 mg/dL		− 53% [− 0.22 ± 0.07]	P = 0.0014
Glucose < 45 mg/dL		− 64% [− 0.14 ± 0.04]	P = 0.0013
Frequency of hypoglycemic events [per day]: mean change from baseline
Glucose < 70 mg/dL	Between-group difference:	− 28% [mean ± SE − 0.16 ± 0.07]	P = 0.0164
Glucose < 55 mg/dL		− 44% [− 0.12 ± 0.04]	P = 0.0017
Glucose < 45 mg/dL		− 49% [− 0.06 ± 0.02]	P = 0.0098
AUC [h/day × mg/dL]
Glucose < 70 mg/dL	Between-group difference:	− 51% [mean ± SE − 7.80 ± 2.20]	P = 0.0005
Glucose < 55 mg/dL		− 60% [− 2.51 ± 0.76]	P = 0.0012
Glucose < 45 mg/dL		− 67% [− 0.70 ± 0.22]	P = 0.0015

Extension phase	Outcome (FGMS vs. baseline) [N = 139]
Subgroup analyses (12 months)
Time spent in hypoglycemia [h/day]
Glucose < 70 mg/dL	Mean change from baseline (start of treatment phase):	− 50% [mean ± SD − 0.70 ± 1.85]	P = 0.0002
Glucose < 55 mg/dL		− 62% [− 0.40 ± 1.09]	P = 0.0002
Glucose < 45 mg/dL		− 67% [− 0.23 ± 0.73]	P = 0.0013
Frequency of hypoglycemic events [per day]
Glucose < 70 mg/dL	Mean change from baseline (start of treatment phase):	− 41% [mean ± SD − 0.27 ± 0.67]	P < 0.0001
Glucose < 55 mg/dL		− 56% [− 0.20 ± 0.49]	P < 0.0001
Glucose < 45 mg/dL		− 62% [− 0.13 ± 0.35]	P = 0.0002
AUC [h/day × mg/dL]
Glucose < 70 mg/dL	Mean change from baseline (start of treatment phase):	− 58% (mean ± SD − 12.73 ± 34.53]	P = 0.0002
Glucose < 55 mg/dL		− 65% [− 4.28 ± 12.76]	P = 0.0007
Glucose < 45 mg/dL		− 69% [− 1.12 ± 3.67]	P = 0.0021

Data from [8, 9]

BG levels are presented as mg/dL, which can be converted to mmol/L by multiplying values by 0.05551

AUC area under the concentration–time curve, FGMS flash glucose monitoring system, HbA1c glycosylated haemoglobin, SMBG self-monitoring of blood glucose