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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

From: A review of flash glucose monitoring in type 2 diabetes

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

  1. Data from [8, 9]
  2. BG levels are presented as mg/dL, which can be converted to mmol/L by multiplying values by 0.05551
  3. AUC area under the concentration–time curve, FGMS flash glucose monitoring system, HbA1c glycosylated haemoglobin, SMBG self-monitoring of blood glucose