Table 2.
Randomized controlled studies providing evidence of glycemic efficacy of rtCGM
| Study | Study design | Study population | Diabetes type | Insulin regimen | Baseline glycemic status (CGM vs. SMBG) | Primary outcomes | Results (CGM vs. SMBG) |
|---|---|---|---|---|---|---|---|
| Lind et al. (2017) [22] | Crossover, 26 weeks | 161 adults | T1DM | MDI | HbA1c ≥7.5% | Difference in HbA1c at week 26 | Adjusted between-group differences: −0.4% (P<0.001) |
| Mean HbA1c: 8.5% vs. 8.5% | 7.9% vs. 8.4% | ||||||
| Beck et al. (2017) [21] | Parallel, 24 weeks | 158 adults and children | T1DM | MDI | HbA1c 7.5%–9.9% | Difference in change in HbA1c from baseline to 24 weeks | Adjusted between-group differences: −0.6% (P<0.001) |
| Mean HbA1c: 8.6% vs. 8.6% | 7.7%% vs. 8.2%% | ||||||
| Heinemann et al. (2018) [25] | Parallel, 26 weeks | 149 adults | T1DMa with severe hypoglycemia | MDI | HbA1c ≤9.0% | Baseline-adjusted number of hypoglycemic events (defined as glucose ≤54 mg/dL for ≥20 min) | Adjusted between group HR: 0.28 (P<0.001) |
| Mean HbA1c: 7.3% vs. 7.6% | 10.8 events to 3.5 events vs. 14.4 events to 13.7 events | ||||||
| Beck et al. (2017) [23] | Parallel, 24 weeks | 158 adults | T2DM | MDI | HbA1c 7.5%–10.0% | HbA1c reduction at 24 weeks | Adjusted between-group differences: −0.3% (P<0.001) |
| Mean HbA1c: 8.5% vs. 8.5% | 7.7% vs. 8.0% | ||||||
| Martens et al. (2021) [24] | Parallel, 8 months | 175 adults | T2DM | Basal insulin | HbA1c 7.8%–11.5% | HbA1c reduction at 8 months | Adjusted between-group differences: −0.4% (P=0.02) |
| Mean HbA1c: 9.1% vs. 9.0% | 8.0% vs. 8.4% |
rtCGM, real-time continuous glucose monitoring; SMBG, self-monitoring blood glucose monitoring; T1DM, type 1 diabetes mellitus; MDI, multiple daily insulin injection; HbA1c, glycosylated hemoglobin; HR, hazard ratio; T2DM, type 2 diabetes mellitus.
a
With a history of impaired hypoglycemia awareness or severe hypoglycemia.