Randomized clinical trials (RCTs) comparing CSII and MDI among people with T2D
| Reference | Study population | Age, years (mean ± SD) | Therapy | Study design and follow-up | Primary endpoint | Primary results in CSII group | Change in HbA1c | Hypoglycemic events (safety) |
|---|---|---|---|---|---|---|---|---|
| Raskin P, 2003 [1] | 132 | 55.1 ± 10.2 | CSII vs. MDI ± OADs | Parallel; 24 weeks | - HbA1c- Eight-point BG profile- Treatment satisfaction | - Reduction of BG at 90’ post-breakfast- Improved treatment satisfaction favoring CSII | −0.62% ± 1.11% vs. −0.46% ± 0.89% (control) NS | No difference |
| Reznik Y, 2014 [14] | 331 | 55.5 ± 9.7 | CSII vs. MDI ± OADs | Interventional (study phase); 6 months | HbA1c | - Reduction in HbA1c- Decrease in 24-h mean glucose concentration- Reduction of time in hyperglycemia | −1.1% ± 1.2% vs. −0.4% ± 1.1% (control) | No difference |
| Aronson R, 2016 [15] | 331 | 55.5 ± 9.7 | CSII vs. MDI ± OADs | Interventional (continuation phase); 12 months | HbA1c | - Sustained improvement of HbA1c in CSII group- Further reduction in MDI group after switching to CSII | −1.1% ± 1.2% vs. −0.4% ± 1.1% (control) | No difference |
| Berthe E, 2007 [18] | 17 | 55.2 ± 6.6 | CSII vs. MDI | Cross-over; 24 weeks | - HbA1c- Six-point BG profile- 24-hour CGM- Treatment satisfaction | - Reduction in HbA1c- Reduction of BG- Increase of TIR- Fall of hyperglycemic excursions | −1.3% vs. −0.4% (control) | No difference |
P < 0.01; P < 0.05. NA: not applicable; NS: not significant; TIR: time in range