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
AMB and AL conceived the idea of the manuscript and designed the project; AA, AC, AMB and EP organized the collected data to review; EP wrote the first draft of the manuscript with the supervision of AMB, AC and AL; AC, AMB and AL contributed to work design and critically reviewed the manuscript. All authors discussed the project, contributed to manuscript revision, read and approved the submitted version.
The authors declare that they have no conflicts of interest.
Not applicable.
Not applicable.
Not applicable.
Not applicable.
Not applicable.
© The Author(s) 2020.