Table Info

Table 1.

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

Declarations

Author contributions

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.

Conflicts of interest

The authors declare that they have no conflicts of interest.

Ethical approval

Not applicable.

Consent to participate

Not applicable.

Consent to publication

Not applicable.

Availability of data and materials

Not applicable.

Funding

Not applicable.

Copyright

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