Needle-free injection of basal insulin improves fasting glucose variability as assessed by continuous glucose monitoring in T2DM: a prospective randomized multicenter open-label crossover study

ABSTRACT

Background

Fasting glucose variability (FGV) extensively promotes the onset and development of diabetic complications. This study aimed to evaluate the FGV in type 2 diabetes mellitus (T2DM) patients administered basal insulin using a needle-free insulin injector (NFII).

Research design and methods

This was a prospective randomized multicenter open-label crossover study. We randomly assigned 48 T2DM patients to receive basal insulin by NFII or conventional insulin pen (CIP) for 7–14 days and were then crossed over after washout. We conducted continuous glucose monitoring to investigate the FGV, our primary outcome was a composite parameter of the FGV with a fasting blood glucose target between 4.4 and 6.1 mmol/L.

Results

The coefficient of variation for sensor glucose at 6 a.m. with CIP was 11.67 (8.70,14.81)% vs. 9.48 (6.48,12.24)% with NFII (p = 0.003), and the coefficient of variation for mean sensor glucose at 5–6 a.m. with CIP was 12.70 (9.17,16.56)% vs. 9.23 (7.01,11.98)% with NFII (p < 0.001). The overall basal insulin dosage with CIP injection was 18.00 (16.00, 20.00) IU vs. 16.00 (12.00, 19.00) IU during NFII (p < 0.003).

Conclusion

Compared with CIP, the use of the NFII to inject basal insulin improved FGV in T2DM.

Clinical trial registration

https://www.chictr.org.cn Identifier is ChiCTR2000034674.

KEYWORDS:

• basal insulin
• continuous glucose monitoring
• fasting glucose variability
• needle-free insulin injection
• type 2 diabetes mellitus

Acknowledgments

We wish to thank ACCDON, LLC for its linguistic assistance during the preparation of this manuscript.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

JZ and QHJ contributed to the study design, data interpretation, and critical review of the manuscript; FS contributed to the literature search, data analysis, data interpretation, and writing of the manuscript; BG contributed to the study design, data interpretation, and editing of the manuscript; LT, ALY, LJR, YX and KYM managed relationships with the individual study centers, recruited patients, and conducted the study; SML and CNH conducted the study; HL provided technical support for the determination of insulin leakage area in this study; and JZ and QHJ were the guarantors of this work, and as such, had full access to all of the data in the study and took overall responsibility for the integrity of the data and the accuracy of the data analysis.

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/17425247.2022.2147504

Additional information

Funding

This work was funded by the National Natural Science Foundation of China (82070839); the Top Talent Fund of Tangdu Hospital; the Key Projects of Shaanxi Provincial Basic Research Program (2020JZ-31) and the National Key R&D Program (No. 2017YFC1309803 and 2017YFC1309804).