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Insulin delivery with a needle-free insulin injector versus a conventional insulin pen in Chinese patients with type 2 diabetes mellitus: A 16-week, multicenter, randomized clinical trial (the FREE study)
BACKGROUND: Insulin therapy is poorly accepted by patients with type 2 diabetes mellitus (T2DM). A needle-free insulin injector has been developed for patients who fear injections or are reluctant to initiate insulin therapy when it is clearly indicated. The objective of this trial was to evaluate t...
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7283138/ https://www.ncbi.nlm.nih.gov/pubmed/32529176 http://dx.doi.org/10.1016/j.eclinm.2020.100368 |
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author | Ji, Linong Gao, Leili Chen, Liming Wang, Yangang Ma, Zhongshu Ran, Xingwu Sun, Zilin Xu, Xiangjin Wang, Guixia Guo, Lixin Shan, Zhongyan |
author_facet | Ji, Linong Gao, Leili Chen, Liming Wang, Yangang Ma, Zhongshu Ran, Xingwu Sun, Zilin Xu, Xiangjin Wang, Guixia Guo, Lixin Shan, Zhongyan |
author_sort | Ji, Linong |
collection | PubMed |
description | BACKGROUND: Insulin therapy is poorly accepted by patients with type 2 diabetes mellitus (T2DM). A needle-free insulin injector has been developed for patients who fear injections or are reluctant to initiate insulin therapy when it is clearly indicated. The objective of this trial was to evaluate the glucose-lowering effect, tolerability, patient satisfaction and compliance with insulin treatment via a needle-free insulin injector (NFII) compared with insulin treatment via a conventional insulin pen (CIP) in patients with T2DM. METHODS: A total of 427 patients with T2DM were enrolled in a prospective, multicenter, randomized, open-label study, and were randomly assigned 1:1 to receive 16 weeks’ treatment with basal insulin or premixed insulin administered either by a NFII or CIP. TRIAL REGISTRATION: ClinicalTrials.gov (NCT03243903). FINDINGS: In the 412 patients who completed the study, the adjusted mean reduction of HbA1c from baseline at week 16 in the NFII group was 0.55% (95% CI −0.71, −0.39), which was non-inferior and statistically superior to the HbA1c reduction in the CIP group (0.26%, 95% CI −0.42, −0.11). Patients in the NFII group showed significantly higher treatment satisfaction scores than those in the CIP group (mean scores, 8.17 ± 1.78 vs. 7.21 ± 2.22, respectively; p<0.0001). The occurrence of hypoglycemia was similar in the two groups, and the NFII group showed reduced incidences of skin scratches, indurations and lower VAS pain scores. INTERPRETATION: Insulin therapy through needle-free injector showed a non-inferior glycemic-lowering effect and a significantly enhanced level of patient satisfaction with insulin treatment compared with conventional insulin therapy through needle injections. In addition, the needle-free injector also had a better safety profile. FUNDING: This study were funded by Beijing QS Medical Technology Co., Ltd, as well as The Major Chronic Non-communicable Disease Prevention and Control Research. |
format | Online Article Text |
id | pubmed-7283138 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Elsevier |
record_format | MEDLINE/PubMed |
spelling | pubmed-72831382020-06-10 Insulin delivery with a needle-free insulin injector versus a conventional insulin pen in Chinese patients with type 2 diabetes mellitus: A 16-week, multicenter, randomized clinical trial (the FREE study) Ji, Linong Gao, Leili Chen, Liming Wang, Yangang Ma, Zhongshu Ran, Xingwu Sun, Zilin Xu, Xiangjin Wang, Guixia Guo, Lixin Shan, Zhongyan EClinicalMedicine Research paper BACKGROUND: Insulin therapy is poorly accepted by patients with type 2 diabetes mellitus (T2DM). A needle-free insulin injector has been developed for patients who fear injections or are reluctant to initiate insulin therapy when it is clearly indicated. The objective of this trial was to evaluate the glucose-lowering effect, tolerability, patient satisfaction and compliance with insulin treatment via a needle-free insulin injector (NFII) compared with insulin treatment via a conventional insulin pen (CIP) in patients with T2DM. METHODS: A total of 427 patients with T2DM were enrolled in a prospective, multicenter, randomized, open-label study, and were randomly assigned 1:1 to receive 16 weeks’ treatment with basal insulin or premixed insulin administered either by a NFII or CIP. TRIAL REGISTRATION: ClinicalTrials.gov (NCT03243903). FINDINGS: In the 412 patients who completed the study, the adjusted mean reduction of HbA1c from baseline at week 16 in the NFII group was 0.55% (95% CI −0.71, −0.39), which was non-inferior and statistically superior to the HbA1c reduction in the CIP group (0.26%, 95% CI −0.42, −0.11). Patients in the NFII group showed significantly higher treatment satisfaction scores than those in the CIP group (mean scores, 8.17 ± 1.78 vs. 7.21 ± 2.22, respectively; p<0.0001). The occurrence of hypoglycemia was similar in the two groups, and the NFII group showed reduced incidences of skin scratches, indurations and lower VAS pain scores. INTERPRETATION: Insulin therapy through needle-free injector showed a non-inferior glycemic-lowering effect and a significantly enhanced level of patient satisfaction with insulin treatment compared with conventional insulin therapy through needle injections. In addition, the needle-free injector also had a better safety profile. FUNDING: This study were funded by Beijing QS Medical Technology Co., Ltd, as well as The Major Chronic Non-communicable Disease Prevention and Control Research. Elsevier 2020-06-04 /pmc/articles/PMC7283138/ /pubmed/32529176 http://dx.doi.org/10.1016/j.eclinm.2020.100368 Text en © 2020 Published by Elsevier Ltd. http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). |
spellingShingle | Research paper Ji, Linong Gao, Leili Chen, Liming Wang, Yangang Ma, Zhongshu Ran, Xingwu Sun, Zilin Xu, Xiangjin Wang, Guixia Guo, Lixin Shan, Zhongyan Insulin delivery with a needle-free insulin injector versus a conventional insulin pen in Chinese patients with type 2 diabetes mellitus: A 16-week, multicenter, randomized clinical trial (the FREE study) |
title | Insulin delivery with a needle-free insulin injector versus a conventional insulin pen in Chinese patients with type 2 diabetes mellitus: A 16-week, multicenter, randomized clinical trial (the FREE study) |
title_full | Insulin delivery with a needle-free insulin injector versus a conventional insulin pen in Chinese patients with type 2 diabetes mellitus: A 16-week, multicenter, randomized clinical trial (the FREE study) |
title_fullStr | Insulin delivery with a needle-free insulin injector versus a conventional insulin pen in Chinese patients with type 2 diabetes mellitus: A 16-week, multicenter, randomized clinical trial (the FREE study) |
title_full_unstemmed | Insulin delivery with a needle-free insulin injector versus a conventional insulin pen in Chinese patients with type 2 diabetes mellitus: A 16-week, multicenter, randomized clinical trial (the FREE study) |
title_short | Insulin delivery with a needle-free insulin injector versus a conventional insulin pen in Chinese patients with type 2 diabetes mellitus: A 16-week, multicenter, randomized clinical trial (the FREE study) |
title_sort | insulin delivery with a needle-free insulin injector versus a conventional insulin pen in chinese patients with type 2 diabetes mellitus: a 16-week, multicenter, randomized clinical trial (the free study) |
topic | Research paper |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7283138/ https://www.ncbi.nlm.nih.gov/pubmed/32529176 http://dx.doi.org/10.1016/j.eclinm.2020.100368 |
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