Ruiming Liang1, Jianyan Long1, Qiuyi Zheng2, Gang Yuan3, Xinwen Chen2, Ziyi Xin4, Fenghua Lai5, Yihao Liu6,7. 1. Clinical Trials Unit, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, 510080, China. 2. Department of Endocrinology, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, 510080, China. 3. Phase I Clinical Trial Center, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, 510080, China. 4. Department of Medical Records, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, 510080, China. 5. Department of Endocrinology, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, 510080, China. laifh@mail2.sysu.edu.cn. 6. Clinical Trials Unit, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, 510080, China. liuyih3@mail2.sysu.edu.cn. 7. Department of Endocrinology, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, 510080, China. liuyih3@mail2.sysu.edu.cn.
Abstract
AIMS: A better understanding of the current features of type 1 diabetes mellitus (T1DM)-related interventional clinical trials is important for improving clinical trial designs and identifying neglected research areas. Therefore, this study aimed to comprehensively assess T1DM-related interventional clinical trials registered in the ClinicalTrials.gov database. METHODS: In this cross-sectional study, T1DM-related clinical trials registered in the ClinicalTrials.gov database were searched on July 1, 2020. The characteristics of the relevant trials were assessed. PubMed and Google Scholar were used to search for publication statuses of primary completed studies. RESULTS: Overall, 1,421 T1DM-related interventional clinical trials were identified for analysis. Of those trials, 509 (35.8%) involved children and 912 (64.2%) involved only adults. Overall, 63.2% of trials enrolled < 50 participants and 61.9% were registered after patient recruitment. Most trials were single-centered (66.0%). The proportions of trials with children were higher than those with only adults with respect to the primary purpose of health service or prevention (13.6% vs. 4.8%), intervention of device (30.8% vs. 23.9%), education or lifestyle (28.9% vs. 11.3%), and dietary supplement (5.7% vs. 2.5%) (all P < 0.01). Only 24.0% of trials had available results after primary completion. The 5-year cumulative publication rate after primary trial completion was < 40%. CONCLUSIONS: T1DM-related interventional clinical trials registered in ClinicalTrials.gov were dominated by small single-center studies. Most trials lacked the availability of results and their respective publications. Large multicenter interventional clinical trials on T1DM are needed, and more attention should be paid to improve the publication and dissemination of clinical trials results.
AIMS: A better understanding of the current features of type 1 diabetes mellitus (T1DM)-related interventional clinical trials is important for improving clinical trial designs and identifying neglected research areas. Therefore, this study aimed to comprehensively assess T1DM-related interventional clinical trials registered in the ClinicalTrials.gov database. METHODS: In this cross-sectional study, T1DM-related clinical trials registered in the ClinicalTrials.gov database were searched on July 1, 2020. The characteristics of the relevant trials were assessed. PubMed and Google Scholar were used to search for publication statuses of primary completed studies. RESULTS: Overall, 1,421 T1DM-related interventional clinical trials were identified for analysis. Of those trials, 509 (35.8%) involved children and 912 (64.2%) involved only adults. Overall, 63.2% of trials enrolled < 50 participants and 61.9% were registered after patient recruitment. Most trials were single-centered (66.0%). The proportions of trials with children were higher than those with only adults with respect to the primary purpose of health service or prevention (13.6% vs. 4.8%), intervention of device (30.8% vs. 23.9%), education or lifestyle (28.9% vs. 11.3%), and dietary supplement (5.7% vs. 2.5%) (all P < 0.01). Only 24.0% of trials had available results after primary completion. The 5-year cumulative publication rate after primary trial completion was < 40%. CONCLUSIONS: T1DM-related interventional clinical trials registered in ClinicalTrials.gov were dominated by small single-center studies. Most trials lacked the availability of results and their respective publications. Large multicenter interventional clinical trials on T1DM are needed, and more attention should be paid to improve the publication and dissemination of clinical trials results.
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