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Current landscape of type 1 diabetes mellitus-related interventional clinical trials registered on ClinicalTrials.gov: a cross-sectional study

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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.

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Data availability

The data that support the findings of this study are available from the corresponding author upon reasonable request.

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Funding

This work was financially supported by the Research Fund of Medical Science and Technology of Guangdong Province (Grant Number: A2020132).

Author information

Author notes

  1. Ruiming Liang and Jianyan Long have contributed equally to this study.

Authors and Affiliations

  1. Clinical Trials Unit, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, 510080, China

    Ruiming Liang, Jianyan Long & Yihao Liu

  2. Department of Endocrinology, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, 510080, China

    Qiuyi Zheng, Xinwen Chen, Fenghua Lai & Yihao Liu

  3. Phase I Clinical Trial Center, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, 510080, China

    Gang Yuan

  4. Department of Medical Records, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, 510080, China

    Ziyi Xin

Authors
  1. Ruiming Liang
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  4. Gang Yuan
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  7. Fenghua Lai
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  8. Yihao Liu
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Contributions

YL and FL designed and supervised the study. JL, RL, and FL collected the data, conducted the data analysis, and wrote the draft manuscript. YL performed critical revision on the manuscript. QZ, GY, ZX, and XC participated in the critical revision of the manuscript. All authors approved the final version before submission.

Corresponding authors

Correspondence to Fenghua Lai or Yihao Liu.

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This work does not contain any studies with human or animal subjects performed by the any of the authors.

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Liang, R., Long, J., Zheng, Q. et al. Current landscape of type 1 diabetes mellitus-related interventional clinical trials registered on ClinicalTrials.gov: a cross-sectional study. Acta Diabetol 58, 723–733 (2021). https://doi.org/10.1007/s00592-020-01627-0

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  • DOI: https://doi.org/10.1007/s00592-020-01627-0

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