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Background <p>Decentralized Clinical Trials (DCT) is an emerged transformative approach in clinical research which incorporates both remote monitoring of the study and home-based activity. DCT enhances recruitment and retention compared to traditional method by activity. DCT enhances recruitment and retention compared to traditional method by activity. DCT enhances recruitment and retention compared to traditional method by disease like T2D remains unexplored in India. Understanding patient’s perception plays a vital role in implementing DCT model.</p> Objective <p>To evaluate the awareness about decentralized clinical trials (DCT) in participants with type 2 diabetes.</p> Methods <p>The observational study evaluated awareness of decentralized clinical trials (DCT) among patients with type 2 diabetes mellitus who participated in clinical trials between January 2022 and July 2024. One hundred participants (age ≥ 18 years) were interviewed during August–October 2024 at Madras Diabetes Research Foundation (MDRF), Chennai, after obtaining Institutional Ethics Committee clearance. Socio-demographic and economic details were obtained by means of a self-constructed Decentralized Insight Survey (DEZIRE) after obtaining informed consent. Data were analyzed using IBM SPSS (Version 27.0).</p> Results <p>The mean age of the participants was 53 ± 9&#xa0;years, and 53% of them were male. Based on the modified Kuppusamy scale (2022), 27% belonged to the lower middle class. Only 22% of the participants were familiar with decentralized clinical trials (DCT), and 30% of the participants preferred DCTs. Factor analysis (KMO = 0.607; Bartlett’s <i>p</i> &lt; 0.001) revealed five factors accounting for 65% of the variance.</p> Conclusion <p>Awareness of decentralized clinical trials (DCT) among type 2 diabetes patients was limited, even with strong preference for remote and hybrid model trials. Factors such as socioeconomic status, comfort with technology, and COVID-19 pandemic experiences influenced the participant’s perception. These results highlight the need for education and support to increase patient interaction with decentralized trial approaches.</p>

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Awareness of Decentralized Clinical Trials (DCT) in patients with type 2 diabetes

  • 期刊论文

  • 发表日期：

    2025年10月26日

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  • Subramani Poongothai,
  • Ranjit Mohan Anjana,
  • Govindan Sri Abinaya,
  • Ulagamathesan Venkatesan,
  • Viswanathan Mohan

摘要

Background

Decentralized Clinical Trials (DCT) is an emerged transformative approach in clinical research which incorporates both remote monitoring of the study and home-based activity. DCT enhances recruitment and retention compared to traditional method by activity. DCT enhances recruitment and retention compared to traditional method by activity. DCT enhances recruitment and retention compared to traditional method by disease like T2D remains unexplored in India. Understanding patient’s perception plays a vital role in implementing DCT model.

Objective

To evaluate the awareness about decentralized clinical trials (DCT) in participants with type 2 diabetes.

Methods

The observational study evaluated awareness of decentralized clinical trials (DCT) among patients with type 2 diabetes mellitus who participated in clinical trials between January 2022 and July 2024. One hundred participants (age ≥ 18 years) were interviewed during August–October 2024 at Madras Diabetes Research Foundation (MDRF), Chennai, after obtaining Institutional Ethics Committee clearance. Socio-demographic and economic details were obtained by means of a self-constructed Decentralized Insight Survey (DEZIRE) after obtaining informed consent. Data were analyzed using IBM SPSS (Version 27.0).

Results

The mean age of the participants was 53 ± 9 years, and 53% of them were male. Based on the modified Kuppusamy scale (2022), 27% belonged to the lower middle class. Only 22% of the participants were familiar with decentralized clinical trials (DCT), and 30% of the participants preferred DCTs. Factor analysis (KMO = 0.607; Bartlett’s p < 0.001) revealed five factors accounting for 65% of the variance.

Conclusion

Awareness of decentralized clinical trials (DCT) among type 2 diabetes patients was limited, even with strong preference for remote and hybrid model trials. Factors such as socioeconomic status, comfort with technology, and COVID-19 pandemic experiences influenced the participant’s perception. These results highlight the need for education and support to increase patient interaction with decentralized trial approaches.