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Comparison between a tubeless, on-body automated insulin delivery system and a tubeless, on-body sensor-augmented pump in type 1 diabetes: a multicentre randomised controlled trial

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Abstract

Aims/hypothesis

This study compares the efficacy and safety of a tubeless, on-body automated insulin delivery (AID) system with that of a tubeless, on-body sensor-augmented pump (SAP).

Methods

This multicentre, parallel-group, RCT was conducted at 13 tertiary medical centres in South Korea. Adults aged 19–69 years with type 1 diabetes who had HbA1c levels of <85.8 mmol/mol (<10.0%) were eligible. The participants were assigned at a 1:1 ratio to receive a tubeless, on-body AID system (intervention group) or a tubeless, on-body SAP (control group) for 12 weeks. Stratified block randomisation was conducted by an independent statistician. Blinding was not possible due to the nature of the intervention. The primary outcome was the percentage of time in range (TIR), blood glucose between 3.9 and 10.0 mmol/l, as measured by continuous glucose monitoring. ANCOVAs were conducted with baseline values and study centres as covariates.

Results

A total of 104 participants underwent randomisation, with 53 in the intervention group and 51 in the control group. The mean (±SD) age of the participants was 40±11 years. The mean (±SD) TIR increased from 62.1±17.1% at baseline to 71.5±10.7% over the 12 week trial period in the intervention group and from 64.7±17.0% to 66.9±15.0% in the control group (difference between the adjusted means: 6.5% [95% CI 3.6%, 9.4%], p<0.001). Time below range, time above range, CV and mean glucose levels were also significantly better in the intervention group compared with the control group. HbA1c decreased from 50.9±9.9 mmol/mol (6.8±0.9%) at baseline to 45.9±7.4 mmol/mol (6.4±0.7%) after 12 weeks in the intervention group and from 48.7±9.1 mmol/mol (6.6±0.8%) to 45.7±7.5 mmol/mol (6.3±0.7%) in the control group (difference between the adjusted means: −0.7 mmol/mol [95% CI −2.0, 0.8 mmol/mol] (−0.1% [95% CI −0.2%, 0.1%]), p=0.366). No diabetic ketoacidosis or severe hypoglycaemia events occurred in either group.

Conclusions/interpretation

The use of a tubeless, on-body AID system was safe and associated with superior glycaemic profiles, including TIR, time below range, time above range and CV, than the use of a tubeless, on-body SAP.

Trial registration

Clinical Research Information Service (CRIS) KCT0008398

Funding

The study was funded by a grant from the Korea Medical Device Development Fund supported by the Ministry of Science and ICT; the Ministry of Trade, Industry and Energy; the Ministry of Health and Welfare; and the Ministry of Food and Drug Safety (grant number: RS-2020-KD000056).

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Abbreviations

AID:

Automated insulin delivery

AP:

Artificial pancreas

CGM:

Continuous glucose monitoring

DTSQ:

Diabetes Treatment Satisfaction Questionnaire

DTSQc:

DTSQ change version

ITSQ:

Insulin Treatment Satisfaction Questionnaire

MDI:

Multiple daily insulin injections

SAP:

Sensor-augmented pump

TAR:

Time above range

TBR:

Time below range

TIR:

Time in range

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Authors and Affiliations

  1. Division of Endocrinology and Metabolism, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea

    Ji Yoon Kim, Sang-Man Jin & Jae Hyeon Kim

  2. Division of Endocrinology and Metabolism, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea

    Eun Seok Kang

  3. Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea

    Soo Heon Kwak

  4. Division of Endocrinology, Department of Internal Medicine, Seoul St Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea

    Yeoree Yang

  5. Division of Endocrinology and Metabolism, Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea

    Jee Hee Yoo

  6. Division of Endocrinology and Metabolism, Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Republic of Korea

    Jae Hyun Bae

  7. Division of Endocrinology and Metabolism, Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Republic of Korea

    Jun Sung Moon

  8. Division of Endocrinology and Metabolism, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea

    Chang Hee Jung

  9. Division of Endocrinology and Metabolism, Department of Medicine, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Republic of Korea

    Ji Cheol Bae & Sunghwan Suh

  10. Division of Endocrinology and Metabolism, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea

    Sun Joon Moon

  11. Division of Endocrinology and Metabolism, Department of Internal Medicine, National Health Insurance Service Ilsan Hospital, Goyang, Republic of Korea

    Sun Ok Song

  12. Department of Endocrinology and Metabolism, College of Medicine, Kyung Hee University, Seoul, Republic of Korea

    Suk Chon

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Correspondence to Jae Hyeon Kim.

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Acknowledgements

Some of the data were presented as an abstract at the 59th Annual Meeting of the EASD in 2023.

Data availability

Data are available from the corresponding author upon reasonable request.

Funding

This work was supported by a grant from the Korea Medical Device Development Fund funded by the Ministry of Science and ICT; the Ministry of Trade, Industry and Energy; the Ministry of Health and Welfare; and the Ministry of Food and Drug Safety (grant number: RS-2020-KD000056). The funding sources had no role in the design and conduct of the study; collection, management, analysis and interpretation of the data; preparation, review or approval of the manuscript; or decision to submit the manuscript for publication.

Author’s relationships and activities

The authors declare that there are no relationships or activities that might bias, or be perceived to bias, their work.

Contribution statement

S-MJ and JHK contributed to the conception and design of the study. JYK, S-MJ, ESK, SHK, YY, JHY, JHB, JSM, CHJ, JCB, SS, SJM, SOS, SC and JHK conducted data collection. JYK, S-MJ and JHK interpreted the results. JYK wrote the initial draft of the manuscript, with revisions by JYK, S-MJ and JHK. JYK, S-MJ, ESK, SHK, YY, JHY, JHB, JSM, CHJ, JCB, SS, SJM, SOS, SC and JHK contributed to reviewing the work critically for important intellectual content and approved the final version to be published. JHK is the guarantor of this work.

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Ji Yoon Kim and Sang-Man Jin contributed equally to this study as first authors.

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Kim, J.Y., Jin, SM., Kang, E.S. et al. Comparison between a tubeless, on-body automated insulin delivery system and a tubeless, on-body sensor-augmented pump in type 1 diabetes: a multicentre randomised controlled trial. Diabetologia 67, 1235–1244 (2024). https://doi.org/10.1007/s00125-024-06155-y

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