Pain alleviation in diabetic neuropathy using hybrid closed loop insulin pumps (PAINLESS) – A randomised crossover trial protocol

Simon Alexander Berry; Ahmed Iqbal; Jackie Elliott; Rajiv Gandhi; Abdul Paracha; Vaios Koutroukas; Mohummad Shaan Goonoo; Mahnoor Fatima Haq; Andrew Gerges; Gordon Sloan; Solomon Tesfaye; Pratik Choudhary; Dinesh Selvarajah

doi:10.1371/journal.pone.0357573

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Pain alleviation in diabetic neuropathy using hybrid closed loop insulin pumps (PAINLESS) – A randomised crossover trial protocol

Simon Alexander Berry ,

Contributed equally to this work with: Simon Alexander Berry, Ahmed Iqbal

Roles Conceptualization, Data curation, Investigation, Methodology, Project administration, Visualization, Writing – original draft, Writing – review & editing

* E-mail: d.selvarajah@sheffield.ac.uk (DS); simon.berry@sheffield.ac.uk (SAB)

Affiliations School of Medicine and Population Health, University of Sheffield, Sheffield, United Kingdom, Department of Diabetes and Endocrinology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom

https://orcid.org/0009-0007-9100-8778

⨯
Ahmed Iqbal ,

Contributed equally to this work with: Simon Alexander Berry, Ahmed Iqbal

Roles Conceptualization, Funding acquisition, Methodology, Supervision, Writing – review & editing

Affiliations School of Medicine and Population Health, University of Sheffield, Sheffield, United Kingdom, Department of Diabetes and Endocrinology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom
⨯
Jackie Elliott,

Roles Conceptualization, Resources, Supervision, Writing – review & editing

Affiliation Department of Diabetes and Endocrinology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom
⨯
Rajiv Gandhi,

Roles Conceptualization, Supervision, Writing – review & editing

Affiliation Department of Diabetes and Endocrinology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom
⨯
Abdul Paracha,

Roles Data curation, Investigation, Project administration

Affiliation Diabetes Research Centre, University of Leicester, Leicester, United Kingdom

https://orcid.org/0009-0008-3025-8703

⨯
Vaios Koutroukas,

Roles Data curation, Writing – review & editing

Affiliation Diabetes Research Centre, University of Leicester, Leicester, United Kingdom

https://orcid.org/0000-0001-6120-8057

⨯
Mohummad Shaan Goonoo,

Roles Investigation, Methodology, Resources

Affiliations School of Medicine and Population Health, University of Sheffield, Sheffield, United Kingdom, Department of Diabetes and Endocrinology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom

https://orcid.org/0000-0003-2793-309X

⨯
Mahnoor Fatima Haq,

Roles Data curation, Investigation

Affiliation Department of Diabetes and Endocrinology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom
⨯
Andrew Gerges,

Roles Data curation, Investigation

Affiliation Department of Diabetes and Endocrinology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom

https://orcid.org/0009-0006-3868-6388

⨯
Gordon Sloan,

Roles Conceptualization, Writing – review & editing

Affiliations School of Medicine and Population Health, University of Sheffield, Sheffield, United Kingdom, Department of Diabetes and Endocrinology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom
⨯
Solomon Tesfaye,

Roles Conceptualization, Methodology, Supervision, Writing – review & editing

Affiliations School of Medicine and Population Health, University of Sheffield, Sheffield, United Kingdom, Department of Diabetes and Endocrinology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom
⨯
Pratik Choudhary ,

Roles Conceptualization, Data curation, Funding acquisition, Investigation, Methodology, Resources, Supervision, Writing – review & editing

¶‡ These authors contributed equally to this work.

Affiliation Diabetes Research Centre, University of Leicester, Leicester, United Kingdom
⨯
Dinesh Selvarajah

Roles Conceptualization, Funding acquisition, Investigation, Methodology, Project administration, Resources, Supervision, Writing – original draft, Writing – review & editing

* E-mail: d.selvarajah@sheffield.ac.uk (DS); simon.berry@sheffield.ac.uk (SAB)

¶‡ These authors contributed equally to this work.

Affiliations School of Medicine and Population Health, University of Sheffield, Sheffield, United Kingdom, Department of Diabetes and Endocrinology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom
⨯

Pain alleviation in diabetic neuropathy using hybrid closed loop insulin pumps (PAINLESS) – A randomised crossover trial protocol

Simon Alexander Berry,
Ahmed Iqbal,
Jackie Elliott,
Rajiv Gandhi,
Abdul Paracha,
Vaios Koutroukas,
Mohummad Shaan Goonoo,
Mahnoor Fatima Haq,
Andrew Gerges,
Gordon Sloan

Published: September 8, 2026
https://doi.org/10.1371/journal.pone.0357573

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