---
title: "PAINLESS trial protocol: Hybrid closed‑loop insulin pumps for painful diabetic neuropathy"
id: "pubmed-42709726"
canonical_url: "https://medichelpline.com/clinical-feed/pubmed-42709726"
content_type: "clinical_feed_article"
specialty: "Pharmacology"
source_name: "PubMed / NCBI"
source_url: "https://pubmed.ncbi.nlm.nih.gov/42709726/"
doi: "10.1371/journal.pone.0357573"
published_at: "2026-09-08T00:00:00.000Z"
evidence_level: "Journal Article"
license: "CC-BY-NC-4.0 / Informational Use"
---
# PAINLESS trial protocol: Hybrid closed‑loop insulin pumps for painful diabetic neuropathy
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/pubmed-42709726
- **Specialty:** [Pharmacology](https://medichelpline.com/clinical-feed/pharmacology.md)
- **Primary Source:** PubMed / NCBI
- **Source URL:** [Original Journal Publication](https://pubmed.ncbi.nlm.nih.gov/42709726/)
- **DOI:** [10.1371/journal.pone.0357573](https://doi.org/10.1371%2Fjournal.pone.0357573)
- **Published At:** 2026-09-08T00:00:00.000Z
- **Evidence Rating:** Journal Article
## Executive GIST (TL;DR)
- Painful diabetic neuropathy (PDN) is a common diabetes complication that causes substantial morbidity. Emerging evidence links **glycaemic variability** with fluctuations in pain intensity. - The PAINLESS trial is a two-centre, randomised crossover protocol designed to test whether reducing glycaemic variability with **hybrid closed loop (HCL)** insulin delivery affects pain intensity in people with type 1 diabetes and PDN. - Forty-nine adults with type 1 diabetes and PDN will each complete two 12-week intervention periods in randomized sequence: (1) standard care including **continuous glucose monitoring (CGM)**, and (2) HCL using the **Tandem t:slim X2** insulin pump with **Control‑IQ** technology. - The primary outcome is change in 7‑day average 24‑hour pain intensity on a 0–10 numerical rating scale (NRS) from baseline to the end of each 12‑week period, collected via daily pain diaries. - Secondary endpoints include responder rates (≥30% and ≥50% reduction in 7‑day NRS), area under the curve (AUC) for daily NRS scores, functional and quality‑of‑life measures (SF‑36, BPI‑MSF), mood (Beck Depression Inventory), health status (EQ‑5D‑5L), and participant/clinician global impression of change. - Exploratory outcomes include neurophysiological tests (Sudoscan, DPN‑Check, Vagus and Vibrosense) and sleep/activity monitoring from Withings devices. - The trial uses an intention‑to‑treat framework and mixed effect models for statistical analysis. Responder and trajectory analyses are planned. Exact statistical details were not reported in the abstract. - The planned timeline is 24 months total: 18 months recruitment and follow up, plus 6 months for close‑out, analyses and dissemination. The study is registered as ISRCTN24233750. - Conflict of interest disclosures are reported for several authors, including industry-funded travel grants, investigator funding, honoraria, and research support; the abstract lists specific relationships for named investigators.
## Clinical Analysis & Structured Key Points
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A randomised crossover trial protocol [Simon Alexander Berry](https://pubmed.ncbi.nlm.nih.gov/?term=Berry+SA&cauthor_id=42709726)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42709726/#full-view-affiliation-1 "School of Medicine and Population Health, University of Sheffield, Sheffield, United Kingdom.")[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42709726/#full-view-affiliation-2 "Department of Diabetes and Endocrinology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom."), [Ahmed Iqbal](https://pubmed.ncbi.nlm.nih.gov/?term=Iqbal+A&cauthor_id=42709726)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42709726/#full-view-affiliation-1 "School of Medicine and Population Health, University of Sheffield, Sheffield, United Kingdom.")[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42709726/#full-view-affiliation-2 "Department of Diabetes and Endocrinology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom."), [Jackie Elliott](https://pubmed.ncbi.nlm.nih.gov/?term=Elliott+J&cauthor_id=42709726)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42709726/#full-view-affiliation-2 "Department of Diabetes and Endocrinology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom."), [Rajiv Gandhi](https://pubmed.ncbi.nlm.nih.gov/?term=Gandhi+R&cauthor_id=42709726)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42709726/#full-view-affiliation-2 "Department of Diabetes and Endocrinology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom."), [Abdul Paracha](https://pubmed.ncbi.nlm.nih.gov/?term=Paracha+A&cauthor_id=42709726)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42709726/#full-view-affiliation-3 "Diabetes Research Centre, University of Leicester, Leicester, United Kingdom."), [Vaios Koutroukas](https://pubmed.ncbi.nlm.nih.gov/?term=Koutroukas+V&cauthor_id=42709726)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42709726/#full-view-affiliation-3 "Diabetes Research Centre, University of Leicester, Leicester, United Kingdom."), [Mohummad Shaan Goonoo](https://pubmed.ncbi.nlm.nih.gov/?term=Goonoo+MS&cauthor_id=42709726)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42709726/#full-view-affiliation-1 "School of Medicine and Population Health, University of Sheffield, Sheffield, United Kingdom.")[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42709726/#full-view-affiliation-2 "Department of Diabetes and Endocrinology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom."), [Mahnoor Fatima Haq](https://pubmed.ncbi.nlm.nih.gov/?term=Haq+MF&cauthor_id=42709726)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42709726/#full-view-affiliation-2 "Department of Diabetes and Endocrinology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom."), [Andrew Gerges](https://pubmed.ncbi.nlm.nih.gov/?term=Gerges+A&cauthor_id=42709726)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42709726/#full-view-affiliation-2 "Department of Diabetes and Endocrinology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom."), [Gordon Sloan](https://pubmed.ncbi.nlm.nih.gov/?term=Sloan+G&cauthor_id=42709726)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42709726/#full-view-affiliation-1 "School of Medicine and Population Health, University of Sheffield, Sheffield, United Kingdom.")[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42709726/#full-view-affiliation-2 "Department of Diabetes and Endocrinology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom."), [Solomon Tesfaye](https://pubmed.ncbi.nlm.nih.gov/?term=Tesfaye+S&cauthor_id=42709726)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42709726/#full-view-affiliation-1 "School of Medicine and Population Health, University of Sheffield, Sheffield, United Kingdom.")[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42709726/#full-view-affiliation-2 "Department of Diabetes and Endocrinology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom."), [Pratik Choudhary](https://pubmed.ncbi.nlm.nih.gov/?term=Choudhary+P&cauthor_id=42709726)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42709726/#full-view-affiliation-3 "Diabetes Research Centre, University of Leicester, Leicester, United Kingdom."), [Dinesh Selvarajah](https://pubmed.ncbi.nlm.nih.gov/?term=Selvarajah+D&cauthor_id=42709726)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42709726/#full-view-affiliation-1 "School of Medicine and Population Health, University of Sheffield, Sheffield, United Kingdom.")[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42709726/#full-view-affiliation-2 "Department of Diabetes and Endocrinology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom.") Affiliations Expand ### Affiliations * 1 School of Medicine and Population Health, University of Sheffield, Sheffield, United Kingdom. * 2 Department of Diabetes and Endocrinology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom. * 3 Diabetes Research Centre, University of Leicester, Leicester, United Kingdom. * PMID: **42709726** * DOI: [ 10.1371/journal.pone.0357573 ](https://doi.org/10.1371/journal.pone.0357573) Item in Clipboard # Pain alleviation in diabetic neuropathy using hybrid closed loop insulin pumps (PAINLESS) - A randomised crossover trial protocol Simon Alexander Berry et al. PLoS One. 2026. Show details Display options Display options Format Abstract PubMed PMID PLoS One Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22PLoS+One%22%5Bjour%5D&sort=date&sort_order=desc) * [ Search in NLM Catalog ](https://www.ncbi.nlm.nih.gov/nlmcatalog?term=%22PLoS+One%22%5BTitle+Abbreviation%5D) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42709726/) . 2026 Sep 8;21(9):e0357573. doi: 10.1371/journal.pone.0357573. eCollection 2026. ### Authors [Simon Alexander Berry](https://pubmed.ncbi.nlm.nih.gov/?term=Berry+SA&cauthor_id=42709726)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42709726/#short-view-affiliation-1 "School of Medicine and Population Health, University of Sheffield, Sheffield, United Kingdom.")[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42709726/#short-view-affiliation-2 "Department of Diabetes and Endocrinology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom."), [Ahmed Iqbal](https://pubmed.ncbi.nlm.nih.gov/?term=Iqbal+A&cauthor_id=42709726)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42709726/#short-view-affiliation-1 "School of Medicine and Population Health, University of Sheffield, Sheffield, United Kingdom.")[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42709726/#short-view-affiliation-2 "Department of Diabetes and Endocrinology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom."), [Jackie Elliott](https://pubmed.ncbi.nlm.nih.gov/?term=Elliott+J&cauthor_id=42709726)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42709726/#short-view-affiliation-2 "Department of Diabetes and Endocrinology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom."), [Rajiv Gandhi](https://pubmed.ncbi.nlm.nih.gov/?term=Gandhi+R&cauthor_id=42709726)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42709726/#short-view-affiliation-2 "Department of Diabetes and Endocrinology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom."), [Abdul Paracha](https://pubmed.ncbi.nlm.nih.gov/?term=Paracha+A&cauthor_id=42709726)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42709726/#short-view-affiliation-3 "Diabetes Research Centre, University of Leicester, Leicester, United Kingdom."), [Vaios Koutroukas](https://pubmed.ncbi.nlm.nih.gov/?term=Koutroukas+V&cauthor_id=42709726)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42709726/#short-view-affiliation-3 "Diabetes Research Centre, University of Leicester, Leicester, United Kingdom."), [Mohummad Shaan Goonoo](https://pubmed.ncbi.nlm.nih.gov/?term=Goonoo+MS&cauthor_id=42709726)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42709726/#short-view-affiliation-1 "School of Medicine and Population Health, University of Sheffield, Sheffield, United Kingdom.")[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42709726/#short-view-affiliation-2 "Department of Diabetes and Endocrinology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom."), [Mahnoor Fatima Haq](https://pubmed.ncbi.nlm.nih.gov/?term=Haq+MF&cauthor_id=42709726)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42709726/#short-view-affiliation-2 "Department of Diabetes and Endocrinology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom."), [Andrew Gerges](https://pubmed.ncbi.nlm.nih.gov/?term=Gerges+A&cauthor_id=42709726)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42709726/#short-view-affiliation-2 "Department of Diabetes and Endocrinology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom."), [Gordon Sloan](https://pubmed.ncbi.nlm.nih.gov/?term=Sloan+G&cauthor_id=42709726)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42709726/#short-view-affiliation-1 "School of Medicine and Population Health, University of Sheffield, Sheffield, United Kingdom.")[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42709726/#short-view-affiliation-2 "Department of Diabetes and Endocrinology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom."), [Solomon Tesfaye](https://pubmed.ncbi.nlm.nih.gov/?term=Tesfaye+S&cauthor_id=42709726)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42709726/#short-view-affiliation-1 "School of Medicine and Population Health, University of Sheffield, Sheffield, United Kingdom.")[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42709726/#short-view-affiliation-2 "Department of Diabetes and Endocrinology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom."), [Pratik Choudhary](https://pubmed.ncbi.nlm.nih.gov/?term=Choudhary+P&cauthor_id=42709726)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42709726/#short-view-affiliation-3 "Diabetes Research Centre, University of Leicester, Leicester, United Kingdom."), [Dinesh Selvarajah](https://pubmed.ncbi.nlm.nih.gov/?term=Selvarajah+D&cauthor_id=42709726)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42709726/#short-view-affiliation-1 "School of Medicine and Population Health, University of Sheffield, Sheffield, United Kingdom.")[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42709726/#short-view-affiliation-2 "Department of Diabetes and Endocrinology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom.") ### Affiliations * 1 School of Medicine and Population Health, University of Sheffield, Sheffield, United Kingdom. * 2 Department of Diabetes and Endocrinology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom. * 3 Diabetes Research Centre, University of Leicester, Leicester, United Kingdom. * PMID: **42709726** * DOI: [ 10.1371/journal.pone.0357573 ](https://doi.org/10.1371/journal.pone.0357573) Item in Clipboard Cite Display options Display options Format Abstract PubMed PMID ## Abstract **Introduction:** Painful diabetic neuropathy (PDN) is a common complication of diabetes that leads to significant co-morbidity. Emerging evidence suggests glycaemic variability may be linked to fluctuations in pain intensity. Hybrid closed loop (HCL) systems reduce glycaemic variability, raising the possibility that they may modify pain intensity. This study aims to evaluate the effects of HCL use on pain intensity in people with PDN. **Materials and methods:** PAINLESS is a two-centre, randomised cross-over study, recruiting 49 adults with type 1 diabetes and PDN. Each participant will complete two 12-week intervention periods in a randomised sequence (1:1): one with standard care including continuous glucose monitoring (CGM) and one with HCL using the Tandem t:slim X2 insulin pump with Control-IQ technology. The primary outcome is the change in 7-day average 24-hour pain intensity [rated on a numerical scale from 0-10 (NRS)] from baseline to the end of each 12-week intervention period as measured by daily pain diaries. Secondary outcomes include measures of pain trajectory/durability [responder rates (30% and 50% pain reduction in 7-day NRS), and the AUC for daily NRS scores], functional and quality of life outcomes [Short Form Health Survey (SF-36), and Short Form of the Brief Pain Inventory (BPI-MSF)], mood [Beck Depression Inventory (BDI)], health status [EQ-5D-5L], and global improvement [participant and clinician reported global impression of change]. Exploratory endpoints will harness neurophysiological assessments including Sudoscan, DPN-Check, Vagus and Vibrosense, and sleep and activity data from Withings devices. Statistical analyses will employ an intention-to-treat approach and mixed effect models. **Timelines:** 24-month trial: 18 months recruitment/follow up, 6 months close-out, analyses and dissemination. **Registration details:** ISRCTN24233750. Copyright: © 2026 Berry et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. [PubMed Disclaimer](https://pubmed.ncbi.nlm.nih.gov/disclaimer/) ## Conflict of interest statement I have read the journal’s policy and the authors of this manuscript have the following competing interests: S.A.B. has received charity-funded travel grants sponsored by Abbott and Eli Lilly. A.I. has received investigator-led funding from Dexcom and Abbott, and has received honoraria from Eli Lilly, Novo Nordisk, Sanofi, Boehringer Ingelheim, Ypsomed, and Diiachi Sankyo as speaker fees. J.E. has received educational / speaker fees from Abbott, Boehringer, Dexcom, Glooko, Insulet, Lilly, Medtronic, Novo Nordisk, Roche, Sanofi, and Ypsomed, and research support from Dexcom. V.K. has received a travel grant from KelCon GmbH, and has received charity-funded travel grants funded by Lilly. G.S has received honoraria from Procter and Gamble, Viat
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