Active Diabetes, Hormones & Metabolism NIHR-supported project Heart, Stroke & Blood

Pain Alleviation In diabetic Neuropathy using hybrid cLosEd loop inSulin pumpS: PAINLESS study

Funder NIHR (part of DHSC)
Recipient organisation NIHR Sheffield Biomedical Research Centre
NIHR support Recorded as supported by this research centre
Period Jan 2025 — Jan 2027

In plain English

AI plain-English summary

For people with painful diabetic neuropathy, standard painkillers often do not work well and come with harsh side effects, leaving many without effective relief. This pilot study tests a new approach: instead of treating the pain directly, it targets the underlying glucose instability that may drive it. Hybrid closed-loop insulin pumps—sometimes called artificial pancreas systems—automatically adjust insulin delivery to keep blood sugar steady. The researchers will give these pumps to a group of patients and compare their pain levels to a waitlist control group. If reducing glycaemic variability lowers pain intensity, it would open a treatment avenue that does not rely on drugs. That could change daily life for millions of people with diabetes who currently endure burning, stabbing, or shooting pain in their feet and legs—pain that disrupts sleep, mobility, and mood. The study is a feasibility trial, so its immediate impact is to show whether a larger, definitive trial is worth running. If the results are positive, it could shift clinical practice toward using glucose-stabilising technology as a pain management tool, not just a diabetes management tool.

View original technical description
Painful diabetic neuropathy is highly prevalent, causes substantial disability and deterioration in quality of life. The mainstay of treatment is pharmacotherapy but is limited by poor efficacy and tolerability. Based on the current trajectory of new drug developments, the emergence and clinical use of more effective compounds is highly unlikely in the next decade. Glycaemic variability (GV) has emerged as a novel, independent risk factor for diabetic neuropathy and correlates with neuropathic pain severity . This suggests that reduced GV could contribute to the treatment of painful diabetic neuropathy. However, no intervention study has been conducted to test this hypothesis to date. Hybrid closed-loop (HCL) insulin pumps have proven effective at stabilizing glucose levels, potentially mitigating GV. Hence, the main aim of this feasibility/pilot study is to evaluate whether reducing glycaemic variability using hybrid closed-loop insulin pumps can effectively reduce pain intensity in patients with painful diabetic neuropathy. The objectives to meet the aims of this study are: Primary objective: to evaluate the preliminary efficacy of reducing glycaemic variability using HCL insulin pumps on pain intensity compared to waitlist control in painful diabetic neuropathy

Researchers

Dinesh Selvarajah (Principal Investigator)

Related Research

Grants with similar aims, by meaning.

Quantifying Artificial Pancreas-related Changes in Diabetic Neuropathy
Optimal Pathway for TreatIng neurOpathic paiN in Diabetes Mellitus (OPTION-DM) trial
Computational AnalySiS of functionAl Neuroimaging and Drug Response in pAinful Diabetic Neuropathy (CASSANDRA-DN) - EME Development Funding Scheme
The Utility of Frequency-Modulated Electromagnetic Neural Stimulation (FREMS) as a Third Line Treatment in Patients with Painful Diabetes-Related Peripheral Neuropathy: A Randomised Controlled Trial
The Development of Contextual Cognitive Behavioural Approach to Painful Diabetic Neuropathy

Original classification

Cardiovascular Disease

Plain English summaries and category classifications on this site are generated by AI and may not perfectly reflect the original research.