News

Diabetes patients denied trials

Published 11 June 2013

A leading University of Brighton diabetes expert today called for more nationwide trials to find a cure for the disease.

It came from Professor Adrian Bone who chaired a roundtable discussion on beta cell renewal – seen as major prospect for helping the UK's 400,000 type 1 patients restart their own insulin production.

He said his group of leading UK and European type 1 diabetes researchers identified current barriers to clinical trials that should be broken down to alleviate this "distressing and debilitating" condition.

His call comes on the eve of Diabetes Week (9-15 June) and echoes the findings of JDRF, the type 1 diabetes charity which claims people with type 1 diabetes are being denied the opportunity to join trials. A JDRF survey has revealed 72 per cent of supporters of the charity who live with the condition have never been informed about medical research at all by their clinicians.

JDRF's report, which Professor Bone contributed to, will be launched at the House of Commons this week (Wednesday 12 June).

Adrian Bone, Professor of Cell and Molecular Biology, leads a University of Brighton team of internationally renowned scientists working at the cutting edge of diabetes research.

He said his UK and European roundtable team concluded: "There is a need to improve links between type 1 diabetes care in children and adults – this would facilitate the recruitment of people with newly diagnosed type 1 diabetes into trials, an important consideration since at this time many patients retain a variable degree of preserved beta-cell function.

"This so-called 'honeymoon period' offers an opportunity to seek to preserve insulin secretory capacity in individual patients for as long as possible, with the additional benefit that it would help researchers to better understand factors governing the deterioration of beta-cell function following diagnosis of type 1 diabetes."

He added: "We need a pan-European clinical trial network, working with industry, and this would greatly improve the opportunities for type 1 diabetes patients to become involved in interventional trials."

The type 1 diabetes charity, JDRF, surveyed more than 800 UK residents living with type 1 diabetes, revealing that 77 per cent have never been given the opportunity by their clinical team to take part in a study to improve medical understanding of the condition. This is despite an overwhelming 96 per cent of those denied the opportunity stating they would be potentially willing to take part in a clinical trial.

Furthermore, 72 per cent of those with type 1 diabetes said they had had not even once been told about medical research by their clinical team.

Participation in UK clinical trials across all areas of medicine is overall on the increase. The chief medical officer, Professor Dame Sally Davies, announced last month that between 15 and 20 per cent of cancer patients are now entering trials, due to a high proportion being invited to do so. But rates vary significantly from condition to condition. JDRF analysis* estimates that less than three per cent of those living with type 1 diabetes are currently taking part in a trial.

*Based upon National Institute for Health Research/ UK Diabetes Research Network data.

This is despite pledges to put medical research at the heart of the changing NHS - and to recognise clinical trials as the lynchpin of the process of developing better treatment, and cures, for diseases and life-threatening chronic conditions such as type 1 diabetes. The Health and Social Care Act 2012 set out the ambition that any willing patient should be offered the chance to participate in clinical research.

Type 1 diabetes, which affects an estimated 400,000 people in the UK, is on the increase. Incidences are increasing most rapidly in children under-five, at a rate of five per cent each year – making the need to support research into the condition more urgent than ever. Type 1 diabetes cannot be prevented by adopting a healthy diet or lifestyle, and those diagnosed require insulin treatment via injections or a pump every day, for the rest of their lives, simply to stay alive. In 2011 type 1 diabetes cost the UK nearly £2bn in direct and indirect costs.

The new statistics were released by JDRF in the countdown to Diabetes Week (9 -15 June). On June 12, JDRF will release the findings of its Type 1 Diabetes Research Roadmap project, which has brought together many of the UK's top type 1 diabetes researchers, including Brighton's Professor Bone, and their counterparts in Europe in a bid to identify why the cure for the condition remains elusive.

The project's final report will state that "the last two decades have seen extraordinary advances in research into type 1," but adds that "type 1 research in the UK still suffers from several significant weaknesses." It highlights that "despite concerted efforts to increase both the quality and quantity of clinical trials … many people with type 1 are still not being routinely offered trials in which to participate."

It adds: "The regulatory steps that must be undertaken to get a clinical trial up and running in the UK are perceived to be some of the most arduous in the world. This reduces the attractiveness of UK research centres and hospitals as settings for clinical trials."

Karen Addington, CEO of JDRF, said: "Until just nine decades ago when insulin was discovered, every single person who developed type 1 diabetes died in a number of weeks or months. It is time now to push on towards finding the cure. But this lack of clinical trial opportunities for those living with type 1 diabetes is a huge obstacle on the path to curing this condition. Government must work with researchers, funders and patient groups to implement the recommendations that will allow the NHS to meet the ambition of putting research and innovation at its heart."

JDRF is also supporting the Okay To Ask campaign, from the National Institute for Health Research (NIHR), which encourages patients to ask about participating in research studies including clinical trials.