Controlled Study of Exhaled breath in type 1 diabetes
Research type
Research Study
Full title
A randomized controlled study to evaluate non-invasive measurement of plasma glucose from exhaled breath by using mass spectrometry in type 1 diabetes.
IRAS ID
132767
Contact name
Mark L. Evans
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge
Research summary
Effective management of diabetes mellitus, affecting tens of millions of patients, requires frequent assessment of plasma glucose which is costly, invasive and expensive (approximately $ 6 billion per annum). Despite 25 years of research looking for a non-invasive alternative, current self-monitoring requires patients to pierce their skin regularly to obtain samples of blood or interstitial fluid. Compliance with regular self-monitoring may be a clinical challenge because of the relative unpleasantness of these current methodologies.
In previous work, we and others have explored the potential for volatile organic compounds (VOCs) in exhaled breath as an alternative, non-invasive indicator of blood glucose/ metabolism. In these “proof of concept” studies, changes in exhaled breath were identified but, importantly, there are potential scientific confounders with all of the work reported to date including our own.
In particular, a significant confounder may be the effects of insulin independent of changes in blood glucose. Here, we aim to examine changes in VOCs with a series of blood glucose alterations achieved experimentally by using the technique of insulin clamping in volunteers with type 1 diabetes (T1D). The study will consist of 2 separate study days in the Addenbrookes Clinical Research Centre, during which circulating insulin and glucose levels will be carefully controlled. Importantly, one of these study days will be a control arm where plasma glucose will be maintained at baseline levels and the other an intervention arm where glucose is altered. By measuring changes in exhaled breath regularly and comparing the 2 studies, this will allow us to determine whether changes are attributable to alterations in plasma glucose.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
13/EE/0340
Date of REC Opinion
18 Oct 2013
REC opinion
Favourable Opinion