Type 1 Diabetes Clinical Trial
Official title:
Towards Simple and Non-invasive Assessment of Residual Beta-cell Function in Type 1 Diabetes
Type 1 diabetes is condition in which progressive autoimmune destruction of
insulin-producing beta-cells leads to absolute insulin deficiency. At the time of clinical
presentation, it is estimated that 50-80% of beta-cell function has been lost. Good
glycaemic control from diagnosis has been shown to preserve beta-cell function. The recent
identification of immuno-interventions able to reduce autoimmune destruction and preserve
beta-cell function has lead to an increased urgency to develop such tools.
With mixed-meal stimulated serum C-peptide being a gold standard, there are currently no
tests that are suited for use in clinical practice to detect and monitor residual beta cell
function. There is a therefore a need for a test that is sufficiently sensitive to assess
beta cell function reserve in Type 1 diabetes for clinical practice purposes, which will be
simple, reproducible and suitable for use even in the non-observed setting.
Using mixed meal stimulation of plasma C-peptide (stable by-product in insulin secretion
that reliably reflects insulin production) response as a reference, we propose to compare
mixed meal stimulated urinary C-peptide as potential candidate for this application. This is
a pilot investigation in which a sample of 30 participants will be recruited.
It is anticipated that the current project will identify a simple method for analysing beta
cell reserve in Type 1 diabetes. This will then be applied to screening clinic populations
of recently diagnosed patients with type 1 diabetes. The aim will be to identify subjects
who may be suitable for early intensified insulin regimes (e.g. insulin pump therapy) and
novel immuno-intervention strategies designed to preserve residual beta cell function and
improve long-term outcomes. Currently such immunointervention has been reserved for subjects
within 3 months of diagnosis only, excluding a significant number of subjects who may
potentially benefit.
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Observational Model: Cohort, Time Perspective: Prospective
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