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editorial
. 2015 Jul 24;183(1):1–7. doi: 10.1111/cei.12656

Table 1.

Recommendations for type 1 diabetes (T1D) research

Research stage Recommendation
Preclinical research • More detailed studies of human T1D pathology are needed
• Intensive investigation should be carried out into the disease cause/driver (other than autoimmunity) such as aberrant sensitivity of beta cells to metabolic stress, viruses, bacteria, etc.
• Biomarkers should be developed which could be used to map the natural history of T1D and therefore establish whether the disease follows a relapsing/remitting, primary progressive or secondary progressive time–course (or indeed whether the time course depends on the individual)
Phase 1 studies • Well‐powered studies are required to determine the optimal and rational combinations of therapies for treatment
• Surrogate markers of beta cell stress/loss need to be developed and tested (e.g. methylated insulin, non‐invasive imaging, immune biomarkers, etc.)
Phase 2 studies • Appropriately‐powered Phase 2 studies are required to account for T1D heterogeneity
• Biomarkers should be developed to enable the stratification of susceptible patient subsets
• Children should be enrolled unless there is any compelling argument (safety/mechanism) not to