Table 2

Regulatory considerations for advancing precision medicine in T2DM

Stage of DiseaseScientific GapImplications
PreventionIdentification of specific mechanisms leading to disease (beyond clinical risks of obesity, diet, sedentary lifestyle)Prevention likely to remain diet and exercise in at-risk individuals particularly showing early signs of dysglycemia ± nontargeted use of hypoglycemic agents
TreatmentLack of data to inform matching of specific underlying disease characteristics in a given patient to optimal therapeutic approach
Predictive biomarkers for secondary complications (micro/macrovascular)
Therapy will remain guided by expert guidelines and empiric treatment
Would allow for tailoring of therapies not just to achieve a glycemic goal but to more precisely mitigate risks of long-term complications