Table 6.

Selected unmet needs for further research and clinical development

Unmet research needs

Long-term rates of progression to stage 3 diabetes in IAb+ individuals without a family history of T1D and progression rates in adults and people of non-European ancestry. The impact of pregnancy in women who are IAb+ and the glycemic changes that may be evident during pregnancy and in the postpartum period, along with risks for progression to stage 3 T1D during and after pregnancy. Neonatal outcomes for infants of women who are IAb+ and the association with glycemic changes during pregnancy. Cost-effectiveness of monitoring strategies for individuals with early-stage T1D. Timing of insulin initiation in people with presymptomatic T1D, including short- and long-term metabolic and mental health outcomes of different strategies. Impact of education alone, independent of other monitoring activities, on frequency of DKA at diagnosis and presentation of T1D. Methods of identifying and monitoring behavioral health needs in early-stage T1D.

Unmet clinical needs

Comprehensive and consistent educational materials that use consistent language and vocabulary when referring to diabetes stages and risk, including translation into region-specific languages. This applies to all impacted people, from affected individuals to expert providers. Validated tools to measure the anxiety, depression, and other mental health behaviors that are specific to early-stage T1D. Sufficient availability of mental health professionals with expertise in T1D, including early-stage T1D in youth and adults. Knowledge and coverage of appropriate monitoring by stakeholders (insurers, clinicians, etc.). Timely access to expert HCPs and centers of expertise for intervention(s) to delay onset of stage 3 T1D.

The key principles presented in this table and in this consensus document will be subject to updating once additional evidence becomes available.

T1D, type 1 diabetes.