To address these limitations, Ma et al. [7] proposed alternative criteria that broaden the diagnostic scope: (i) new-onset fulminant insulin-dependent diabetes or hyperglycemic crisis (e.g., DKA or hyperosmolar hyperglycemic state (HHS)); or (ii) unexplained worsening of pre-existing diabetes or prediabetes, defined as a >50% increase in fasting plasma glucose, the need for treatment escalation (e.g., addition of insulin or another agent), or the development of new-onset DKA, ketonuria, or ketonemia. This evidence concerns the gene INS and type 1 diabetes mellitus.