Cardiovascular outcomes trial data from EMPA-REG OUTCOME, CAROLINA and CARMELINA: Assessment of a novel staging system for type 2 diabetes.

AIMS: To apply the diabetes staging system (DSS), a novel disease staging system similar to what is used in oncology but designed to improve diabetes management, to three large type 2 diabetes (T2D) cardiovascular (CV) outcome trials to assess whether increasing DSS stage was associated with higher rates of all-cause mortality (ACM) and/or CV death. MATERIALS AND METHODS: The DSS uses discrete CV events (none to ≥3: Stage 1 to 4), end-stage kidney disease (Stage 5) and microvascular complications (none to 3: A to D) to determine disease stage in individuals with T2D. The DSS stage for patients from the CAROLINA, EMPA-REG OUTCOME and CARMELINA trials was determined. Incidence rates for ACM/CV death were calculated across DSS stages and Cox regression analyses were performed. RESULTS: The risk of ACM or CV death increased with increasing DSS (Stage 1 to 5; P for trend <0.0001) in all trials. In CAROLINA, the risk of ACM and CV death increased with increasing number of microvascular complications (A to D; both P for trend <0.0001), similar in CARMELINA (P for trend = 0.0020 and 0.0005, respectively). In EMPA-REG OUTCOME, having all three microvascular complications (Stage D), versus none, increased the risk of ACM and CV death (P = 0.0015 and 0.0010, respectively). CONCLUSIONS: Applying the DSS across T2D clinical trial populations with different CV risk revealed a significantly increased risk of ACM and CV death with higher DSS stage. The DSS may merit assessment in other T2D populations and evaluation of the impact of additional outcomes, such as heart failure, could also be worthwhile.

TNM cancer staging: can it help develop a novel staging system for type 2 diabetes?

Type 2 diabetes (DM2) constitutes 90%-95% of the diabetes cases and is increasing at an alarming rate in the world. The Centers for Disease Control and Prevention (CDC) estimates that more than 29 million people in the United States have diabetes, which often causes mortality from macrovascular complications and morbidity from microvascular complications. Despite these troubling facts, there is currently no widely accepted staging system for DM2 like there is for cancer. TNM oncologic staging has taken a complex condition like cancer and conveyed likelihood of survival in simple alpha-numeric terms that both patients and providers can understand. Oncology is now entering the era of precision medicine where cancer treatment is increasingly being tailored to each patient's cancer. In contrast, DM2 lacks a staging system and remains a largely invisible disease even though it kills more Americans and costs more to treat than cancer. Is a comparable staging system for DM2 possible? We propose the Diabetes Staging System for DM2 that utilizes macrovascular events, microvascular complications, estimated glomerular filtration rate (GFR), and hemoglobin A1C to stage DM2.

Proactive Living: A Unique Model for the Promotion of Lifestyle Medicine.

Lifestyle medicine (LM) is a growing field focused on maintenance of health and reversal of chronic diseases; however, it is still unfamiliar to many as it lacks a mechanism to set itself apart from other medical specialties, which focus primarily on management of established diseases and their symptoms. Given that employers have many incentives to maintain and improve the health of their employees, the corporate wellness space (corporate wellness) represents a considerable opportunity for LM. Proactive Living, a company at the confluence of LM and corporate wellness, promotes and connects LM practitioners with employers and employees through a mobile app (PAL App). The app is designed to improve health literacy, encourage healthy lifestyle behaviors, and engage individuals in their own health, while simultaneously helping LM practitioners market LM and grow their practice.