A Specialized Risk-Stratification Platform and Tailored Diabetes Prevention Program for Post-Partum to Reduce Progression to Type 2 Diabetes - Gestational diabetes mellitus (GDM) refers to the development of hyperglycemia in pregnant women who did not exhibit diabetic symptoms before pregnancy. GDM affects nearly 25% of pregnancies each year and imposes an annual cost burden of up to $1.6 billion in the U.S. Further, approximately 70% of women diagnosed with GDM eventually develop Type 2 diabetes (T2D) after childbirth, with disproportionately higher progression among certain subpopulations. A recent study showed a fourfold increased risk of T2D after GDM among Black individuals, and a threefold increased risk among Hispanic and South/Southeast Asian individuals relative to White individuals. Barriers such as transportation challenges, health literacy, and language obstacles at the time of delivery explain 46% of the increased risk of postpartum diabetes among Hispanic people, 72% among Black people, and 14% among South/Southeast Asian people, creating a critical window for early intervention to reduce lifelong cardio-metabolic risk. Current GDM care involves manual logging of meals and glucose readings, often leading to incomplete data and hindering treatment accuracy. This often results in missing data from forgotten paper logs, which limits physicians’ ability to assess conditions and adjust treatments effectively. While existing large-scale lifestyle modification studies have demonstrated sustained reductions in T2D conversion rates, current remote monitoring technologies fall short of maternal-fetal medicine needs, often lacking contextual information such as glucose ranges specific to gestation and postpartum stages, and failing to adequately serve the broad spectrum of the community facing elevated postpartum risk for T2D. The lack of a data-tracking system and comprehensive database hampers the development of predictive analytics for postpartum risk stratification. Therefore, there is a compelling need to shift current approaches by tailoring diabetes prevention programs (DPPs) to the unique requirements of the post-GDM population to maximize effectiveness in preventing diabetes and improving cardiometabolic health in the long term. Malama has developed a HIPAA-compliant and electronic health record (EHR)-integrated, web-based dashboard for providers to monitor patients in real time and remotely through the use of patient kits, including FDA-cleared devices like continuous blood glucose monitors (CGMs), blood glucose meters (BGMs), lancets, and test strips. These medical devices can be paired with Malama’s smartphone application to support access for patients regardless of location, as providers are able to monitor patients remotely. In Phase I of this SBIR Fast-Track application, Malama Health intends to utilize existing post-GDM management data with newly collected data from subpopulations at higher risk of T2D to develop a method of risk stratification for postpartum women previously diagnosed with GDM. This stratification method will be tested and validated using an independent cohort not used for algorithm training. In Phase II, Malama Health will create a first-of-its-kind post-GDM DPP based on individual risk profiles and determine whether these comprehensive interventions can prevent T2D development among the GDM-diagnosed, postpartum population.
