DH10--Notice of Intent to Sole Source Signos Continuous Glucose Monitoring - GLP 1 Alternative Pilot

Performance Work Statement DRAFT Purpose The Veterans Health Administration seeks to evaluate the Continuous Glucose Monitoring technology with an AI driven mobile application platform as a potential non-pharmacological intervention to support weight management and metabolic health among Veterans. This pilot is intended to address the needs of individuals who are not eligible for, have not responded to, or prefer to avoid pharmacologic treatments such as GLP-1 receptor agonists. The initiative will assess the feasibility and effectiveness of integrating Continuous Glucose Monitoring technology with an AI-driven mobile application to deliver real-time insights, support behavior change, and promote weight loss. The contractor will be responsible for full deployment, onboarding, ongoing support, and secure handling of Patient Generated Data in alignment with VA requirements. Throughout the pilot, key outcomes—including weight change, metabolic indicators, user engagement, and adherence—will be monitored to generate a comprehensive evaluation. The findings will inform the VA’s understanding of clinical impact, total cost per participant, and comparative value relative to GLP-1 therapies, supporting data-driven decisions regarding potential future adoption or expansion. Scope The purpose of this effort is to pilot and evaluate the Continuous Glucose Monitoring technology with an AI driven mobile application platform as a non-pharmacological solution for weight management and metabolic health among Veterans. The contractor shall provide all necessary personnel, equipment, software, and support services to deploy and operate a solution that combines Continuous Glucose Monitoring (CGM) devices with an AI-driven mobile application. The platform must enable real-time tracking of glucose response to food and deliver actionable insights to support behavior change and weight loss. The pilot will focus on Veterans who are not eligible for, have not responded to, or prefer to avoid pharmacologic treatments such as GLP-1 receptor agonists. The contractor shall ensure full deployment, participant onboarding, ongoing support, and secure collection of Patient Generated Data in accordance with VA requirements. Throughout the period of performance, the contractor shall monitor and report on key outcomes, including weight change, metabolic indicators (as available), user engagement, and adherence. At the conclusion of the pilot, the contractor shall provide a comprehensive evaluation that includes clinical outcomes, total cost per participant, and a cost-benefit comparison against GLP-1 treatment approaches, along with clear, data-driven recommendations regarding scalability and potential adoption within the VA system. -- 1 of 2 -- Data The Vendor shall provide participant onboarding and access to the Continuous Glucose Monitoring technology with an AI driven mobile application platform. During onboarding, the Vendor shall collect only the participant information necessary to establish user accounts and activate the Continuous Glucose Monitor (CGM) device. The platform shall collect and store participant-generated health data (PGHD), including CGM readings and participant-entered wellness information such as meals, exercise, sleep, and weight, for the purpose of providing metabolic health insights and coaching. The Vendor shall protect all participant information in accordance with applicable privacy, security, and contractual requirements. The Continuous Glucose Monitoring technology with an AI driven mobile application platform shall not connect to VA information systems or the VA Electronic Health Record (EHR), and no VA clinical data shall be transmitted to or accessed by the Vendor. All information collected by the platform shall be provided directly by participating Veterans. Based upon a review of the PWS/SOW and Appendix A as presented, the contractor will not have access to VA sensitive information or PII/PHI to fulfill the terms of the contract. A BAA will not be required. -- 2 of 2 --