DreaMed Advisor Pro

DreaMed Advisor Pro is a decision-support software intended to assist healthcare professionals in optimizing insulin pump therapy for Type 1 diabetes patients by analyzing CGM, SMBG, and insulin delivery data. Utilizing algorithmic analysis of this data, the device generates recommendations for basal rate, carbohydrate ratio, and correction factor adjustments, aiming to improve glycemic management based on established patterns and validated against expert opinion.

DreaMed Advisor Pro is a decision-support software designed for healthcare professionals to aid in the management of patients with Type 1 diabetes. It is intended for individuals aged 6 to 65 years who use insulin pumps with rapid-acting U-100 insulin analogs and monitor their glucose levels via Continuous Glucose Monitoring (CGM) and/or self-management blood glucose (SMBG) meters. The software gathers and analyzes information from qualified Diabetes Management Systems (DMS), including glucose readings, insulin dosing logs, and meal data collected during routine care. Its primary function is to generate recommendations for optimizing a patient’s insulin pump settings, specifically the basal rate, carbohydrate ratio (CR), and correction factor (CF), without considering the full clinical status of the patient, thus not replacing clinical judgment. Following data collection over a minimum of 12 valid days within a 21-day period, DreaMed Advisor Pro produces summary data and recommendations, which may also include advice on behavioral changes. These results are transmitted to the DMS for physician review, who can then approve, reject, or modify the suggestions before issuing an updated treatment plan. Non-clinical validation, including design testing and human factors studies, confirmed the device performs as intended. Retrospective clinical studies further demonstrated that the software's recommendations, even when based solely on SMBG data, were comparable in directional accuracy for basal, CR, and CF adjustments to those made by diabetes experts.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. What are the specific criteria for a "valid day" of data beyond the minimum glucose readings and insulin records, particularly concerning meal data integration?; How does the DreaMed Advisor Pro algorithm weigh CGM data versus SMBG data when both are available for generating insulin therapy recommendations?; What were the quantitative metrics used to determine that the DreaMed Advisor Pro's recommendations were "significantly as good as" those of experts in the retrospective clinical study?; Could you elaborate on the types of "behavioral changes" the software might suggest and the evidence base supporting these non-pharmacological recommendations?; What safeguards or logic are in place if the inputted insulin pump settings are already outside the device's specified "acceptable range" for basal rate, CR, or CF at the time of analysis?