Systems and methods for medical device settings initialization and adaptation

Inventors

Constantin, Alexandra E. • Trahan, Alexander • Fu, Larry • YARMOHAMMADI, Zahra

Assignees

Tandem Diabetes Care Inc

Abstract

Systems and methods implement algorithms for initializing medical devices, including by programming initial medical device settings. Further, systems and methods implement adaptive algorithms for changing medical device settings. Settings initialization algorithms can calculate the settings most likely to be applicable for the patient at-issue using databases of positive clinical outcomes and respective therapy settings for existing users. Settings adaptation algorithm are configured to update medical device therapy settings at one or more intervals including based on databases of positive clinical outcomes and respective therapy settings for existing users.

Core Innovation

The invention provides a system for programming a medical device that uses a patient population database to initialize therapy settings. The system receives at least one parameter from a user of the medical device, retrieves data from the patient population database including existing medical device settings and respective outcomes for existing other patients, and fits at least one distribution to the retrieved data. Based on the fitted distribution(s), the system selects a plurality of likely device settings and programs the medical device using the received parameter(s) and the selected plurality of likely device settings.

The invention further relates to adapting medical device settings by using operational data tied to a review period based on a most recent change to at least one medical device setting. During adaptation, the system retrieves operational data for the review period and segments the operational data into a plurality of influential settings. For at least one influential setting, the system calculates a mismatch based on at least one distribution from the patient population database and adjusts the influential setting when the probability of the influential setting is outside of a mismatch range.

The invention constrains the adjusted influential settings to determine adjusted medical device settings. The approach is directed to medical device therapy settings programming and adaptive updating, including settings such as TDI, daily basal requirement, CR, and ISF, and supports configuring the outcomes and device context as glycemic outcomes and a medical device such as an ambulatory infusion pump.

Claims Coverage

The provided independent claims include two inventive concepts: (i) programming a medical device using user parameters, patient population database data, distribution fitting, and selection of likely device settings; and (ii) adapting medical device settings using review-period operational data, segmentation into influential settings, distribution-based mismatch/probability evaluation, mismatch-range-triggered adjustment, and constraining to determine adjusted settings.

Across the independent claims, the core coverage is a distribution-driven initialization of likely device settings from a patient population database and a constrained, review-period mismatch/probability adaptation loop that segments operational data into influential settings and updates settings when probabilities fall outside a mismatch range.

Stated Advantages

Documented Applications

No documented applications found