US-12622622-B2 - Blood glucose states based on sensed brain activity

US12622622B2US 12622622 B2US12622622 B2US 12622622B2US-12622622-B2

Abstract

Blood glucose states based at least on sensed brain activity data. Blood glucose states may be predicted states using prediction models, and may be real-time or future glucose states. One or more wearable sensors, optionally adapted for use in either single channel or dual channel sensing, can record brain activity signals and communicate brain activity signal data to a remote device.

Inventors

Casey HALPERN
Emily Mirro
Cammie ROLLE
Emmanuel Dumont

Assignees

SYNCHNEURO, INC.

Dates

Publication Date: 20260512
Application Date: 20240301

Claims (2)

1 . A method of predicting a glucose state of a subject, comprising: during an initial subject process that includes time while the subject is asleep, non-invasively sensing personal brain activity or information indicative thereof from the subject with a wearable sensor sized and configured to be positioned at a behind an ear or forehead location, the wearable sensor configured to wirelessly communicate to a second device in wireless communication with the wearable sensor; receiving or generating personal glucose information of the subject using a glucose sensor being worn by the subject while the subject is wearing the wearable sensor, the glucose sensor worn at a location different than the wearable sensor; and creating a personalized prediction model using at least the personal brain activity or information indicative thereof and the received or generated personal glucose information, the personalized prediction model adapted to predict a future predicted glucose state; at a time subsequent to the initial subject process, and while the subject is asleep, sensing personal brain activity or information indicative thereof from the subject with the wearable sensor; predicting, using the personalized prediction model, the personal future predicted glucose state of the subject based at least partially on the subsequently sensed personal brain activity or information indicative thereof; and outputting instructions that create a visual display on a subject device that is indicative of the personal future predicted glucose state.
2 . A method of predicting a glucose state of a subject, comprising: during an initial subject process that includes time only when the subject is asleep, non-invasively sensing personal brain activity or information indicative thereof from the subject with a wearable sensor configured to be positioned at a behind an ear or forehead location, the wearable sensor configured to wirelessly communicate to a second device in wireless communication with the wearable sensor; receiving or generating personal glucose information of the subject using a glucose sensor that is worn by the subject while the subject is wearing the wearable sensor, the glucose sensor worn at a location different than the wearable sensor; and creating a personalized prediction model using at least the personal brain activity or information indicative thereof and the received or generated personal glucose information; at a time subsequent to the initial subject process, and while the subject is asleep, sensing personal brain activity or information indicative thereof from the subject with the wearable sensor; predicting, using the personalized prediction model, a personal future glucose risk indicator of the subject based at least partially on the subsequently sensed personal brain activity or information indicative thereof; and outputting instructions that create a visual display on a subject device that is indicative of the personal future glucose risk indicator.

Description

CROSS REFERENCE TO RELATED APPLICATIONS This application claims priority to the following U.S. Provisional Patent Applications, the disclosures of which are fully incorporated by reference herein in their entireties for all purposes: Provisional Patent Application No. 63/487,880, filed Mar. 1, 2023; Provisional Patent Application No. 63/503,345, filed May 19, 2023; Provisional Patent Application No. 63/487,845, filed Mar. 1, 2023; and Provisional Patent Application No. 63/487,870, filed Mar. 1, 2023. INCORPORATION BY REFERENCE All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. This application incorporates by reference herein the following publications in their entireties for all purposes: U.S. Pat. Nos. 6,572,542; 8,118,741; and 11,020,035. This application incorporates by reference herein WO/2023/183798A2 in its entirety and for all purposes. Glucose monitors and/or insulin delivery devices and uses thereof, such as those described in, for example only, U.S. Pat. Nos. 9,585,607; 10,827,956; 11,744,943; 11,672,422; and 11,064,917 are incorporated by reference herein in their entireties for all purposes. PCT publication WO/2023/034820A1 is incorporated by reference herein in its entirety for all purposes. The entire disclosure of U.S. Prov. App. No. 63/238,583, filed Aug. 30, 2021, to which the WO2023034820A1 application claims priority, is also incorporated by reference herein in its entirety for all purposes. The following article is also incorporated by reference herein in its entirety for all purposes: Huang, Y., Wang, J. B., Parker, J. J. et al. Spectro-spatial features in distributed human intracranial activity proactively encode peripheral metabolic activity. Nat Commun 14, 2729 (2023) (https://doi.org/10.1038/s41467-023-38253-7). BACKGROUND Blood glucose is one of the most important blood parameters to understand and measure, whether on a personal basis or more generalized to a larger segment of a population. Technology exists to estimate blood glucose levels in near real-time. For example only, continuous glucose monitors (“CGM”) include a small sensor inserted under the skin, such as the abdomen or arm. The sensor measures the interstitial glucose (“ISG”) level, which is believed to be indicative of blood glucose levels. The sensor may sample ISG every few minutes (e.g. five minutes). A transmitter can wirelessly send the information to a monitor, which may optionally be part of an insulin pump, or which may be a separate device, such as a smartphone or tablet. CGMs are essentially estimating existing or current interstitial fluid glucose levels, and because ISG levels follow or lag blood glucose levels by several minutes (e.g., 3-12 mins.), the estimated blood glucose levels (based on the ISG) provided by CGMs are estimates of past blood glucose levels. There are a wide variety of reasons why understanding glucose levels may be beneficial for a subject. For example only, diabetic patients with glucose monitor systems can include an insulin pump that can automatically initiate insulin injection if glucose levels get too high. A threshold glucose level may be set (stored) in the CGM such that insulin may be delivered once the glucose level reaches the preset threshold. Individualized thresholds may be set for patients, and the thresholds may need to be reset over time (currently at office visits), such as if changes in the patient's life necessitate resetting the threshold (e.g., going through puberty). Currently, the best insulin pumps for diabetes management achieve a peripheral glucose target range of 70 to 180 mg/dL<70% of the time, which is not ideal and still quite broad of a glycemic range. A desire to understand glucose levels is not, however, limited to diabetic patients. Hypoglycemia, for example, which can require medical attention, is a state in which the blood sugar (glucose) level is lower than the standard range, often considered as a blood sugar of 70 milligrams per deciliter (mg/dL), or 3.9 millimoles per liter (mmol/L) or lower. While hypoglycemia may be related to diabetes management, it can occur and be associated with any non-diabetes medical conditions and/or environments (e.g., in healthy individuals, intensive care unit (ICU) patients, fatigue). Reversing hypoglycemia may include high sugar food or drink (e.g., juice) and/or medicine to raise the blood glucose level. Hypoglycemia, if left untreated, may lead to loss of consciousness and/or seizures. Additionally, hyperglycemia is a condition when blood glucose levels are higher than the standard range, often considered above 180 milligrams per deciliter (mg/dL). Hyperglycemia, which is commonly linked to diabetes, occurs when the body has too little insulin (the hormone that transports glucose into cells), or if the b