Description:

Wearable medical device for continuous blood glucose monitoring in Diabetes patients
Field of the Invention
[0001] The present disclosure relates to wearable healthcare devices, more particularly, to continuous blood glucose monitoring systems for diabetes patients integrating minimally invasive sensors and wireless communication.
Background
[0002] The background description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.
[0003] Diabetes mellitus is a chronic metabolic disorder characterized by dysregulated glucose metabolism, requiring lifelong monitoring and management. Accurate assessment of blood glucose levels is essential for preventing complications such as neuropathy, retinopathy, nephropathy, and cardiovascular disease. Conventional glucose monitoring methods primarily involve finger-prick blood sampling using portable glucometers. Although widely used, such methods are limited by their intermittent nature, inability to capture real-time fluctuations, and patient discomfort associated with frequent sampling.
[0004] Continuous glucose monitoring systems have been developed to address these limitations. These devices employ subcutaneous sensors to measure glucose levels in interstitial fluid, providing dynamic insights into glucose variability. However, existing systems face challenges including sensor drift, calibration requirements, limited battery life, bulky form factors, and inconsistent accuracy under variable physiological and environmental conditions. Additionally, data from such devices often require manual logging or synchronization, limiting their seamless integration into clinical workflows.
[0005] Recent advances in wearable electronics, wireless communication, and data analytics have created opportunities for next-generation glucose monitoring systems. Miniaturized micro-needle arrays reduce invasiveness, enzymatic sensing platforms improve sensitivity, and energy-efficient wireless protocols enable prolonged device usage. However, current devices still lack integrated predictive analytics capable of forecasting glycemic excursions, thereby reducing their ability to prevent severe hypo- or hyperglycemic episodes. Moreover, many systems are not optimized for multi-analyte monitoring or long-term wear in daily life conditions involving water exposure, skin stress, and mobility.
[0006] Accordingly, there remains a need for a wearable medical device that integrates minimally invasive sensing, real-time processing, predictive analytics, secure wireless communication, and cloud-based integration. The disclosed system addresses these unmet needs by providing a robust platform that supports continuous monitoring, predictive alerts, and physician-accessible dashboards, thereby enhancing diabetes management at both patient and clinical levels.
Summary
[0007] The following presents a simplified summary of various aspects of this disclosure in order to provide a basic understanding of such aspects. This summary is not an extensive overview of all contemplated aspects, and is intended to neither identify key or critical elements nor delineate the scope of such aspects. Its purpose is to present some concepts of this disclosure in a simplified form as a prelude to the more detailed description that is presented later.
[0008] The following paragraphs provide additional support for the claims of the subject application.
[0009] The disclosure pertains to a wearable medical device for continuous blood glucose monitoring in diabetes patients is disclosed. The device comprises a transcutaneous sensor element configured for minimally invasive penetration into interstitial fluid, a biochemical sensing unit employing enzymatic electrodes functionalized with glucose oxidase, and a signal conditioning circuit configured to process electrochemical responses into digital glucose values. A wireless communication module transmits processed data to external systems, while a power management unit optimizes energy usage through rechargeable batteries, wireless charging, and energy harvesting.
[00010] The device further includes a user interface configured to provide real-time glucose levels and predictive alerts for hypo- and hyperglycemic events. Machine learning algorithms incorporated into the analytics platform utilize historical and real-time data to forecast glucose variability. Data may be transmitted securely to a cloud-based physician dashboard, enabling aggregated analytics across multiple patients for treatment optimization. The device housing is configured with skin-adhesive, water-resistant enclosures enabling multi-day wear without discomfort.
[00011] The method of operation includes sensor insertion, continuous glucose detection, signal processing, wireless data transmission, predictive analysis, and real-time feedback through local and cloud-based interfaces. Integration of minimally invasive sensing with predictive analytics provides technical benefits including reduced patient burden, early warning of glycemic excursions, and enhanced clinical decision support.
Brief Description of the Drawings
[00012] The features and advantages of the present disclosure would be more clearly understood from the following description taken in conjunction with the accompanying drawings in which:
[00013] FIG. 1 illustrates a deployment architecture diagram of the wearable glucose monitoring device showing integration between the on-body sensor module, mobile application, cloud analytics platform, and physician dashboard, in accordance with the embodiments of the present disclosure.
[00014] FIG. 2 illustrates a method flow diagram of the operational sequence of the device beginning with interstitial glucose detection, progressing through signal conditioning, wireless transmission, predictive analytics, and alert presentation, in accordance with the embodiments of the present disclosure.
[00015] FIG. 3 illustrates a block diagram of the wearable device hardware showing interconnection of the transcutaneous sensor, biochemical sensing unit, signal conditioning electronics, wireless module, power management circuit, and user interface, in accordance with the embodiments of the present disclosure.

Detailed Description
[00016] In the following detailed description of the invention, reference is made to the accompanying drawings that form a part hereof, and in which is shown, by way of illustration, specific embodiments in which the invention may be practiced. In the drawings, like numerals describe substantially similar components throughout the several views. These embodiments are described in sufficient detail to claim those skilled in the art to practice the invention. Other embodiments may be utilized and structural, logical, and electrical changes may be made without departing from the scope of the present invention. The following detailed description is, therefore, not to be taken in a limiting sense, and the scope of the present invention is defined only by the appended claims and equivalents thereof.
[00017] The use of the terms “a” and “an” and “the” and “at least one” and similar referents in the context of describing the invention (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The use of the term “at least one” followed by a list of one or more items (for example, “at least one of A and B”) is to be construed to mean one item selected from the listed items (A or B) or any combination of two or more of the listed items (A and B), unless otherwise indicated herein or clearly contradicted by context. The terms “comprising,” “having,” “including,” and “containing” are to be construed as open-ended terms (i.e., meaning “including, but not limited to,”) unless otherwise noted. Recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., “such as”) provided herein, is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention unless otherwise claimed. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the invention.
[00018] Pursuant to the "Detailed Description" section herein, whenever an element is explicitly associated with a specific numeral for the first time, such association shall be deemed consistent and applicable throughout the entirety of the "Detailed Description" section, unless otherwise expressly stated or contradicted by the context.
[00019] The disclosed wearable medical device for continuous blood glucose monitoring in diabetes patients is designed as an integrated wearable system comprising sensing, processing, communication, and analytics functions within a compact and skin-adherent platform. The device operates continuously to provide uninterrupted monitoring of interstitial glucose concentrations, thereby improving management of diabetes through real-time insights and predictive capabilities.
[00020] The device begins with a sensor element configured as a minimally invasive micro-needle array. Said array penetrates superficial skin layers and accesses interstitial fluid without causing significant pain or tissue trauma. Each micro-needle is fabricated from biocompatible polymer or metallic alloy materials, coated with functional enzymes such as glucose oxidase that catalyze glucose oxidation. The enzymatic reaction produces an electrochemical signal proportional to glucose concentration. The sensor element is designed to remain stable under multi-day wear, maintaining accuracy through anti-fouling surface treatments and biocompatible coatings.
[00021] The biochemical sensing unit incorporates the transcutaneous sensor within an electrochemical detection module. This module includes reference electrodes, counter electrodes, and working electrodes arranged in an optimized configuration to enhance signal stability. Redox reactions occurring at the electrodes generate current responses that are directly correlated with interstitial glucose concentration. The sensing unit is configured for multiplexing, enabling optional monitoring of other analytes such as lactate or ketone bodies, thereby providing expanded metabolic insight into patient physiology.
[00022] The signal conditioning circuit processes raw electrochemical responses. Low-noise amplifiers enhance weak currents, while analog-to-digital converters digitize signals for further analysis. Temperature compensation algorithms correct for thermal variations affecting enzymatic activity, ensuring consistent performance across environments. The processed signals are stored in a local memory buffer before wireless transmission.
[00023] The wireless communication module transmits data securely to external devices. Communication protocols include Bluetooth Low Energy for smartphone integration, Wi-Fi for home networks, and near-field communication for clinical point-of-care readers. Data security is achieved through encryption standards and authentication protocols, ensuring confidentiality and compliance with healthcare data regulations. The

wireless communication enables seamless integration into mobile applications, physician dashboards, and telemedicine platforms.
[00024] The power management unit extends operational life. Rechargeable lithium-polymer batteries are integrated within the device housing. Wireless charging coils enable charging without removal of the device. Energy harvesting circuits utilizing thermoelectric or kinetic energy from the patient’s body may further support extended operation. Power optimization algorithms regulate duty cycles of sensing and transmission, balancing accuracy with energy efficiency.
[00025] The user interface provides real-time feedback through both local and external platforms. On-device indicators may display alerts for hypoglycemia or hyperglycemia. Smartphone applications present continuous glucose traces, trend arrows, and predictive alerts generated by machine learning models. Predictive analytics leverage historical and real-time data to forecast impending glycemic excursions, enabling proactive intervention.
[00026] In a first embodiment, the device operates as a standalone continuous glucose monitor with smartphone integration. The device provides real-time glucose values, alarms, and trend data, enabling patients to adjust therapy and diet. The technical benefit of this embodiment is patient empowerment and reduction of hypoglycemic risk.
[00027] In a second embodiment, the device integrates with an insulin pump to form a closed-loop artificial pancreas system. Data from the wearable sensor directly informs insulin dosing algorithms, creating automated feedback control. The technical benefit of this embodiment is improved glycemic stability through dynamic dosing adjustments.
[00028] In a third embodiment, the device functions as part of a multi-patient clinical monitoring system. Data from multiple devices is aggregated into a cloud-based analytics platform accessible to physicians. The platform applies population-level analytics, enabling optimization of treatment strategies. The technical benefit of this embodiment is enhanced clinical oversight and population management.
[00029] Operational flows are reiterated across contexts. For patient self-management, the device provides immediate glucose values and predictive warnings. For integrated therapy, the device interfaces with automated dosing systems. For clinical oversight, the device contributes to cloud-based analytics and physician dashboards. Each flow demonstrates adaptability of the device to individual, therapeutic, and clinical scales.
[00030] Thus, the disclosed wearable medical device integrates minimally invasive sensing, biochemical analysis, predictive modeling, wireless communication, and clinical integration. Technical benefits include reduced patient burden, improved glycemic forecasting, enhanced therapy optimization, and regulatory-compliant data management. Through expanded embodiments, the device demonstrates versatility across patient self-care, automated therapy, and clinical oversight, providing a comprehensive solution for continuous glucose monitoring in diabetes patients.
[00031] Figure 1 provides a deployment architecture diagram representing the interaction between patient-facing and clinical-facing components. The wearable device collects glucose data and transmits it wirelessly to a paired smartphone. The smartphone application stores data locally, presents glucose trends, and relays information to a cloud analytics server. The cloud server aggregates multi-patient datasets, applies machine learning algorithms for predictive forecasting, and provides analytics dashboards accessible to physicians. Physicians review aggregated data and issue treatment adjustments through secure platforms, which are relayed back to the patient application. This deployment arrangement demonstrates integration across patient, device, and healthcare ecosystems. The technical benefit is seamless synchronization of real-time patient monitoring with centralized clinical oversight, supporting both individual management and large-scale population analytics.
[00032] Figure 2 provides a method flow diagram illustrating the operational stages of the device. The process begins with glucose detection via micro-needle sensors inserted into interstitial fluid. Detected signals undergo biochemical catalysis generating electrochemical outputs. These outputs are converted and amplified by signal conditioning circuits. The processed signals are transmitted wirelessly to paired devices. Data is subjected to predictive analytics using algorithms that compare real-time readings with historical patterns to forecast glycemic excursions. Final results are presented to the patient through alerts and to physicians through dashboards. This flow emphasizes sequential execution of sensing, processing, analysis, and feedback, demonstrating a closed-loop cycle that ensures both patient awareness and clinical engagement.
[00033] Figure 3 provides a block diagram representing the internal hardware of the wearable device. The transcutaneous sensor array connects to the biochemical sensing unit. The sensing unit routes electrochemical responses into the signal conditioning electronics comprising low-noise amplifiers and analog-to-digital converters. The conditioned data is directed to the wireless communication module, which transmits results outward. The power management circuit regulates energy distribution across all subsystems and provides rechargeable battery support. The user interface presents essential glucose readings and device alerts. The block diagram illustrates modular composition, demonstrating how sensor inputs are converted into actionable outputs within a compact device. Technical benefits include optimized signal fidelity, efficient energy usage, and reliable communication pathways enabling uninterrupted glucose monitoring.
[00034] Operations in accordance with a variety of aspects of the disclosure is described above would not have to be performed in the precise order described. Rather, various steps can be handled in reverse order or simultaneously or not at all.
[00035] While several implementations have been described and illustrated herein, a variety of other means and/or structures for performing the function and/or obtaining the results and/or one or more of the advantages described herein may be utilized, and each of such variations and/or modifications is deemed to be within the scope of the implementations described herein. More generally, all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings is/are used. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific implementations described herein. It is, therefore, to be understood that the foregoing implementations are presented by way of example only and that, within the scope of the appended claims and equivalents thereto, implementations may be practiced otherwise than as specifically described and claimed. Implementations of the present disclosure are directed to each individual feature, system, article, material, kit, and/or method described herein. In addition, any combination of two or more such features, systems, articles, materials, kits, and/or methods, if such features, systems, articles, materials, kits, and/or methods are not mutually inconsistent, is included within the scope of the present disclosure.
 

Claims
I/We Claim:
1. A wearable medical device for continuous blood glucose monitoring in diabetes patients, comprising: a transcutaneous sensor element configured to penetrate interstitial fluid for real-time glucose detection; a biochemical sensing unit comprising enzymatic electrodes functionalized with glucose oxidase or equivalent catalytic agents; a signal conditioning circuit configured to convert electrochemical reactions into voltage or current signals; a wireless communication module configured to transmit processed data to external devices including smartphones and clinical monitoring platforms; a power management unit comprising rechargeable batteries and energy optimization circuits; and a user interface configured to present continuous glucose concentration levels and alerts for hypoglycemic or hyperglycemic events, wherein the wearable device enables uninterrupted monitoring for improved disease management.
2. The device of claim 1, wherein the sensor element comprises a minimally invasive micro-needle array fabricated from biocompatible polymers or metallic alloys, thereby reducing patient discomfort during prolonged wear.
3. The device of claim 1, wherein the biochemical sensing unit further comprises multi-analyte electrodes configured to measure additional parameters including lactate and ketone levels, thereby providing expanded metabolic insights for diabetes management.
4. The device of claim 1, wherein the signal conditioning circuit incorporates analog-to-digital converters, low-noise amplifiers, and temperature compensation algorithms, thereby ensuring accurate glucose measurements across varying environmental conditions.
5. The device of claim 1, wherein the wireless communication module comprises Bluetooth Low Energy, Wi-Fi, or near-field communication, thereby enabling secure and low-power transmission of glucose data to personal or clinical systems.
6. The device of claim 1, wherein the power management unit integrates wireless charging coils and energy harvesting circuits configured to extend operational duration without frequent battery replacement.
7. The device of claim 1, wherein the user interface further comprises predictive alerts generated through machine learning models, wherein said alerts are based on real-time glucose variability and historical patient data.
8. The device of claim 1, wherein the system further comprises a cloud-based analytics platform configured to aggregate multi-patient data, apply statistical modeling, and provide physician dashboards for treatment optimization.
9. The device of claim 1, wherein the device housing comprises water-resistant, skin-adhesive enclosures designed for multi-day wear, thereby ensuring robust operation during daily activities.
10. The device of claim 1, wherein integration of minimally invasive sensing, real-time data processing, secure communication, and predictive alert generation within a wearable platform provides continuous blood glucose monitoring for personalized management of diabetes patients.

Wearable medical device for continuous blood glucose monitoring in Diabetes patients
Abstract
A wearable medical device for continuous blood glucose monitoring in diabetes patients is disclosed. The device comprises a transcutaneous micro-needle sensor for interstitial fluid access, a biochemical sensing unit employing enzymatic electrodes, and a signal conditioning circuit configured for accurate conversion of electrochemical responses. A wireless communication module transmits data securely to smartphones and clinical systems. A power management unit with rechargeable batteries and wireless charging extends operational duration. A user interface provides real-time glucose levels and predictive alerts generated by machine learning models. Data may be integrated into a cloud-based analytics platform for physician dashboards and treatment optimization. The device housing comprises skin-adhesive, water-resistant materials enabling multi-day wear. Integration of minimally invasive sensing, predictive analytics, and wireless connectivity provides a comprehensive platform for continuous glucose monitoring in diabetes patients.
Fig. 1

, Claims:Claims
I/We Claim:
1. A wearable medical device for continuous blood glucose monitoring in diabetes patients, comprising: a transcutaneous sensor element configured to penetrate interstitial fluid for real-time glucose detection; a biochemical sensing unit comprising enzymatic electrodes functionalized with glucose oxidase or equivalent catalytic agents; a signal conditioning circuit configured to convert electrochemical reactions into voltage or current signals; a wireless communication module configured to transmit processed data to external devices including smartphones and clinical monitoring platforms; a power management unit comprising rechargeable batteries and energy optimization circuits; and a user interface configured to present continuous glucose concentration levels and alerts for hypoglycemic or hyperglycemic events, wherein the wearable device enables uninterrupted monitoring for improved disease management.
2. The device of claim 1, wherein the sensor element comprises a minimally invasive micro-needle array fabricated from biocompatible polymers or metallic alloys, thereby reducing patient discomfort during prolonged wear.
3. The device of claim 1, wherein the biochemical sensing unit further comprises multi-analyte electrodes configured to measure additional parameters including lactate and ketone levels, thereby providing expanded metabolic insights for diabetes management.
4. The device of claim 1, wherein the signal conditioning circuit incorporates analog-to-digital converters, low-noise amplifiers, and temperature compensation algorithms, thereby ensuring accurate glucose measurements across varying environmental conditions.
5. The device of claim 1, wherein the wireless communication module comprises Bluetooth Low Energy, Wi-Fi, or near-field communication, thereby enabling secure and low-power transmission of glucose data to personal or clinical systems.
6. The device of claim 1, wherein the power management unit integrates wireless charging coils and energy harvesting circuits configured to extend operational duration without frequent battery replacement.
7. The device of claim 1, wherein the user interface further comprises predictive alerts generated through machine learning models, wherein said alerts are based on real-time glucose variability and historical patient data.
8. The device of claim 1, wherein the system further comprises a cloud-based analytics platform configured to aggregate multi-patient data, apply statistical modeling, and provide physician dashboards for treatment optimization.
9. The device of claim 1, wherein the device housing comprises water-resistant, skin-adhesive enclosures designed for multi-day wear, thereby ensuring robust operation during daily activities.
10. The device of claim 1, wherein integration of minimally invasive sensing, real-time data processing, secure communication, and predictive alert generation within a wearable platform provides continuous blood glucose monitoring for personalized management of diabetes patients.