IRVINE, CA, United States
IRVINE, CA, United States

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Patent
Glumetrics, Inc. | Date: 2013-05-14

Embodiments of the present invention relate to analyte sensors comprising a heparin coating, and methods of coating analyte sensors. The heparin can be stably associated with at least a portion of a porous membrane that covers a portion of the analyte sensors. The heparin can be photochemically linked to the coating through the formation of covalent bonds.


Embodiments of the invention are directed to an optical sensor for detecting glucose. The sensor comprises a chemical indicator system disposed within a gap between the distal end of an optical fiber and an atraumatic tip portion, wherein the optical fiber and atraumatic tip portion are coupled by a coupling member, such as a rod or hypotube or cage that traverses the gap. The sensor further comprises a means for generating and detecting an optical reference signal unrelated to the glucose, such that ratiometric correction of glucose measurements for artifacts in the optical system is enabled.


Disclosed herein are methods of estimating an analyte concentration which include generating a signal indicative of the analyte concentration, generating a signal indicative of a temperature, generating a signal indicative of a pH, and transforming the signal indicative of the analyte concentration utilizing an equation of the form of a modified Michaelis-Menten equation depending on Michaelis-Menten parameters, wherein values of the Michaelis-Menten parameters are set based upon data which includes temperature and pH calibration parameters, the signal indicative of a temperature, and the signal indicative of a pH. Also disclosed herein are measurement devices which employ the aforementioned methods.


Patent
Glumetrics, Inc. | Date: 2012-04-25

Novel pyridinium salts functionalized with boronic acid and methods of making them are disclosed. When combined with a fluorescent dye, the compounds are useful in the detection of polyhydroxyl-substituted organic molecules.


Patent
Glumetrics, Inc. | Date: 2011-04-27

Embodiments of the invention are directed to a delivery device and method for deploying an optical analyte sensor. The delivery device comprises hollow tubes configured to operate telescopically. The optical sensor is configured to retract and extend from a distal end of the delivery device, by sliding the telescoping tubes with respect to one another. The delivery device may also have a locking mechanism such that the distal end portion of the sensor will extend to a preset locked position beyond the delivery device, e.g., during calibration and deployment. The device is capable of being used to ship, calibrate, and deploy the sensor while maintaining sterility and avoiding exposure to the external environment.


Disclosed are embodiments that relate to the deployment of a glucose sensor comprising an optical fiber into a physiological fluid, wherein the optical fiber has disposed along a distal region thereof a chemical indicator system comprising a fluorophore and a glucose binding moiety immobilized within a hydrogel, wherein the components of the chemical indicator system are in a dry state before deployment. Also disclosed is a one-point in vivo calibration of the chemical indicator system based on an independently measured glucose concentration.


A method for achieving tight glycemic control in a patient in need thereof is disclosed. The method comprises deploying an equilibrium glucose sensor within a blood vessel in the patient, coupling the sensor to a monitor that displays the blood glucose concentration, and administering a blood glucose regulator when the blood glucose concentration varies outside of the predetermined concentration range. The blood glucose regulator is administered in an amount sufficient to return the blood glucose concentration to within the predetermined concentration range, thereby achieving tight glycemic control.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 427.82K | Year: 2011

DESCRIPTION (provided by applicant): The Juvenile Diabetes Research Foundation (JDRF) estimates that up to 3 million people in the United States may have Type 1 diabetes. Recent large clinical trials have demonstrated the therapeutic benefits of continuousglucose monitors (CGMs), leading the way to increased availability of insurance reimbursement of these devices. An estimated 50,000 people with diabetes currently use CGMs, but adoption is forecast to grow steadily to 250,000 users as insulin pump users exchange their devices for next generation pumps with integrated CGMs. This represents a 500 million market opportunity. However, currently available CGMs have technical shortcomings that limit both near-term widespread clinical adoption and longer-term progress towards an artificial pancreas. These limitations include inaccuracy in the hypoglycemic range, frequent calibration requirements, and long run-in times. More importantly, the eventual successful commercialization of an artificial pancreas will likely require the use of multiple redundant sensors for safety. There could be substantial advantages associated with the use of a non-enzymatic, redundant sensor in this context, namely, avoidance of common mode failures. GluMetrics is a venture capital-backed company developing the GluCath Intravascular Continuous Glucose Monitoring System (GluCath System). The sensor in this device uses a novel quenched fluorescence chemical mechanism deployed via an optical fiber. The GluCath System is designed for use incritically-ill patients undergoing intensive insulin therapy. Clinical feasibility has been demonstrated in fifty-two healthy volunteer subjects with Type 1 diabetes mellitus for up to 24 h duration. In these studies, the GluCath sensor was placed in a peripheral vein in the arm. The results agreed closely with a reference glucose analyzer with a 7.5% mean absolute relative difference (MARD), 94.7% of results in the clinically accurate A region of the Clarke Error Grid and 95% of results meeting the accuracy criteria of the ISO 15197 standard. The proposed research is to modify the GluCath sensor for use in subcutaneous tissue. The objective of this phase I project is to demonstrate performance of a subcutaneous GluCath sensor in an animal model for 24 h.Subsequent phase II work will include the demonstration of safety and efficacy in extended duration human clinical studies and prototype development of miniaturized optical and electrical components and a suitable automated insertion device. PUBLICHEALTH RELEVANCE: An estimated 3 million Americans have Type 1 diabetes. Continuous glucose monitors have been shown to provide significant therapeutic advantages, but current enzymatic sensor technologies have had limited clinical adoption and may not besufficiently accurate for closed loop control. GluMetrics proposes to develop a novel and more accurate non-enzymatic based glucose sensor capable of achieving a high level of clinical accuracy over the entire physiological range (40 to 400 mg/dL), but especially in the hypoglycemic range (lt 70 mg/dL).


The present invention relates to a sensor for percutaneous insertion and intravascular residence without an indwelling cannula. In preferred embodiments, a glucose sensor is inserted into a blood vessel using a removable cannula. After the cannula is removed, the glucose sensor remains within the blood vessel by itself and forms a seal with the patients tissue.


Patent
Glumetrics, Inc. | Date: 2013-07-25

Embodiments of the present invention are directed to an optical sensor capable of measuring two analytes simultaneously with a single indicator system. In preferred embodiments, the sensor comprises a fluorescent dye having acid and base forms that facilitate ratiometric pH sensing, wherein the dye is further associated with a glucose binding moiety and configured to generate a signal that varies in intensity with the concentration of glucose.

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