Abstract: In a method of recalibrating continuous glucose monitoring data from a user, operable on a digital processor, an indication from the user that the user has taken a meal is received (806). A self-monitored of blood glucose levels from the user (810) at two separate times during a day corresponding to when the user has taken a meal. A glucose signal is received from a continuous glucose monitoring sensor (818) at times corresponding to the two separate times that the user has taken a meal. Two reconstructed blood glucose values based on the glucose signal from the continuous monitoring sensor at times when the at least two self-monitored of blood glucose levels are received from the user. A linear regression is performed (822) using y=ax+b, wherein x corresponds to the two reconstructed blood glucose values and y corresponds to the two self-monitored of blood glucose levels thereby generating an estimation of a and b.

Abstract: A method (400) controls the delivery of insulin in a diabetic patient (P) based on data (d) representative of at least a fraction of a meal (m(k+i)) that the patient (P) will consume. The method provides from a block (R) representative of conventional therapy or open loop rule that the patient (P) is subject to, based on the data (d) representative of at least a fraction of the meal (m(k+i)), a reference insulin value (u0). The method is also based on data representative of the difference between input data (?), a reference glycemic level, and feedback data (yCGM) representative of the glycemic level detected in the patient (P). A control module (301; 401) provides a value of insulin (i) to be delivered to the patient (P) based on the various representative data.

Abstract: A method, system, and device for improving the accuracy of a continuous glucose monitoring sensor by estimating a CGM signal at a time t+PH using a value of CGM at time t, using a real-time short-time glucose prediction horizon to estimate the real time denoised CGM value with a noise estimation algorithm.

Abstract: Systems and methods for providing sensitive and specific alarms indicative of glycemic condition are provided herein. In an embodiment, a method of processing sensor data by a continuous analyte sensor includes: evaluating sensor data using a first function to determine whether a real time glucose value meets a first threshold; evaluating sensor data using a second function to determine whether a predicted glucose value meets a second threshold; activating a hypoglycemic indicator if either the first threshold is met or if the second threshold is predicted to be met; and providing an output based on the activated hypoglycemic indicator.

Abstract: Systems and methods for providing sensitive and specific alarms indicative of glycemic condition are provided herein. In an embodiment, a method of processing sensor data by a continuous analyte sensor includes: evaluating sensor data using a first function to determine whether a real time glucose value meets a first threshold; evaluating sensor data using a second function to determine whether a predicted glucose value meets a second threshold; activating a hypoglycemic indicator if either the first threshold is met or if the second threshold is predicted to be met; and providing an output based on the activated hypoglycemic indicator.

Abstract: A device for generating alerts for Hypo and Hyperglycemia Prevention from Continuous Glucose Monitoring (CGM) determines a dynamic risk based on both information of glucose level and a trend obtainable from a CGM signals. The device includes a display whose color depends on the DR (for example, red for high DR, green for low risk). When DR exceeds a certain threshold, alerts are generated to suggest the patient to pay attention to the current glucose reading and to its trend, both of which are shown on the display in numbers and symbols (e.g. an arrow with different slope or color).

Abstract: A mathematical model of type 1 diabetes (T1D) patient decision-making can be used to simulate, in silico, realistic glucose/insulin dynamics, for several days, in a variety of subjects who take therapeutic actions (e.g. insulin dosing) driven by either self-monitoring blood glucose (SMBG) or continuous glucose monitoring (CGM). The decision-making (DM) model can simulate real-life situations and everyday patient behaviors, Accurate submodels of SMBG and CGM measurement errors are incorporated in the comprehensive DM model. The DM model accounts for common errors the patients are used to doing in their diabetes management, such as miscalculations of meal carbohydrate content, early/delayed insulin administrations and missed insulin boluses. The DM model can be used to assess in silico if/when CGM can safely substitute SMBG in T1D management, to develop and test guidelines for CGM driven insulin dosing, to optimize and individualize off-line insulin therapies and to develop and test decision support systems.

Abstract: In a method of determining insulin sensitivity in a patient, glucose level is sensed continuously. A first area under the curve representing the glucose level over time is calculated. An amount of insulin that has been administered to the patient is sensed. An estimation of insulin on board the patient is calculated based on the glucose level and the amount of insulin administered to the patient. A second area under the curve representing the insulin on board over time is calculated. Patient data indicative of at least one patient physical parameter is received. Information indicative of amount of glucose ingested by the patient during a meal is received. An insulin sensitivity output indicative of ability of insulin to stimulate glucose utilization and inhibit glucose production in the patient based on the first and second area under the curve, the patient data and the meal information is generated.

Abstract: A device for generating alerts for Hypo and Hyperglycemia Prevention from Continuous Glucose Monitoring (CGM) determines a dynamic risk based on both information of glucose level and a trend obtainable from a CGM signals. The device includes a display whose color depends on the DR (for example, red for high DR, green for low risk). When DR exceeds a certain threshold, alerts are generated to suggest the patient to pay attention to the current glucose reading and to its trend, both of which are shown on the display in numbers and symbols (e.g. an arrow with different slope or color).

Abstract: A device for monitoring a diabetic patient includes continuous glucose monitoring system that is configured to generate glucose data indicative of the patient's actual glucose level. An continuous subcutaneous insulin infusion pump is configured to inject insulin into the patient and that is configured to generate insulin data regarding when and how much insulin has been injected into the patient. A processor, programmed with a discrete-time reiterative filter, calculates a predicted glucose level corresponding to a predicted glucose level currently expected to be sensed by the continuous glucose monitoring system, based on the insulin data and the glucose data over time and is also programed to generate an alert when the actual glucose level is different from the predicted glucose level by a predetermined amount. An alert generating device is coupled to the processor and is configured to generate an aesthetically-sensible event corresponding to the generation of the alert.

Abstract: A simulator for in-silico testing of Type 1 diabetes patients uses a model that puts in relation plasma concentrations, i.e., glucose G and insulin /, with glucose fluxes, i.e. endogenous glucose production (EGP), glucose rate of appearance (Ra), glucose utilization by the tissues (U), renal extraction (E), and insulin fluxes, i.e., rate of insulin appearance from the subcutaneous tissues (SC) and insulin degradation (D). A module is also included to describe counter-regulation, i.e. glucagon kinetics, secretion and action. A glucagon subcutaneous absorption model enables simulation of dual hormone control.

Abstract: Continuous Glucose Monitoring (CGM) devices provide glucose concentration measurements in the subcutaneous tissue with limited accuracy and precision. Therefore, CGM readings cannot be incorporated in a straightforward manner in outcome metrics of clinical trials e.g. aimed to assess new glycaemic-regulation therapies. To define those outcome metrics, frequent Blood Glucose (BG) reference measurements are still needed, with consequent relevant difficulties in outpatient settings. Here we propose a “retrofitting” algorithm that produces a quasi continuous time BG profile by simultaneously exploiting the high accuracy of available BG references (possibly very sparsely collected) and the high temporal resolution of CGM data (usually noisy and affected by significant bias).

Abstract: Systems and methods for providing sensitive and specific alarms indicative of glycemic condition are provided herein. In an embodiment, a method of processing sensor data by a continuous analyte sensor includes: evaluating sensor data using a first function to determine whether a real time glucose value meets a first threshold; evaluating sensor data using a second function to determine whether a predicted glucose value meets a second threshold; activating a hypoglycemic indicator if either the first threshold is met or if the second threshold is predicted to be met; and providing an output based on the activated hypoglycemic indicator.

Abstract: Systems and methods for providing sensitive and specific alarms indicative of glycemic condition are provided herein. In an embodiment, a method of processing sensor data by a continuous analyte sensor includes: evaluating sensor data using a first function to determine whether a real time glucose value meets a first threshold; evaluating sensor data using a second function to determine whether a predicted glucose value meets a second threshold; activating a hypoglycemic indicator if either the first threshold is met or if the second threshold is predicted to be met; and providing an output based on the activated hypoglycemic indicator.

Abstract: Systems and methods for providing sensitive and specific alarms indicative of glycemic condition are provided herein. In an embodiment, a method of processing sensor data by a continuous analyte sensor includes: evaluating sensor data using a first function to determine whether a real time glucose value meets a first threshold; evaluating sensor data using a second function to determine whether a predicted glucose value meets a second threshold; activating a hypoglycemic indicator if either the first threshold is met or if the second threshold is predicted to be met; and providing an output based on the activated hypoglycemic indicator.

Abstract: In alternative embodiments, the invention provides formulations, pharmaceutical compositions, devices and other products of manufacture comprising a therapeutically effective mixture of an insulin and a pramlintide, and methods for making and using them.

Abstract: A method (400) controls the delivery of insulin in a diabetic patient (P) based on data (d) representative of at least a fraction of a meal (m(k+i)) that the patient (P) will consume. The method provides from a block (R) representative of conventional therapy or open loop rule that the patient (P) is subject to, based on the data (d) representative of at least a fraction of the meal (m(k+i)), a reference insulin value (u0). The method is also based on data representative of the difference between input data (?), a reference glycemic level, and feedback data (yCGM) representative of the glycemic level detected in the patient (P). A control module (301; 401) provides a value of insulin (i) to be delivered to the patient (P) based on the various representative data.

Abstract: Systems and methods for providing sensitive and specific alarms indicative of glycemic condition are provided herein. In an embodiment, a method of processing sensor data by a continuous analyte sensor includes: evaluating sensor data using a first function to determine whether a real time glucose value meets a first threshold; evaluating sensor data using a second function to determine whether a predicted glucose value meets a second threshold; activating a hypoglycemic indicator if either the first threshold is met or if the second threshold is predicted to be met; and providing an output based on the activated hypoglycemic indicator.

Abstract: Systems and methods for providing sensitive and specific alarms indicative of glycemic condition are provided herein. In an embodiment, a method of processing sensor data by a continuous analyte sensor includes: evaluating sensor data using a first function to determine whether a real time glucose value meets a first threshold; evaluating sensor data using a second function to determine whether a predicted glucose value meets a second threshold; activating a hypoglycemic indicator if either the first threshold is met or if the second threshold is predicted to be met; and providing an output based on the activated hypoglycemic indicator.

Abstract: A device for monitoring a diabetic patient includes continuous glucose monitoring system that is configured to generate glucose data indicative of the patient's actual glucose level. An continuous subcutaneous insulin infusion pump is configured to inject insulin into the patient and that is configured to generate insulin data regarding when and how much insulin has been injected into the patient. A processor, programmed with a discrete-time reiterative filter, calculates a predicted glucose level corresponding to a predicted glucose level currently expected to be sensed by the continuous glucose monitoring system, based on the insulin data and the glucose data over time and is also programed to generate an alert when the actual glucose level is different from the predicted glucose level by a predetermined amount. An alert generating device is coupled to the processor and is configured to generate an aesthetically-sensible event corresponding to the generation of the alert.