Patent Application
20210369969
This disclosure relates to an insulin delivery arrangement comprising a hand-operable insulin delivery device which includes an adjusting unit for presetting of an insulin dose in increments and an applicator unit that can be triggered to deliver or apply the preset insulin dose to a user. This disclosure further concerns a method for dosing adjustment of such an insulin delivery arrangement.
To date, patients with diabetes employing an insulin injection pen widely use a bolus calculator application on a smart phone or blood glucose meter to get a meal bolus recommendation. The patient therefore has to enter the carbohydrate amounts he wants to eat into the bolus calculator, the bolus calculator then calculates insulin units to be administered and then the patient has to rotate the dial on the pen for the corresponding insulin amount to be injected.
U.S. Publication No. 2018/0121630 A1 discloses that administration of insulin via insulin (injection) pens has been widely accepted by patients and providers in the ambulatory setting, and in recent years, the inpatient acute care setting as well. Insulin pens offer several advantages over the traditional insulin vial and syringe. A greater degree of comfort at the injection site and ease of use for the patient provide a better experience. Further, a dial on the insulin pen enables dose selection and makes dose accuracy more precise.
U.S. Publication No. 2016/117481 A1 discloses a system for managing insulin administration or insulin dosing. A method of administering insulin includes receiving subcutaneous information for a patient at a computing device and executing a subcutaneous outpatient program for determining recommended insulin dosages.
WO 2016/019192 A1 discloses an insulin injector with intelligence and communication capabilities that is capable of providing optimized bolus doses of insulin based on information received from a glucose sensor. Embodiments also relate to injectors that communicate data within a health system to provide information to interested parties including the patient and their healthcare provider.
U.S. Publication No. 2016/0279336 A1 discloses that the patient enables, turns on, or otherwise manipulates an insulin pen to deliver a bolus of fluid to the patient's body as desired throughout the day. For example, at meal time, the patient may utilize the blood glucose meter to obtain a current glucose measurement value, and then turn on the injection pen to initiate a meal bolus. In such embodiments, the patient provides an amount of carbohydrates associated with the meal. For example, the patient may manipulate user interface elements associated with the injection pen to input the carbohydrate amount directly to the injection pen, or alternatively, the patient may manipulate the electronic device to receive and then transfer, to the injection pen, a carbohydrate amount that is input to the client application on the electronic device. Additionally, in embodiments where the injection pen does not communicate with the blood glucose meter, the patient may input the current glucose measurement value to the injection pen. Based at least in part on the input carbohydrate amount, the current glucose measurement value, and the stored patient specific parameter values, the injection pen automatically calculates or otherwise determines a meal bolus amount configured to compensate for the carbohydrates in a patient specific manner. When the bolus amount determined by the injection pen is confirmed or otherwise accepted by a user, the injection pen automatically configures its actuation arrangement to precisely deliver the bolus amount automatically in response to manual actuation of a user interface element of the injection pen (e.g., a button associated with fluid delivery).
This disclosure further improves the known insulin delivery devices and systems and dosing methods and eases the burden of insulin dosing decisions and reduces the number of steps to be taken by the user for injecting a bolus.
This disclosure is based on the idea of determining and displaying to the user, while dialing the insulin-dosage, in parallel an equivalent amount of carbohydrates that can be eaten when the user would inject the dialed units of insulin. Thus, an insulin delivery arrangement or system is proposed in which a dose converter is adapted to receive the presetting or actual setting value for the insulin dose as an input and to provide as an output a carbohydrate value equivalent to an amount of meal carbohydrates which can be compensated by the actual setting for the insulin dose, and wherein a display is provided for displaying the carbohydrate value to the user. In this way, the user can be saved the step of inputting the amount of carbohydrates, but only increment the insulin dose while simultaneously or in parallel an indication of the respective amounts of carbohydrates that would be compensated by the selected dose of insulin is displayed. The user is released from complex mental calculations and/or associated input operations, while at the same time, the insulin delivery device can be manipulated in a simple manner as intended, thus improving glycemic control and treatment satisfaction for patients with diabetes. Thus, this disclosure
In one embodiment an insulin delivery arrangement is disclosed comprising
In one embodiment, the hand-operable insulin delivery device includes an adjusting unit (also referred to herein as “adjuster”) for manually presetting an insulin dose. The adjusting unit may thus comprise a mechanically operated dose setting member (also referred to herein as “dose setter”) for manually presetting an insulin dose. The adjusting unit may, for example, comprise a stepwise rotatable dial for manual presetting of an insulin dose. The hand-operable insulin delivery device, as a simple example, may thus be formed as an insulin pen which includes an adjusting unit comprising a stepwise rotatable dial for manual presetting of an insulin dose. The hand-operable insulin delivery device in this disclosure can thus do without an electrically operated dose setting member (which, e.g., would receive input via touch screen or plus/minus buttons).
Preferably, a rotatable dial is provided for presetting the insulin dose in a plurality of steps or increments, more preferred in at least 5 steps. Advantageously, the dose converter is formed by a digital processor adapted to solve insulin to carbohydrate transformations. Alternatively, in very simple to manufacture designs, an analog mechanism may be used as a calculator.
A further improvement provides that the display is provided as a digital screen to display the carbohydrate values in parallel to the dialed insulin units. For this purpose, it may also be conceivable to employ an analog sliding scale.
A still further improvement in this direction provides that the adjusting unit is formed as a stepwise rotatable dial, and that the carbohydrate value is simultaneously changed on the display corresponding to a degree of rotation of the dial.
In order to further simplify design and use, the insulin delivery device is formed as an insulin injection pen and the dose converter is part of the insulin injection pen.
In this connection, it is also advantageous if the display is arranged on a surface, specifically an end face of the generally cylindrical insulin injection pen.
One or more advantageous embodiments may further comprise a remote mobile device, preferably a smart phone or a smart watch, which is arranged separate from the insulin delivery device, wherein the mobile device is adapted to wirelessly communicate with the insulin delivery device and preferably includes the dose converter as a mobile application. In this way, widely-used smart wearable devices can be used to fulfil additional resource demanding tasks.
In particular, when rotating the dial for the insulin-dosage on an insulin pen, a signal is transmitted to the remote device that starts the remote bolus or dose converter. If the pen transmits insulin dosage information, the converter unit calculates the equivalent amount of carbohydrates and displays it.
In this connection, it is advantageous when the display for displaying the carbohydrate value is provided on the mobile device. It is also conceivable to additionally or alternatively use the display of another connected wearable device like a smart watch or fitness tracker.
A further improvement in user handling provides that the remote device is configured to automatically retrieve and process the actual setting for the insulin dose upon a user manipulation of the insulin delivery device. In one embodiment, the remote device is thus configured to automatically retrieve and process the actual setting for the insulin dose upon a rotation of the dial. In another embodiment, the insulin delivery device is configured to automatically send the actual setting for the insulin dose to the remote mobile device upon a rotation of the dial.
As a still further advantageous measure, a glucose meter, in particular a continuous monitoring glucose meter, is configured to provide a glucose measurement value to the dose converter. Thereby, it is possible to additionally consider glucose information for improved bolus calculation.
One or more advantageous embodiments may further comprise that the glucose measurement value is retrieved from a glucose meter by means of the remote device, and that the glucose measurement value and, where appropriate, other patient specific data are transmitted from the remote device to the insulin delivery device.
Another improvement in this direction provides that the dose converter is configured to include a user-specific correction bolus in a calculation of the carbohydrate value.
For improved user convenience, it is advantageous if the insulin delivery device has an activation circuit which triggers transmission of user specific parameters from the remote device when the insulin delivery device is activated.
In particular, while dialling the insulin-dosage, an insulin pen in parallel displays the equivalent amount of carbohydrates that can be compensated in a meal. The equivalent carbohydrate amount is calculated using a pen-integrated dose converter that also considers cases of elevated glucose which require a correction bolus, where glucose data and patient specific parameters for bolus calculation are transmitted from a remote device to the pen.
In even more sophisticated embodiments, the dose converter has a software routine to determine the carbohydrate value based on the actual setting value for the insulin dose and at least one of a measured glucose value, a target glucose value, an insulin to carbohydrate ratio, an insulin sensitivity factor and a basal insulin dose.
Another aspect of this disclosure concerns a method for dosing adjustment of an insulin delivery arrangement comprising the steps of
In this way, the same advantages are achieved as detailed above in connection to the insulin delivery systems.
The above-mentioned aspects of exemplary embodiments will become more apparent and will be better understood by reference to the following description of the embodiments taken in conjunction with the accompanying drawings, wherein:
The embodiments described below are not intended to be exhaustive or to limit the invention to the precise forms disclosed in the following detailed description. Rather, the embodiments are chosen and described so that others skilled in the art may appreciate and understand the principles and practices of this disclosure.
As depicted in
The insulin pen 12 includes a removable pen cap 22 to protect an applicator unit (also referred to herein as “applicator”) 24 illustrated schematically in broken lines as comprising a distal projecting injection needle 26 and an insulin cartridge 28.
The adjusting unit 14 comprises a manually rotatable dial 30 for a user to preset an insulin dosage to be delivered upon final triggering of the applicator unit 24. The dial 30 is formed as a dose knob which can be turned forward or backward (arrow 32) to increase or decrease the insulin dose. For feedback to the user on the actual setting, the adjusting unit 14 further comprises a dose counter 34 as an analog sliding scale which is connected to the dial 30, where the adjusted insulin dose 36 lines up in the center.
In exemplary embodiments described herein, the dose converter 16 includes a digital processor 38 which receives an actual setting or rotational position of the dial 30 as an input value. As explained in more detail below, the dose converter 16 then calculates a carbohydrate value equivalent to an amount of carbohydrates in a meal which can be compensated by the insulin dose according to the actual setting.
As depicted in
In alternative embodiments, the dose converter 16 may be simply provided by an analog mechanism which is mechanically coupled to the dial 14 on the input side and further coupled to an analog graduated scale to show the carbohydrate value similar to the dose counter 34.
The primary mobile device 44 is shown as a smartphone, whereas the secondary device may be a smart watch or a fitness tracker. The shown devices 12,46,48 are in wireless communication with the smart phone 44, e.g., using Bluetooth protocols, as illustrated by radio signals 50 in
In some cases, the smartphone 44 can include the dose converter 16 as a mobile application 52 running on the internal processor. In exemplary embodiments, the screen of the smartphone may be used as the display 20′ for indicating the calculated carbohydrate value 18 to the user. For further user convenience, the smartphone 44 may automatically retrieve and process the actual setting for the insulin dose upon a user manipulation of the insulin pen 12. The synchronization may occur with indexed positions or clicks from the dial 30 to provide haptic or acoustic feedback to the user.
The glucose meter 48 is illustrated as a body wearable instrument which allows continuous measurements of glucose independent of user interaction. In other cases, the mobile device 44 may prompt the user to take a measurement and to transmit or input the glucose measurement value.
In further embodiments of the insulin delivery system, when the insulin pen 12 is activated, glucose data and patient specific parameters for bolus calculation are transmitted from the smartphone 44 to the pen 12. Glucose data is transmitted to the smartphone from the connected glucose meter 48. Such a communication may be triggered by an activation circuit (not shown) on the pen 12. Then, the display 20 of the pen 12 can be used to indicate glucose data, the insulin dosage and the equivalent carbohydrate value.
Upon calculation of the carbohydrate value, the dose converter 16 may include a user specific correction bolus, based on a difference between a current and a target (blood) glucose value. For example, if the current blood glucose is 200 mg/dl and the target blood glucose is 150 mg/dl, then the output of the carbohydrate value will remain at Zero for the first steps of rotation of the dial 30, as the corresponding amount of insulin is needed only for lowering blood glucose.
The simplest embodiment might use only one (user-defined) insulin-to-carbohydrate ratio to indicate for the patient how many grams of carbohydrates one unit of insulin can compensate for. This may be implemented in a mechanical bolus converter by a simple sliding scale.
In a more advanced embodiment, different insulin-to-carbohydrate ratios might be defined depending on the time of the day (e.g., morning, lunch, dinner time) for the patient. If the current glucose value is considered in the bolus calculation, a patient-specific insulin sensitivity factor might be considered which reflects the patient's sensitivity to insulin (e.g., an amount of drop in glucose level per unit of insulin administered). If the glucose value is below target level at lunch time when the user wants to eat certain amount of carbohydrate, he would have to inject less insulin to bring his glucose back in target level than in a situation where the current glucose value was normal or even above the target level.
For the latter option, it is preferable to display the information on the smart watch 46 in addition or alternatively to the smartphone 44. In this case the user would only have to take out the pen 12 from his pocket (not the smartphone) and have a look on the display 20″ of his smart watch 46 showing the amount of carbohydrates he may eat with the dialed amount of insulin.
In a more advanced calculation routine, the dose converter 16 has a software routine to determine the carbohydrate value (Ct) based on the actual setting value for the insulin dose (It) and other user events and/or parameters, such as a measured glucose value Gt, a target glucose value Tg, an insulin to carbohydrate ratio ICR (i.e., amount of carbohydrates needed to match the glucose lowering effect of one unit U of insulin, given in U/g), and an insulin sensitivity factor ISF (as a measure for the decrease in glucose level caused by one unit of administered insulin, given in U/(mg/dl).
The carbohydrate value then may be calculated as follows:
In one embodiment, dose converter 16 has a more general software routine. The carbohydrate value (Ct) may be determined as follows:
wherein It is the setting value for the insulin dose at the actual time t, Gt is the actual measured glucose value, Tt is the actual target glucose value,
and wherein
Φt=[(Ct1,It1,Gt1, . . . ), . . . ,(Ctn,Itn,Gtn, . . . )] (3)
describes the history of user events (e.g., meals (indicated as ingested carbohydrates C), insulin injections I, measured glucose values G) from a past timepoint t1 until a cutoff time tn in the past,
and wherein
θt=[(ISFt,ICRt,Tt, . . . ), . . . ,(ISFtn,ICRtn,Ttn, . . . )] (4),
wherein θt describes the history of user parameters (e.g., insulin sensitivity factor ISF, insulin to carbohydrate ratio ICR, target glucose value T) from timepoint t1 until cutoff time tn in the past.
A variation of parameters over time can thus be considered. E.g., different insulin-to-carbohydrate ratios might be defined depending on the time of the day for the patient.
If needed, further events and parameters (indicated as “ . . . ” in the equations (3) and (4) above) than those exemplified above, such as a basal insulin dose, body weight and physiologic activity can also be considered.
In general, it is known in the art to match meal insulin to carbohydrate intake for insulin bolus size calculation, which is carbohydrate driven in the way that the user has to do bolus calculations. In contrast, the insulin driven approach of this disclosure allows much simpler interaction.
While exemplary embodiments have been disclosed hereinabove, the present invention is not limited to the disclosed embodiments. Instead, this application is intended to cover any variations, uses, or adaptations of this disclosure using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains and which fall within the limits of the appended claims.
| Number | Date | Country | Kind |
|---|---|---|---|
| 19 158 950.6 | Feb 2019 | EP | regional |
This application is a continuation of PCT/EP2020/054431, filed Feb. 20, 2020, which claims priority to EP 19158950.6, filed Feb. 22, 2019, the entire disclosures of both of which are hereby incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/EP2020/054431 | Feb 2020 | US |
| Child | 17404455 | US |
