INSULIN DELIVERY ARRANGEMENT AND METHOD FOR INSULIN DOSING

Abstract

The disclosure concerns an insulin delivery arrangement including a hand-operable insulin delivery device which includes an adjusting unit for presetting of an insulin dose and an applicator unit that can be triggered to deliver the preset insulin dose to a user. In order to ease burden of insulin dosing, a dose converter is adapted to receive an actual setting 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 respective insulin dose. A display is used for displaying the carbohydrate value in parallel to the insulin dose.

Claims

1. An insulin delivery arrangement, comprising: a hand-operable insulin delivery device having an adjuster configured to manually preset an insulin dose and an applicator which can be triggered to deliver the preset insulin dose to a user; a dose converter configured to receive the manually preset 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 preset insulin dose; and a display configured to display the carbohydrate value to the user.

2. The arrangement of claim 1, wherein the dose converter is formed by a digital processor or by an analog mechanism.

3. The arrangement of claim 1, wherein the display comprises a digital screen or an analog sliding scale.

4. The arrangement according to claim 1, wherein the adjuster includes a stepwise rotatable dial, and the carbohydrate value is changed on the display synchronously to a rotation of the dial.

5. The arrangement according to claim 1, wherein the insulin delivery device comprises an insulin injection pen and the dose converter is part of the insulin injection pen.

6. The arrangement of claim 5, wherein the display is arranged on a surface of the insulin injection pen.

7. The arrangement according to claim 1, further comprising a remote mobile device arranged separate from the insulin delivery device and adapted to wirelessly communicate with the insulin delivery device.

8. The arrangement of claim 7, wherein the mobile device includes the dose converter as a mobile application.

9. The arrangement of claim 7, wherein the mobile device comprises a smart phone and/or a smart watch.

10. The arrangement of claim 7, wherein the remote mobile device is configured to automatically retrieve and process the presetting for the insulin dose upon a user manipulation of the insulin delivery device.

11. The arrangement of claim 7, wherein the display for displaying the carbohydrate value is provided on the remote mobile device.

12. The arrangement according to claim 1, further comprising a continuous monitoring glucose meter configured to provide a glucose measurement value to the dose converter.

13. The arrangement of claim 12, wherein the glucose measurement value is retrieved from the glucose meter by the remote mobile device, and wherein the glucose measurement value is transmitted from the remote mobile device to the insulin delivery device.

14. The arrangement according to claim 1, wherein the dose converter is configured to include a user-specific correction bolus in a calculation of the carbohydrate value.

15. The arrangement according to claim 1, wherein the insulin delivery device has an activation circuit which triggers transmission of user specific parameters from the remote mobile device when the insulin delivery device is activated.

16. The arrangement according to claim 1, wherein the dose converter has a routine to determine the carbohydrate value based on the preset 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.

17. A method for dosing adjustment of an insulin delivery arrangement, comprising: presetting an insulin dose in a hand-operable insulin delivery device by user manipulation of an adjusting unit; automatically providing the preset insulin dose as an input to a dose converter without additional user interaction; receiving as an output from the dose converter a carbohydrate value equivalent to an amount of meal carbohydrates; and displaying the carbohydrate value in parallel to the presetting of the insulin dose.

18. The method of claim 17, wherein the presetting comprises rotating a stepwise rotatable dial.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0039] 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:

[0040] FIG. 1 depicts in a perspective view an arrangement of an insulin injection pen and a dose converter for calculating an amount of carbohydrate equivalent to an adjusted insulin dose;

[0041] FIG. 2 shows a proximal end of the insulin pen including a digital display to indicate the carbohydrate value; and

[0042] FIG. 3 illustrates a further exemplary insulin delivery system comprising an insulin pen, a smartphone and a glucose meter.

DESCRIPTION

[0043] 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.

[0044] As depicted in FIG. 1, an exemplary embodiment of an insulin delivery arrangement 10 comprises an insulin pen 12 having an adjusting unit or adjuster 14 for presetting of an insulin dose and further comprising a dose converter 16 schematically illustrated as being integrated in the insulin pen 12, wherein the dose converter 16 is adapted to receive an actual setting value for the insulin dose as an input and to provide an equivalent carbohydrate value as an output 18 on a digital display 20.

[0045] 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.

[0046] 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.

[0047] 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.

[0048] As depicted in FIG. 2, the carbohydrate value or output 18 of the dose converter 16 is indicated in digital form on the display screen 20 on the proximal end of the pen 12. Thus, the user can directly take notice of the carbohydrate value while turning the dial 30 to find the appropriate setting. The display 20 may also provide additional information, such as a dose memory 40 to visualize insulin units last injected. It is also conceivable that the display 20 is arranged on the long side of the pen 12 preferably in the vicinity of the scale 34.

[0049] 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.

[0050] FIG. 3 depicts a more enhanced insulin delivery system 42 comprising an insulin pen 12, a primary remote mobile device 44, if needed a secondary mobile device 46, and a glucose meter 48.

[0051] 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 FIG. 3.

[0052] 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.

[0053] 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.

[0054] 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.

[0055] 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.

[0056] 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.

[0057] 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.

[0058] 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.

[0059] In a more advanced calculation routine, the dose converter 16 has a software routine to determine the carbohydrate value (C.sub.t) based on the actual setting value for the insulin dose (I.sub.t) and other user events and/or parameters, such as a measured glucose value G.sub.t, a target glucose value T.sub.g, 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).

[0060] The carbohydrate value then may be calculated as follows:

[00001]$\begin{array}{cc}{C}_t=\left({I_{t^{-}}\left(G_{t^{-}}{T}_g\right)}^{*}ISF\right)/ICR& \left(1\right)\end{array}$

[0061] In one embodiment, dose converter 16 has a more general software routine. The carbohydrate value (C.sub.t) may be determined as follows:

[00002]$\begin{array}{cc}{C}_t=f\left(I_t,G_t,T_t,{\Phi }_t,{\theta }_t\right)& \left(2\right)\end{array}$

wherein I.sub.t is the setting value for the insulin dose at the actual time t, G.sub.t is the actual measured glucose value, T.sub.t is the actual target glucose value,
and wherein

Φ.sub.t=[(C.sub.t1,I.sub.t1,G.sub.t1, . . . ), . . . ,(C.sub.tn,I.sub.tn,G.sub.tn, . . . )]  (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

θ.sub.t=[(ISF.sub.t,ICR.sub.t,T.sub.t, . . . ), . . . ,(ISF.sub.tn,ICR.sub.tn,T.sub.tn, . . . )]  (4),

wherein θ.sub.t 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.

[0062] 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.

[0063] 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.

[0064] 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.

[0065] 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.