CROSS REFERENCE TO RELATED APPLICATIONS

This application is a U.S. national stage application under 35 USC § 371 of International Application No. PCT/EP2015/076169, filed on Nov. 10, 2015, which claims priority to European Patent Application 14192728.5 filed on Nov. 11, 2014, the entire contents of which are incorporated herein by reference.

TECHNICAL FIELD

The present disclosure relates to an apparatus, system and method for collecting data relating to a medicament dosage from a medication delivery device.

BACKGROUND

A variety of diseases exists that require regular treatment by injection of a medicament. Such injection can be performed by using injection devices, which are applied either by medical personnel or by patients themselves. As an example, type-1 and type-2 diabetes can be treated by patients themselves by injection of insulin doses, for example once or several times per day. For instance, a pre-filled disposable insulin pen can be used as an injection device. Alternatively, a re-usable pen may be used. A re-usable pen allows replacement of an empty medicament cartridge by a new one. Either pen may come with a set of one-way needles that are replaced before each use. The insulin dose to be injected can then for instance be manually selected at the insulin pen by turning a dosage knob and observing the actual dose from a dosage window or display of the insulin pen. The dose is then injected by inserting the needle into a suited skin portion and pressing an injection button of the insulin pen.

To be able to monitor insulin injection, for instance to prevent false handling of the insulin pen, to keep track of the doses already applied or to provide a basis for decisions regarding changes and/or continuation of medical treatment, it is desirable to measure information related to a condition and/or use of the injection device, for example, one or more of the injected insulin type, dose and timing of the injection, in a manner that is reliable and accurate.

WO2011/117212 A1 and WO2013/120777 A1 disclose apparatuses configured for releasable attachment to a medical device or for releasably receiving at least a part of the medical device, such as an injection pen. The apparatus comprises one or more optical sensors for determining information relating to a condition or use of the medical device, such as a dosage to be dispensed by the device, programmed into the device by a user. In particular, the apparatus disclosed in WO2013/120777 A1 is configured to, if a user does not press a confirmation button prior to performing an injection, to confirm the dosage amount detected by the one or more optical sensors, a graphic may be displayed suggesting that the user confirms the displayed dose.

For applications such as monitoring medicament dosages, it is important that the sensor data is obtained and processed reliably. In particular, it is important that the recorded dosage, and any indications provided to the user regarding a currently programmed dosage, are accurate, to avoid administration of an incorrect dosage amount.

SUMMARY

According to a first aspect, a data collection device includes a camera, a display, a user interface configured to receive confirmation of a medicament dosage amount programmed into a medicament delivery device, and a processing arrangement configured to capture images of a medicament dose indicator of the medicament delivery device using the camera, display at least a part of the images on a display of the data collection device, determine whether an injection has been administered without prior user confirmation of the medicament dosage amount programmed into the medicament delivery device based on one or more of the images and, in response to a determination an injection has been administered without the prior user confirmation, prompt the user to set a medicament dosage amount for the administered injection for storing in a dosage log, receive a user input of setting the medicament dosage amount and store the medicament dosage amount.

This aspect also provides a medicament delivery system including such a data collection device and a medicament delivery device. In some embodiments, the data collection device is configured for attachment to the medicament delivery device. Such attachment may be releasable, so that the data collection device can be reused with different medicament delivery devices. The medicament delivery device may be an injector pen, such as an insulin injector pen.

Such a data collection device may improve the reliability of recording the delivery of medication to a user, by detecting the occurrence of an injection with an unknown dosage and requesting that the user rectifies the omission promptly.

For example, a dosage log may be maintained in which collected data pertaining to injections administered by the user may be stored. Such data may include one or more of medicament dosage amounts, medicament types and the data and time of the administration of an injection. Such a dosage log may be stored in the data collection device. Alternatively, or additionally, the data collection device may transmit the data to another device where the log is maintained. Such logs may be used to monitor and/or review the user's treatment, for example, when deciding whether changes should be made to the user's medication.

Further, the dosage amounts presented on the display are taken from captured images, without performing a procedure such as optical character recognition to identify the optical dosage amount shown in the image. By using the image, rather than an identified numerical value, the risk of administrating an incorrect dosage due to an erroneous numeral value being identified automatically and displayed may be reduced.

The determination that an injection has been administered without prior confirmation of the medicament dosage amount may be based on input received from the user, such as a specific confirmation that an injection has been performed or an instruction to begin setting of the medicament dosage amount of an administered injection. Alternatively, or additionally, the administration of an injection may be performed automatically, for example, by detecting changes in the dosage amount displayed by the medicament dosage indicator and/or by determining when the displayed dosage amount is a predetermined number, such as zero. Particularly where automatic detection is used, the user may be asked to confirm whether the injection has been administered, to distinguish between a situation in which an injection has been administered without confirmation of the medicament dosage amount and another situation where an injection has not been administered. This may take the form of a specific request for user to provide confirmation, however the receipt of a user instruction to begin setting of a medicament dosage amount may also be treated as confirmation that an injection has been performed.

Prompting the user may include one or more of requesting that the user confirms a suggested dosage amount, requesting that a user provides input indicating the dosage amount, for example by adjusting the suggested dosage amount, and requesting the user indicates whether an unspecified dosage amount is to be recorded.

Setting a dosage amount by a user may include user input confirming a suggested dosage amount displayed by the data collection device and/or user input adjusting a displayed dosage amount. Alternatively, the user may provide specific input indicating an unknown or unspecified medicament dosage amount.

The processing arrangement may be configured to determine that an injection has been administered based on a determination of a medicament dosage amount shown in one or more images of the medicament dosage indicator captured by the camera. For example, the processing arrangement may determine whether a dosage amount shown by the medicament dosage indicator in an image captured by the camera is equal to zero and to determine that the injection has been administered based at least in part on detection of a zero dosage amount or other predetermined dosage amount.

The user interface may be configured to allow a user to indicate the programmed medicament dosage amount by indicating a numerical value in response to the prompt. For example, the processing arrangement may be configured to display an image of a suggested dosage amount to the user and to prompt the user by requesting confirmation of the suggested dosage amount. The processing arrangement may also allow the user to adjust the suggested dosage amount or to proceed with recording the injection with an unknown dosage amount. Where a suggested dosage amount is displayed, the suggested dosage amount may be a highest dosage amount programmed into the delivery device prior to the injection identified from a captured image, or a most recent dosage amount programmed into the delivery device prior to the injection shown in a part of a captured image, of an amount based on one or more confirmed medicament dosage amounts of respective injections administered previously, such as a most recently confirmed dosage amount or an average of multiple previously confirmed dosage amounts. The display of the suggested dosage amount may be in the form of a graphic showing a numerical value, or part of one of the images captured by the camera showing a medicament dosage amount. The data collection device may allow a user to select one from the image showing the suggested dosage amount and a plurality of stored reference images to indicate the medicament dosage amount delivered in the injection. In another example, the user may be requested to re-program the medicament delivery device with the previously administered dosage amount so that the camera can capture a new image for user confirmation.

To determine whether an injection has been administered, the processing arrangement may be configured to determine one or more of the numerical value of a medicament dosage amount displayed by the medicament dosage indicator, whether the medicament dosage amount displayed by the medicament dosage indicator is increasing or decreasing and/or whether the medicament dosage indicator in one of the captured images shows a dosage amount of zero.

According to another aspect, there is provided a method of collecting medicament dosage information from a medical delivery device using a data collection device, the method including capturing images of a medicament dose indicator of the medicament delivery device using a camera of the data collection device, displaying the images on a display of the data collection device, the data collection device determining whether an injection has been administered by the medicament delivery device without prior user confirmation of the medicament dosage amount programmed into the medicament delivery device based on one or more of the images, and the data collection device, in response to a determination an injection has been administered without the prior user confirmation, prompting the user to indicate the medicament dosage amount programmed into the medicament delivery device for the injection.

The determination that an injection has been administered may be based on a determination of a medicament dosage amount shown in one or more images of the medicament dosage indicator captured by the camera using at least one of optical pattern recognition and optical character recognition. For example, the determination may be based at least in part on a determination of whether a dosage amount shown by the medicament dosage indicator in an image captured by the camera is equal to a predetermined amount, such as zero.

The determining that the injection has been administered may be based on a determination of whether the dosage amount shown by the medicament dosage indicator is decreasing.

The prompting of the user may include displaying a suggested dosage amount and permitting at least one of user confirmation and adjustment of the suggested dosage amount.

