Insulin Delivery Profile

While in a GAP Discoverable Mode for initial connection to a Collector, the Insulin Delivery Sensor should include the Insulin Delivery Service UUID defined in [10] in the Service UUID’s AD type field of the Advertising Data. This enhances the user experience as an Insulin Delivery Sensor may be identified by the Collector before initiating a connection.

For an enhanced user experience, an Insulin Delivery Sensor should include the Local Name (containing either the complete or shortened value of the Device Name characteristic as defined in [9]) in its Advertising Data or Scan Response Data.

For an enhanced user experience, an Insulin Delivery Sensor should include the value of the Appearance characteristic defined in [2] in its Advertising data or Scan Response data.

In the following sections, the words a “Target Address AD Type” are intended to refer to either of the defined Target Address AD Types.

To reset a status exposed by the IDD Status Changed characteristic, the Collector shall write the Reset Status Op Code followed by a Flags field as defined in the IDD Status Changed characteristic to the IDD Status Reader Control Point.

The Collector shall wait for the Response Code Op Code indication with Response Code Value set to Success indicating success of the operation as per the request or an error value as described in Section 4.15.5.

To get further updates by changes of the Flags field of the IDD Status Changed characteristic, the Collector shall use this procedure (for details see Section 4.6).

If a bit of the Flags Operand is set to 1, the Server will reset the corresponding status of the IDD Status Changed characteristic by setting it to 0. If a bit of the Flags Operand is set to 0, the status will be retained.

Typically the Collector is informed about status changes of the Insulin Delivery Sensor by evaluating the IDD Status Changed Flags field (e.g., Therapy Control State Changed bit set). Then the Collector reads the relevant status values (e.g., IDD Status characteristic) and finally informs the Insulin Delivery Sensor about the completed evaluation and processing by executing the Reset Status.

To get the IDs of the potential seven current active boluses, the Collector shall write the Get Active Bolus IDs Op Code to the IDD Status Reader Control Point.

The Collector shall wait for the Get Active Bolus IDs Response Op Code indication with an Active Bolus ID record indicating success of the operation as per the request or a Response Code Op Code indication with an error value as described in Section 4.15.5.

The Active Bolus ID record contains the Bolus IDs of the active boluses in the order of their start time (i.e., the Bolus ID1 field contains the ID of the oldest bolus and the Bolus ID7 field the ID of the latest delivered bolus).

If the Insulin Delivery Sensor responds with a Number of Active Boluses being more than 7, the 7 Active Bolus ID fields refer to the ones with the oldest start date time. In this case the Collector may use the IDD RACP (see Section 4.13) to retrieve information about the programmed boluses by reading the Bolus Programmed Events. However this is assumed as an exceptional case.

The Collector can use this procedure after receiving an active bolus status change signaled by the Active Bolus Status Changed bit of the Flags field of the IDD Status Changed characteristic (see Section 4.6).

To get the details about a currently active bolus, the Collector shall use the Get Active Bolus Delivery procedure with the associated bolus ID.

To get delivery information about a specific active bolus, the Collector shall write the Get Active Bolus Delivery Op Code followed by a Bolus ID and a desired Bolus Value Selection to the IDD Status Reader Control Point. The Bolus Value Selection Operand specifies if the programmed, remaining (e.g., remaining insulin amount) or delivered values (e.g., already delivered insulin amount) are returned in the response of this procedure.

The Collector shall wait for the Get Active Bolus Delivery Response Op Code indication with an Active Bolus Delivery record indicating success of the operation as per the request or a Response Code Op Code indication with an error value as described in Section 4.15.5.

The Collector can use this procedure after receiving an active bolus status change signaled by the Active Bolus Status Changed bit of the Flags field of the IDD Status Changed characteristic (see Section 4.6).

The Collector shall be able to handle a Bolus Delay Time of 0xFFFF in the response if the Bolus Value Selection Operand is set to Delivered, which means that the Bolus Delay Time is not applicable with that Bolus Value Selection Operand.

To get the active basal rate setting including the TBR, the Collector shall write the Get Active Basal Rate Delivery Op Code to the IDD Status Reader Control Point.

The Collector shall wait for the Get Active Basal Delivery Response Op Code indication with an Active Basal Delivery record indicating success of the operation as per the request or a Response Code Op Code indication with an error value as described in Section 4.15.5.

The Collector can use this procedure after receiving an active basal rate status change signaled by the Active Basal Rate Status Changed bit of the Flags field of IDD Status Changed characteristic (see Section 4.6).

To get the total daily delivered bolus and basal insulin from midnight until now, the Collector shall write the Get Total Daily Insulin Status Op Code to the IDD Status Reader Control Point.

The Collector shall wait for the Get Total Daily Insulin Status Response Op Code indication with a Total Daily Insulin Status record indicating success of the operation as per the request or a Response Code Op Code indication with an error value as described in Section 4.15.5.

The received total daily insulin amounts refer to the current date time of the Insulin Delivery Sensor (i.e., if the date time is changed, the insulin amounts always refer to the current date time).

The Collector can use this procedure after receiving a total daily insulin status change signaled by the Total Daily Insulin Status Changed bit of the Flags field of the IDD Status Changed characteristic (see Section 4.6).

If the insulin delivery device does not support boluses, the Collector shall be able to handle a value of 0 for the Total Daily Insulin Sum of Bolus Delivered. If the insulin delivery device does not support a basal rate, the Collector shall be able to handle a value of 0 for the Total Daily Insulin Sum of Basal Delivered field (see IDD Features Flags in Section 4.9).

To get the value of an internal counter of the insulin delivery device, the Collector shall write the Get Counter Op Code followed by a Counter Type and Counter Value Selection field to the IDD Status Reader Control Point.

The Collector shall wait for the Get Counter Response Op Code indication with a Counter record indicating success of the operation as per the request or a Response Code Op Code indication with an error value as described in Section 4.15.5.

The Counter Value Selection field of the Operand specifies the value of the Counter Value field contained in the response from the Sensor for the Get Counter procedure. For a Counter Value Selection set to Remaining, the Counter Value is the remaining time before the requested Counter Type expires. A negative value for the remaining time means the counter has already expired. In this case, the absolute value of the remaining time provides the time since expiration. For a Counter Value Selection set to Elapsed, the Counter Value is the elapsed time since the requested Counter Type started. The elapsed time value is never negative.

An insulin delivery device may have a restricted lifetime, warranty or loaner time. This procedure shall be used by a Collector to get the remaining or elapsed values of those counters.

To get the amounts of the delivered bolus and basal insulin, the Collector shall write the Get Delivered Insulin Op Code to the IDD Status Reader Control Point.

The Collector shall wait for the Get Delivered Insulin Response Op Code indication with a Delivered Insulin record indicating success of the operation as per the request or a Response Code Op Code indication with an error value as described in Section 4.15.5.

A Collector can use this procedure to get a delta of the delivered insulin by executing it periodically.

If an amount exceeds a value of 80,000.00 IU, a rollover will occur on the Insulin Delivery Sensor and the Collector will receive a delivered bolus or basal amount starting from 0.

The Collector shall accept a delivered bolus or basal amount set to 0 due to a rollover by the Server if an amount exceeds a value of 80,000.00 IU.

If the Collector was connected to the Insulin Delivery Sensor previously, the Collector can detect a rollover by checking if a retrieved amount is less than the one from the previous execution of this procedure. Depending on the implementation of the Collector, the frequency it executes this procedure and the insulin amount delivered, the Collector can determine that only one rollover has occurred.

To get the amount and remaining duration of the Insulin On Board, which has been delivered by the insulin delivery device, the Collector shall write the Get Insulin On Board Op Code to the IDD Status Reader Control Point.

The Collector shall wait for the Get Insulin On Board Response Op Code indication with an amount of Insulin On Board indicating success of the operation as per the request or a Response Code Op Code indication with an error value as described in Section 4.15.5.

This section defines the common behavior of the following IDD Command control point procedures to read profile templates. These are templates of a series of time blocks that define a specific therapy setting. Each time block contains such a therapy setting to be applied for a specific duration:

Before reading a profile template the Collector should ensure that this template is configured (see Section 4.11.2.18).

Depending on the number of time blocks of a profile, the entire profile (i.e., all defined time blocks of that profile) could be sent in several steps by one or many responses of the Server (i.e., in each step the IDD Command Data characteristic is notified, see Section 4.12). The Collector shall wait for the corresponding response Op Code notification (e.g., Read Basal Rate Profile Template Response) of the IDD Command Data characteristic for each response with a Profile Template record indicating success of the current step as per the request (i.e., the receipt of a Profile Template record containing one or several time blocks). Finally, the Collector shall wait for the corresponding Response Code Op Code indication (e.g., Request Op Code set to Read Basal Rate Profile Template and Response Code set to Success) of the IDD Command Control Point indicating success of the operation (i.e., the receipt of the complete profile). In case of an error, the Collector shall be able to handle a Response Code Op Code indication with an error value as described in Section 4.15.5.

This section defines the common behavior of the following IDD Command control point procedures to write profile templates (also see Section 4.11.2.1 for an explanation of profile templates and their time blocks):

Before writing a profile template the Collector should ensure that this template is configurable (see Section 4.11.2.18) and that the number of time blocks does not exceed the maximum number of supported time blocks for that profile (see Get Template Status and Details procedure in Section 4.11.2.18).

Depending on the number of time blocks of a profile, the profile may be sent in several steps by one or many executions of this procedure (i.e., in each step a Profile Template record containing one or several time blocks is sent). The Collector shall use the First Time Block Number Index field of the Profile Template record to specify the index of the time blocks to be sent within the entire profile. The Collector should ensure that the First Time Block Number Index field as well as the total number of time blocks do not exceed the maximum number of supported time blocks (see Get Template Status and Details procedure in Section 4.11.2.18) and that the First Time Block Number Index field is not less than 1.

The Collector initiates a transaction (i.e., to send the first time blocks of the profile) with the first write of the Op Code of the procedure to the IDD Command control point. The bit 0 (End Transaction) of the Flags field shall be set to False except in the last procedure of the transaction when it shall be set to 1 (also see Section 4.15.3).

The Collector shall wait for a corresponding Response Op Code indication (e.g., Write Basal Rate Profile Template Response) after each execution of the procedure with a Flags field, a Profile Template Number field and a First Time Block Number Index field indicating success of the current step as per the request. When the Collector executes the procedure to send the last time block or time blocks of the profile, the Collector shall wait for a corresponding Response Op Code indication (e.g., Write Basal Rate Profile Template Response) with a Flags field with bit 0 set to 1 (Transaction Completed) and a Profile Template Number field as well as a First Time Block Number Index field indicating the success of the operation (i.e., the complete write of the profile). As soon as a template is written successfully by the Collector, its status is set to Configured by the Insulin Delivery Sensor.

If the Collector writes a profile template to the IDD Command Control Point and the profile template fails the plausibility check on the Insulin Delivery Sensor, it will receive a Response Code CP indication with the Response Code Value set to Plausibility check failed (also see Section 3.7.2.1.2 in [1]).

In case of an error the Collector shall be able to handle a Response Code Op Code indication with an error value as described in Section 4.15.5. In addition, the Collector may restart the transaction and may send the entire profile again.

To set the therapy state of the insulin delivery device, the Collector shall write the Set Therapy Control State Op Code followed by a Therapy Control State field to the IDD Command Control Point.

The Collector shall wait for the Response Code Op Code indication with Response Code Value set to Success indicating success of the operation as per the request or an error value as described in Section 4.15.5.

To activate the flight mode of the insulin delivery device, the Collector shall write the Set Flight Mode Op Code to the IDD Command Control Point. The flight mode places the insulin delivery device to a mode accepted by the avionic authorities to allow inflight usage.

The Collector shall wait for the Response Code Op Code indication with Response Code Value set to Success indicating success of the operation as per the request or an error value as described in Section 4.15.5.

To snooze an annunciation of the Insulin Delivery Sensor, which is expected to still be active until it is confirmed, the Collector shall write the Snooze Annunciation Op Code followed by an Annunciation Instance ID field to the IDD Command Control Point.

The Collector shall wait for the Snooze Annunciation Response Op Code indication with an Annunciation Instance ID field indicating success of the operation as per the request or a Response Code Op Code indication with an error value as described in Section 4.15.5.

The Collector should be able to handle the following changes of characteristic values as soon as this procedure is executed successfully:

If the snoozing time (its value is left to the implementation of the Insulin Delivery Sensor) is over, the Collector should be able to handle the following changes of characteristic values:

To confirm an annunciation of the Insulin Delivery Sensor, the Collector shall write the Confirm Annunciation Op Code followed by an Annunciation Instance ID field to the IDD Command Control Point.

The Collector shall wait for the Confirm Annunciation Response Op Code indication with an Annunciation Instance ID field indicating success of the operation as per the request or a Response Code Op Code indication with an error value as described in Section 4.15.5.

After successful execution of this procedure, the Collector should be able to handle that the Annunciation Status Changed bit of the Flags field of the IDD Status Changed characteristic (see Section 4.6) will be set to 1.

After the Collector successfully executes the Confirm Annunciation procedure, the IDD Annunciation Status characteristic does not provide information about that annunciation.

To read a basal rate profile template of the Insulin Delivery Sensor, the Collector shall write the Read Basal Rate Profile Template Op Code followed by a Basal Rate Profile Template Number field to the IDD Command Control Point.

For the Read Basal Rate Profile Template procedure the common behavior of reading profile templates apply (see Section 4.11.2.1).

To write a basal rate profile template to the Insulin Delivery Sensor, the Collector shall write the Write Basal Rate Profile Template Op Code followed by a Basal Rate Profile Template record to the IDD Command Control Point.

For the Write Basal Rate Profile Template procedure the common behavior of writing profile templates apply (see Section 4.11.2.2).

To set a new or change a currently active temporary basal rate, the Collector shall write the Set TBR Adjustment Op Code followed by a TBR record to the IDD Command Control Point.

The Collector shall wait for the Response Code Op Code indication with Response Code Value set to Success indicating success of the operation as per the request or an error value as described in Section 4.15.5.

If the Insulin Delivery Sensor supports TBR templates (see IDD Features Flags in Section 4.9), the Collector can set a TBR adjustment from a stored TBR template by attaching the TBR Template Number field in the TBR record with the value of the TBR template number to set and then shall indicate its presence by setting bit 0 of the Flags field to True (TBR Template Number Present). In this case the Insulin Delivery Sensor will use the settings of the corresponding TBR template denoted by the TBR Template Number field and ignore the values of the fields that are available in that TBR template. The Collector can read the TBR settings of that template before executing this procedure (see Section 4.11.2.11). Furthermore, before applying this TBR template the Collector should ensure that it is configured (see Section 4.11.2.18).

If the settings of a currently active TBR are to be changed (i.e., the settings are to be overwritten completely), the Collector shall set bit 2 of the Flags field to True (Change TBR). If otherwise there is currently no active TBR and a TBR shall be activated, the Collector shall set this bit to False.

To cancel a currently active TBR, the Collector shall write the Cancel TBR Adjustment Op Code to the IDD Command Control Point.

The Collector shall wait for the Response Code Op Code indication with Response Code Value set to Success indicating success of the operation as per the request or an error value as described in Section 4.15.5.

Before getting a TBR template the Collector should ensure that this template is configured (see Section 4.11.2.18).

To get the parameters of specific TBR Template of the Insulin Delivery Sensor, the Collector shall write the Get TBR Template Op Code followed by a TBR Template Number field to the IDD Command Control Point.

The Collector shall wait for the Get TBR Template Response Op Code indication with a TBR Template record indicating success of the operation as per the request or a Response Code Op Code indication with an error value as described in Section 4.15.5.

Before setting a TBR template the Collector shall ensure that this template is configurable (see Section 4.11.2.18).

To set the parameters of specific TBR Template of the Insulin Delivery Sensor, the Collector shall write the Set TBR Template Op Code followed by a TBR Template record to the IDD Command Control Point.

The Collector shall wait for the Set TBR Template Response Op Code indication with a TBR Template Number field indicating success of the operation as per the request or a Response Code Op Code indication with an error value as described in Section 4.15.5.

Before setting a bolus, the Collector can check if a bolus of a specific type is currently available by using the Get Available Boluses procedure (see Section 4.11.2.15).

To set a bolus, the Collector shall write the Set Bolus Op Code followed by a Bolus record to the IDD Command Control Point.

The Collector shall wait for the Set Bolus Response Op Code indication with a Bolus ID field of the new set bolus indicating success of the operation as per the request or a Response Code Op Code indication with an error value as described in Section 4.15.5.

If the Collector sets a bolus and the specified type is currently not available on the Insulin Delivery Sensor, it will receive a Response Code CP indication with the Response Code Value set to Maximum Bolus Number reached.

If the Insulin Delivery Sensor supports a bolus delay time (see IDD Features Flags in Section 4.9), the Client can attach the Bolus Delay Time field in the Bolus record and then shall indicate its presence by setting bit 0 of the Flags field to True (Bolus Delay Time Present).

If the Insulin Delivery Sensor supports bolus templates (see IDD Features Flags in Section 4.9), the Client can set a bolus from a stored bolus template by attaching the Bolus Template Number field in the Bolus record with the value of the bolus template number to set and then shall indicate its presence by setting bit 1 of the Flags field to True (Bolus Template Number Present). In this case the Insulin Delivery Sensor will use the settings of the corresponding Bolus template denoted by the Bolus Template Number field and ignore the values of the fields that are available in that bolus template. The Collector can read the bolus parameters of that template by executing the Get Bolus Template procedure before setting a bolus (see Section 4.11.2.16). In addition, the Collector should ensure that this bolus template is configured (see Section 4.11.2.18).

If the Insulin Delivery Sensor supports a bolus activation type (see IDD Features Flags in Section 4.9), the Client can attach the Bolus Activation Type field in the Bolus record and then shall indicate its presence by setting bit 2 of the Flags field to True (Bolus Activation Type Present).

If the Collector sets the Bolus Type to “Extended” in the Operand, it should set the Bolus Fast Amount field to 0, or otherwise it will receive an error.

If the Collector sets the Bolus Type to “Fast” in the Operand, it should set the Bolus Extended Amount and Bolus Duration fields to 0, or otherwise it will receive an error.

To cancel a set bolus, the Collector shall write the Cancel Bolus Op Code followed by a Bolus ID field to the IDD Command Control Point.

The Collector shall wait for the Cancel Bolus Response Op Code indication with a Bolus ID field of the canceled bolus indicating success of the operation as per the request or a Response Code Op Code indication with an error value as described in Section 4.15.5.

To check which bolus types are currently available, the Collector shall write the Get Available Boluses Op Code to the IDD Command Control Point.

The Collector shall wait for the Get Available Boluses Response Op Code indication with a Flags field of the available bolus types indicating success of the operation as per the request or a Response Code Op Code indication with an error value as described in Section 4.15.5.

The Collector should use this procedure before executing the Set Bolus procedure (see Section 4.11.2.13).

Before getting a bolus template the Collector should ensure that this template is configured (see Section 4.11.2.18).

To get the parameters of a bolus template, the Collector shall write the Get Bolus Template Op Code followed by a Bolus Template Number field to the IDD Command Control Point.

The Collector shall wait for the Get Bolus Template Response Op Code indication with a Bolus Template record indicating success of the operation as per the request or a Response Code Op Code indication with an error value as described in Section 4.15.5.

The Collector should use this procedure before setting a bolus based on a bolus template (see Section 4.11.2.13).

Before setting a bolus template the Collector should ensure that this template is configurable (see Section 4.11.2.18).

To set the parameters of a bolus template, the Collector shall write the Set Bolus Template Op Code followed by a Bolus Template record to the IDD Command Control Point.

The Collector shall wait for the Set Bolus Template Response Op Code indication with a Bolus Template Number field of the set bolus template indicating success of the operation as per the request or a Response Code Op Code indication with an error value as described in Section 4.15.5.

If the Insulin Delivery Sensor supports a bolus delay time (see IDD Features Flags in Section 4.9), the Client can attach the Bolus Delay Time field in the Bolus record and then shall indicate its presence by setting bit 0 of the Flags field to True (Bolus Delay Time Present).

If the Collector sets the Bolus Type to “Extended” in the Operand, it shall set the Bolus Fast Amount field to 0. If the Collector sets the Bolus Type to “Fast” in the Operand, it shall set the Bolus Extended Amount and Bolus Duration fields to 0.

To get the status and details of all supported templates (i.e., if they are configured and / or configurable, maximum number of supported time blocks, starting template number and number of templates), the Collector shall write the Get Template Status and Details Op Code to the IDD Command Control Point.

The Collector only can read (e.g., Read Basal Rate Profile procedure, see Section 4.11.2.7), apply (e.g., Set Bolus procedure or Activate Profile Templates procedure, see Sections 4.11.2.13 and 4.11.2.20 respectively) and reset (see Section 4.11.2.19) configured templates. Otherwise the corresponding procedure will return an error. If a template is written by the Collector, then its status is set to Configured by the Insulin Delivery Sensor. The Collector shall use this procedure to check if a template is configured before reading, applying or resetting a template.

The Collector only can write configurable templates. Otherwise the corresponding procedure will return an error. Templates that are not configurable might be predefined by the Insulin Delivery Sensor and then cannot be changed by the Collector (i.e., the template is not configurable, but it is configured, because it is set by the Insulin Delivery Sensor). The Collector shall use this procedure to check if a template is configurable before writing a template.

The Collector may use this procedure to only present templates in a UI that are configured in case of reading and applying templates or that are configurable in case of writing templates.

The maximum number of supported time blocks for a Profile Template type defines the maximum number of time blocks the Collector can set for that Profile Template type when writing a template (e.g., basal rate profile template).

The starting template number and number of templates are used to determine the template number range for a template type. Each supported template type has a defined range of unique template numbers such that a template can be referred to with only its template number. For example, if the basal rate profile template type has a starting template number set to 1 and number of templates set to 3, then template numbers 1, 2, and 3 identify basal rate profile templates, and these template numbers cannot be used to identify a template of another template type.

Depending on the number of template types supported, all the template details could be sent in one or many responses of the Server. The Collector shall wait for the Get Template Status and Details Response Op Code notification of the IDD Command Data characteristic for each supported template type with a template status and details record. Once all the template status and details records have been reported for all supported template types, the Collector shall wait for the corresponding Response Code Op Code indication with Request Op Code set to Get Template Status and Details and Response Code set to Success of the IDD Command Control Point indicating success of the procedure. In case of an error the Collector shall be able to handle a Response Code Op Code indication with an error value as described in Section 4.15.5

To reset the status of one or many templates (i.e., marking it or them as “not configured”), the Collector shall write the Reset Template Status Op Code followed by a Number of Templates to Reset field and a Template Numbers field to the IDD Command Control Point.

The Collector shall wait for the Reset Template Status Response Op Code indication with a Number of Templates Reset field and a Template Numbers field of the reset templates indicating success of the operation as per the request or a Response Code Op Code indication with an error value as described in Section 4.15.5.

The Collector can only reset templates that are both configurable and configured (see Section 4.11.2.18), otherwise this procedure will return an error. In addition, an active basal rate profile template, an ISF profile template, an I:CHO ratio profile template, or target glucose range profile template cannot be reset if it is in use by the Sensor Application (e.g., by a bolus calculator).

The Collector may use this procedure to remove one or more templates within a UI from a list of readable or usable templates (i.e., the UI could only show the configured templates).

Before activating a profile template, the Collector should ensure that it is configured (see Section 4.11.2.18).

To activate profile templates on the Insulin Delivery Sensor, the Collector shall write the Activate Profile Templates Op Code followed by a Number of Profile Templates to Activate field and a Profile Template Numbers field identifying the profile templates to activate to the IDD Command Control Point.

The Collector shall wait for the Activate Profile Templates Response Op Code indication with a Number of Profile Templates Activated field and a Profile Template Numbers field indicating success of the operation as per the request or an error value as described in Section 4.15.5.

Once a basal rate profile template is activated, it cannot be deactivated, but the Collector can activate another basal rate profile template or, if the active basal rate profile is configurable, set the basal rate of the active basal rate profile template to 0 IU/h.

Once an ISF, an I:CHO ratio, or a target glucose range profile template is activated, it cannot be deactivated, but the Collector can activate another profile template of that type.

To get all the currently activated profile templates, the Collector shall write the Get Activated Profile Templates Op Code to the IDD Command Control Point.

The Collector shall wait for the Get Activated Profile Templates Response Op Code indication with a Number of Activated Profile Templates field and a conditional Profile Template Numbers field indicating success of the operation as per the request or a Response Code Op Code indication with an error value as described in Section 4.15.5.

The Collector may use this procedure to get the activated profile templates which have been activated by another Collector.

The Collector shall be able to handle the following responses:

To start the priming after a reservoir refill or a replacement of the infusion set, the Collector shall write the Start Priming Op Code followed by an Amount field to the IDD Command Control Point.

The Collector shall wait for the Response Code Op Code indication with Response Code Value set to Success indicating success of the operation as per the request or an error value as described in Section 4.15.5.

This procedure starts the filling of the fluidic path of the insulin delivery device with the provided amount of insulin and the Insulin Delivery Sensor stops the priming as soon as this insulin amount is delivered.

The Collector can stop the priming at any time by executing the Stop Priming procedure (see Section 4.11.2.23).

If the Collector receives an erroneous response from the Insulin Delivery Sensor (e.g., an Attribute Protocol Error code of Invalid CRC), the Collector can determine if the priming was started by reading the IDD Status characteristic (see Section 4.7) and checking if the Operational State is Priming.

To stop the priming after executing the Start Priming procedure (see Section 4.11.2.22), the Collector shall write the Stop Priming Op Code to the IDD Command Control Point.

The Collector shall wait for the Response Code Op Code indication with Response Code Value set to Success indicating success of the operation as per the request or an error value as described in Section 4.15.5.

If the Collector receives an erroneous response from the Insulin Delivery Sensor (e.g., an Attribute Protocol Error code of Invalid CRC), the Collector can determine if the priming was stopped by reading the IDD Status characteristic (see Section 4.7) and checking if the Operational State is not Priming anymore.

To set the initial fill level of the reservoir after a reservoir refill or replacement, the Collector shall write the Set Initial Reservoir Fill Level Op Code followed by a Fill Level field to the IDD Command Control Point.

The Collector shall wait for the Response Code Op Code indication with Response Code Value set to Success indicating success of the operation as per the request or an error value as described in Section 4.15.5.

If the insulin delivery device does not have the capability to detect the initial fill level of the reservoir or the initial fill level is not predetermined, the Collector should use this procedure before requesting to deliver insulin (e.g., priming, setting a bolus).

To reset the Reservoir Insulin Operation Time counter, the Collector shall write the Reset Reservoir Insulin Operation Time Op Code to the IDD Command Control Point.

The Collector shall wait for the Response Code Op Code indication with Response Code Value set to Success indicating success of the operation as per the request or an error value as described in Section 4.15.5.

The Collector can use the Get Counter procedure (see Section 4.10.2.6) with the Counter Type set to Reservoir Insulin Operation Time and the Counter Value Selection field set to the desired value to retrieve the Reservoir Insulin Operation Time counter (e.g., if the insulin delivery device supports a counter for the Insulin Operation Time and does not have the capability to reset that counter, the Collector should use this procedure after a reservoir refill or replacement).

To read an ISF profile template of the Insulin Delivery Sensor, the Collector shall write the Read ISF Profile Template Op Code followed by an ISF Profile Template Number field to the IDD Command Control Point.

For the Read ISF Profile Template procedure the common behavior of reading profile templates apply (see Section 4.11.2.1).

To write an ISF profile template to the Insulin Delivery Sensor, the Collector shall write the Write ISF Profile Template Op Code followed by an ISF Profile Template record to the IDD Command Control Point.

For the Write ISF Profile Template procedure the common behavior of writing profile templates apply (see Section 4.11.2.2).

To read an I:CHO ratio profile template of the Insulin Delivery Sensor, the Collector shall write the Read I2CHO Ratio Profile Template Op Code followed by an I2CHO Ratio Profile Template Number field to the IDD Command Control Point.

For the Read I2CHO Ratio Profile Template procedure the common behavior of reading profile templates apply (see Section 4.11.2.1).

To write an I:CHO ratio profile template to the Insulin Delivery Sensor, the Collector shall write the Write I2CHO Ratio Profile Template Op Code followed by an I2CHO Ratio Profile Template record to the IDD Command Control Point.

For the Write I2CHO Ratio Profile Template procedure the common behavior of writing profile templates apply (see Section 4.11.2.2).

To read a target glucose range profile template of the Insulin Delivery Sensor, the Collector shall write the Read Target Glucose Range Profile Template Op Code followed by a Target Glucose Range Profile Template Number field to the IDD Command Control Point.

For the Read Target Glucose Range Profile Template procedure the common behavior of reading profile templates apply (see Section 4.11.2.1).

To write a target glucose range profile template to the Insulin Delivery Sensor, the Collector shall write the Write Target Glucose Range Profile Template Op Code followed by a Target Glucose Range Profile Template record to the IDD Command Control Point.

For the Write Target Glucose Range Profile Template procedure the common behavior of writing profile templates apply (see Section 4.11.2.2).

To get the maximum bolus amount, the Collector shall write the Get Max Bolus Amount Op Code to the IDD Command Control Point.

The Collector shall wait for the Get Max Bolus Amount Response Op Code indication with a Max Bolus Amount field indicating success of the operation as per the request or a Response Code Op Code indication with an error value as described in Section 4.15.5.

To set the maximum bolus amount, the Collector shall write the Set Max Bolus Amount Op Code followed by a Max Bolus Amount field to the IDD Command Control Point.

The Collector shall wait for the Response Code Op Code indication with Response Code Value set to Success indicating success of the operation as per the request or an error value as described in Section 4.15.5.

If the Collector writes an Op Code to the IDD Command Control Point characteristic which requires notifications of the IDD Command Data characteristic and its Client Characteristic Configuration descriptor is not configured for notifications, it will receive a Response Code CP indication with the Attribute Protocol Application error code set to Client Characteristic Configuration Descriptor Improperly Configured.

If there is an IDD Command Control Point specific error that is also specific to certain procedures, this error is described in the procedure section.

Certain IDD RACP procedures use a Filter Type that is used to determine the portion of the stored records on the Insulin Delivery Sensor that the procedure applies to. The format of the Filter Type and the IDD RACP procedures that have a Filter Type Operand is defined in [1]. The Collector may filter using either the filters Sequence Number, Sequence Number filtered by Reference Time Event or Sequence Number filtered by Non-Reference Time Event.

The Sequence Number filter is used when a procedure should apply to specific history record or a range of history records. The Sequence Number that is used is obtained from the Sequence Number field in the IDD History Data characteristic.

The Sequence Number filtered by Reference Time Event filter can be used when the Collector needs a specific range of dates and times. This filter type includes an additional filter by Reference Time Event. Due to the fact that only the Reference Time Events include absolute time stamps (all other history events contain a Time Offset field which references the previous Reference Time Event) the Collector can use the Sequence Numbers of the received Reference Time Events to request a specific range of dates and times.

The Sequence Number filtered by Non-Reference Time Event filter can be used when the Collector already received Reference Time Events by using the Filter Type Sequence Number filtered by Reference Time Event and just wants to get the missing Non-Reference Time Events to read all event types from the Insulin Delivery Sensor. In addition, this Filter Type may be used when the Collector needs to delete a specific range of events and wants to avoid that also Reference Time Events are deleted, because otherwise all events referring to the deleted Reference Time Events would lose their time stamp.

To request the number of stored records from an Insulin Delivery Sensor, the Collector shall use the Report Number of Stored Records procedure. To receive the number based on filter criteria, an appropriate Operator and Operand shall be used. Refer to [1] for Operand requirements when used with a specific Operator and note that in some cases, no Operand is used.

The Collector shall wait for the Number of Stored Records Response IDD RACP indication containing the number of stored records available in the Insulin Delivery Sensor as per the request. The Number of Stored Records Response IDD RACP indication ends the Report Number of Stored Records procedure. In special circumstances, a Collector may request an abort of this procedure. See Section 4.13.2.5 for details on that procedure.

If after requesting the number of stored records, the Collector receives a Response Code IDD RACP indication with a Response Code Value that represents an error condition, see Section 4.15.5 for general error handling procedures.

The value returned by the Number of Stored Records procedure is intended to be used either for the user interface (UI) on the Collector or to enable the Collector to acquire an estimate of the number of records it might receive to verify it has sufficient resources. The Collector should not rely on this value as a means of determining if new records are available from the Insulin Delivery Sensor. The Collector should always request new records by filtering with a Sequence Number or Sequence Number filtered by Reference Time Event incremented from a previous transfer session.

To request deletion of stored records within the Insulin Delivery Sensor, the Collector shall use the Delete Stored Records procedure. To delete a selected set of stored records based on filter criteria, an appropriate Operator and Operand shall be used. Refer to [1] for Operand requirements when used with a specific Operator and note that in some cases, no Operand is used.

The Collector shall wait for the Response Code IDD RACP indication with the Response Code Value set to Success indicating successful deletion of records as per the request or for the procedure to time out according to the procedure time out operation described in Section 4.15.4. In special circumstances, a Collector may require an abort of this procedure. See Section 4.13.2.5 for details on the Abort Operation procedure.

If after requesting the deletion of stored records, the Collector receives a Response Code IDD RACP indication with a Response Code Value that represents an error condition, see Section 4.15.5 for general error handling procedures.

To request the transfer of stored records from the Insulin Delivery Sensor, the Collector shall use the Report Stored Records procedure. To receive a selected set of stored records based on filter criteria, an appropriate Operator and Operand shall be used. Refer to [1] for Operand requirements when used with a specific Operator and note that in some cases, no Operand is used. In special circumstances, a Collector may require an abort of this procedure. See Section 4.13.2.5 for details on that procedure.

Once all history records for a given request have been successfully indicated by the Insulin Delivery Sensor, the Insulin Delivery Sensor will send a Response Code IDD RACP indication with the Response Code Value set to Success.

The Collector may also receive a Response Code IDD RACP indication with the Response Code Value representing an error condition that occurred in processing the request. A description of specific error conditions and recommended procedures is described below. However, see Section 4.15.5 for descriptions of general error conditions.

If after requesting stored records the Collector receives a Response Code IDD RACP indication with the Response Code Value set to No Records found, this indicates that the Insulin Delivery Sensor does not have any stored records that meet the specified criteria.

If after requesting and receiving stored records the Collector receives a Response Code IDD RACP indication with the Response Code Value set to Procedure not completed this indicates that the Insulin Delivery Sensor was required to interrupt its data transfer before completion for an unspecified reason. If this occurs, the Collector should reattempt the data transfer using the same Op Code and Operator, but should modify the filter criteria in the Operand such that data already successfully received does not need to be retransmitted.

If a condition arises where a Collector is no longer able to receive the requested data, the Collector may request to abort the data transfer as described in Section 4.13.2.5.

To abort a procedure that a Collector initiated, the Collector shall use the Abort Operation Op Code with the Operator set to Null and no Operand.

The Collector shall then wait for the Response Code IDD RACP indication with the Response Code Value set to Success indicating successful aborting of the procedure or for the procedure to time out according to the procedure time out operation described in Section 4.15.4. Although Insulin Delivery Sensors are required to stop the data transfer after they have sent the Response Code Value of Success, they may still have some records queued for transfer. These will be sent and require acknowledgement from the Collector before the transfer will be fully terminated. The Collector may choose to process or ignore these additional records but shall be tolerant of this lag in the termination of the transfer.

The Request Op Code in the Operand of the Response Code IDD RACP indication is used to determine if a Response Code IDD RACP indication is received in response to an Abort Operation procedure, or the procedure that the Abort Operation is trying to abort. If the Abort Operation procedure is completed successfully, then the Collector will receive the Response Code IDD RACP indication with the Request Op Code in the Operand set to Abort Operation but will not receive an IDD RACP indication for the aborted procedure.

The Collector may also receive a Response Code IDD RACP indication with the Request Op Code in the Operand set to Abort Operation and the Response Code Value representing an error condition that occurred in processing the request. Though in practice not all Response Code Values may be returned for an Abort Operation procedure, a Collector shall be able to handle receiving all defined Response Code Values in response to this procedure. A description of specific error conditions and recommended procedures is described below. However, see Section 4.15.5 for descriptions of general error conditions.

If after executing the Abort Operation procedure, the Collector receives a Response Code IDD RACP indication with the Request Op Code in the Operand set to Abort Operation and the Response Code Value set to Abort unsuccessful, this indicates that the Insulin Delivery Sensor is unable to process that the running procedure has been aborted (see IDD RACP in [10]). How the Collector handles this situation is left to the implementation.

If the Collector writes an Op Code to the IDD Record Access Control Point which requires notifications of the IDD History Data characteristic and its Client Characteristic Configuration descriptor is not configured for notifications, it will receive a Response Code CP indication with the Attribute Protocol Application error code set to Client Characteristic Configuration Descriptor Improperly Configured.

If the Collector writes an Operator to the IDD Record Access Control Point that is invalid, it will receive a Response Code IDD RACP indication with the Response Code Value set to Invalid Operator.

If the Collector writes an Operator to the IDD Record Access Control Point that is not supported by the Insulin Delivery Sensor (i.e., the IDD RACP Operator is not supported, see [1]), it will receive a Response Code IDD RACP indication with the Response Code Value set to Operator not supported.

If the Collector writes a Filter Type within an Operand to the IDD Record Access Control Point that is not supported by the Insulin Delivery Sensor, it will receive a Response Code IDD RACP indication with the Response Code Value set to Operand not supported.

The Collector may write to the control point characteristic using one of the supported Op Codes in Table 4.5, Table 4.6, or Table 4.7 to request an Insulin Delivery Sensor to perform a procedure. This includes parameters that are valid within the context of that Op Code as defined in [1].

For control point procedures that require a sequence of writes (see Section 4.11.2.2 for more details) the Collector shall complete all necessary writes for that procedure before starting a different control point procedure.

If the Insulin Delivery Sensor supports E2E-Protection, the Collector shall fulfill the following requirements:

If the Collector supports E2E-Protection, it shall fulfill the following requirements:

If a CP procedure times out (see Section 4.15.4 for details of how this may occur), then it should disconnect the link and to reconnect to the Sensor.

In case of a timeout during a profile template reading procedure of the IDD Command CP (Read Basal Rate Profile Template, Read ISF Profile Template, Read I2CHO Ratio Profile Template) the Collector may consider the received Profile Template records to be valid. However the Collector should not assume that the profile template was received completely and should check if the sum of all received time block durations is 24 h. If the received profile template is not complete (i.e., the sum of the time block durations is not 24 h), the Collector may perform the procedure again, when a new link is established.

In case of a timeout during a profile template writing procedure of the IDD Command CP (Write Basal Rate Profile Template, Write ISF Profile Template, Write I2CHO Ratio Profile Template) the Server aborts the write transaction. The Collector may then retry writing the profile template, when a new link is established (also see Section 3.7.2.1.2 in [1]). In that case the Collector may start a new transaction and may send the entire profile template again.

In the case of a procedure timeout during a Report Stored Records procedure of the IDD RACP, the Collector may consider the received history records to be valid. However the Collector should not assume that the records received consist of all of the available records on the Sensor that match the filter criteria, i.e., the Collector should assume that the records received during a Report Stored Records procedure that has timed out are an incomplete set of records based on the filter criteria. The Collector may then perform the procedure again, when a new link is established, adjusting the filter criteria based on the records received during the aborted transfer.