Frequently asked questions
General questions
When will the AP® be approved for the market?
The AP is approved for the European market since February 2020. This means that the device is allowed to be produced and supplied in Europe. First, the AP will become available within several projects in The Netherlands. You can read more about this in the next question.
Is the AP® available for everyone?
No, not yet. The AP will be introduced to the Dutch market through several projects. These are necessary to monitor the long term use of the AP and to realize reimbursement of the device. This approach results from regulation for medical innovations and the fact that the AP is a new product, not a variant of an existing product, such as an insulin pump.
Can children use the AP®?
No, not yet. The AP is currently only available for adults with diabetes type 1. A pilot study with children is in development. Furthermore, we are working on a reduction of the AP so that the next model will be more user friendly, also for children.
What is the size of the AP®?
The dimensions of the AP are: 11,9×7,7×3,7cm.
In the further development of the AP, we take wearability and dimensions into account. We are aiming for a model that is smaller and will be even easier to wear and operate.
How do you wear the AP®?
The AP device is worn at the front of the body. You can use accessories that Inreda develops: a hip bag, a special shirt or a belt bag. It is important to wear the AP day and night.
Daily life
Is it possible to swim with the AP®?
The transmitters are waterproof for 30 minutes at a depth of 1 meter. The AP is not waterproof and cannot be used during swimming. Taking into account the limits of the transmitters, you can swim.
Is it possible to take a shower with the AP®?
The AP cannot be used while taking a shower and must be disconnected. However, you do not need to remove the transmitters.
What do I do with the AP® when I go to sleep?
You also use the AP device during the night. Inreda has developed a shirt in order to wear the AP at night. This shirt has a special pocket for the AP and it keeps the device close to your body.
Can I play sports with the AP®?
You can use the AP during multiple sports, such as running and cycling. In contact sports and sports with a high risk of falls and/or bumps, such as football and hockey, the AP needs to be disconnected. The transmitters do not need to be removed.
Can I use the AP® during a flight?
You can use the AP device during flights with commercial airplanes (with a pressurized cabin) when the next points are taken into account:
- The AP and the transmitters must not be exposed to the radiation from the metal detection port or the bagage scanner. You must indicate to the customs staff that you wish to be frisked.
- During ascending and descending of the aircraft it is advsed to check the infusion sets for air bubble formation. When this occurs it can be solved by flushing the tube.
Availability
Will I receive a reimbursement for the AP®?
Not yet. We strive to receive reimbursement (full or partial) after finishing the projects. We expect this to be in 2026.
I need to change my pump; can I start using the AP®?
No, unfortunately that is not yet possible. The first availability on the market will be within several projects in order to collect data about the effectiveness of the AP when used by a larger group of people and during a longer period of time. Under General you will find more information about the projects.
What does the AP®cost?
The first availability of the AP will be in several projects. Participation in one of these projects does not involve costs for the device including disposables.
Can I buy the AP®?
It is not yet possible to buy the AP. The first availability on the market will be within several projects. These are necessary to monitor the long term use of the AP with larger groups of people.
How do I get started with the AP®?
If your hospital participates in a project, you and your diabetes treatment team will discuss whether the AP is a suitable diabetes treatment for you. If so, your treatment team will register you at Inreda Diabetic.
Sensor & Transmitter
How many sensors are used with the AP®?
The AP uses two Guardian sensors. The measurement of one sensor is used for the treatment. The second sensor continuously monitors the measurements of the first sensor.
How are the measurements sent from the sensor to the AP®?
A transmitter is attached to each sensor. The transmitter sends the data from the sensor to the AP via a wireless connection.
How long should a sensor run in?
The sensor has a run-in time of 6 hours. After that, the sensor can be calibrated and then the sensor is in use.
How long can I use a sensor?
A sensor has an average lifetime of 7 days. If the sensor needs to be replaced, the AP will give an alarm signal. Preferably do not replace the sensors at the same time to avoid interruption of treatment.
Insulin
What type of insulin is used in the AP®?
The AP works with pre-filled Humalog cartridges.
When do you have to change the insulin?
The insuline cartridge should be changed when it is (almost) empty. The AP will give an alarm when you need to change the insulin cartridge.
Which infusion sets are used for the AP®?
The Accu-Chek infusion sets of Roche Diabetes Care are used in the AP system. One for insulin and one for glucagon. The AP system is not compatible with other infusion sets.
When do you have to change the infusion sets?
The insulin infusion set should be changed after three days.
Glucagon
What type of glucagon is used in the AP®?
The AP uses GlucaGen. There are no standard pre-filled cartridges available yet. The glucagon cartridge must therefore be filled manually and can then be placed in the AP.
When do you have to change the glucagon?
The glucagon that is used in the AP should be changed every day.
Which infusion sets are used for the AP®?
The Accu-Chek infusion sets of Roche Diabetes Care are used in the AP system. One for insulin and one for glucagon. The AP system is not compatible with other infusion sets.
When do you have to change the infusion sets?
The glucagon infusion set should be changed every day.
Participation
How do I get selected for using the AP®?
If your hospital participates in a project, you and your diabetes treatment team will discuss whether the AP is a suitable treatment for you. If so, your treatment team will register you at Inreda Diabetic.
I filled in an application form; Is it now certain that i can participate in a project?
Thank you for your application. Participation in a project depends on many factors. Unfortunately, we cannot guarantee that you are selected.
Application forms
Can I recieve information about the AP®?
Certainly. To do so, please fill in the sign up on our website.
Would you like to help us with the further development of the AP®?
We would like to call on you to help us with the further development of the AP, for example with a survey, test or research. If you want to participate in this, you can sign up on our website.
Service
What guidance can I expect when I start using the AP®?
We want to do everything we can to ensure that you can work properly with the AP as soon as possible. You will receive training from Inreda® Diabetic for this; in small groups you can familiarize yourself with the AP and exchange experiences with others. Before coming to the training, you will complete an e-learning program that you can follow on your own time. In addition, you will work with an Inreda coach who is available for you during the first few weeks.