Frequently asked questions 

General questions

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.

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.

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.

The dimensions of the AP are: 11,9x7,7x3,7cm.
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.

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

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. 

The AP cannot be used while taking a shower and must be disconnected. However, you do not need to remove the transmitters.

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.

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. 

You can use the AP device during flights with commercial airplanes (with a pressurized cabin) when the next points are taken into account: 

1. 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.

2. 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

Not yet. We strive to receive reimbursement (full or partial) after finishing the projects. We expect this to be in 2024.

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.

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.

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. 

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

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. 

A transmitter is attached to each sensor. The transmitter sends the data from the sensor to the AP via a wireless connection. 

The sensor has a run-in time of 6 hours. After that, the sensor can be calibrated and then the sensor is in use.

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

The AP works with pre-filled Humalog cartridges.

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.

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. 

The insulin infusion set should be changed after three days.

Glucagon

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.

The glucagon that is used in the AP should be changed every day.

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. 

The glucagon infusion set should be changed every day.

Participation

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.

Thank you for your application. Participation in a project depends on many factors. Unfortunately, we cannot guarantee that you are selected. 

Application forms

Certainly. To do so, please fill in the sign up on our website.

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

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.