FAQ

The Kaleido pump is water-resistant up to a depth of 1.5m for up to one hour.

If you plan to swim longer or dive deeper, you will need to pause and remove your pump. When paused, your handset will track the amount of insulin missed. For daily activities, if you are about to take a bath or shower, water depth shouldn’t be an issue, but consider the water temperature. It is recommended to pause and remove your pump to avoid exposing it (and your insulin) to high temperatures.

Remember to keep your handset dry at all times.

We think an app is a great idea! Currently, the Kaleido Hybrid Closed Loop system does not have a mobile app, but we are actively working on developing one that will be available soon. As you may know, medical devices take time to develop and receive approval for commercialization. Please follow our social media channels to stay updated.

In the meantime, with the DBLG1 handset, we ensure a reliable connection and optimal system performance. The DBLG1 handset is directly connected to the cloud platform YourLoops, features a user-friendly touchscreen interface, and has a large, long-lasting battery.

You can place your infusion sets on suitable parts of your body. These are areas with more fatty tissue, such as your stomach, lower back and upper arms.

If you use Kaleido with DBLG1 Hybrid Closed Loop system, please avoid placing the infusion site on your upper legs. This is due to the variability in blood flow in the legs, whether you are resting or engaged in physical activity, which affects insulin absorption. The algorithm is not designed for such infusion sites and using them could increase the risk of hypoglycemia. Please consult the User Guide and seek further advice from your healthcare professional.

In case you use the Kaleido stand-alone, you can wear it on your stomach, lower back, upper arms, and upper legs. Please consult the User Manual and seek further advice from your healthcare professional.

The Hybrid Closed Loop system works with Diabeloop’s DBLG1 handset and algorithm. This handset receives data continuously from the Dexcom G6 Continuous Glucose Monitor from which insulin dosing decisions are made in real-time.

Several published clinical studies have examined the Time-in-Range (TIR) before and during the use of the Kaleido Hybrid Closed Loop system. We have thoroughly investigated the performance of the system which shows that the:

• Time in Range increased from 57.3% to 68.8% after using the Kaleido Hybrid Closed Loop system;
• Time in High Range dropped from 36.1% to 32.6% after using the Kaleido Hybrid Closed Loop system;
• Time Below Range decreased from 6% to 2.4% after using the Kaleido Hybrid Closed Loop system.

For more information, please have a look at:
Benhamou et al (2021). Diabetes Obes Metab
Benhamou et al (2019). Lancet Digit Health
Amadou et al (2021). Diabetes Care
Kariyawasam et al (2022). Lancet Digit Health

The following tips are not intended to substitute professional medical advice, diagnosis, or treatment. Always seek the advice of your healthcare professional with any questions you may have regarding your diabetes management.

An important goal for diabetes management is reducing the time spent with high or low blood glucose levels. These are known as hyperglycemia and hypoglycemia, respectively. Did you know that there are 42 factors that can affect glucose levels, including sleep, stress, and medications (Diatribe: 42 Factors That Affect Blood Glucose)? No matter what pump you use, there are a few golden rules to follow. Here are some tips to help prevent high or low blood glucose levels:

• Use U-100 Humalog or NovoRapid insulin from a vial that is at room temperature and not expired.
• Do not prefill Kaleido insulin cartridges and store them in the fridge, or refill and reuse them.
• Always evacuate the air from the insulin cartridge before filling it with insulin, and prime it twice after the tab is unhooked from the insulin cartridge cradle.
• Be aware that when insulin gets warmer, it can form small air bubbles and lose effectiveness. Avoid using Kaleido in high-temperature environments like hot showers, baths, jacuzzis, or saunas. Remember, Kaleido can be paused and removed as needed!

If you experience high blood glucose levels, always follow your healthcare provider’s recommendations. If your levels do not come down within the timeframe advised by your healthcare provider following a correction bolus, this may indicate the need for backup therapy. If you suspect your Kaleido system is not performing as expected, fill a new insulin cartridge with room temperature insulin, use a new infusion set in a new location, and seek medical advice from your healthcare provider as needed.

Safety first: if your blood glucose levels remain high, always follow the recommendations from your healthcare team. Detailed information is available in the Kaleido User Manual.

Consult your healthcare professional to discuss the benefits and potential challenges of using Kaleido. Consider factors such as your lifestyle, blood glucose control, and comfort with technology.

Using medical devices poses some risks. Possible risks include site infections, infusion set issues, and the risk of diabetic ketoacidosis if insulin delivery is interrupted. Regular site rotation and proper hygiene can minimize these risks. Always carry backup supplies and monitor your blood glucose levels closely.

Our goal is to ensure that Kaleido is fully reimbursed in every market where we’re active in. Your healthcare provider can give you more information on how insulin pump therapy might work for you and determine whether Kaleido could be a good fit.

Both pumps that come with our Starter Kit are rechargeable, reusable, and have a four-year warranty.

Kaleido is not yet approved for use in children and adolescents. Kaleido is CE-marked and approved for adults aged 18 and up. Approval of the Kaleido Hybrid Closed Loop system for children and adolescents is definitely on our roadmap, and it will require a clinical study. Please follow our news sections or social media channels for updates.

Kaleido has not yet been adequately studied in pregnant women. If you need a solution in the immediate future, the CamAPS® FX System together with the mylife YpsoPump is approved for use during pregnancy. Always discuss with your healthcare professional before choosing the system that works best for you.

Dependent on your country, you might get the opportunity from Kaleido or your local distributor to trial Kaleido for three months. Contact your local distributor for more information.

We understand that you may want to test our body patches for skin reactions. We’re happy to provide a sample for you to try. In The Netherlands and Germany, you can request a demo patch through our website.

Please consult with your healthcare professional to arrange a demo infusion set. Since infusion sets involve inserting a needle into your body, we do not recommend trying out new infusion sets without medical assistance beforehand.

We have certified trainers, as well as trained healthcare professionals and distribution partners readily available to assist with your onboard. Depending on your location and distributor, a certified trainer will be available to train you on using the Kaleido (Hybrid Closed Loop system).

Your Kaleido trainer will determine the training location and inform you of the available options in advance.

Training duration can vary depending on the trainer and the country but on average, the Kaleido and DBLG1 training lasts between 3 and 5 hours. Your trainer will provide you with more details upfront, including the location and duration.

If you receive your Kaleido Starter Kit, DBLG1, and Top-Up Kits before your scheduled training, please bring them to the training session.

Yes, instructional videos are available on our website and on our YouTube channel. 

Each pump’s battery lasts up to three days on a full charge, with a maximum insulin capacity of 200 units during that period.

Kaleido pump batteries are designed to last for one cartridge cycle, typically up to three days on a full charge. To avoid disruptions, it’s recommended not to let your pump run out of battery. If your pump’s battery depletes more quickly than expected, please contact Kaleido Care.

Typically, you charge one pump while using the other. To charge, simply use the provided connection cable and charging dock. The first charge can take up to 2 hours. After that, your pump battery will be fully charged in 1.5 to 4 hours. A green light on the charging dock will indicate when your pump is fully charged.

Kaleido pumps are waterproof (IP68) for 1 hour up to 1.5 metres.

The handset and charging systems are not waterproof.

The Kaleido pump is very small compared to most other pumps, measuring only 12.5 mm in height, 50 mm in length, and 35 mm in width. This compact size makes Kaleido ideal for wearing as a patch pump on your arm or belly, or for sliding into your pocket when using a 30 cm tube.

If one or both of your Kaleido pumps malfunction, contact Kaleido Care for assistance. Ensure you have a backup plan in place, such as using insulin pens or syringes, to manage your diabetes until the issue is resolved.

Kaleido insulin cartridges hold 200 units of insulin. If 200 units are not enough for three days, don’t worry! With Kaleido, you can simply fill a new insulin cartridge and click it into place.

Kaleido is currently approved for use with NovoRapid and Humalog U-100 rapid-acting insulins. We are exploring the possibility of expanding our approval to include additional insulin types in the future.

Please contact your healthcare professional if you experience overconsumption. In such cases, many of our users are eligible for reimbursement of an additional Top-Up Kits. Our pump and body patches are available as separate products.

Air bubbles are a common challenge for any type of insulin pump. Insulin may release small amounts of gas over time, and changes in temperature or altitude can increase the likelihood of air bubbles forming. If you notice large air bubbles in the cartridge, they were likely present after filling, even if not immediately visible at first. They could have been trapped in the corners of the cartridge. With normal daily use, these bubbles can start to move and become visible.

The four main causes of air in the insulin cartridge are:

1. Not evacuating air before filling: Make sure to fully evacuate the air from the insulin cartridge using the supplied syringe before filling it with insulin.
2. Temperature changes or cold insulin: Always use room temperature insulin. Avoid using insulin that has just come from the fridge.
3. Repeatedly inserting the filling needle into hole 2 of the insulin cartridge septum: Ensure you have at least 2.5 ml of insulin in your syringe, use only the needles from your Top-Up Kit, and insert the needle into hole 2 only once during the filling process.
4. Refilling used insulin cartridges: Always use a new, fully filled insulin cartridge each time you perform a cartridge change.

Filling the cartridge is like riding a bike: it takes a bit of learning in the beginning, but most people get the hang of it quickly and can do it very fast after a few weeks. We explain all the filling steps in this video.

Currently, we do not have plans to introduce steel cannulas in the near future.

We chose to offer soft cannulas instead of steel ones. Soft cannulas are flexible, providing superior comfort and a lower risk of skin irritation compared to rigid steel cannulas. Teflon cannulas cause fewer immunoreactive skin reactions and minimize movement at the insertion site, which reduces delivery issues. While steel cannulas are less likely to kink, advancements in soft cannula technology have effectively addressed this concerns. Clinical evidence shows no difference between steel and soft cannula cannulas in glycemic control, though steel cannulas often need to be changed within 24-48 hours. Overall, the benefits of soft cannulas make them the preferred choice for most people with diabetes and healthcare professionals alike.

You can read further about the scientific evidence here:

1. https://www.nature.com/articles/s41598-017-18790-0
2. https://diabetesjournals.org/diabetes/article/72/Supplement_1/905-P/149853/905-P-Clinical-Comparison-of-Infusion-Sets-with
3. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9024214/
4. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3887416/

The cannula of our infusion set is made of Teflon. The infusion set and patches are made of non-woven acrylate.

If your skin is sensitive or prone to irritation, please consult your healthcare professional, who can recommend topical treatments, skin barriers, or provide additional medical guidance. Remember, what works for one person may not work for everyone. You may need to try several different products or methods to find the best solution for you, in collaboration with your healthcare professional.

If your infusion set gets dislodged, immediately replace it with a new one to avoid a gap in insulin delivery, which could result in high blood glucose levels. Carry spare supplies with you at all times.

While the Kaleido handset battery can last up to 2 days and charges in up to 4 hours, we recommend charging it regularly, just as you charge your mobile phone. Even if the Kaleido handset runs out of battery, the connected pump will remain unaffected and will continue delivering all programmed insulin as planned.

It takes 2 to 4 hours to fully charge a Kaleido handset. We recommend making it a habit to charge it regularly, just as you do with your mobile phone.

The Kaleido handset and charging systems are not waterproof.

However, the Kaleido pumps are waterproof (IP68), and can be submerged for up to 1 hour at a depth of up to 1.5m.

The Kaleido handset, distinct from the DBLG1 handset used for the Hybrid Closed Loop, is quite small and slim, measuring 9 mm in height (less than a centimeter!), 107 mm in length, and 50 mm in width.

Using your connection cable, you can upload all your handset data to Glooko®.

Your handset’s history provides a record of everything that’s happened with your Kaleido today and over the past seven days. Behind the scenes, Kaleido handsets store up to 90 days of data. This includes details such as how much you bolused, the times you set temporary basal rates, your saved blood glucose levels, Kaleidoculator recommendations, and when you last changed your insulin cartridge and pump, among other things.

You can continue to use the Kaleido handset when its battery level is below 25%. The Kaleido handset will display a low-priority alarm to alert you of the low battery. We recommend charging your handset every evening, but if the low battery alert appears, charge it as soon as possible.

You can switch off the sound on your Kaleido handset to mute the blood glucose reminders and charging sounds. Instead of a sound, your handset will vibrate. However, you cannot turn off the alarm sounds, as they are essential for notifying you when something requires your attention.

When you’re jumping in the shower, trying on new clothes, or going for a swim, you may want to remove your pump. To give you complete flexibility, you can choose to pause and remove your pump at any time. Be sure to close the protective cover whenever disconnected from the infusion set.

The best part is that your handset will keep track of how much insulin you’ve missed while your pump is paused, allowing you to make an informed decision about your insulin delivery when you’re ready to reconnect. If you plan to remove your pump for an extended period, or if you’re going to swap your pump, insulin cartridge, or prime your infusion set, be sure to stop your pump instead.

You can store up to 7 basal rates in your Kaleido handset. This enables you to create different basal profiles for various scenarios, such as a regular day at the office, weekends, holidays, or during your period.

Kaleido calculates Insulin-on-Board (IOB) using a linear decay model that includes all boluses. This calculation is based on your personal insulin activity time, which can be set from 2 hours up to 8 hours in half-hour increments. Insulin-on-Board is also a key component of the Kaleidoculator, Kaleido’s bolus calculator.

Insulin-on-Board (IOB) is calculated as follows:

Last Bolus × ((insulin activity duration − time since last bolus) / insulin activity duration).

The IOB calculates the last bolus in 10-minute time slots. The screen that displays your live calculation of IOB updates every 10 seconds. All boluses that have occurred within the insulin activity duration (as set in ‘personal info’) are used to calculate the IOB.

Our bolus calculator is called Kaleidoculator. There are several settings that help Kaleidoculator make its calculations: your Target blood glucose, insulin-to-carb ratios, insulin-to-blood-glucose ratios, and insulin activity time (which helps Kaleidoculator determine your Insulin-on-Board). All of these settings should be configured and amended with the help of your healthcare professional.

Taking into account your personal settings, the carbs you’ve entered (if you’re eating), and the glucose level you’ve added (if applicable), Kaleido uses a linear decay model (including all boluses) to calculate Insulin-on-Board. With each bolus, you can decide whether to include the Insulin-on-Board in the calculation.

Kaleidoculator leverages all these settings to make its recommendation. Once you have the recommendation, you can choose to deliver it as either a Quick or an Extended Bolus, and you can adjust the recommendation if you wish.

Alarm Code 1090 indicates that the insulin cartridge is not detected.

This alarm will repeat, and the following message appears on your Kaleido handset screen: ‘Your insulin cartridge has come out of your pump while it was pumping. Your pump has been stopped.’

If you encounter this alarm, acknowledge it using the handset. Since the pump is not detecting the insulin cartridge, manually acknowledging the alarm is the only way to stop the beeping. If the problem persists, contact Kaleido Care for further assistance.

Your DBLG1 handset will continue to display the CGM values on the screen, but the insulin will be delivered according to your basal safety profile. To set a temporary basal profile or administer a bolus, you can use the pump control feature in the DBLG1 handset by navigating to System status > Pump > + > Pump control.

We don’t offer a protective screen for the DBLG1 handset, but some of our users have found compatible protective screens/cases from third-party providers.

The DBLG1 handset is not water-resistant or waterproof, so you’ll need to keep it dry if you plan to shower or spend time in the pool.

However, the Kaleido pump is waterproof, allowing you to use it while exercising or relaxing in the pool at depths of up to 1.5 meters for a maximum of 1 hour without any concerns.

This alarm indicates that “Loop mode” failed to start. The system is only delivering your basal safety profile. This alarm is triggered only if “Loop mode” is OFF.

If you encounter this alarm, first check that the sensor and the pump are running. You can then restart “Loop mode” from the System status screen. Please note that restarting may take some time. If the problem persists, please contact us for further assistannce.

Regardless of the network connection, your data are stored on your DBLG1 handset for up to 3 months. If you have a poor network connection, the data will be transferred once the internet connection is restored. If you have been disconnected for a long time, the amount of data to transfer could be significant, and it may take several minutes or even hours before all data is transfered to YourLoops.

Your Glucose Management Indicator (GMI) is calculated using a formula that requires a minimum of two weeks of your CGM data. You can see your estimated GMI value in the ‘Trends’ view on YourLoops.

However, some periods are excluded from the calculation when no CGM measurements are available. These periods include when you:

• Are changing the CGM sensor, during the warm-up period;
• Are not wearing the CGM sensor;
• Have a connection issue between the CGM sensor and the DBLG1 handset;
• Have your DBLG1 handset turned off;
• Are using the confidential mode.

Yes, you can! Your Kaleido pump will continue to deliver your insulin while you’re in the air—no trouble at all.

For the Kaleido handset:
There is no need to set the handset in Flight mode. Kaleido uses only a Bluetooth® Low Energy wireless connection to link your pump to your handset. You can use your devices with confidence while you fly.

For the DBLG1 handset:
Enabling Flight mode will disconnect your handset’s cellular connection for 3 to 24 hours but maintain Bluetooth functionality. While Flight mode is on, YourLoops will not receive any data. Data transmission will resume when Flight mode is switched off. Data from active Confidential mode during Flight mode is not transferred either.

Do not use your pump or handset near a magnetic field, as this could damage both devices. This includes exposure to magnetic clasps, MRI, X-ray, and CT scanners. Pause or stop your pump, remove it from your body, and store it safely away from the magnetic field of these devices. Since the infusion set contains a small piece of ferromagnetic metal, be sure to bring your inserter and a spare infusion set so you can resume pumping immediately after the MRI, CT, or X-ray scan.

The Kaleido pump is waterproof up to 1.5 meters, so it’s safe to use while showering. However, it’s important to consider that water temperature should not be very high. We recommend pausing and removing your pump to avoid exposing it (and especially your insulin!) to high temperatures. Remember to keep your handset dry at all times.

Although Kaleido pumps are waterproof up to 1.5m for up to 1 hour, they are not are not suitable for scuba diving. If you plan to dive deeper than 1.5m, you will need to pause and remove your pump first. Please consult your healthcare professional to discuss managing your diabetes in this situation.

That’s completely up to you! We designed Kaleido to be worn during various physical activities, so you can keep it on and continue your insulin delivery without any issues. However, if you prefer to take your pump off for high-impact sports, that’s perfectly fine. Simply pause your pump, take it off and store it somewhere safe.

No, Kaleido is designed to operate in temperatures between +5°C and +37°C. The high temperature and humidity in the sauna can negatively affect both the quality of the insulin and the function of your pumps. We recommend pausing your pump and leaving it, along with the handset, outside the sauna. Your handset will keep track of the amount of insulin you’ve missed.

Be cautious of detached patches and infusion sets due to sweat and consider bringing extras supplies. Ask your healthcare professional for tips on managing your blood glucose levels while enjoying the sauna!

Kaleido is designed to operate at altitudes up to 2500m (8202 feet) and temperatures between +5°C and +37°C.

Extreme altitudes, temperatures, or atmospheric conditions may affect your pump’s performance. Keep this in mind, take care, and always have alternative means of insulin therapy with you when engaging in activities at extreme altitudes or temperatures.

ViCentra, the company behind Kaleido, is headquartered in The Netherlands at the following address: Rijnzathe 6, 3454 PV Utrecht, The Netherlands