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Categories
- About the Kaleido system
- Availability & Access
- Demo materials
- Getting started
- Kaleido pump
- Insulin Cartridge
- Infustion Set & Patches
- Kaleido handset (stand-alone)
- Hybrid Closed Loop system
- DBLG2 - General
- DBLG2 - Safety and reliability
- DBLG2 - Technical details
- DBLG2 - Training and use
- YourLoops
- Travel & Holiday with Kaleido
- Sport & Exercise
- Company
- Career
About the Kaleido system
What differentiates Kaleido from other pumps?
We believe medical devices don’t have to look … overly medical. That’s why we focus heavily on Kaleido’s design, usability, and customer service. But don’t just take our word for it – ask other Kaleido users about their experiences!
Is Kaleido waterproof?
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.
Does Kaleido have an App?
Where can I wear Kaleido?
If you use Kaleido with DBLG2, 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.
With which algorithm does the Kaleido Hybrid Closed Loop system work?
The Hybrid Closed Loop system works with Diabeloop’s self-learning DBLG2 algorithm. Diabeloop’s DBLG algortihm is proven across 10,000+ users in everyday life.
What are the clinical results of the Kaleido Hybrid Closed Loop system?
- 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.
I have a High BG – what should I do?
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!
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.
How do I know if Kaleido is right for me?
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.
Are there risks or complications associated with using an insulin pump / Kaleido?
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.
Is Kaleido covered by my health insurance?
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.
Availability & Access
In which countries is Kaleido available?
What's the warranty period of the reusable Kaleido pump?
Both pumps that come with our Starter Kit are rechargeable, reusable, and have a four-year warranty.
Is Kaleido suitable for children and adolescents?
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.
Is Kaleido approved for pregnant people?
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.
Demo materials
Can I see a Kaleido pump in real-life?
Do you offer a trial period?
Can I try a demo patch?
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.
Do you offer demo infusion sets?
Getting started
What do I receive when I get started with Kaleido?
Who gives the Kaleido training?
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).
Where does my training take place?
How long does the Kaleido training take?
Do you have instructional videos?
Yes, instructional videos are available on our website and on our YouTube channel.
Kaleido pump
How does the pump infuse insulin?
How long will the pump battery last?
What if the pump runs out of battery?
How long does it take to charge the pump?
Is the Kaleido pump waterproof?
What's the size of the pump?
What should I do if my insulin pump malfunctions?
Insulin Cartridge
Which tube lengths are available?
How many units of insulin does the cartridge hold?
What types of insulin can I use with Kaleido?
Can I get more consumables, like patches, infusion sets or cartridges?
Why do air bubbles form sometime after the insulin cartridge has been filled without air bubbles?
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.
How do I fill the insulin cartridge?
Infusion Set & Patches
What kind of infusion sets do you offer?
Do you offer Steel canula ?
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/
What's the material for your infusion sets?
The cannula of our infusion set is made of Teflon. The infusion set and patches are made of non-woven acrylate.
What kind of material is the patch made?
Our patches are made with a medical non-woven polyester with acrylate adhesive intended for ‘stick-to-skin’ application and have been tested to make sure they are safe to use on the skin. The patches are checked if they are toxic, cause irritation, or trigger allergic reactions. Since they passed these tests, they are considered safe for skin contact. The medical non-woven polyester with acrylate adhesive has been assessed against applicable regulatory requirements for the presence of substances of interest due to probable serious effects to human health. Applicable regulatory datasheet containing the assessed chemicals and/or compounds of interest can be found here.
Always consult your Healthcare Professional in case of an allergic reaction or hypersensitivity with the material |
Is there anything changed in the material of the Patch / infusion set?
If you experience an allergic reaction or sensitivity (i.e., irritation), please consult your healthcare professional.
Good to know is that our patches are made with a medical non-woven polyester with acrylate adhesive intended for ‘stick-to-skin application. They have been tested for toxicity, irritation, and allergic reactions and are confirmed safe for skin contact. The material has been assessed against applicable regulatory requirements for the presence of substances of interest due to probable serious effects to human health. Applicable regulatory datasheet containing the assessed chemicals and/or compounds of interest can be found here.
How can I avoid skin irritation from adhesives?
What should I do if my infusion set gets dislodged?
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.
I have inflammation / skin irritation, what to do?
We recommend discussing with your healthcare professional to find the best fit for your needs. We’ve heard from users and healthcare professionals that there are many options available that might work to prevent skin issues
Kaleido handset (stand-alone)
How long will the Kaleido handset battery last?
What happens if the Kaleido handset runs out of battery?
How long does it take to charge the Kaleido handset?
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.
Is the Kaleido handset waterproof?
What's the size of the Kaleido handset?
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.
How do I upload my data from my Kaleido handset to my computer?
When the Kaleido handset battery is going low, can I still use all functionalities of my pump and handset?
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.
Can I switch off the alarms (and alerts) on the Kaleido handset?
Can I (temporarily) pause the pump via the Kaleido handset?
How many basal profiles does Kaleido store?
How does the Insulin on Board (IOB) work on the Kaleido handset?
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.
How does Kaleido calculate Insulin on Board (IOB)?
How does the boluscalculator work on the Kaleido handset?
What does alarm code 1090 mean on the Kaleido handset?
Hybrid Closed Loop system
With which sensors does the Kaleido Hybrid Closed Loop system work?
How can you use the DBLG2 without loop mode on?
What does alarm code 22000 mean?
DBLG2 - General
What is DBLG2?
Can I start with DBLG2
What is the difference between DBLG1 and DBLG2?
What are the key benefits of the DBLG2?
Can I try the DBLG2 app?
DBLG2 - Safety and reliability
What safety mechanisms are in place in case the smartphone crashes or the app fails?
What happens during a software update – can it cause interruptions in daily use?
What happens if I have no network/Wi-Fi – does the app still work fully?
What about battery life of my smartphone and the pump – does the app increase power consumption?
Pump: the battery life of the pump does not change. A full charge lasts for one cartridge cycle (up to 3 days of use). You always have two pumps so you can rotate and charge the spare one.
How reliable is the Bluetooth connection between app, pump, and sensor – are there known disconnections?
- The pump continues delivering the basal safety profile,
- The app alerts you of the disconnection,
- Reconnection usually happens automatically once devices are back in range.
DBLG2 - Technical details
Where can I get my activation code?
Which phone can be used?
There you’ll find the up-to-date list of Android smartphones that are tested and approved for use with the DBLG2 app.
Is the app available for iPhone smartphones?
How can I install the DBLG2 app? How does it work?
DBLG2 - Training and use
How are users trainings conducted – is special training required?
Can I use the Dexcom app on my mobile phone? While using DBLG2?
Which sensor can be used?
What if I do not want to use my phone?
Can I pair multiple devices (e.g., smartphone and tablet), or only one control device?
Can I use my smartphone for other things (music, sports apps, calls) without affecting pump control?
- Bluetooth® and notifications remain enabled,
- you have not stopped your pump, and
- battery optimization for DBLG2 is disabled.
Can I customize or disable alerts/alarms (e.g., for hypoglycaemia)?
When loop mode is ON, you can configure alerts for rescue carbs are recommended (Alert number 20300) and rapid rise in glycaemia (Alert number 20102) to always sound, even if your phone is in silent mode or if Do Not Disturb mode is active.
If loop mode is OFF but your Dexcom G7 is connected, you may receive alarms and/or alerts relating to your glycemia. Three alerts are configurable – their values can be adjusted, but the sound cannot. These include signal loss and glucose threshold alerts (when loop mode is off).
Note that Night Mode can be used to reduce the number of alarms received at night, so you can enjoy a good night of sleep and wake up rested.
YourLoops
Where is my YourLoops data stored ?
What happens to my data if the connection between DBLG2 and YourLoops is temporarily interrupted?
How is the glucose management indicator (GMI) / eHbA1c calculated in YourLoops?
- 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 your smartphone;
- Have your smartphone turned off;
- Are using the confidential mode.
Travel & Holiday with Kaleido
How should I handle airport security procedures when wearing the Kaleido?
It’s a good idea to ask your healthcare provider for a letter confirming that you’re wearing your Kaleido and carrying insulin for medical reasons.
Electromagnetic waves (including X-rays) and full-body scanners (such as AIT or millimeter wave scanners) may damage your system. If you need to go through security, keep your system (sensor and pump) on your body. Do not pass through a body scanner; instead, request a full-body pat down and visual inspection.
If you have any concerns, you can always contact your airline before you travel to put your mind at ease. When you travel, it pays off to think ahead, so make sure you take plenty of supplies with you, as well as a backup form of insulin therapy, just in case.
Can I take my Kaleido system on a plane?
When in flightmode, Kaleido and DBLG2 will continue to work with your Bluetooth. As a reminder you will be required to access WiFi or 4G-5G networks at least once every 2 weeks.
I need an X-ray/MRI/CT, can I leave my pump on?
Sport & Exercise
Can I go swimming with Kaleido?
Can I take a bath or shower with Kaleido ?
Can I scuba dive with Kaleido?
Can I exercise with Kaleido?
Can I go in a sauna with Kaleido?
What's the maximum altitude Kaleido is tested for?
Company
Whom can I contact if I have questions?
+31 (0) 800 19 10
Where is ViCentra located and where is the Kaleido produced/manufactured?
Want to join us?
Career
Want to join us?
We don’t take recruitment lightly – we look for innovative, talented, and fun people who believe in our mission to improve diabetes care. Do you think you could be the new member of our team? Check out the roles we’re currently recruiting for on our website https://hellokaleido.com/about-vicentra/careers/
If you don’t see a role that’s right for you, or if we’re not actively recruiting right now, but you think you can still make a difference, email us at recruitment@ViCentra.com.
Videos
Take a scroll through our Kaleido videos. They might not be Oscar winning material but they’re packed full of useful info and we’re pretty proud of them! Need a visual reminder of how to do a 3-day set change? Or how to fill your insulin cartridge? We’ve got everything you need.
Downloads
A quick check online is sometimes just easier than digging out your user manual. So, for whenever you might need it, you can find our Kaleidopedia right here.
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Software version 2.6.0 REV2Software version 2.6.0 REV2
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Software version 2.6.0 REV1Software version 2.6.0 REV1
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Software version 2.5.0Software version 2.5.0
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Software version 2.4.0Software version 2.4.0
User guides Diabeloop DBLG1
User guide DBLG1 REV9 mg/dL (1.18)
User guide DBLG1 REV3 mmol/L (1.18)
More...
User guide DBLG1 REV9 mg/dL (1.18)
User guide DBLG1 REV3 mmol/L (1.18)
More...
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User guide DBLG1 REV8 mg/dLUser guide DBLG1 REV8 mg/dL
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User guide DBLG1 REV7 mg/dLUser guide DBLG1 REV7 mg/dL
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User guide DBLG1 REV5 mg/dLUser guide DBLG1 REV5 mg/dL
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Complete overview DBLG1 user guidesComplete overview DBLG1 user guides
User guides Diabeloop DBLG2
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User guide DBLG2 REV 3 mg/dLUser guide DBLG2 REV 3 mg/dL
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User guide DBLG2 REV 3 mmol/LUser guide DBLG2 REV 3 mmol/L
User guide Kaleido Controller
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Kaleido ControllerKaleido Controller
Brochures
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Kaleido with DBLG2 BrochureKaleido with DBLG2 Brochure
YourLoops, and DBLG1 are either registered trademarks or trademarks of Diabeloop SA in Europe and/or in other countries. Dexcom® and Dexcom G6® are registered trademarks of Dexcom, Inc. in the United States and/or other countries. DBLG1 System is available only on prescription. DBLG1 System is indicated for Adults only. DBLG1 System is a CE 0123 marked medical device (except for configurations used exclusively during clinical investigations). Illustrations may vary depending on DBLG1 System configurations. Please be reminded that the User Manual for the medical device serves as the primary document for ensuring the safe operation of the system.