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About the Kaleido system
What differentiates Kaleido from other pumps?
Is Kaleido waterproof?
Does Kaleido have an App?
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.
Where can I wear Kaleido?
With which algorithm does the Kaleido Hybrid Closed Loop work?
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.
What are the clinical results of the Kaleido Hybrid Closed Loop system?
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
I have a High BG – what should I do?
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.
DBLG2
What is DBLG2?
DBLG2 is a self-learning algorithm that, in combination with Kaleido and CGM, represents the next-generation hybrid closed-loop system. DBLG2 is controlled directly via a smartphone. Like DBLG1, DBLG2 uses real-time glucose data, personalized parameters, and auto-learning to make life with diabetes easier.
What are the features of DBLG2?
Here are the highlights of DBLG2:
-Full app-control via smartphone
-Self-learning algorithm for more freedom and less daily effort
-New standards in personalization through: Mode Physical Activity, ZEN-Mode, Meal Announcement, and Night Mode
What is the DBLG2 Pre-Launch Panel?
Internal and external users test the system and provide valuable feedback. Initial results are promising. The Pre-Launch participant group has already been selected.
When will DBLG2 be available?
A wider launch is expected during 2026 – with a focus on late summer 2026.
How about the compatibility with Dexcom G6/G7?
In pre-launch-phase DBLG2 will be compatible with G6, later with G7.
Will there be an upgrade for existing Kaleido user?
Yes, upgrades are planned, details to follow.
Availability & Access
In which countries is Kaleido available?
Kaleido is available in Germany, The Netherlands, and France.
If you choose Kaleido, you will be using one of the smallest insulin pumps, designed to let you live on your own terms. To start using Kaleido, contact your healthcare provider, who can prescribe it if you are eligible for insulin pump therapy.
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?
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?
Kaleido & DBLG1 (hybrid closed loop)
With which sensors does the Kaleido Hybrid Closed Loop work?
For glucose level readings, the system uses exclusively Dexcom’s G6 sensor. The DBLG1 system integrates the Dexcom G6 CGM with the Kaleido pump and the DBLG1 self-learning algorithm. The system continuously monitors your glucose levels and adjusts insulin delivery in real-time to maintain glucose levels within the specified target range.
The Dexcom G7 is not yet compatible with the DBLG1, but the integration is underway. We will provide updates via our news section and social media when it becomes available. Additionally, we do not currently have integration with the FreeStyle Libre, but we are exploring this feature. We encourage you to express your interest in this feature to Abbott!
Can you explain the impact of the user acknowledging or ignoring notifications, alerts or alarms?
How can you use the DBLG1 without loop mode on?
Is there a protective screen for the DBLG1?
Is the DBLG1 handset waterproof?
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.
What does alarm code 22000 mean on the DBLG1 handset?
Yourloops
Where is my YourLoops data stored ?
If the DBLG1 cannot transfer data to YourLoops due to poor network connectivity, is all the data transferred once the connection is resumed?
How is the glucose management indicator (GMI) / eHbA1c calculated in YourLoops?
Travel & Holiday with Kaleido
How should I handle airport security procedures when wearing the Kaleido?
Can I take my Kaleido system on a plane?
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?
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
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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 of user guides by DiabeloopComplete overview of user guides by Diabeloop
Brochures
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Kaleido colour combinationsKaleido colour combinations
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Kaleido Handset Settings FormKaleido Handset Settings Form
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.