DBLG2 - Diabetes Management

Diabeloop’s hybrid closed-loop system for Type 1 diabetes, now available for smartphones**

DBLG2 is a system for automated insulin delivery in Type 1 diabetes, also called hybrid closed-loop system. It is classified as a medical device and requires a prescription and an activation code provided by a healthcare professional.

HOW DBLG2 SYSTEM WORKS

Every 5 minutes, a glucose measurement is transmitted via Bluetooth® to the DBLG2 application. DBLG2 then analyzes the data and decides to:
- Maintain the current settings.
- Reduce or even stop insulin delivery.
- Recommend a specific quantity of rescue carbs to take to prevent hypoglycemia.
- Increase insulin delivery and deliver a bolus to correct hyperglycemia.

DESIGNED TO ADAPT TO EACH INDIVIDUAL

The only technology that can be fully personalized according to the physiology and lifestyle of the patient.
- Easy setup with 5 parameters.
- Immediately operates in closed-loop mode once the sensor is initialized.
- New, easy-to-read interface for all user profiles.
- Simplified meal declarations with pre-defined quantities for breakfast, lunch and dinner.
- Quantified rescue carb recommendations.
- Automatic data transfer to the YourLoops web platform, 24 hours a day.

PERSONALIZABLE THERAPY WITH DBLG2'S CUSTOMISABLE PARAMETERS

- Including 5 adjustable aggressiveness settings (3 meals + normoglycemia and hyperglycemia).
- Practical, customizable modes such as Zen mode - target blood glucose level raised for a set period of time, and the new Night mode.
- A patented self-learning system to individualize and optimize meal management starting on the seventh day.


Access our privacy policy https://www.diabeloop.com/privacy-policy

Compatibility and availability of DBLG2 may depend on your country of residency.

DBLG2 System requires an insulin pump and a Dexcom G6 CGM to function.

DBLG2 System is compatible with the Kaleido insulin pump by ViCentra.

**The DBLG2 application is compatible with Android™ Smartphones and requires an internet connection. For a list of compatible devices, visit Diabeloop web site www.diabeloop.com.

INSTRUCTIONS FOR USE - WARNINGS :
- Please follow the instructions for use provided in electronic format.
- Unit: mg/dl or mmol/l
- DBLG2 compatible with Kaleido-Dexcom G6

The electronic version of the DBLG2 instructions for use (DBLG2-RA-IFU-001) is available on Diabeloop web site (https://www.diabeloop.com/resources). It can be downloaded from there as a PDF document. The paper version of the DBLG2 instructions for use can be requested by any DBLG2 user to contact@diabeloop.fr and it will be provided within 7 calendar days.

REFERENCES:
Basic UDI-DI: 376036478DBLG2-swST
Name: DBLG2and-sw-KAL-G6
UDI-DI: 3760364780198

Recorded as DBLG2and-MK-LAD-001-en-Rev0-DBLG2 for Android Store-en