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. INTENDED PURPOSE The DBLG2 software is intended for adult patients with type 1 diabetes who are aged 18 or older, as well as healthcare professionals who have been trained on the system and will assist the patient in its use. The main function of the DBLG2 software is to adjust the insulin delivery at the correct time in order to maintain the patient’s blood glucose in the target range and thus minimize both hypoglycemic events and long-term complications associated with elevated average glycemia. To do this, the DBLG2 software takes into account the patient’s profile, glycemia (current and predicted), announced meals and physical activities. 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://dblg2.dbl-diabetes.com/documents/PrivacyPolicy.html#en Compatibility and availability of DBLG2 may depend on your country of residency. DBLG2 System requires an insulin pump and a Dexcom G6 or Dexcom G7 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-Dexcom G7 The electronic version of the DBLG2 instructions for use (DBLG2-RA-IFU-001, DBLG2-RA-IFU-002) is available on Diabeloop web site (https://dbl-diabetes.com/resources#DBLG2). 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 [email protected] and it will be provided within 7 calendar days. REFERENCES: Name: DBLG2and-sw UDI-DI: 3760364780310 Basic UDI-DI: 376036478DBLG2-swST LEGAL COMPLIANCE INFORMATION: DBLG2 is a MDSW-App (Medical Device Software App) Notified Body number: 0123 Certificate number: G70 116116 0004 Single Registration Number (SRN): FR-MF-000007564 Recorded as DBLG2and-MK-LAD-001-en-Rev1-DBLG2 for Android Store-en