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NCT07835685

Glycemic Control and Quality of Life Evolution for Patients With T1D Using the myLoop Powered by CamAPS FX System in Combination With FreeStyle Libre 3 / 3 Plus Sensors in France

Sponsor: mylife Diabetes Care AG

View on ClinicalTrials.gov

Summary

The goal of this observational study is to learn how glucose control changes over one year in people with type 1 diabetes who use the myLoop with CamAPS FX and Freestyle Libre 3 or FreeStyle Libre 3 Plus during usual care in France. The main question it aims to answer is: • How time in range (TIR) changes after one year of use. Time in range is the percentage of time glucose levels stay within the target range. As secondary aims, the study aims to answer how other glucose measures (other than TIR, for example Time Above / Below Range) change at six months and one year. Participants who are prescribed the myLoop with CamAPS FX during usual care for Type 1 Diabetes will: * agree to have their routine clinical data on diabetes management and related complications before and after starting therapy with myLoop with CamAPS FX used for this study. * answer online survey questions about their quality of life, use of the device and features and treatment satisfaction at six months and one year.

Official title: Evolution in Glycemic Control and Quality of Life in Patients With Type 1 Diabetes Using the myLoop System With FreeStyle Libre 3 / 3 Plus Sensors in a Real-World Setting in France

Key Details

Gender

All

Age Range

2 Years - Any

Study Type

OBSERVATIONAL

Enrollment

220

Start Date

2026-10

Completion Date

2028-04

Last Updated

2026-10-01

Healthy Volunteers

Conditions

Diabetes Type 1

Interventions

OTHER

No Intervention: Observational Cohort

Observational Cohort

Inclusion Criteria: * Patient has Type 1 Diabetes. * Patient is 2 years or older if using FreeStyle Libre 3 Plus. * Patient is 4 years or older if using FreeStyle Libre 3. * Patient and their diabetes doctor have decided that the patient will use the myLoop with CamAPS FX and the FreeStyle Libre 3 or FreeStyle Libre 3 Plus as part of their diabetes treatment. * The patient, or their parent/legal guardian if they are under 18, has a smartphone that works with CamAPS FX. * The patient, or their parent/legal guardian if they are under 18, has a working email address and mobile phone number. For adult patients: * The patient has received the study information and has signed a consent form agreeing to take part in the study and to the use of their personal data for the study. * Patient can read and understand French. * Patient agrees to complete the online questionnaires and is able to use a smartphone. For patients under 18 years of age: * The patient's parent(s) or legal guardian(s) signed a consent form agreeing for the patient to take part in the study and for the patient's personal data to be used for the study. At least one parent or legal guardian must provide consent, as applicable. The patient will also be asked, appropriate for their age and understanding, to agree to take part in the study. * Patient and/or their parent or legal guardian, as applicable, can read and understand French. * Patient is old enough to complete the questionnaires, or their parent or legal guardian agrees to complete the online questionnaires; the person completing the questionnaires is able to use a smartphone. Exclusion Criteria: * Patient is currently using, or has used in the past 6 months, any hybrid closed-loop, fully closed-loop, or homemade ("do-it-yourself") closed-loop system. * Patient is under a legal protection measure, such as guardianship or another form of court-ordered protection. * Patient has a medical reason why the myLoop with CamAPAS FX and FreeStyle Libre 3/3 Plus system should not be used, including any reason listed in the most recent instructions for use of any of these medical devices. * Patient has an unresolved skin condition where the sensor and/or pump tubing would be placed, such as psoriasis, dermatitis herpetiformis, a skin rash, or a staphylococcal (staph) infection. * Patient is expected to not be able to continue follow-up at the study center for the next 12 months.