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.
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.
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.
The study population will be recruited in France from 20 public or private hospitals and clinics which are qualified as insulin pump initiating centers according to national health reimbursement criteria.
Cohort
Prospective
No Intervention: Observational Cohort
Other interventionObservational Cohort
Change from Baseline in the percentage of time in the 70 - 180 mg/dL range (TIR) at 12 Months
Percentage of time in the 70 - 180 mg/dL range (TIR) at 6 months
Percentage of time in the 70 - 140 mg/dL range (TITR) at 6 Months
Percentage of time in the 70 - 140 mg/dL range (TITR) at 12 Months
Percentage of time above 250 mg/dL (TAR > 250 mg/dL) at 6 Months
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mylife Diabetes Care AG
Lead sponsor
Abbott Diabetes Care, Inc - providing financial support for the study
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
