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Impact of the Mylife CamAPS FX System With the DEXCOM G6 Sensor on T1D Patients in France

NCT07048795 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 125

Last updated 2026-03-03

No results posted yet for this study

Summary

This is a non-interventional, longitudinal, prospective, multicenter, post market-registration and national study conducted in France. The study is conducted among participants with type 1 diabetes (T1D) using the mylife CamAPS FX hybrid closed-loop insulin delivery system combined with the DEXCOM G6 Continuous Glucose Monitoring (CGM) sensor (the System).

The main objective of the study is to evaluate, under real-life conditions, the impact of the System on glycemic control in participants with T1D after one year of use.

Secondary objectives include assessing participant-reported outcomes, such as quality-of-life, treatment satisfaction, fear of hypoglycemia, and sleep quality, describing complications related to the system, the rate of hybrid closed-loop usage over one year, and analyzing system usage parameters (e.g., Boost/Ease-Off mode use, insulin-to-carbohydrate ratios, alarms).

The study will involve approximately 125 participants (including 100 adults and 25 minors) across 20 centers in France.

Endocrinologists / diabetes specialists will monitor participants over the 12-month period after they start using the system and collect data at the three data collection time points.

Conditions

  • Diabetes Type 1

Interventions

OTHER

No Intervention: Observational Cohort

No intervention

Sponsors & Collaborators

  • Qualees SAS

    collaborator UNKNOWN

  • CamDiab Ltd

    collaborator UNKNOWN

  • mylife Diabetes Care AG

    lead INDUSTRY

Principal Investigators

  • Emmanuel SONNET, MD · Centre Hospitalier Universitaire de Brest - Cavale Blanche Hospital

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-11
Primary Completion
2027-03-31
Completion
2027-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07048795 on ClinicalTrials.gov