What is this study trying to find out about type 1 diabetes?

This study is evaluating how the mylife CamAPS FX system combined with the Dexcom G6 sensor affects blood sugar control in people with type 1 diabetes over one year. It also looks at quality of life, treatment satisfaction, fear of low blood sugar, and sleep quality. The study is sponsored by mylife Diabetes Care AG and takes place in France under real-life conditions.

Who may be eligible for this type 1 diabetes clinical trial?

Eligible participants are people with type 1 diabetes using a Dexcom or Abbott Libre glucose sensor for at least 14 days before starting the study system. Both adults and minors can join if they can give consent or have parental consent, understand French, and agree to complete questionnaires. People currently using other closed-loop systems or with certain medical conditions may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this type 1 diabetes clinical trial?

Study-related care, including the use of the system and all trial visits, is provided at no cost. However, personal travel or other expenses are not guaranteed to be covered and may vary for each participant.

Actively Recruiting

All Genders

ID07048795

Impact of the Mylife CamAPS FX System with the DEXCOM G6 Sensor on Blood Sugar Control and Quality of Life in Patients with Type 1 Diabetes in Real-Life Conditions in France

Led by mylife Diabetes Care AG · Updated on 2026-03-03

125

Participants Needed

Research Sites

39 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the impact of the mylife CamAPS FX hybrid closed-loop insulin delivery system combined with the DEXCOM G6 Continuous Glucose Monitoring sensor on people with type 1 diabetes in France. This non-interventional, prospective, multicenter study aims to evaluate how the system affects blood sugar control over one year of real-life use. It also explores quality of life, treatment satisfaction, fear of low blood sugar, sleep quality, and system usage patterns. Participants include about 125 adults and minors with type 1 diabetes starting to use the system under normal care conditions. Endocrinologists and diabetes specialists monitor them and collect data at three times during the 12-month period after system initiation. The study does not involve invasive procedures and follows European medical device regulations. During the study, researchers collect continuous glucose monitoring data and measure changes in time spent in target glucose ranges, average glucose levels, variability, and HbA1c at baseline, 3 months, and 12 months. They also gather patient-reported outcomes through questionnaires on quality of life, treatment satisfaction, fear of hypoglycemia, and sleep quality. Safety and adverse events related to the system are tracked, along with system usage details. Participants are followed closely for one year to assess these outcomes under usual care.

CONDITIONS

Brief Title

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

Who Can Participate

All Genders

Eligibility Criteria

You may qualify if you...

Patients with type 1 diabetes using a Dexcom or Abbott Libre glucose sensor for at least 14 days before starting the mylife YpsoPump, with at least 70% sensor coverage
Patients for whom a diabetes specialist decides to start the mylife CamAPS FX hybrid closed-loop system
Patients who have received information and given consent for participation and personal data processing
Adult patients who have signed informed consent or minors whose parents have signed consent
Adult patients, minors able to complete questionnaires, or parents of minors able to read and understand French
Adult patients, minors, or parents agreeing to complete online self-questionnaires

You will not qualify if you...

Patients who used any hybrid or fully closed-loop insulin system or do-it-yourself loop within the past 6 months
Patients participating or recently participated in another clinical trial preventing participation
Patients or parents unable to give consent
Patients under legal protection measures (guardianship, curatorship, or legal safeguard)
Patients with contraindications to the mylife CamAPS FX system according to its instructions for use
Patients with unresolved skin conditions at sensor or tubing sites
Patients with unstable diabetic retinopathy requiring laser treatment
Patients with conditions or treatments altering glucose metabolism that could affect blood sugar control
Patients who cannot be followed by the center due to planned relocation within 12 months

Research Team

Emmanuel SONNET, MD

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