Actively Recruiting
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
20
Research Sites
39 weeks
Total Duration
On this page
Sponsors
M
mylife Diabetes Care AG
Lead Sponsor
Q
Qualees SAS
Collaborating Sponsor
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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants who begin using the mylife CamAPS FX system combined with the Dexcom G6 sensor are observed under real-life management conditions.
Visits at baseline, 3 months, and 12 months
Trial Site Locations
Total: 20 locations
1
CHU Amiens
Amiens, France, 80054
Actively Recruiting
2
Hôtel Dieu-Pédiatrie
Angers, France, 49933
Actively Recruiting
3
CH Victor Dupouy
Argenteuil, France, 95107
Actively Recruiting
4
Hôpital Bois Guillaume
Bois-Guillaume, France, 76230
Actively Recruiting
5
CHU Brest - Hôpital La Cavale Blanche
Brest, France, 29609
Actively Recruiting
6
Hôpital Femme Mère Enfant Lyon
Bron, France, 69677
Actively Recruiting
7
CHU Grenoble Alpes
Grenoble, France, 38042
Actively Recruiting
8
Groupe Hospitalier de la Rochelle Ré Aunis
La Rochelle, France, 17019
Actively Recruiting
9
Hospices Civils de Lyon DIAB-Ecare
Lyon, France, 69008
Actively Recruiting
10
Hôpital Européen
Marseille, France, 13003
Actively Recruiting
11
Hôpital Europeen Georges Pompidou
Paris, France, 75015
Actively Recruiting
12
Hôpital Universitaire Necker Enfants Malades
Paris, France, 75015
Actively Recruiting
13
Groupe hospitalier Bichat Claude Bernard
Paris, France, 75018
Actively Recruiting
14
CH Périgueux
Périgueux, France, 24000
Actively Recruiting
15
CHU Poitiers
Poitiers, France, 86021
Not Yet Recruiting
16
Hôpital NOVO, Site Pontoise
Pontoise, France, 95300
Actively Recruiting
17
CHU Toulouse
Toulouse, France, 31059
Not Yet Recruiting
18
CHRU Nancy-Hôpitaux de Brabois Adultes
Vandœuvre-lès-Nancy, France, 54511
Actively Recruiting
19
CH Bretagne Atlantique
Vannes, France, 56017
Actively Recruiting
20
Hôpital Robert Schuman-UNEOS
Vantoux, France, 57070
Actively Recruiting
Research Team
E
Emmanuel SONNET, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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