Actively Recruiting
Impact of the Mylife CamAPS FX System With the DEXCOM G6 Sensor on T1D Patients in France
Led by mylife Diabetes Care AG · Updated on 2026-03-03
125
Participants Needed
20
Research Sites
102 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
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
Official 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 who have used a Dexcom or Abbott Libre glucose sensor for at least 14 days with at least 70% coverage before starting the mylife YpsoPump
- Patients whose diabetes specialist decides to start the mylife CamAPS FX hybrid closed-loop system
- Patients who received study information and gave consent to participate and for data processing
- Adults who signed informed consent or minors whose parents signed consent for participation
- Adults, minors able to complete questionnaires, or parents able to read and understand French
- Adults, minors, or parents willing to complete online self-questionnaires
You will not qualify if you...
- Patients who used any hybrid closed-loop, fully closed-loop, or do-it-yourself loop system in the past 6 months
- Patients participating or who participated in another clinical trial in the past month that prevents participation
- Patients or parents unable to give consent
- Patients under legal protection measures such as guardianship or curatorship
- Patients with contraindications to the mylife CamAPS FX hybrid closed-loop system according to instructions
- Patients with unresolved skin conditions at sensor or tubing placement sites
- Patients with unstable diabetic retinopathy requiring laser treatment
- Patients with conditions or treatments affecting glucose metabolism significantly
- 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
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
CONTACT
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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