Impact of the Mylife CamAPS FX System With the DEXCOM G6 Sensor on T1D Patients in France
NCT ID: NCT07048795
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
125 participants
OBSERVATIONAL
2025-12-11
2027-12-31
Brief Summary
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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, meal announcements).
The study will involve approximately 125 participants (including 100 adults and 25 minors) across 20 centers in France.
The study is "non-interventional", which means that care and treatment are carried out as per the routine standard treatment by the endocrinologists / diabetes specialists. The decision to initiate treatment with the System is made independently of the study participation.
Participants in the study will be followed up as part of routine care at 3 visits coinciding with the three data collection time points in the study: at inclusion (baseline, Visit 0), at around 3 months (Visit 1), and around 12 months (Visit 2) after activation of the hybrid closed-loop mode.
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. Continuous glucose sensor (CGM) and insulin pump data will also be collected.
Participants will also be asked at the three data collection time points to complete online questionnaires on their experience with diabetes.
Detailed Description
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This study is carried following the European Regulation (EU) 2017/745 on medical devices (Medical Devices Regulation, MDR) and thus falls into the category of clinical investigations (CI) of Medical Devices (MD).
The System evaluated in this clinical investigation bears CE-marking (market approval according to the MDR) and is used in accordance with its intended purpose. As this study does not involve any invasive or burdensome procedures, it is classified as a non-invasive PMCF investigation of category 4.1. according to the French National Agency for the Safety of Medicines and Health Products (ANSM).
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Participants with type 1 diabetes initiating the hybrid closed-loop system studied
Participants (adults and minors) with type 1 diabetes (T1D) initiating the mylife CamAPS FX system combined with the Dexcom G6 sensor, under real-life management conditions
No Intervention: Observational Cohort
No intervention
Interventions
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No Intervention: Observational Cohort
No intervention
Eligibility Criteria
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Inclusion Criteria
* Patient having used continuous glucose measurement with the Dexcom G6 CGM sensor at least 70% of the time during the 14-day period prior to the V0 visit.
* Patient for whom the diabetes specialist decides to initiate the mylife CamAPS FX hybrid closed loop in accordance with the reimbursement criteria applicable at the time of inclusion in the study.
* Patient who received the information sheets and gave their consent to participate in the study and to the processing of their personal data.
* Adult patient who signed an informed consent form to participate in the study or minor patient whose parents signed an informed consent form for their child's participation in the study.
* Adult patient, minor patient old enough to complete the questionnaires or parent of a minor patient able to read and understand French.
* Adult patient / minor patient capable to complete the questionnaires or parent of a minor patient who agrees to complete the online self-questionnaires.
Exclusion Criteria
* Patient taking part or having taken part in the previous month in a diabetes trial.
* Patient or parent unable to give consent.
* Protected Patient (subject to a legal protection measure: guardianship, curatorship or legal safeguard).
* Patient with a contraindication to the prescription of the mylife CamAPS FX hybrid closed-loop ( according to the Instructions For Use, IFU).
* Patient with an unresolved skin condition in the area of sensor placement and/or in the tubing placement area (e.g. psoriasis, dermatitis herpetiformis, rash, staphylococcal infection).
* Patient with unstable diabetic retinopathy requiring laser treatment.
* Patient with associated pathology or treatment that alters glucose metabolism.
* Patient whose follow-up cannot be carried out by the centre (relocation planned within 12 months of inclusion).
ALL
No
Sponsors
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Qualees SAS
UNKNOWN
CamDiab Ltd
UNKNOWN
mylife Diabetes Care AG
INDUSTRY
Responsible Party
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Principal Investigators
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Emmanuel SONNET, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire de Brest - Cavale Blanche Hospital
Locations
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CHU Amiens
Amiens, , France
Hôtel Dieu-Pédiatrie
Angers, , France
CH Victor Dupouy
Argenteuil, , France
Hôpital Bois Guillaume
Bois-Guillaume, , France
CHU Brest - Hôpital La Cavale Blanche
Brest, , France
Hôpital Femme Mère Enfant Lyon
Bron, , France
CHU Grenoble Alpes
Grenoble, , France
Groupe Hospitalier de la Rochelle Ré Aunis
La Rochelle, , France
Hospices Civils de Lyon DIAB-Ecare
Lyon, , France
Hôpital Européen
Marseille, , France
Hôpital Europeen Georges Pompidou
Paris, , France
Hôpital Universitaire Necker Enfants Malades
Paris, , France
Groupe hospitalier Bichat Claude Bernard
Paris, , France
CH Périgueux
Périgueux, , France
CHU Poitiers
Poitiers, , France
Hôpital NOVO, Site Pontoise
Pontoise, , France
CHU Reims American Memorial Hospital
Reims, , France
CHRU Nancy-Hôpitaux de Brabois Adultes
Vandœuvre-lès-Nancy, , France
CH Bretagne Atlantique
Vannes, , France
Hôpital Robert Schuman-UNEOS
Vantoux, , France
Countries
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Central Contacts
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Other Identifiers
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2024-A00207-40
Identifier Type: -
Identifier Source: org_study_id