Impact of the Mylife CamAPS FX System With the DEXCOM G6 Sensor on T1D Patients in France
ConditionDiabetes Type 1
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
Sponsormylife Diabetes Care AG
About this trial
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.
The study will involve approximately 125 participants (including 100 adults and 25 minors) across 22 centers in France. Patients will be followed up for 12 months.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with type 1 diabetes who have been using a Dexcom or Abbott Libre glucose sensor (any model) for at least 14 days prior to the date of installation of the mylife YpsoPump, with at least 70% coverage, under the same sensor.
Patient for whom the diabetes specialist decides to initiate the mylife CamAPS FX hybrid closed loop.
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.
Disqualifiers
Patient who used a hybrid closed-loop system, a fully closed-loop system, or a do-it-yourself loop system, regardless of the brand or model, within the past 6 months.
Patients participating or having participated in a clinical trial in the previous month that prevents them from participating in other studies.
Patient or parent unable to give consent.
Protected Patient (subject to a legal protection measure: guardianship, curatorship or legal safeguard).
Trial population
The study population will be recruited from 22 French participating centers, which are defined as insulin pump initiation hospital centers according to the definition of the Francophone Diabetic Society.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No Intervention: Observational Cohort
Other interventionNo intervention
Treatment groups
125 Participants
are divided into 1 treatment groupGroup A: Participants with type 1 diabetes initiating the hybrid closed-loop system1 intervention
Trial outcomes
Primary outcomes
1
Change in Time in Range (TIR)
Change in Time in Range (TIR, 70-180 mg/dL; for pregnant women: TIR, 63-140 mg/dL) (%)
Time frame
Baseline and 3 monthsSecondary outcomes
1
Change in Time in Range (TIR)
Change in Time in Range (TIR, 70-180 mg/dL; for pregnant women: TIR, 63-140 mg/dL) (%)
Time frame
Baseline and 12 months2
Change in Time In Tight Range (TITR)
Change in Time In Tight Range (TITR, 70 - 140 mg/dL) (%)
Time frame
Baseline, 3 and 12 months3
Change in Time Above Range (TAR)
Change in Time Above Range (TAR, \> 250 mg/dL and \> 180 mg/dL; for pregnant women: TAR, \> 140 mg/dL) (%)
Time frame
Baseline, 3 months, and 12 months4
Change in Time Below Range (TBR)
Change in Time Below Range (TBR, \< 70 mg/dL and \< 54 mg/dL; for pregnant women: TBR, \< 63 mg/dL and \< 54 mg/dL) (%)
Time frame
Baseline, 3 and 12 monthsSponsors and contacts
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Source ClinicalTrials.gov