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NCT Number: NCT07048795

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

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.

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Key information

Conditions

Diabetes Type 1 Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Amiens, Amiens, France

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About this study

This study, called EPICAM-PMCF-G6, is part of a Post-Market Clinical Follow-up (PMCF) requested by the French Health Technology Assessment Committee (CNEDiMTS), following the listing of the System for reimbursement under the national healthcare system in France.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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 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).
  • 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 a concomitant condition or treatment that alters glucose metabolism and that, in the investigator's judgment, is likely to have a significant impact on glycemic control;
  • Patient whose follow-up cannot be carried out by the centre (relocation planned within 12 months of inclusion).

Treatment and study plan

No Intervention: Observational Cohort

Other

No intervention

Primary outcomes

  1. Change in Time in Range (TIR)

    Time frame: Baseline and 3 months

    Change in Time in Range (TIR, 70-180 mg/dL; for pregnant women: TIR, 63-140 mg/dL) (%)

Secondary outcomes

  1. Change in Time in Range (TIR)

    Time frame: Baseline and 12 months

    Change in Time in Range (TIR, 70-180 mg/dL; for pregnant women: TIR, 63-140 mg/dL) (%)

  2. Change in Time In Tight Range (TITR)

    Time frame: Baseline, 3 and 12 months

    Change in Time In Tight Range (TITR, 70 - 140 mg/dL) (%)

  3. Change in Time Above Range (TAR)

    Time frame: Baseline, 3 months, and 12 months

    Change in Time Above Range (TAR, > 250 mg/dL and > 180 mg/dL; for pregnant women: TAR, > 140 mg/dL) (%)

  4. Change in Time Below Range (TBR)

    Time frame: Baseline, 3 and 12 months

    Change in Time Below Range (TBR, < 70 mg/dL and < 54 mg/dL; for pregnant women: TBR, < 63 mg/dL and < 54 mg/dL) (%)

  5. Change in average glucose levels from CGM sensor data

    Time frame: Baseline, 3 months and 12 months

    Change in average glucose levels from CGM sensor data (mg/dL)

  6. Change in Standard Deviation (SD) of glucose

    Time frame: Baseline, 3 months and 12 months

    Change in Standard Deviation (SD) of glucose

  7. Change in Coefficient of Variation (CV) of glucose

    Time frame: Baseline, 3 months and 12 months

    Change in Coefficient of Variation (CV) of glucose derived from CGM sensor data (%)

  8. Change in Glucose Management Indicator (GMI)

    Time frame: Baseline, 3 months and 12 months

    Change in Glucose Management Indicator (GMI) (%) derived from CGM sensor data

  9. Change in HbA1c

    Time frame: Baseline, 3 months and 12 months

    Change in HbA1c (%)

  10. Time in hybrid closed-loop

    Time frame: 3 months and 12 months

    Time spent in hybrid closed-loop (%)

  11. System usage modalities

    Time frame: 3 months and 12 months

    Description of evolution rate of advanced features

  12. Change in the PAID questionnaire score

    Time frame: Baseline, 3 months and 12 months

    Self-administered questionnaire: Problem Areas In Diabetes (PAID)

    Following versions will be used: Adult version (18 and above), Teen version (PAID-T) in adolescents aged 12-18 years, and for their parents (P-PAID-T), Children version (PAID-C) in children aged 8-11 years and their parents (P-PAID-C). P-PAID-C will be also used in parents of children aged <8 years.

    The Problem Areas in Diabetes (PAID) questionnaire assesses diabetes-related emotional distress across patients and caregivers using age- and role-specific versions. The PAID (adults), PAID-T (teens), and PAID-C (children) are self-reported, while P-PAID-T and P-PAID-C are completed by parents of teens and children, respectively. All versions use Likert scales and are typically transformed to a 0-100 score, with higher values indicating greater distress.

  13. Change in the DTSQ questionnaire score

    Time frame: Baseline, 3 months and 12 months

    Self-administered questionnaire: Diabetes Treatment Satisfaction Questionnaire (DTSQs)

    Following versions will be used: Adult version (18 and above), Teen version (DTSQs-Teen) in adolescents aged 13-18 years. For their parents and parents of children aged <13 years, Parent version (DTSQs-Parent) will be used.

    DTSQQs for adults contains 8 items, DTSQs-Teen has 12 items and DTSQs-Parent has 14 items. The total score of the DTSQs is calculated by summing six items (excluding perceived hypo/hyperglycaemia), each rated 0 to 6, resulting in a total score from 0 to 36, with higher scores indicating better treatment satisfaction.

  14. Change in the HFS-II questionnaire score

    Time frame: Baseline, 3 months and 12 months

    Self-administered questionnaire Hypoglycemia Fear Survey II (HFS-II).

    The following versions will be used: Adult version, Children version (HFS-II children) for children aged 6 years and above, Parent version (HFS-II parent) for children aged 8 years and above, and Parent version for children aged <8 years (HFS-II parent of young children).

    HFS-II consists of items ranging from 0 (never) to 4 (almost always) (9 items in the Adult version, 25 in the Teen version and 26 in the Parent versions). It is composed of two subscales: a Behavior score and a Worry score, with higher scores reflecting greater behavioral or emotional impact.

  15. Change in the PSQI questionnaire score

    Time frame: Baseline, 3 months and 12 months

    Self-administered questionnaire: Pittsburgh Sleep Quality Index (PSQI).

    The questionnaire will be used in adults and parents. It contains 19 items which are grouped into 7 components that contribute to the overall score. Each component is scored from 0 to 3, where 0 indicates no difficulty and 3 indicates severe difficulty. The 7 component scores are summed to produce a total score ranging from 0 to 21.

  16. Perceived changes in quality of life, treatment satisfaction, fear of hypoglycemia, and sleep quality

    Time frame: Baseline, at 3 months and 12 months

    Participant reported perceived changes in quality of life, treatment satisfaction, fear of hypoglycemia and sleep quality measured with a question " Patient Global Impression of Change " (PGIC) (one for each dimension).

    Each PGIC will be used in adults, parents and children aged 11 years and above and consisting of one question with 7 modalities from 'Much worse" to "Much better".

  17. Safety / Adverse events related to the use of the System

    Time frame: 3 months and 12 months

    Number of diabetic ketoacidosis events, severe hypoglycemia requiring assistance (medical and non-medical), unplanned hospitalizations related to diabetes and other complications related to the use of the system that meet the predefined acceptance criteria based on safety parameters for the target devices.

Study contacts

Contact information is provided by the study sponsor or research team.

Ingo Braun, Dr.

CONTACT

[email protected]

+41582347132

Sponsors and collaborators

Lead sponsor

mylife Diabetes Care AG

Industry

Collaborators

  • CamDiab Ltd
  • Qualees SAS

Registry information

Official study title

Impact de l'Utilisation du système Mylife CamAPS FX associé au Capteur DEXCOM G6 Sur le contrôle glycémique et la qualité de Vie de Patients DT1, en Vie réelle, en France

Acronym: EPICAM-G6

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 2, 2025
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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