Glycemic Control and Quality of Life Evolution for Patients With T1D Using the myLoop Powered by CamAPS FX System in Combination With FreeStyle Libre 3 / 3 Plus Sensors in France
28 de septiembre de 2026 actualizado por: mylife Diabetes Care AG
Evolution in Glycemic Control and Quality of Life in Patients With Type 1 Diabetes Using the myLoop System With FreeStyle Libre 3 / 3 Plus Sensors in a Real-World Setting in France
The goal of this observational study is to learn how glucose control changes over one year in people with type 1 diabetes who use the myLoop with CamAPS FX and Freestyle Libre 3 or FreeStyle Libre 3 Plus during usual care in France. The main question it aims to answer is:
• How time in range (TIR) changes after one year of use. Time in range is the percentage of time glucose levels stay within the target range.
As secondary aims, the study aims to answer how other glucose measures (other than TIR, for example Time Above / Below Range) change at six months and one year.
Participants who are prescribed the myLoop with CamAPS FX during usual care for Type 1 Diabetes will:
- agree to have their routine clinical data on diabetes management and related complications before and after starting therapy with myLoop with CamAPS FX used for this study.
- answer online survey questions about their quality of life, use of the device and features and treatment satisfaction at six months and one year.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
De observación
Inscripción (Estimado)
220
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
2 años y mayores (Niño, Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
The study population will be recruited in France from 20 public or private hospitals and clinics which are qualified as insulin pump initiating centers according to national health reimbursement criteria.
Descripción
Inclusion Criteria:
- Patient has Type 1 Diabetes.
- Patient is 2 years or older if using FreeStyle Libre 3 Plus.
- Patient is 4 years or older if using FreeStyle Libre 3.
- Patient and their diabetes doctor have decided that the patient will use the myLoop with CamAPS FX and the FreeStyle Libre 3 or FreeStyle Libre 3 Plus as part of their diabetes treatment.
- The patient, or their parent/legal guardian if they are under 18, has a smartphone that works with CamAPS FX.
- The patient, or their parent/legal guardian if they are under 18, has a working email address and mobile phone number.
For adult patients:
- The patient has received the study information and has signed a consent form agreeing to take part in the study and to the use of their personal data for the study.
- Patient can read and understand French.
- Patient agrees to complete the online questionnaires and is able to use a smartphone.
For patients under 18 years of age:
- The patient's parent(s) or legal guardian(s) signed a consent form agreeing for the patient to take part in the study and for the patient's personal data to be used for the study. At least one parent or legal guardian must provide consent, as applicable. The patient will also be asked, appropriate for their age and understanding, to agree to take part in the study.
- Patient and/or their parent or legal guardian, as applicable, can read and understand French.
- Patient is old enough to complete the questionnaires, or their parent or legal guardian agrees to complete the online questionnaires; the person completing the questionnaires is able to use a smartphone.
Exclusion Criteria:
- Patient is currently using, or has used in the past 6 months, any hybrid closed-loop, fully closed-loop, or homemade ("do-it-yourself") closed-loop system.
- Patient is under a legal protection measure, such as guardianship or another form of court-ordered protection.
- Patient has a medical reason why the myLoop with CamAPAS FX and FreeStyle Libre 3/3 Plus system should not be used, including any reason listed in the most recent instructions for use of any of these medical devices.
- Patient has an unresolved skin condition where the sensor and/or pump tubing would be placed, such as psoriasis, dermatitis herpetiformis, a skin rash, or a staphylococcal (staph) infection.
- Patient is expected to not be able to continue follow-up at the study center for the next 12 months.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Change from Baseline in the percentage of time in the 70 - 180 mg/dL range (TIR) at 12 Months
Periodo de tiempo: Baseline and 12 Months
|
Baseline and 12 Months
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Percentage of time in the 70 - 180 mg/dL range (TIR) at 6 months
Periodo de tiempo: Baseline and 6 months
|
Baseline and 6 months
|
|
Percentage of time in the 70 - 140 mg/dL range (TITR) at 6 Months
Periodo de tiempo: Baseline and 6 Months
|
Baseline and 6 Months
|
|
Percentage of time in the 70 - 140 mg/dL range (TITR) at 12 Months
Periodo de tiempo: Baseline and 12 Months
|
Baseline and 12 Months
|
|
Percentage of time above 250 mg/dL (TAR > 250 mg/dL) at 6 Months
Periodo de tiempo: Baseline and 6 Months
|
Baseline and 6 Months
|
|
Percentage of time above 250 mg/dL (TAR > 250 mg/dL) at 12 Months
Periodo de tiempo: Baseline and 12 Months
|
Baseline and 12 Months
|
|
Percentage of time above 180 mg/dL (TAR > 180 mg/dL) at 6 Months
Periodo de tiempo: Baseline and 6 Months
|
Baseline and 6 Months
|
|
Percentage of time above 180 mg/dL (TAR > 180 mg/dL) at 12 Months
Periodo de tiempo: Baseline and 12 Months
|
Baseline and 12 Months
|
|
Percentage of time below 70 mg/dL (TBR < 70 mg/dL) at 6 Months
Periodo de tiempo: Baseline and 6 Months
|
Baseline and 6 Months
|
|
Percentage of time below 70 mg/dL (TBR < 70 mg/dL) at 12 Months
Periodo de tiempo: Baseline and 12 Months
|
Baseline and 12 Months
|
|
Percentage of time below 54 mg/dL (TBR < 54 mg/dL) at 6 Months
Periodo de tiempo: Baseline and 6 Months
|
Baseline and 6 Months
|
|
Percentage of time below 54 mg/dL (TBR < 54 mg/dL) at 12 Months
Periodo de tiempo: Baseline and 12 Months
|
Baseline and 12 Months
|
|
Mean glucose derived from CGM data (mg/dL)
Periodo de tiempo: Baseline and 6 Months
|
Baseline and 6 Months
|
|
Mean glucose derived from CGM data (mg/dL)
Periodo de tiempo: Baseline and 12 Months
|
Baseline and 12 Months
|
|
Glucose standard deviation (SD) derived from CGM data (mg/dL)
Periodo de tiempo: Baseline and 6 Months
|
Baseline and 6 Months
|
|
Glucose standard deviation (SD) derived from CGM data (mg/dL)
Periodo de tiempo: Baseline and 12 Months
|
Baseline and 12 Months
|
|
Glucose coefficient of variation (CV) derived from CGM data
Periodo de tiempo: Baseline and 6 Months
|
Baseline and 6 Months
|
|
Glucose coefficient of variation (CV) derived from CGM data
Periodo de tiempo: Baseline and 12 Months
|
Baseline and 12 Months
|
|
Glucose Management Indicator (GMI) derived from CGM data
Periodo de tiempo: Baseline and 6 Months
|
Baseline and 6 Months
|
|
Glucose Management Indicator (GMI) derived from CGM data
Periodo de tiempo: Baseline and 12 Months
|
Baseline and 12 Months
|
|
Glucose Risk Index (GRI) derived from CGM data
Periodo de tiempo: Baseline and 6 Months
|
Baseline and 6 Months
|
|
Glucose Risk Index (GRI) derived from CGM data
Periodo de tiempo: Baseline and 12 Months
|
Baseline and 12 Months
|
|
Change in HbA1c levels (%)
Periodo de tiempo: Baseline and 6 Months
|
Baseline and 6 Months
|
|
Change in HbA1c levels (%)
Periodo de tiempo: Baseline and 12 Months
|
Baseline and 12 Months
|
|
Patients aged ≥ 18 years: Diabetes Quality of Life - Brief Clinical Inventory (DQL-BCI)
Periodo de tiempo: Baseline and 6 Months
|
Baseline and 6 Months
|
|
Patients aged ≥ 18 years: Diabetes Quality of Life - Brief Clinical Inventory (DQL-BCI)
Periodo de tiempo: Baseline and 12 Months
|
Baseline and 12 Months
|
|
Patients aged 13-17 years: Diabetes Quality of Life for Youth scale - Short Form (DQOLY-SF)
Periodo de tiempo: Baseline and 6 Months
|
Baseline and 6 Months
|
|
Patients aged 13-17 years: Diabetes Quality of Life for Youth scale - Short Form (DQOLY-SF)
Periodo de tiempo: Baseline and 12 Months
|
Baseline and 12 Months
|
|
Patients <13: Quality of Life questionnaire (animated emoji scale)
Periodo de tiempo: Baseline and 6 Months
|
Baseline and 6 Months
|
|
Patients <13: Quality of Life questionnaire (animated emoji scale)
Periodo de tiempo: Baseline and 12 Months
|
Baseline and 12 Months
|
|
Patients aged ≥ 18 years: Problem Areas In Diabetes (PAID)
Periodo de tiempo: Baseline and 6 Months
|
Baseline and 6 Months
|
|
Patients aged ≥ 18 years: Problem Areas In Diabetes (PAID)
Periodo de tiempo: Baseline and 12 Months
|
Baseline and 12 Months
|
|
Patients aged 13-17 years: Problem Areas In Diabetes-Teen (PAID-T)
Periodo de tiempo: Baseline and 6 Months
|
Baseline and 6 Months
|
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Patients aged 13-17 years: Problem Areas In Diabetes-Teen (PAID-T)
Periodo de tiempo: Baseline and 12 Months
|
Baseline and 12 Months
|
|
Patients < 13: Parent-Problem Areas In Diabetes-Children (P-PAID-C)
Periodo de tiempo: Baseline and 6 Months
|
Baseline and 6 Months
|
|
Patients < 13: Parent-Problem Areas In Diabetes-Children (P-PAID-C)
Periodo de tiempo: Baseline and 12 Months
|
Baseline and 12 Months
|
|
Patients aged ≥ 18 years: Diabetes Treatment Satisfaction Questionnaire (DTSQs)
Periodo de tiempo: Baseline and 6 Months
|
Baseline and 6 Months
|
|
Patients aged ≥ 18 years: Diabetes Treatment Satisfaction Questionnaire (DTSQs)
Periodo de tiempo: Baseline and 12 Months
|
Baseline and 12 Months
|
|
Patients aged 13-17 years: Diabetes Treatment Satisfaction Questionnaire-Teen (DTSQs-T)
Periodo de tiempo: Baseline and 6 Months
|
Baseline and 6 Months
|
|
Patients aged 13-17 years: Diabetes Treatment Satisfaction Questionnaire-Teen (DTSQs-T)
Periodo de tiempo: Baseline and 12 Months
|
Baseline and 12 Months
|
|
Patients aged < 13 years: Diabetes Treatment Satisfaction Questionnaire-Parent (DTSQs-Parent)
Periodo de tiempo: Baseline and 6 Months
|
Baseline and 6 Months
|
|
Patients aged < 13 years: Diabetes Treatment Satisfaction Questionnaire-Parent (DTSQs-Parent)
Periodo de tiempo: Baseline and 12 Months
|
Baseline and 12 Months
|
|
Patients aged ≥ 13 years: Pittsburgh Sleep Quality Index (PSQI)
Periodo de tiempo: Baseline and 6 Months
|
Baseline and 6 Months
|
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Patients aged ≥ 13 years: Pittsburgh Sleep Quality Index (PSQI)
Periodo de tiempo: Baseline and 12 Months
|
Baseline and 12 Months
|
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Patients aged < 13 years: Children's Sleep Habits Questionnaire - Short-Form (SF-CSHQ)
Periodo de tiempo: Baseline and 6 Months
|
Baseline and 6 Months
|
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Patients aged < 13 years: Children's Sleep Habits Questionnaire - Short-Form (SF-CSHQ)
Periodo de tiempo: Baseline and 12 Months
|
Baseline and 12 Months
|
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Patients aged ≥ 18 years: INSPIRE questionnaire
Periodo de tiempo: Baseline and 6 Months
|
Baseline and 6 Months
|
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Patients aged ≥ 18 years: INSPIRE questionnaire
Periodo de tiempo: Baseline and 12 Months
|
Baseline and 12 Months
|
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Patients aged 13-17 years: INSPIRE Youth questionnaire
Periodo de tiempo: Baseline and 6 Months
|
Baseline and 6 Months
|
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Patients aged 13-17 years: INSPIRE Youth questionnaire
Periodo de tiempo: Baseline and 12 Months
|
Baseline and 12 Months
|
|
Patients < 13 years: INSPIRE Parent questionnaire
Periodo de tiempo: Baseline and 6 Months
|
Baseline and 6 Months
|
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Patients < 13 years: INSPIRE Parent questionnaire
Periodo de tiempo: Baseline and 12 Months
|
Baseline and 12 Months
|
|
Patients aged ≥ 18 years: Hypoglycemia Fear Survey II (HFS-II) questionnaire
Periodo de tiempo: Baseline and 6 Months
|
Baseline and 6 Months
|
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Patients aged ≥ 18 years: Hypoglycemia Fear Survey II (HFS-II) questionnaire
Periodo de tiempo: Baseline and 12 Months
|
Baseline and 12 Months
|
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Patients aged 13-17 years: Hypoglycemia Fear Survey II - Child (HFS-II-C) questionnaire
Periodo de tiempo: Baseline and 6 Months
|
Baseline and 6 Months
|
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Patients aged 13-17 years: Hypoglycemia Fear Survey II - Child (HFS-II-C) questionnaire
Periodo de tiempo: Baseline and 12 Months
|
Baseline and 12 Months
|
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Patients aged < 13 years: Hypoglycemia Fear Survey - Parents of Young Children II (HFS-PYC II) questionnaire
Periodo de tiempo: Baseline and 6 Months
|
Baseline and 6 Months
|
|
Patients aged < 13 years: Hypoglycemia Fear Survey - Parents of Young Children II (HFS-PYC II) questionnaire
Periodo de tiempo: Baseline and 12 Months
|
Baseline and 12 Months
|
|
Patients ≥ 13 years / Parents of Patients ≥ 2 years: System Usability Scale (SUS) questionnaire
Periodo de tiempo: Baseline and 6 Months
|
Baseline and 6 Months
|
|
Patients ≥ 13 years / Parents of Patients ≥ 2 years: System Usability Scale (SUS) questionnaire
Periodo de tiempo: Baseline and 12 Months
|
Baseline and 12 Months
|
|
Changes in quality of life, mental health, treatment satisfaction, diabetes burden and sleep quality: Patient Global Impression of Change (PGIC)
Periodo de tiempo: at 12 Months
|
at 12 Months
|
|
Patients aged > 12 years and non-pregnant women: questionnaire on Liberty mode
Periodo de tiempo: at 12 Months
|
at 12 Months
|
|
Percentage of time in hybrid closed-loop (%)
Periodo de tiempo: at 6 Months
|
at 6 Months
|
|
Percentage of time in hybrid closed-loop (%)
Periodo de tiempo: at 12 Months
|
at 12 Months
|
|
Percentage of time using different system features (%)
Periodo de tiempo: at 6 Months
|
at 6 Months
|
|
Percentage of time using different system features (%)
Periodo de tiempo: at 12 Months
|
at 12 Months
|
|
Number of Safety / Adverse Events: Severe Hypoglycemia
Periodo de tiempo: At 6 Months
|
At 6 Months
|
|
Number of Safety / Adverse Events: Severe Hypoglycemia
Periodo de tiempo: At 12 Months
|
At 12 Months
|
|
Number of Safety / Adverse Events: Diabetic Ketoacidosis (DKA)
Periodo de tiempo: At 6 Months
|
At 6 Months
|
|
Number of Safety / Adverse Events: Diabetic Ketoacidosis (DKA)
Periodo de tiempo: At 12 Months
|
At 12 Months
|
|
Number of Safety / Adverse Events: Unplanned diabetes-related hospitalizations
Periodo de tiempo: At 6 Months
|
At 6 Months
|
|
Number of Safety / Adverse Events: Unplanned diabetes-related hospitalizations
Periodo de tiempo: At 12 Months
|
At 12 Months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de octubre de 2026
Finalización primaria (Estimado)
1 de abril de 2028
Finalización del estudio (Estimado)
1 de abril de 2028
Fechas de registro del estudio
Enviado por primera vez
17 de septiembre de 2026
Primero enviado que cumplió con los criterios de control de calidad
17 de septiembre de 2026
Publicado por primera vez (Actual)
23 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de octubre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
28 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CIV-FR-26-08-059499
- 2026-A01226-45 (Otro identificador: ANSM France)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .