Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

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 setembro de 2026 atualizado 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Diabetes tipo 1

Intervenção / Tratamento

Outro: No Intervention: Observational Cohort

Tipo de estudo

Observacional

Inscrição (Estimado)

220

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

2 anos e mais velhos (Filho, Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Modelos de observação: COHORT
Perspectivas de Tempo: PROSPECTIVE

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Prazo
Change from Baseline in the percentage of time in the 70 - 180 mg/dL range (TIR) at 12 Months Prazo: Baseline and 12 Months	Baseline and 12 Months

Medidas de resultados secundários

Medida de resultado	Prazo
Percentage of time in the 70 - 180 mg/dL range (TIR) at 6 months Prazo: Baseline and 6 months	Baseline and 6 months
Percentage of time in the 70 - 140 mg/dL range (TITR) at 6 Months Prazo: Baseline and 6 Months	Baseline and 6 Months
Percentage of time in the 70 - 140 mg/dL range (TITR) at 12 Months Prazo: Baseline and 12 Months	Baseline and 12 Months
Percentage of time above 250 mg/dL (TAR > 250 mg/dL) at 6 Months Prazo: Baseline and 6 Months	Baseline and 6 Months
Percentage of time above 250 mg/dL (TAR > 250 mg/dL) at 12 Months Prazo: Baseline and 12 Months	Baseline and 12 Months
Percentage of time above 180 mg/dL (TAR > 180 mg/dL) at 6 Months Prazo: Baseline and 6 Months	Baseline and 6 Months
Percentage of time above 180 mg/dL (TAR > 180 mg/dL) at 12 Months Prazo: Baseline and 12 Months	Baseline and 12 Months
Percentage of time below 70 mg/dL (TBR < 70 mg/dL) at 6 Months Prazo: Baseline and 6 Months	Baseline and 6 Months
Percentage of time below 70 mg/dL (TBR < 70 mg/dL) at 12 Months Prazo: Baseline and 12 Months	Baseline and 12 Months
Percentage of time below 54 mg/dL (TBR < 54 mg/dL) at 6 Months Prazo: Baseline and 6 Months	Baseline and 6 Months
Percentage of time below 54 mg/dL (TBR < 54 mg/dL) at 12 Months Prazo: Baseline and 12 Months	Baseline and 12 Months
Mean glucose derived from CGM data (mg/dL) Prazo: Baseline and 6 Months	Baseline and 6 Months
Mean glucose derived from CGM data (mg/dL) Prazo: Baseline and 12 Months	Baseline and 12 Months
Glucose standard deviation (SD) derived from CGM data (mg/dL) Prazo: Baseline and 6 Months	Baseline and 6 Months
Glucose standard deviation (SD) derived from CGM data (mg/dL) Prazo: Baseline and 12 Months	Baseline and 12 Months
Glucose coefficient of variation (CV) derived from CGM data Prazo: Baseline and 6 Months	Baseline and 6 Months
Glucose coefficient of variation (CV) derived from CGM data Prazo: Baseline and 12 Months	Baseline and 12 Months
Glucose Management Indicator (GMI) derived from CGM data Prazo: Baseline and 6 Months	Baseline and 6 Months
Glucose Management Indicator (GMI) derived from CGM data Prazo: Baseline and 12 Months	Baseline and 12 Months
Glucose Risk Index (GRI) derived from CGM data Prazo: Baseline and 6 Months	Baseline and 6 Months
Glucose Risk Index (GRI) derived from CGM data Prazo: Baseline and 12 Months	Baseline and 12 Months
Change in HbA1c levels (%) Prazo: Baseline and 6 Months	Baseline and 6 Months
Change in HbA1c levels (%) Prazo: Baseline and 12 Months	Baseline and 12 Months
Patients aged ≥ 18 years: Diabetes Quality of Life - Brief Clinical Inventory (DQL-BCI) Prazo: Baseline and 6 Months	Baseline and 6 Months
Patients aged ≥ 18 years: Diabetes Quality of Life - Brief Clinical Inventory (DQL-BCI) Prazo: Baseline and 12 Months	Baseline and 12 Months
Patients aged 13-17 years: Diabetes Quality of Life for Youth scale - Short Form (DQOLY-SF) Prazo: Baseline and 6 Months	Baseline and 6 Months
Patients aged 13-17 years: Diabetes Quality of Life for Youth scale - Short Form (DQOLY-SF) Prazo: Baseline and 12 Months	Baseline and 12 Months
Patients <13: Quality of Life questionnaire (animated emoji scale) Prazo: Baseline and 6 Months	Baseline and 6 Months
Patients <13: Quality of Life questionnaire (animated emoji scale) Prazo: Baseline and 12 Months	Baseline and 12 Months
Patients aged ≥ 18 years: Problem Areas In Diabetes (PAID) Prazo: Baseline and 6 Months	Baseline and 6 Months
Patients aged ≥ 18 years: Problem Areas In Diabetes (PAID) Prazo: Baseline and 12 Months	Baseline and 12 Months
Patients aged 13-17 years: Problem Areas In Diabetes-Teen (PAID-T) Prazo: Baseline and 6 Months	Baseline and 6 Months
Patients aged 13-17 years: Problem Areas In Diabetes-Teen (PAID-T) Prazo: Baseline and 12 Months	Baseline and 12 Months
Patients < 13: Parent-Problem Areas In Diabetes-Children (P-PAID-C) Prazo: Baseline and 6 Months	Baseline and 6 Months
Patients < 13: Parent-Problem Areas In Diabetes-Children (P-PAID-C) Prazo: Baseline and 12 Months	Baseline and 12 Months
Patients aged ≥ 18 years: Diabetes Treatment Satisfaction Questionnaire (DTSQs) Prazo: Baseline and 6 Months	Baseline and 6 Months
Patients aged ≥ 18 years: Diabetes Treatment Satisfaction Questionnaire (DTSQs) Prazo: Baseline and 12 Months	Baseline and 12 Months
Patients aged 13-17 years: Diabetes Treatment Satisfaction Questionnaire-Teen (DTSQs-T) Prazo: Baseline and 6 Months	Baseline and 6 Months
Patients aged 13-17 years: Diabetes Treatment Satisfaction Questionnaire-Teen (DTSQs-T) Prazo: Baseline and 12 Months	Baseline and 12 Months
Patients aged < 13 years: Diabetes Treatment Satisfaction Questionnaire-Parent (DTSQs-Parent) Prazo: Baseline and 6 Months	Baseline and 6 Months
Patients aged < 13 years: Diabetes Treatment Satisfaction Questionnaire-Parent (DTSQs-Parent) Prazo: Baseline and 12 Months	Baseline and 12 Months
Patients aged ≥ 13 years: Pittsburgh Sleep Quality Index (PSQI) Prazo: Baseline and 6 Months	Baseline and 6 Months
Patients aged ≥ 13 years: Pittsburgh Sleep Quality Index (PSQI) Prazo: Baseline and 12 Months	Baseline and 12 Months
Patients aged < 13 years: Children's Sleep Habits Questionnaire - Short-Form (SF-CSHQ) Prazo: Baseline and 6 Months	Baseline and 6 Months
Patients aged < 13 years: Children's Sleep Habits Questionnaire - Short-Form (SF-CSHQ) Prazo: Baseline and 12 Months	Baseline and 12 Months
Patients aged ≥ 18 years: INSPIRE questionnaire Prazo: Baseline and 6 Months	Baseline and 6 Months
Patients aged ≥ 18 years: INSPIRE questionnaire Prazo: Baseline and 12 Months	Baseline and 12 Months
Patients aged 13-17 years: INSPIRE Youth questionnaire Prazo: Baseline and 6 Months	Baseline and 6 Months
Patients aged 13-17 years: INSPIRE Youth questionnaire Prazo: Baseline and 12 Months	Baseline and 12 Months
Patients < 13 years: INSPIRE Parent questionnaire Prazo: Baseline and 6 Months	Baseline and 6 Months
Patients < 13 years: INSPIRE Parent questionnaire Prazo: Baseline and 12 Months	Baseline and 12 Months
Patients aged ≥ 18 years: Hypoglycemia Fear Survey II (HFS-II) questionnaire Prazo: Baseline and 6 Months	Baseline and 6 Months
Patients aged ≥ 18 years: Hypoglycemia Fear Survey II (HFS-II) questionnaire Prazo: Baseline and 12 Months	Baseline and 12 Months
Patients aged 13-17 years: Hypoglycemia Fear Survey II - Child (HFS-II-C) questionnaire Prazo: Baseline and 6 Months	Baseline and 6 Months
Patients aged 13-17 years: Hypoglycemia Fear Survey II - Child (HFS-II-C) questionnaire Prazo: Baseline and 12 Months	Baseline and 12 Months
Patients aged < 13 years: Hypoglycemia Fear Survey - Parents of Young Children II (HFS-PYC II) questionnaire Prazo: Baseline and 6 Months	Baseline and 6 Months
Patients aged < 13 years: Hypoglycemia Fear Survey - Parents of Young Children II (HFS-PYC II) questionnaire Prazo: Baseline and 12 Months	Baseline and 12 Months
Patients ≥ 13 years / Parents of Patients ≥ 2 years: System Usability Scale (SUS) questionnaire Prazo: Baseline and 6 Months	Baseline and 6 Months
Patients ≥ 13 years / Parents of Patients ≥ 2 years: System Usability Scale (SUS) questionnaire Prazo: 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) Prazo: at 12 Months	at 12 Months
Patients aged > 12 years and non-pregnant women: questionnaire on Liberty mode Prazo: at 12 Months	at 12 Months
Percentage of time in hybrid closed-loop (%) Prazo: at 6 Months	at 6 Months
Percentage of time in hybrid closed-loop (%) Prazo: at 12 Months	at 12 Months
Percentage of time using different system features (%) Prazo: at 6 Months	at 6 Months
Percentage of time using different system features (%) Prazo: at 12 Months	at 12 Months
Number of Safety / Adverse Events: Severe Hypoglycemia Prazo: At 6 Months	At 6 Months
Number of Safety / Adverse Events: Severe Hypoglycemia Prazo: At 12 Months	At 12 Months
Number of Safety / Adverse Events: Diabetic Ketoacidosis (DKA) Prazo: At 6 Months	At 6 Months
Number of Safety / Adverse Events: Diabetic Ketoacidosis (DKA) Prazo: At 12 Months	At 12 Months
Number of Safety / Adverse Events: Unplanned diabetes-related hospitalizations Prazo: At 6 Months	At 6 Months
Number of Safety / Adverse Events: Unplanned diabetes-related hospitalizations Prazo: At 12 Months	At 12 Months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

mylife Diabetes Care AG

Colaboradores

Abbott Diabetes Care, Inc - providing financial support for the study

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de outubro de 2026

Conclusão Primária (Estimado)

1 de abril de 2028

Conclusão do estudo (Estimado)

1 de abril de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

17 de setembro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ