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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 września 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

220

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

2 lata i starsze (Dziecko, Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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.

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Modele obserwacyjne: COHORT
  • Perspektywy czasowe: PROSPECTIVE

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Ramy czasowe
Change from Baseline in the percentage of time in the 70 - 180 mg/dL range (TIR) at 12 Months
Ramy czasowe: Baseline and 12 Months
Baseline and 12 Months

Miary wyników drugorzędnych

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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Współpracownicy

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 października 2026

Zakończenie podstawowe (Szacowany)

1 kwietnia 2028

Ukończenie studiów (Szacowany)

1 kwietnia 2028

Daty rejestracji na studia

Pierwszy przesłany

17 września 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

17 września 2026

Pierwszy wysłany (Rzeczywisty)

23 września 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

1 października 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

28 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • CIV-FR-26-08-059499
  • 2026-A01226-45 (Inny identyfikator: ANSM France)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .