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
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
Status
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Typ studiów
Typ studiów
Zapisy (Szacowany)
Zapisy
Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
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
Jak projektuje się badanie?
Szczegóły projektu
- Modele obserwacyjne: COHORT
- Perspektywy czasowe: PROSPECTIVE
Co mierzy badanie?
Podstawowe miary wyniku
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
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
Sponsor
Sponsor
Współpracownicy
Współpracownicy
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Rozpoczęcie studiów
Zakończenie podstawowe (Szacowany)
Zakończenie podstawowe
Ukończenie studiów (Szacowany)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
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)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
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