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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

2026. szeptember 28. frissítette: 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.

A tanulmány áttekintése

Állapot

Még nincs toborzás

Körülmények

1-es típusú cukorbetegség

Beavatkozás / kezelés

Egyéb: No Intervention: Observational Cohort

Tanulmány típusa

Megfigyelő

Beiratkozás (Becsült)

220

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

2 év és régebbi (Gyermek, Felnőtt, Idősebb felnőtt)

Egészséges önkénteseket fogad

Nem

Tanulmányozható nemek

Összes

Mintavételi módszer

Nem valószínűségi minta

Tanulmányi populáció

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.

Leírás

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.

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

Megfigyelési modellek: COHORT
Időperspektívák: PROSPECTIVE

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő	Időkeret
Change from Baseline in the percentage of time in the 70 - 180 mg/dL range (TIR) at 12 Months Időkeret: Baseline and 12 Months	Baseline and 12 Months

Másodlagos eredményintézkedések

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

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

mylife Diabetes Care AG

Együttműködők

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

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Becsült)

2026. október 1.

Elsődleges befejezés (Becsült)

2028. április 1.

A tanulmány befejezése (Becsült)

2028. április 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2026. szeptember 17.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak