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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. September 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Diabetes Typ 1

Intervention / Behandlung

Sonstiges: No Intervention: Observational Cohort

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

220

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

2 Jahre und älter (Kind, Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Beobachtungsmodelle: COHORT
Zeitperspektiven: PROSPECTIVE

Was misst die Studie?

Primäre Ergebnismessungen

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

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

mylife Diabetes Care AG

Mitarbeiter

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Oktober 2026

Primärer Abschluss (Geschätzt)

1. April 2028

Studienabschluss (Geschätzt)

1. April 2028

Studienanmeldedaten

Zuerst eingereicht

17. September 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat