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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 сентября 2026 г. обновлено: 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.

Обзор исследования

Статус

Еще не набирают

Условия

Диабет 1 типа

Вмешательство/лечение

Другой: No Intervention: Observational Cohort

Тип исследования

Наблюдательный

Регистрация (Оцененный)

220

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

2 года и старше (Ребенок, Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Метод выборки

Невероятностная выборка

Исследуемая популяция

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.

Описание

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.

Учебный план

В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Наблюдательные модели: COHORT
Временные перспективы: PROSPECTIVE

Что измеряет исследование?

Первичные показатели результатов

Мера результата	Временное ограничение
Change from Baseline in the percentage of time in the 70 - 180 mg/dL range (TIR) at 12 Months Временное ограничение: Baseline and 12 Months	Baseline and 12 Months

Вторичные показатели результатов

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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

mylife Diabetes Care AG

Соавторы

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

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Оцененный)

1 октября 2026 г.

Первичное завершение (Оцененный)

1 апреля 2028 г.

Завершение исследования (Оцененный)

1 апреля 2028 г.

Даты регистрации исследования

Первый отправленный

17 сентября 2026 г.

Впервые представлено, что соответствует критериям контроля качества