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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

2026년 9월 28일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

당뇨병 유형 1

개입 / 치료

다른: No Intervention: Observational Cohort

연구 유형

관찰

등록 (추정된)

220

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

2년 이상 (어린이, 성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

관찰 모델: COHORT
시간 관점: PROSPECTIVE

연구는 무엇을 측정합니까?

주요 결과 측정

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

2차 결과 측정

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

mylife Diabetes Care AG

협력자

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

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 10월 1일

기본 완료 (추정된)

2028년 4월 1일

연구 완료 (추정된)

2028년 4월 1일

연구 등록 날짜

최초 제출

2026년 9월 17일

QC 기준을 충족하는 최초 제출