NCT07835685尚未招募不适用
Impact of the myLoop Powered by CamAPS FX System in Combination With FreeStyle Libre 3 / 3 Plus Sensors on Glycemic Control and Quality of Life in Patients With T1D in France
mylife Diabetes Care AG0 个研究点目标入组 220 人开始时间: 2026年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 220
- 主要终点
- Change from Baseline in the percentage of time in the 70 - 180 mg/dL range (TIR) at 12 Months
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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.
结局指标
主要结局
Change from Baseline in the percentage of time in the 70 - 180 mg/dL range (TIR) at 12 Months
时间窗: Baseline and 12 Months
次要结局
- Change in HbA1c levels (%)(Baseline and 6 Months)
- Change in HbA1c levels (%)(Baseline and 12 Months)
- Number of Safety / Adverse Events: Severe Hypoglycemia(At 6 Months)
- Glucose Risk Index (GRI) derived from CGM data(Baseline and 12 Months)
- Percentage of time in the 70 - 180 mg/dL range (TIR) at 6 months(Baseline and 6 months)
- Percentage of time in the 70 - 140 mg/dL range (TITR) at 6 Months(Baseline and 6 Months)
- Percentage of time in the 70 - 140 mg/dL range (TITR) at 12 Months(Baseline and 12 Months)
- Percentage of time above 250 mg/dL (TAR > 250 mg/dL) at 6 Months(Baseline and 6 Months)
- Percentage of time above 250 mg/dL (TAR > 250 mg/dL) at 12 Months(Baseline and 12 Months)
- Percentage of time above 180 mg/dL (TAR > 180 mg/dL) at 6 Months(Baseline and 6 Months)
- Percentage of time above 180 mg/dL (TAR > 180 mg/dL) at 12 Months(Baseline and 12 Months)
- Percentage of time below 70 mg/dL (TBR < 70 mg/dL) at 6 Months(Baseline and 6 Months)
- Percentage of time below 70 mg/dL (TBR < 70 mg/dL) at 12 Months(Baseline and 12 Months)
- Percentage of time below 54 mg/dL (TBR < 54 mg/dL) at 6 Months(Baseline and 6 Months)
- Percentage of time below 54 mg/dL (TBR < 54 mg/dL) at 12 Months(Baseline and 12 Months)
- Mean glucose derived from CGM data (mg/dL)(Baseline and 6 Months)
- Mean glucose derived from CGM data (mg/dL)(Baseline and 12 Months)
- Glucose standard deviation (SD) derived from CGM data (mg/dL)(Baseline and 6 Months)
- Glucose standard deviation (SD) derived from CGM data (mg/dL)(Baseline and 12 Months)
- Glucose coefficient of variation (CV) derived from CGM data(Baseline and 6 Months)
- Glucose coefficient of variation (CV) derived from CGM data(Baseline and 12 Months)
- Glucose Management Indicator (GMI) derived from CGM data(Baseline and 6 Months)
- Glucose Management Indicator (GMI) derived from CGM data(Baseline and 12 Months)
- Glucose Risk Index (GRI) derived from CGM data(Baseline and 6 Months)
- Patients aged ≥ 18 years: Diabetes Quality of Life - Brief Clinical Inventory (DQL-BCI)(Baseline and 6 Months)
- Patients aged ≥ 18 years: Diabetes Quality of Life - Brief Clinical Inventory (DQL-BCI)(Baseline and 12 Months)
- Patients aged 13-17 years: Diabetes Quality of Life for Youth scale - Short Form (DQOLY-SF)(Baseline and 6 Months)
- Patients aged 13-17 years: Diabetes Quality of Life for Youth scale - Short Form (DQOLY-SF)(Baseline and 12 Months)
- Patients <13: Quality of Life questionnaire (animated emoji scale)(Baseline and 6 Months)
- Patients <13: Quality of Life questionnaire (animated emoji scale)(Baseline and 12 Months)
- Patients aged ≥ 18 years: Problem Areas In Diabetes (PAID)(Baseline and 6 Months)
- Patients aged ≥ 18 years: Problem Areas In Diabetes (PAID)(Baseline and 12 Months)
- Patients aged 13-17 years: Problem Areas In Diabetes-Teen (PAID-T)(Baseline and 6 Months)
- Patients aged 13-17 years: Problem Areas In Diabetes-Teen (PAID-T)(Baseline and 12 Months)
- Patients < 13: Parent-Problem Areas In Diabetes-Children (P-PAID-C)(Baseline and 6 Months)
- Patients < 13: Parent-Problem Areas In Diabetes-Children (P-PAID-C)(Baseline and 12 Months)
- Patients aged ≥ 18 years: Diabetes Treatment Satisfaction Questionnaire (DTSQs)(Baseline and 6 Months)
- Patients aged ≥ 18 years: Diabetes Treatment Satisfaction Questionnaire (DTSQs)(Baseline and 12 Months)
- Patients aged 13-17 years: Diabetes Treatment Satisfaction Questionnaire-Teen (DTSQs-T)(Baseline and 6 Months)
- Patients aged 13-17 years: Diabetes Treatment Satisfaction Questionnaire-Teen (DTSQs-T)(Baseline and 12 Months)
- Patients aged < 13 years: Diabetes Treatment Satisfaction Questionnaire-Parent (DTSQs-Parent)(Baseline and 6 Months)
- Patients aged < 13 years: Diabetes Treatment Satisfaction Questionnaire-Parent (DTSQs-Parent)(Baseline and 12 Months)
- Patients aged ≥ 13 years: Pittsburgh Sleep Quality Index (PSQI)(Baseline and 6 Months)
- Patients aged ≥ 13 years: Pittsburgh Sleep Quality Index (PSQI)(Baseline and 12 Months)
- Patients aged < 13 years: Children's Sleep Habits Questionnaire - Short-Form (SF-CSHQ)(Baseline and 6 Months)
- Patients aged < 13 years: Children's Sleep Habits Questionnaire - Short-Form (SF-CSHQ)(Baseline and 12 Months)
- Patients aged ≥ 18 years: INSPIRE questionnaire(Baseline and 6 Months)
- Patients aged ≥ 18 years: INSPIRE questionnaire(Baseline and 12 Months)
- Patients aged 13-17 years: INSPIRE Youth questionnaire(Baseline and 6 Months)
- Patients aged 13-17 years: INSPIRE Youth questionnaire(Baseline and 12 Months)
- Patients < 13 years: INSPIRE Parent questionnaire(Baseline and 6 Months)
- Patients < 13 years: INSPIRE Parent questionnaire(Baseline and 12 Months)
- Patients aged ≥ 18 years: Hypoglycemia Fear Survey II (HFS-II) questionnaire(Baseline and 6 Months)
- Patients aged ≥ 18 years: Hypoglycemia Fear Survey II (HFS-II) questionnaire(Baseline and 12 Months)
- Patients aged 13-17 years: Hypoglycemia Fear Survey II - Child (HFS-II-C) questionnaire(Baseline and 6 Months)
- Patients aged 13-17 years: Hypoglycemia Fear Survey II - Child (HFS-II-C) questionnaire(Baseline and 12 Months)
- Patients aged < 13 years: Hypoglycemia Fear Survey - Parents of Young Children II (HFS-PYC II) questionnaire(Baseline and 6 Months)
- Patients aged < 13 years: Hypoglycemia Fear Survey - Parents of Young Children II (HFS-PYC II) questionnaire(Baseline and 12 Months)
- Patients ≥ 13 years / Parents of Patients ≥ 2 years: System Usability Scale (SUS) questionnaire(Baseline and 6 Months)
- Patients ≥ 13 years / Parents of Patients ≥ 2 years: System Usability Scale (SUS) questionnaire(Baseline and 12 Months)
- Changes in quality of life, mental health, treatment satisfaction, diabetes burden and sleep quality: Patient Global Impression of Change (PGIC)(at 12 Months)
- Patients aged > 12 years and non-pregnant women: questionnaire on Liberty mode(at 12 Months)
- Percentage of time in hybrid closed-loop (%)(at 6 Months)
- Percentage of time in hybrid closed-loop (%)(at 12 Months)
- Percentage of time using different system features (%)(at 6 Months)
- Percentage of time using different system features (%)(at 12 Months)
- Number of Safety / Adverse Events: Severe Hypoglycemia(At 12 Months)
- Number of Safety / Adverse Events: Diabetic Ketoacidosis (DKA)(At 6 Months)
- Number of Safety / Adverse Events: Diabetic Ketoacidosis (DKA)(At 12 Months)
- Number of Safety / Adverse Events: Unplanned diabetes-related hospitalizations(At 6 Months)
- Number of Safety / Adverse Events: Unplanned diabetes-related hospitalizations(At 12 Months)
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