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.
Study Type
OBSERVATIONAL
Enrollment
220
Observational Cohort
Change from Baseline in the percentage of time in the 70 - 180 mg/dL range (TIR) at 12 Months
Time frame: Baseline and 12 Months
Percentage of time in the 70 - 180 mg/dL range (TIR) at 6 months
Time frame: Baseline and 6 months
Percentage of time in the 70 - 140 mg/dL range (TITR) at 6 Months
Time frame: Baseline and 6 Months
Percentage of time in the 70 - 140 mg/dL range (TITR) at 12 Months
Time frame: Baseline and 12 Months
Percentage of time above 250 mg/dL (TAR > 250 mg/dL) at 6 Months
Time frame: Baseline and 6 Months
Percentage of time above 250 mg/dL (TAR > 250 mg/dL) at 12 Months
Time frame: Baseline and 12 Months
Percentage of time above 180 mg/dL (TAR > 180 mg/dL) at 6 Months
Time frame: Baseline and 6 Months
Percentage of time above 180 mg/dL (TAR > 180 mg/dL) at 12 Months
Time frame: Baseline and 12 Months
Percentage of time below 70 mg/dL (TBR < 70 mg/dL) at 6 Months
Time frame: Baseline and 6 Months
Percentage of time below 70 mg/dL (TBR < 70 mg/dL) at 12 Months
Time frame: Baseline and 12 Months
Percentage of time below 54 mg/dL (TBR < 54 mg/dL) at 6 Months
Time frame: Baseline and 6 Months
Percentage of time below 54 mg/dL (TBR < 54 mg/dL) at 12 Months
Time frame: Baseline and 12 Months
Mean glucose derived from CGM data (mg/dL)
Time frame: Baseline and 6 Months
Mean glucose derived from CGM data (mg/dL)
Time frame: Baseline and 12 Months
Glucose standard deviation (SD) derived from CGM data (mg/dL)
Time frame: Baseline and 6 Months
Glucose standard deviation (SD) derived from CGM data (mg/dL)
Time frame: Baseline and 12 Months
Glucose coefficient of variation (CV) derived from CGM data
Time frame: Baseline and 6 Months
Glucose coefficient of variation (CV) derived from CGM data
Time frame: Baseline and 12 Months
Glucose Management Indicator (GMI) derived from CGM data
Time frame: Baseline and 6 Months
Glucose Management Indicator (GMI) derived from CGM data
Time frame: Baseline and 12 Months
Glucose Risk Index (GRI) derived from CGM data
Time frame: Baseline and 6 Months
Glucose Risk Index (GRI) derived from CGM data
Time frame: Baseline and 12 Months
Change in HbA1c levels (%)
Time frame: Baseline and 6 Months
Change in HbA1c levels (%)
Time frame: Baseline and 12 Months
Patients aged ≥ 18 years: Diabetes Quality of Life - Brief Clinical Inventory (DQL-BCI)
Time frame: Baseline and 6 Months
Patients aged ≥ 18 years: Diabetes Quality of Life - Brief Clinical Inventory (DQL-BCI)
Time frame: Baseline and 12 Months
Patients aged 13-17 years: Diabetes Quality of Life for Youth scale - Short Form (DQOLY-SF)
Time frame: Baseline and 6 Months
Patients aged 13-17 years: Diabetes Quality of Life for Youth scale - Short Form (DQOLY-SF)
Time frame: Baseline and 12 Months
Patients <13: Quality of Life questionnaire (animated emoji scale)
Time frame: Baseline and 6 Months
Patients <13: Quality of Life questionnaire (animated emoji scale)
Time frame: Baseline and 12 Months
Patients aged ≥ 18 years: Problem Areas In Diabetes (PAID)
Time frame: Baseline and 6 Months
Patients aged ≥ 18 years: Problem Areas In Diabetes (PAID)
Time frame: Baseline and 12 Months
Patients aged 13-17 years: Problem Areas In Diabetes-Teen (PAID-T)
Time frame: Baseline and 6 Months
Patients aged 13-17 years: Problem Areas In Diabetes-Teen (PAID-T)
Time frame: Baseline and 12 Months
Patients < 13: Parent-Problem Areas In Diabetes-Children (P-PAID-C)
Time frame: Baseline and 6 Months
Patients < 13: Parent-Problem Areas In Diabetes-Children (P-PAID-C)
Time frame: Baseline and 12 Months
Patients aged ≥ 18 years: Diabetes Treatment Satisfaction Questionnaire (DTSQs)
Time frame: Baseline and 6 Months
Patients aged ≥ 18 years: Diabetes Treatment Satisfaction Questionnaire (DTSQs)
Time frame: Baseline and 12 Months
Patients aged 13-17 years: Diabetes Treatment Satisfaction Questionnaire-Teen (DTSQs-T)
Time frame: Baseline and 6 Months
Patients aged 13-17 years: Diabetes Treatment Satisfaction Questionnaire-Teen (DTSQs-T)
Time frame: Baseline and 12 Months
Patients aged < 13 years: Diabetes Treatment Satisfaction Questionnaire-Parent (DTSQs-Parent)
Time frame: Baseline and 6 Months
Patients aged < 13 years: Diabetes Treatment Satisfaction Questionnaire-Parent (DTSQs-Parent)
Time frame: Baseline and 12 Months
Patients aged ≥ 13 years: Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline and 6 Months
Patients aged ≥ 13 years: Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline and 12 Months
Patients aged < 13 years: Children's Sleep Habits Questionnaire - Short-Form (SF-CSHQ)
Time frame: Baseline and 6 Months
Patients aged < 13 years: Children's Sleep Habits Questionnaire - Short-Form (SF-CSHQ)
Time frame: Baseline and 12 Months
Patients aged ≥ 18 years: INSPIRE questionnaire
Time frame: Baseline and 6 Months
Patients aged ≥ 18 years: INSPIRE questionnaire
Time frame: Baseline and 12 Months
Patients aged 13-17 years: INSPIRE Youth questionnaire
Time frame: Baseline and 6 Months
Patients aged 13-17 years: INSPIRE Youth questionnaire
Time frame: Baseline and 12 Months
Patients < 13 years: INSPIRE Parent questionnaire
Time frame: Baseline and 6 Months
Patients < 13 years: INSPIRE Parent questionnaire
Time frame: Baseline and 12 Months
Patients aged ≥ 18 years: Hypoglycemia Fear Survey II (HFS-II) questionnaire
Time frame: Baseline and 6 Months
Patients aged ≥ 18 years: Hypoglycemia Fear Survey II (HFS-II) questionnaire
Time frame: Baseline and 12 Months
Patients aged 13-17 years: Hypoglycemia Fear Survey II - Child (HFS-II-C) questionnaire
Time frame: Baseline and 6 Months
Patients aged 13-17 years: Hypoglycemia Fear Survey II - Child (HFS-II-C) questionnaire
Time frame: Baseline and 12 Months
Patients aged < 13 years: Hypoglycemia Fear Survey - Parents of Young Children II (HFS-PYC II) questionnaire
Time frame: Baseline and 6 Months
Patients aged < 13 years: Hypoglycemia Fear Survey - Parents of Young Children II (HFS-PYC II) questionnaire
Time frame: Baseline and 12 Months
Patients ≥ 13 years / Parents of Patients ≥ 2 years: System Usability Scale (SUS) questionnaire
Time frame: Baseline and 6 Months
Patients ≥ 13 years / Parents of Patients ≥ 2 years: System Usability Scale (SUS) questionnaire
Time frame: Baseline and 12 Months
Changes in quality of life, mental health, treatment satisfaction, diabetes burden and sleep quality: Patient Global Impression of Change (PGIC)
Time frame: at 12 Months
Patients aged > 12 years and non-pregnant women: questionnaire on Liberty mode
Time frame: at 12 Months
Percentage of time in hybrid closed-loop (%)
Time frame: at 6 Months
Percentage of time in hybrid closed-loop (%)
Time frame: at 12 Months
Percentage of time using different system features (%)
Time frame: at 6 Months
Percentage of time using different system features (%)
Time frame: at 12 Months
Number of Safety / Adverse Events: Severe Hypoglycemia
Time frame: At 6 Months
Number of Safety / Adverse Events: Severe Hypoglycemia
Time frame: At 12 Months
Number of Safety / Adverse Events: Diabetic Ketoacidosis (DKA)
Time frame: At 6 Months
Number of Safety / Adverse Events: Diabetic Ketoacidosis (DKA)
Time frame: At 12 Months
Number of Safety / Adverse Events: Unplanned diabetes-related hospitalizations
Time frame: At 6 Months
Number of Safety / Adverse Events: Unplanned diabetes-related hospitalizations
Time frame: At 12 Months
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