Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07835685

Impact of the myLoop Powered by CamAPS FX System in Combination With FreeStyle Libre 3 / 3 Plus Sensors on T1D Patients 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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Diabetes Type 1 Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No Intervention: Observational Cohort

Other

Observational Cohort

Primary outcomes

  1. 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

Secondary outcomes

  1. Percentage of time in the 70 - 180 mg/dL range (TIR) at 6 months

    Time frame: Baseline and 6 months

  2. Percentage of time in the 70 - 140 mg/dL range (TITR) at 6 Months

    Time frame: Baseline and 6 Months

  3. Percentage of time in the 70 - 140 mg/dL range (TITR) at 12 Months

    Time frame: Baseline and 12 Months

  4. Percentage of time above 250 mg/dL (TAR > 250 mg/dL) at 6 Months

    Time frame: Baseline and 6 Months

  5. Percentage of time above 250 mg/dL (TAR > 250 mg/dL) at 12 Months

    Time frame: Baseline and 12 Months

  6. Percentage of time above 180 mg/dL (TAR > 180 mg/dL) at 6 Months

    Time frame: Baseline and 6 Months

  7. Percentage of time above 180 mg/dL (TAR > 180 mg/dL) at 12 Months

    Time frame: Baseline and 12 Months

  8. Percentage of time below 70 mg/dL (TBR < 70 mg/dL) at 6 Months

    Time frame: Baseline and 6 Months

  9. Percentage of time below 70 mg/dL (TBR < 70 mg/dL) at 12 Months

    Time frame: Baseline and 12 Months

  10. Percentage of time below 54 mg/dL (TBR < 54 mg/dL) at 6 Months

    Time frame: Baseline and 6 Months

  11. Percentage of time below 54 mg/dL (TBR < 54 mg/dL) at 12 Months

    Time frame: Baseline and 12 Months

  12. Mean glucose derived from CGM data (mg/dL)

    Time frame: Baseline and 6 Months

  13. Mean glucose derived from CGM data (mg/dL)

    Time frame: Baseline and 12 Months

  14. Glucose standard deviation (SD) derived from CGM data (mg/dL)

    Time frame: Baseline and 6 Months

  15. Glucose standard deviation (SD) derived from CGM data (mg/dL)

    Time frame: Baseline and 12 Months

  16. Glucose coefficient of variation (CV) derived from CGM data

    Time frame: Baseline and 6 Months

  17. Glucose coefficient of variation (CV) derived from CGM data

    Time frame: Baseline and 12 Months

  18. Glucose Management Indicator (GMI) derived from CGM data

    Time frame: Baseline and 6 Months

  19. Glucose Management Indicator (GMI) derived from CGM data

    Time frame: Baseline and 12 Months

  20. Glucose Risk Index (GRI) derived from CGM data

    Time frame: Baseline and 6 Months

  21. Glucose Risk Index (GRI) derived from CGM data

    Time frame: Baseline and 12 Months

  22. Change in HbA1c levels (%)

    Time frame: Baseline and 6 Months

  23. Change in HbA1c levels (%)

    Time frame: Baseline and 12 Months

  24. Patients aged ≥ 18 years: Diabetes Quality of Life - Brief Clinical Inventory (DQL-BCI)

    Time frame: Baseline and 6 Months

  25. Patients aged ≥ 18 years: Diabetes Quality of Life - Brief Clinical Inventory (DQL-BCI)

    Time frame: Baseline and 12 Months

  26. Patients aged 13-17 years: Diabetes Quality of Life for Youth scale - Short Form (DQOLY-SF)

    Time frame: Baseline and 6 Months

  27. Patients aged 13-17 years: Diabetes Quality of Life for Youth scale - Short Form (DQOLY-SF)

    Time frame: Baseline and 12 Months

  28. Patients <13: Quality of Life questionnaire (animated emoji scale)

    Time frame: Baseline and 6 Months

  29. Patients <13: Quality of Life questionnaire (animated emoji scale)

    Time frame: Baseline and 12 Months

  30. Patients aged ≥ 18 years: Problem Areas In Diabetes (PAID)

    Time frame: Baseline and 6 Months

  31. Patients aged ≥ 18 years: Problem Areas In Diabetes (PAID)

    Time frame: Baseline and 12 Months

  32. Patients aged 13-17 years: Problem Areas In Diabetes-Teen (PAID-T)

    Time frame: Baseline and 6 Months

  33. Patients aged 13-17 years: Problem Areas In Diabetes-Teen (PAID-T)

    Time frame: Baseline and 12 Months

  34. Patients < 13: Parent-Problem Areas In Diabetes-Children (P-PAID-C)

    Time frame: Baseline and 6 Months

  35. Patients < 13: Parent-Problem Areas In Diabetes-Children (P-PAID-C)

    Time frame: Baseline and 12 Months

  36. Patients aged ≥ 18 years: Diabetes Treatment Satisfaction Questionnaire (DTSQs)

    Time frame: Baseline and 6 Months

  37. Patients aged ≥ 18 years: Diabetes Treatment Satisfaction Questionnaire (DTSQs)

    Time frame: Baseline and 12 Months

  38. Patients aged 13-17 years: Diabetes Treatment Satisfaction Questionnaire-Teen (DTSQs-T)

    Time frame: Baseline and 6 Months

  39. Patients aged 13-17 years: Diabetes Treatment Satisfaction Questionnaire-Teen (DTSQs-T)

    Time frame: Baseline and 12 Months

  40. Patients aged < 13 years: Diabetes Treatment Satisfaction Questionnaire-Parent (DTSQs-Parent)

    Time frame: Baseline and 6 Months

  41. Patients aged < 13 years: Diabetes Treatment Satisfaction Questionnaire-Parent (DTSQs-Parent)

    Time frame: Baseline and 12 Months

  42. Patients aged ≥ 13 years: Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Baseline and 6 Months

  43. Patients aged ≥ 13 years: Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Baseline and 12 Months

  44. Patients aged < 13 years: Children's Sleep Habits Questionnaire - Short-Form (SF-CSHQ)

    Time frame: Baseline and 6 Months

  45. Patients aged < 13 years: Children's Sleep Habits Questionnaire - Short-Form (SF-CSHQ)

    Time frame: Baseline and 12 Months

  46. Patients aged ≥ 18 years: INSPIRE questionnaire

    Time frame: Baseline and 6 Months

  47. Patients aged ≥ 18 years: INSPIRE questionnaire

    Time frame: Baseline and 12 Months

  48. Patients aged 13-17 years: INSPIRE Youth questionnaire

    Time frame: Baseline and 6 Months

  49. Patients aged 13-17 years: INSPIRE Youth questionnaire

    Time frame: Baseline and 12 Months

  50. Patients < 13 years: INSPIRE Parent questionnaire

    Time frame: Baseline and 6 Months

  51. Patients < 13 years: INSPIRE Parent questionnaire

    Time frame: Baseline and 12 Months

  52. Patients aged ≥ 18 years: Hypoglycemia Fear Survey II (HFS-II) questionnaire

    Time frame: Baseline and 6 Months

  53. Patients aged ≥ 18 years: Hypoglycemia Fear Survey II (HFS-II) questionnaire

    Time frame: Baseline and 12 Months

  54. Patients aged 13-17 years: Hypoglycemia Fear Survey II - Child (HFS-II-C) questionnaire

    Time frame: Baseline and 6 Months

  55. Patients aged 13-17 years: Hypoglycemia Fear Survey II - Child (HFS-II-C) questionnaire

    Time frame: Baseline and 12 Months

  56. Patients aged < 13 years: Hypoglycemia Fear Survey - Parents of Young Children II (HFS-PYC II) questionnaire

    Time frame: Baseline and 6 Months

  57. Patients aged < 13 years: Hypoglycemia Fear Survey - Parents of Young Children II (HFS-PYC II) questionnaire

    Time frame: Baseline and 12 Months

  58. Patients ≥ 13 years / Parents of Patients ≥ 2 years: System Usability Scale (SUS) questionnaire

    Time frame: Baseline and 6 Months

  59. Patients ≥ 13 years / Parents of Patients ≥ 2 years: System Usability Scale (SUS) questionnaire

    Time frame: Baseline and 12 Months

  60. 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

  61. Patients aged > 12 years and non-pregnant women: questionnaire on Liberty mode

    Time frame: at 12 Months

  62. Percentage of time in hybrid closed-loop (%)

    Time frame: at 6 Months

  63. Percentage of time in hybrid closed-loop (%)

    Time frame: at 12 Months

  64. Percentage of time using different system features (%)

    Time frame: at 6 Months

  65. Percentage of time using different system features (%)

    Time frame: at 12 Months

  66. Number of Safety / Adverse Events: Severe Hypoglycemia

    Time frame: At 6 Months

  67. Number of Safety / Adverse Events: Severe Hypoglycemia

    Time frame: At 12 Months

  68. Number of Safety / Adverse Events: Diabetic Ketoacidosis (DKA)

    Time frame: At 6 Months

  69. Number of Safety / Adverse Events: Diabetic Ketoacidosis (DKA)

    Time frame: At 12 Months

  70. Number of Safety / Adverse Events: Unplanned diabetes-related hospitalizations

    Time frame: At 6 Months

  71. Number of Safety / Adverse Events: Unplanned diabetes-related hospitalizations

    Time frame: At 12 Months

Interested in participating?

Not yet recruiting

Trial opening soon.

Get Notified

Sponsors and collaborators

Lead sponsor

mylife Diabetes Care AG

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 23, 2026
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.