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Not yet recruitingNCT07835685Updated Oct 1, 2026

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

An observational study in Diabetes Type 1, sponsored by mylife Diabetes Care AG. Not yet recruiting. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2026-10-01.

Sponsored by mylife Diabetes Care AG · Observational

Updated Oct 1, 2026Title changedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
220
Ages
2 Years and older
Sex
All
01

Study summary

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.
02

Conditions studied

  • Diabetes Type 1

Keywords

  • Type 1 Diabetes
  • Pancreas, Artificial
  • CGM Device
  • Insulin Infusion System
  • Hybrid Closed Loop
  • CamAPS FX
  • myLoop
  • YpsoPump insulin pump
  • Real-World prospective study
  • Glucose Metabolism Disorders
  • Autoimmune Diseases
  • Endocrine System Diseases
03

In context

Diabetes Mellitus, Type 1

3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.

This study's planned enrollment of 220 is above the median of 125 across 792 observational studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

mylife Diabetes Care AG is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
220 participants (estimated)
Patient registry
No

Interventions

  • OtherNo Intervention: Observational Cohort

    Observational Cohort

06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Apr 2028, 18 months later.

Of 50 industry-sponsored observational studies under Diabetes Mellitus, Type 1, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 42. This study's planned 18 months is below that.

Counting every sponsor, half of 299 studies reached it within 30 months; a quarter within 12 and three quarters within 69.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 17, 2026
First posted
Sep 23, 2026
StartEst.
Oct 2026
Primary completionEst.
Apr 2028
CompletionEst.
Apr 2028
Last update
Oct 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Title
ImpactGlycemic 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 on T1D Patients in France
Oct 1, 2026
Show all 1 update
  1. Oct 1, 2026
    Title ImpactGlycemic 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 on T1D Patients in France
    + 1 other change: responsible party

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07835685
Lead sponsor
mylife Diabetes Care AG
Collaborators
Abbott Diabetes Care, Inc - providing financial support for the study
Responsible party
Sponsor
First posted
Sep 23, 2026
Start date
Oct 2026 (estimated)
Primary completion
Apr 2028 (estimated)
Completion
Apr 2028 (estimated)
Last update
Oct 1, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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