Diabetes Type 1NCT07835685
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 of Diabetes Type 1, run by mylife Diabetes Care AG.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Diabetes Type 1
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Show all 14Show fewer
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
Read more
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.
- Conditions
- Diabetes Type 1
- Being tested
- No Intervention: Observational Cohort
- 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
- Medical subject headings
- Diabetes Mellitus, Type 1, Glucose Metabolism Disorders, Autoimmune Diseases, Endocrine System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
Observational Cohort
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the percentage of time in the 70 - 180 mg/dL range (TIR) at 12 Months
Measured: Baseline and 12 Months
Secondary outcomes (71)
Percentage of time in the 70 - 180 mg/dL range (TIR) at 6 months
Measured: Baseline and 6 months
Percentage of time in the 70 - 140 mg/dL range (TITR) at 6 Months
Measured: Baseline and 6 Months
Percentage of time in the 70 - 140 mg/dL range (TITR) at 12 Months
Measured: Baseline and 12 Months
Percentage of time above 250 mg/dL (TAR > 250 mg/dL) at 6 Months
Measured: Baseline and 6 Months
Percentage of time above 250 mg/dL (TAR > 250 mg/dL) at 12 Months
Measured: Baseline and 12 Months
Percentage of time above 180 mg/dL (TAR > 180 mg/dL) at 6 Months
Measured: Baseline and 6 Months
Percentage of time above 180 mg/dL (TAR > 180 mg/dL) at 12 Months
Measured: Baseline and 12 Months
Percentage of time below 70 mg/dL (TBR < 70 mg/dL) at 6 Months
Measured: Baseline and 6 Months
Percentage of time below 70 mg/dL (TBR < 70 mg/dL) at 12 Months
Measured: Baseline and 12 Months
Percentage of time below 54 mg/dL (TBR < 54 mg/dL) at 6 Months
Measured: Baseline and 6 Months
Percentage of time below 54 mg/dL (TBR < 54 mg/dL) at 12 Months
Measured: Baseline and 12 Months
Mean glucose derived from CGM data (mg/dL)
Measured: Baseline and 6 Months
Mean glucose derived from CGM data (mg/dL)
Measured: Baseline and 12 Months
Glucose standard deviation (SD) derived from CGM data (mg/dL)
Measured: Baseline and 6 Months
Glucose standard deviation (SD) derived from CGM data (mg/dL)
Measured: Baseline and 12 Months
Glucose coefficient of variation (CV) derived from CGM data
Measured: Baseline and 6 Months
Glucose coefficient of variation (CV) derived from CGM data
Measured: Baseline and 12 Months
Glucose Management Indicator (GMI) derived from CGM data
Measured: Baseline and 6 Months
Glucose Management Indicator (GMI) derived from CGM data
Measured: Baseline and 12 Months
Glucose Risk Index (GRI) derived from CGM data
Measured: Baseline and 6 Months
Glucose Risk Index (GRI) derived from CGM data
Measured: Baseline and 12 Months
Change in HbA1c levels (%)
Measured: Baseline and 6 Months
Change in HbA1c levels (%)
Measured: Baseline and 12 Months
Patients aged ≥ 18 years: Diabetes Quality of Life - Brief Clinical Inventory (DQL-BCI)
Measured: Baseline and 6 Months
Patients aged ≥ 18 years: Diabetes Quality of Life - Brief Clinical Inventory (DQL-BCI)
Measured: Baseline and 12 Months
Patients aged 13-17 years: Diabetes Quality of Life for Youth scale - Short Form (DQOLY-SF)
Measured: Baseline and 6 Months
Patients aged 13-17 years: Diabetes Quality of Life for Youth scale - Short Form (DQOLY-SF)
Measured: Baseline and 12 Months
Patients <13: Quality of Life questionnaire (animated emoji scale)
Measured: Baseline and 6 Months
Patients <13: Quality of Life questionnaire (animated emoji scale)
Measured: Baseline and 12 Months
Patients aged ≥ 18 years: Problem Areas In Diabetes (PAID)
Measured: Baseline and 6 Months
Patients aged ≥ 18 years: Problem Areas In Diabetes (PAID)
Measured: Baseline and 12 Months
Patients aged 13-17 years: Problem Areas In Diabetes-Teen (PAID-T)
Measured: Baseline and 6 Months
Patients aged 13-17 years: Problem Areas In Diabetes-Teen (PAID-T)
Measured: Baseline and 12 Months
Patients < 13: Parent-Problem Areas In Diabetes-Children (P-PAID-C)
Measured: Baseline and 6 Months
Patients < 13: Parent-Problem Areas In Diabetes-Children (P-PAID-C)
Measured: Baseline and 12 Months
Patients aged ≥ 18 years: Diabetes Treatment Satisfaction Questionnaire (DTSQs)
Measured: Baseline and 6 Months
Patients aged ≥ 18 years: Diabetes Treatment Satisfaction Questionnaire (DTSQs)
Measured: Baseline and 12 Months
Patients aged 13-17 years: Diabetes Treatment Satisfaction Questionnaire-Teen (DTSQs-T)
Measured: Baseline and 6 Months
Patients aged 13-17 years: Diabetes Treatment Satisfaction Questionnaire-Teen (DTSQs-T)
Measured: Baseline and 12 Months
Patients aged < 13 years: Diabetes Treatment Satisfaction Questionnaire-Parent (DTSQs-Parent)
Measured: Baseline and 6 Months
Patients aged < 13 years: Diabetes Treatment Satisfaction Questionnaire-Parent (DTSQs-Parent)
Measured: Baseline and 12 Months
Patients aged ≥ 13 years: Pittsburgh Sleep Quality Index (PSQI)
Measured: Baseline and 6 Months
Patients aged ≥ 13 years: Pittsburgh Sleep Quality Index (PSQI)
Measured: Baseline and 12 Months
Patients aged < 13 years: Children's Sleep Habits Questionnaire - Short-Form (SF-CSHQ)
Measured: Baseline and 6 Months
Patients aged < 13 years: Children's Sleep Habits Questionnaire - Short-Form (SF-CSHQ)
Measured: Baseline and 12 Months
Patients aged ≥ 18 years: INSPIRE questionnaire
Measured: Baseline and 6 Months
Patients aged ≥ 18 years: INSPIRE questionnaire
Measured: Baseline and 12 Months
Patients aged 13-17 years: INSPIRE Youth questionnaire
Measured: Baseline and 6 Months
Patients aged 13-17 years: INSPIRE Youth questionnaire
Measured: Baseline and 12 Months
Patients < 13 years: INSPIRE Parent questionnaire
Measured: Baseline and 6 Months
Patients < 13 years: INSPIRE Parent questionnaire
Measured: Baseline and 12 Months
Patients aged ≥ 18 years: Hypoglycemia Fear Survey II (HFS-II) questionnaire
Measured: Baseline and 6 Months
Patients aged ≥ 18 years: Hypoglycemia Fear Survey II (HFS-II) questionnaire
Measured: Baseline and 12 Months
Patients aged 13-17 years: Hypoglycemia Fear Survey II - Child (HFS-II-C) questionnaire
Measured: Baseline and 6 Months
Patients aged 13-17 years: Hypoglycemia Fear Survey II - Child (HFS-II-C) questionnaire
Measured: Baseline and 12 Months
Patients aged < 13 years: Hypoglycemia Fear Survey - Parents of Young Children II (HFS-PYC II) questionnaire
Measured: Baseline and 6 Months
Patients aged < 13 years: Hypoglycemia Fear Survey - Parents of Young Children II (HFS-PYC II) questionnaire
Measured: Baseline and 12 Months
Patients ≥ 13 years / Parents of Patients ≥ 2 years: System Usability Scale (SUS) questionnaire
Measured: Baseline and 6 Months
Patients ≥ 13 years / Parents of Patients ≥ 2 years: System Usability Scale (SUS) questionnaire
Measured: Baseline and 12 Months
Changes in quality of life, mental health, treatment satisfaction, diabetes burden and sleep quality: Patient Global Impression of Change (PGIC)
Measured: at 12 Months
Patients aged > 12 years and non-pregnant women: questionnaire on Liberty mode
Measured: at 12 Months
Percentage of time in hybrid closed-loop (%)
Measured: at 6 Months
Percentage of time in hybrid closed-loop (%)
Measured: at 12 Months
Percentage of time using different system features (%)
Measured: at 6 Months
Percentage of time using different system features (%)
Measured: at 12 Months
Number of Safety / Adverse Events: Severe Hypoglycemia
Measured: At 6 Months
Number of Safety / Adverse Events: Severe Hypoglycemia
Measured: At 12 Months
Number of Safety / Adverse Events: Diabetic Ketoacidosis (DKA)
Measured: At 6 Months
Number of Safety / Adverse Events: Diabetic Ketoacidosis (DKA)
Measured: At 12 Months
Number of Safety / Adverse Events: Unplanned diabetes-related hospitalizations
Measured: At 6 Months
Number of Safety / Adverse Events: Unplanned diabetes-related hospitalizations
Measured: At 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- mylife Diabetes Care AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Abbott Diabetes Care, Inc - providing financial support for the study
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07835685
- Sponsor's protocol ID
- CIV-FR-26-08-059499
- Other IDs
- 2026-A01226-45
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07835685
- Acronym / sponsor ID
- CIV-FR-26-08-059499
- Conditions
- Diabetes Type 1
- Keywords
- Type 1 Diabetes, Pancreas, Artificial, CGM Device, Insulin Infusion System, Hybrid Closed Loop, CamAPS FX, myLoop, YpsoPump insulin pump
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- mylife Diabetes Care AGIndustry (pharma, biotech, devices)
- Collaborators
- Abbott Diabetes Care, Inc - providing financial support for the study
- Study start
- Oct 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention: Observational CohortObservational Cohort | Other | – |
Primary outcome
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
71 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Type 1, run by mylife Diabetes Care AG.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.